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Sample records for whiplash trial protocol

  1. A randomised clinical trial of a comprehensive exercise program for chronic whiplash: trial protocol

    Directory of Open Access Journals (Sweden)

    Latimer Jane

    2009-12-01

    Full Text Available Abstract Background Whiplash is the most common injury following a motor vehicle accident. Approximately 60% of people suffer persistent pain and disability six months post injury. Two forms of exercise; specific motor relearning exercises and graded activity, have been found to be effective treatments for this condition. Although the effect sizes for these exercise programs, individually, are modest, pilot data suggest much larger effects on pain and disability are achieved when these two treatments are combined. The aim of this study is to investigate the effectiveness and cost-effectiveness of this comprehensive exercise approach for chronic whiplash. Methods/Design A multicentre randomised controlled trial will be conducted. One hundred and seventy-six participants with chronic grade I to II whiplash will be recruited in Sydney and Brisbane, Australia. All participants will receive an educational booklet on whiplash and in addition, those randomised to the comprehensive exercise group (specific motor relearning and graded activity exercises will receive 20 progressive and individually-tailored, 1 hour exercise sessions over a 12 week period (specific motor relearning exercises: 8 sessions over 4 weeks; graded activity: 12 sessions over 8 weeks. The primary outcome to be assessed is pain intensity. Other outcomes of interest include disability, health-related quality of life and health service utilisation. Outcomes will be measured at baseline, 14 weeks, 6 months and 12 months by an assessor who is blinded to the group allocation of the subjects. Recruitment is due to commence in late 2009. Discussion The successful completion of this trial will provide evidence on the effectiveness and cost-effectiveness of a simple treatment for the management of chronic whiplash. Trial registration ACTRN12609000825257

  2. Trauma-focused cognitive behaviour therapy and exercise for chronic whiplash: protocol of a randomised, controlled trial.

    Science.gov (United States)

    Campbell, Letitia; Kenardy, Justin; Andersen, Tonny; McGregor, Leanne; Maujean, Annick; Sterling, Michele

    2015-10-01

    As a consequence of a road traffic crash, persistent pain and disability following whiplash injury are common and incur substantial personal and economic costs. Up to 50% of people who experience a whiplash injury will never fully recover and up to 30% will remain moderately to severely disabled by the condition. The reason as to why symptoms persist past the acute to sub-acute stage and become chronic is unclear, but likely results from complex interactions between structural injury, physical impairments, and psychological and psychosocial factors. Psychological responses related to the traumatic event itself are becoming an increasingly recognised factor in the whiplash condition. Despite this recognition, there is limited knowledge regarding the effectiveness of psychological interventions, either delivered alone or in combination with physiotherapy, in reducing the physical and pain-related psychological factors of chronic whiplash. Pilot study results have shown positive results for the use of trauma-focused cognitive behaviour therapy to treat psychological factors, pain and disability in individuals with chronic whiplash. The results have indicated that a combined approach could not only reduce psychological symptoms, but also pain and disability. The primary aim of this randomised, controlled trial is to investigate the effectiveness of combined trauma-focused cognitive behavioural therapy, delivered by a psychologist, and physiotherapy exercise to decrease pain and disability of individuals with chronic whiplash and post-traumatic stress disorder (PTSD). The trial also aims to investigate the effectiveness of the combined therapy in decreasing post-traumatic stress symptoms, anxiety and depression. A total of 108 participants with chronic whiplash-associated disorder (WAD) grade II of > 3 months and whiplash injury and will have immediate clinical applicability in Australia, Denmark and the wider international community. The study will also have

  3. Implementation of a guideline-based clinical pathway of care to improve health outcomes following whiplash injury (Whiplash ImPaCT: protocol of a randomised, controlled trial

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    Trudy Rebbeck

    2016-04-01

    Discussion: This research is significant as it will be the first study to address the heterogeneity of whiplash by implementing a clinical pathway of care that matches evidence-based interventions to projected risk of poor recovery. The results of this trial have the potential to change clinical practice for WAD, thereby maximising treatment effects, improving patient outcomes, reducing costs and maintaining the compulsory third party system.

  4. Protocol of a randomized controlled trial of the effectiveness of physician education and activation versus two rehabilitation programs for the treatment of Whiplash-associated Disorders: The University Health Network Whiplash Intervention Trial

    OpenAIRE

    C?t?, Pierre; Cassidy, J David; Carette, Simon; Boyle, Eleanor; Shearer, Heather M; Stupar, Maja; Ammendolia, Carlo; van der Velde, Gabrielle; Hayden, Jill A; Yang, Xiaoqing; van Tulder, Maurits; Frank, John W

    2008-01-01

    Abstract Background Whiplash injuries are an important public health problem that is associated with significant disability and high health care utilization. Recent cohort studies suggest that physician care may be the most effective treatment for patients with whiplash-associated disorders. However, these findings have not been tested in a randomized controlled trial. The purpose of this study is to determine which of physician care or two rehabilitation programs of care is most effective in...

  5. Protocol of a randomized controlled trial of the effectiveness of physician education and activation versus two rehabilitation programs for the treatment of Whiplash-associated Disorders: The University Health Network Whiplash Intervention Trial

    Directory of Open Access Journals (Sweden)

    Ammendolia Carlo

    2008-12-01

    Full Text Available Abstract Background Whiplash injuries are an important public health problem that is associated with significant disability and high health care utilization. Recent cohort studies suggest that physician care may be the most effective treatment for patients with whiplash-associated disorders. However, these findings have not been tested in a randomized controlled trial. The purpose of this study is to determine which of physician care or two rehabilitation programs of care is most effective in improving recovery of patients with recent whiplash associated disorders. Methods and Design We designed a pragmatic randomized clinical trial. A total of 444 participants (148 in each of three arms who reside in Southern Ontario, Canada will be recruited from a large insurer. We will include individuals who are 18 years of age or older and who are diagnosed with Grade I or II Whiplash-associated Disorders. Participants will be randomized to physician-based education and activation or one of two rehabilitation programs of care currently in use in Ontario. Our primary outcome, self-rated global recovery and all secondary outcomes (neck pain intensity, whiplash disability, health-related quality of life, depressive symptomatology and satisfaction with care will be measured at baseline by a trial coordinator and at 6 weeks, 3, 6, 9 and 12 months follow-up by an interviewer who is blind to the participants' baseline characteristics and treatment allocation. We will also collect information on general health status, other injuries, comorbidities, expectation of recovery, work status, pain coping, legal representation, and co-interventions. The primary intention-to-treat analysis will compare time to recovery between the three interventions. This trial will have 90% power at an alpha of 0.05 to detect a 20% difference in the rate of perceived recovery at one year. Secondary analyses will compare the health outcomes, rate of recurrence and the rate of adverse

  6. Protocol of a randomized controlled trial of the effectiveness of physician education and activation versus two rehabilitation programs for the treatment of Whiplash-associated Disorders: The University Health Network Whiplash Intervention Trial

    Science.gov (United States)

    Côté, Pierre; Cassidy, J David; Carette, Simon; Boyle, Eleanor; Shearer, Heather M; Stupar, Maja; Ammendolia, Carlo; van der Velde, Gabrielle; Hayden, Jill A; Yang, Xiaoqing; van Tulder, Maurits; Frank, John W

    2008-01-01

    Background Whiplash injuries are an important public health problem that is associated with significant disability and high health care utilization. Recent cohort studies suggest that physician care may be the most effective treatment for patients with whiplash-associated disorders. However, these findings have not been tested in a randomized controlled trial. The purpose of this study is to determine which of physician care or two rehabilitation programs of care is most effective in improving recovery of patients with recent whiplash associated disorders. Methods and Design We designed a pragmatic randomized clinical trial. A total of 444 participants (148 in each of three arms) who reside in Southern Ontario, Canada will be recruited from a large insurer. We will include individuals who are 18 years of age or older and who are diagnosed with Grade I or II Whiplash-associated Disorders. Participants will be randomized to physician-based education and activation or one of two rehabilitation programs of care currently in use in Ontario. Our primary outcome, self-rated global recovery and all secondary outcomes (neck pain intensity, whiplash disability, health-related quality of life, depressive symptomatology and satisfaction with care) will be measured at baseline by a trial coordinator and at 6 weeks, 3, 6, 9 and 12 months follow-up by an interviewer who is blind to the participants' baseline characteristics and treatment allocation. We will also collect information on general health status, other injuries, comorbidities, expectation of recovery, work status, pain coping, legal representation, and co-interventions. The primary intention-to-treat analysis will compare time to recovery between the three interventions. This trial will have 90% power at an alpha of 0.05 to detect a 20% difference in the rate of perceived recovery at one year. Secondary analyses will compare the health outcomes, rate of recurrence and the rate of adverse events between intervention

  7. Protocol for an economic evaluation alongside the University Health Network Whiplash Intervention Trial: cost-effectiveness of education and activation, a rehabilitation program, and the legislated standard of care for acute whiplash injury in Ontario

    Science.gov (United States)

    2011-01-01

    Background Whiplash injury affects 83% of persons in a traffic collision and leads to whiplash-associated disorders (WAD). A major challenge facing health care decision makers is identifying cost-effective interventions due to lack of economic evidence. Our objective is to compare the cost-effectiveness of: 1) physician-based education and activation, 2) a rehabilitation program developed by Aviva Canada (a group of property and casualty insurance providers), and 3) the legislated standard of care in the Canadian province of Ontario: the Pre-approved Framework Guideline for Whiplash developed by the Financial Services Commission of Ontario. Methods/Design The economic evaluation will use participant-level data from the University Health Network Whiplash Intervention Trial and will be conducted from the societal perspective over the trial's one-year follow-up. Resource use (costs) will include all health care goods and services, and benefits provided during the trial's 1-year follow-up. The primary health effect will be the quality-adjusted life year. We will identify the most cost-effective intervention using the incremental cost-effectiveness ratio and incremental net-benefit. Confidence ellipses and cost-effectiveness acceptability curves will represent uncertainty around these statistics, respectively. A budget impact analysis will assess the total annual impact of replacing the current legislated standard of care with each of the other interventions. An expected value of perfect information will determine the maximum research expenditure Canadian society should be willing to pay for, and inform priority setting in, research of WAD management. Discussion Results will provide health care decision makers with much needed economic evidence on common interventions for acute whiplash management. Trial Registration http://ClinicalTrials.gov identifier NCT00546806 [Trial registry date: October 18, 2007; Date first patient was randomized: February 27, 2008] PMID

  8. Protocol for an economic evaluation alongside the University Health Network Whiplash Intervention Trial: cost-effectiveness of education and activation, a rehabilitation program, and the legislated standard of care for acute whiplash injury in Ontario

    Directory of Open Access Journals (Sweden)

    van der Velde Gabrielle

    2011-07-01

    Full Text Available Abstract Background Whiplash injury affects 83% of persons in a traffic collision and leads to whiplash-associated disorders (WAD. A major challenge facing health care decision makers is identifying cost-effective interventions due to lack of economic evidence. Our objective is to compare the cost-effectiveness of: 1 physician-based education and activation, 2 a rehabilitation program developed by Aviva Canada (a group of property and casualty insurance providers, and 3 the legislated standard of care in the Canadian province of Ontario: the Pre-approved Framework Guideline for Whiplash developed by the Financial Services Commission of Ontario. Methods/Design The economic evaluation will use participant-level data from the University Health Network Whiplash Intervention Trial and will be conducted from the societal perspective over the trial's one-year follow-up. Resource use (costs will include all health care goods and services, and benefits provided during the trial's 1-year follow-up. The primary health effect will be the quality-adjusted life year. We will identify the most cost-effective intervention using the incremental cost-effectiveness ratio and incremental net-benefit. Confidence ellipses and cost-effectiveness acceptability curves will represent uncertainty around these statistics, respectively. A budget impact analysis will assess the total annual impact of replacing the current legislated standard of care with each of the other interventions. An expected value of perfect information will determine the maximum research expenditure Canadian society should be willing to pay for, and inform priority setting in, research of WAD management. Discussion Results will provide health care decision makers with much needed economic evidence on common interventions for acute whiplash management. Trial Registration http://ClinicalTrials.gov identifier NCT00546806 [Trial registry date: October 18, 2007; Date first patient was randomized: February

  9. Trauma-focused cognitive behaviour therapy and exercise for chronic whiplash: protocol of a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    Letitia Campbell

    2015-10-01

    Discussion: This study will provide a definitive evaluation of the effects of adding trauma-focused cognitive behaviour therapy to physiotherapy exercise for individuals with chronic WAD and PTSD. This study is likely to influence the clinical management of whiplash injury and will have immediate clinical applicability in Australia, Denmark and the wider international community. The study will also have implications for both health and insurance policy makers in their decision-making regarding treatment options and funding.

  10. Value-based cognitive-behavioural therapy for the prevention of chronic whiplash associated disorders: protocol of a randomized controlled trial.

    Science.gov (United States)

    Andersen, Tonny Elmose; Ravn, Sophie Lykkegaard; Roessler, Kirsten Kaya

    2015-09-01

    Whiplash injury is the most common traffic-related injury affecting thousands of people every year. Conservative treatments have not proven effective in preventing persistent symptoms and disability after whiplash injury. Early established maladaptive pain behaviours within the first weeks after the injury may explain part of the transition from acute to chronic whiplash associated disorder (WAD). Hence, early targeting of psychological risk factors such as pain catastrophizing, fear-avoidance-beliefs, depression, and symptoms of posttraumatic stress disorder (PTSD) may be important in preventing the development of chronic WAD. Some evidence exists that targeting fear-avoidance beliefs and PTSD with exposure strategies and value-based actions may prevent development of persistent disability after whiplash injury. Yet, the results have to be tested in a randomized controlled trial (RCT). The primary objective of the present study is to test whether a specifically tailored value-based cognitive-behavioural therapy program (V-CBT) is able to prevent the development of persistent disability, pain, and psychological distress if delivered within the first three months after a whiplash injury. The current study is a two-armed randomized controlled study with a crossover design. Group A is scheduled for V-CBT within one week of randomization and group B with a delayed onset 3 months after randomization. If the study detects significant effects of V-CBT as a preventive intervention, the study will provide new insights of preventive treatment for patients with WAD and thereby serve as an important step towards preventing the chronic condition. Current Controlled Trials Registration September 19, 2014: NCT02251028.

  11. StressModEx--Physiotherapist-led Stress Inoculation Training integrated with exercise for acute whiplash injury: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Ritchie, Carrie; Kenardy, Justin; Smeets, Rob; Sterling, Michele

    2015-07-01

    Whiplash associated disorders are the most common non-hospitalised injuries following a road traffic crash. Up to 50% of individuals who experience a whiplash injury will not fully recover and report ongoing pain and disability. Most recovery, if it occurs, takes place in the first 2-3 months post injury, indicating that treatment provided in the early stages is critical to long-term outcome. However, early management approaches for people with acute whiplash associated disorders are modestly effective. One reason may be that the treatments have been non-specific and have not targeted the processes shown to be associated with poor recovery, such as post-traumatic stress symptoms. Targeting and modulating these early stress responses in the early management of acute whiplash associated disorders may improve health outcomes. Early aggressive psychological interventions in the form of psychological debriefing may be detrimental to recovery and are now not recommended for management of early post-traumatic stress symptoms. In contrast, Stress Inoculation Training (SIT) is a cognitive behavioural approach that teaches various general problem-solving and coping strategies to manage stress-related anxiety (ie, relaxation training, cognitive restructuring and positive self-statements) and provides important information to injured individuals about the impact of stress on their physical and psychological wellbeing. While referral to a psychologist may be necessary in some cases where acute stress disorder or other more significant psychological reactions to stress are evident, in the case of acute whiplash injuries, it is neither feasible nor necessary for a psychologist to deliver the early stress modulation intervention to all injured individuals. The feasibility of using other specially trained health professionals to deliver psychological interventions has been explored in conditions such as chronic low back pain, chronic whiplash and cancer, but few trials have studied

  12. Dry needling and exercise for chronic whiplash - a randomised controlled trial

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    Souvlis Tina

    2009-12-01

    Full Text Available Abstract Background Chronic whiplash is a common and costly problem. Sensory hypersensitivity is a feature of chronic whiplash that is associated with poor responsiveness to physical treatments such as exercise. Modalities such as dry-needling have shown some capacity to modulate sensory hypersensitivity, suggesting that when combined with advice and exercise, such an approach may be more effective in the management of chronic whiplash. The primary aim of this project is to investigate the effectiveness of dry-needling, advice and exercise for chronic whiplash. Method/Design A double-blind randomised controlled trial will be conducted. 120 participants with chronic whiplash, grade II will be randomised to receive either 1 dry-needling, advice and exercise or 2 sham dry-needling, advice and exercise. All participants will receive an educational booklet on whiplash. Participants who are randomised to Group 1 will receive 6 treatments of combined dry-needling and exercise delivered in the first 3 weeks of the 6 week program, and 4 treatments of exercise only in the last 3 weeks of the program. Participants randomised to Group 2 will receive an identical protocol, except that a sham dry-needling technique will be used instead of dry-needling. The primary outcome measures are the Neck Disability Index (NDI and participants' perceived recovery. Outcomes will be measured at 6, 12, 24 and 52 weeks after randomization by an assessor who is blind to the group allocation of the participants. In parallel, an economic analysis will be conducted. Discussion This trial will utilise high quality trial methodologies in accordance with CONSORT guidelines. The successful completion of this trial will provide evidence of the effectiveness and cost-effectiveness of a combined treatment approach for the management of chronic whiplash. Trial registration ACTRN12609000470291

  13. Protocol for an economic evaluation alongside University Health Network Whiplash Intervention Trial: Cost-effectiveness of education and activation, a rehabilitation program, and the legislated standard of care for acute whiplash injury in Ontario

    NARCIS (Netherlands)

    van de Velde, G.; Cote, P.; Bayoumi, A.M.; Cassidy, J.D.; Boyle, E.; Shearer, H.M.; Stupar, M.; Jacobs, C.; Ammendolia, C.; Carette, S.; van Tulder, M.W.

    2011-01-01

    Background: Whiplash injury affects 83% of persons in a traffic collision and leads to whiplash-associated disorders (WAD). A major challenge facing health care decision makers is identifying cost-effective interventions due to lack of economic evidence. Our objective is to compare the

  14. Protocol for an economic evaluation alongside the University Health Network Whiplash Intervention Trial: cost-effectiveness of education and activation, a rehabilitation program, and the legislated standard of care for acute whiplash injury in Ontario

    OpenAIRE

    van der Velde Gabrielle; Côté Pierre; Bayoumi Ahmed M; Cassidy J David; Boyle Eleanor; Shearer Heather M; Stupar Maja; Jacobs Craig; Ammendolia Carlo; Carette Simon; van Tulder Maurits

    2011-01-01

    Abstract Background Whiplash injury affects 83% of persons in a traffic collision and leads to whiplash-associated disorders (WAD). A major challenge facing health care decision makers is identifying cost-effective interventions due to lack of economic evidence. Our objective is to compare the cost-effectiveness of: 1) physician-based education and activation, 2) a rehabilitation program developed by Aviva Canada (a group of property and casualty insurance providers), and 3) the legislated st...

  15. Acute Whiplash Injury Study (AWIS): a protocol for a cluster randomised pilot and feasibility trial of an Active Behavioural Physiotherapy Intervention in an insurance private setting

    Science.gov (United States)

    Wiangkham, Taweewat; Duda, Joan; Haque, M Sayeed; Price, Jonathan; Rushton, Alison

    2016-01-01

    Introduction Whiplash-associated disorder (WAD) causes substantial social and economic burden internationally. Up to 60% of patients with WAD progress to chronicity. Research therefore needs to focus on effective management in the acute stage to prevent the development of chronicity. Approximately 93% of patients are classified as WADII (neck complaint and musculoskeletal sign(s)), and in the UK, most are managed in the private sector. In our recent systematic review, a combination of active and behavioural physiotherapy was identified as potentially effective in the acute stage. An Active Behavioural Physiotherapy Intervention (ABPI) was developed through combining empirical (modified Delphi study) and theoretical (social cognitive theory focusing on self-efficacy) evidence. This pilot and feasibility trial has been designed to inform the design of an adequately powered definitive randomised controlled trial. Methods and analysis Two parallel phases. (1) An external pilot and feasibility cluster randomised double-blind (assessor and participants), parallel two-arm (ABPI vs standard physiotherapy) clinical trial to evaluate procedures and feasibility. Six UK private physiotherapy clinics will be recruited and cluster randomised by a computer-generated randomisation sequence. Sixty participants (30 each arm) will be assessed at recruitment (baseline) and at 3 months postbaseline. The planned primary outcome measure is the neck disability index. (2) An embedded exploratory qualitative study using semistructured indepth interviews (n=3–4 physiotherapists) and a focus group (n=6–8 patients) and entailing the recruitment of purposive samples will explore perceptions of the ABPI. Quantitative data will be analysed descriptively. Qualitative data will be coded and analysed deductively (identify themes) and inductively (identify additional themes). Ethics and dissemination This trial is approved by the University of Birmingham Ethics Committee (ERN_15-0542). Trial

  16. A three-group study, internet-based, face-to-face based and standard- management after acute whiplash associated disorders (WAD – choosing the most efficient and cost-effective treatment: study protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bring Annika

    2009-07-01

    contribute to the creation of a cost-effective behavioural medicine approach to management of acute Whiplash Associated Disorders. The results of this study will answer an important question; on what extent and how should these patients be treated at acute stage and how much does the best management cost. Trial registration number Current Controlled Trials ISRCTN61531337

  17. Managing Injuries of the Neck Trial (MINT): design of a randomised controlled trial of treatments for whiplash associated disorders

    Science.gov (United States)

    Lamb, Sarah E; Gates, Simon; Underwood, Martin R; Cooke, Matthew W; Ashby, Deborah; Szczepura, Ala; Williams, Mark A; Williamson, Esther M; Withers, Emma J; Mt Isa, Shahrul; Gumber, Anil

    2007-01-01

    Background A substantial proportion of patients with whiplash injuries develop chronic symptoms. However, the best treatment of acute injuries to prevent long-term problems is uncertain. A stepped care treatment pathway has been proposed, in which patients are given advice and education at their initial visit to the emergency department (ED), followed by review at three weeks and physiotherapy for those with persisting symptoms. MINT is a two-stage randomised controlled trial to evaluate two components of such a pathway: 1. use of The Whiplash Book versus usual advice when patients first attend the emergency department; 2. referral to physiotherapy versus reinforcement of advice for patients with continuing symptoms at three weeks. Methods Evaluation of the Whiplash Book versus usual advice uses a cluster randomised design in emergency departments of eight NHS Trusts. Eligible patients are identified by clinicians in participating emergency departments and are sent a study questionnaire within a week of their ED attendance. Three thousand participants will be included. Patients with persisting symptoms three weeks after their ED attendance are eligible to join an individually randomised study of physiotherapy versus reinforcement of the advice given in ED. Six hundred participants will be randomised. Follow-up is at 4, 8 and 12 months after their ED attendance. Primary outcome is the Neck Disability Index (NDI), and secondary outcomes include quality of life and time to return to work and normal activities. An economic evaluation is being carried out. Conclusion This paper describes the protocol and operational aspects of a complex intervention trial based in NHS emergency and physiotherapy departments, evaluating two components of a stepped-care approach to the treatment of whiplash injuries. The trial uses two randomisations, with the first stage being cluster randomised and the second individually randomised. PMID:17257408

  18. Melatonin for chronic whiplash syndrome with delayed melatonin onset randomised, placebo-controlled trial

    NARCIS (Netherlands)

    Wieringen, S. van; Jansen, T.; Smits, M.G.; Nagtegaal, J.E.; Coenen, A.M.L.

    2001-01-01

    Objective: To assess the influence of melatonin in patients with chronic whiplash syndrome and delayed melatonin onset. Design: Randomised, double-blind, placebo-controlled, parallel-group trial. One-week baseline was followed by a 4-week treatment period with either melatonin or placebo. In the

  19. Development and delivery of a physiotherapy intervention for the early management of whiplash injuries: the Managing Injuries of Neck Trial (MINT) Intervention.

    Science.gov (United States)

    Williamson, Esther; Williams, Mark; Hansen, Zara; Joseph, Stephen; Lamb, Sarah E

    2009-03-01

    This paper describes the development and implementation of a physiotherapy intervention for a large multicentred randomised controlled trial of the early management of whiplash injuries in a National Health Service setting. Participants were eligible if they were classified as having whiplash-associated disorder grades I to III and self-referred for treatment within 6 weeks of injury. The intervention development was informed through a variety of methods including the current evidence base, published guidelines, clinician opinion, a pilot study and expert opinion. The intervention was targeted at known, potentially modifiable risk factors for poor recovery, and utilised manual therapy, exercises and psychological strategies. The treatment was individually tailored, with a maximum of six treatments allowed within the trial protocol over an 8-week period. The intervention was delivered to 300 participants. The amount and types of treatments delivered are described.

  20. Managing Injuries of the Neck Trial (MINT): a randomised controlled trial of treatments for whiplash injuries.

    Science.gov (United States)

    Lamb, S E; Williams, M A; Williamson, E M; Gates, S; Withers, E J; Mt-Isa, S; Ashby, D; Castelnuovo, E; Underwood, M; Cooke, M W

    2012-01-01

    To examine the clinical effectiveness of a stepped care approach over a 12-month period after an acute whiplash injury; to estimate the costs and cost-effectiveness of each strategy including treatments and subsequent health-care costs; and to gain participants' perspective on experiencing whiplash injury, NHS treatment, and recovery within the context of the Managing Injuries of the Neck Trial (MINT). Two linked, pragmatic, randomised controlled trials. In Step 1, emergency departments (EDs) were cluster randomised to usual care advice (UCA) or The Whiplash Book advice (WBA)/active management advice. In Step 2, participants were individually randomised to either a single session of advice from a physiotherapist or a physiotherapy package of up to six sessions. An economic evaluation and qualitative study were run in parallel with the trial. Twelve NHS trusts in England comprising 15 EDs. People who attended EDs with an acute whiplash injury of whiplash-associated disorder grades I-III were eligible for Step 1. People who had attended EDs with whiplash injuries and had persistent symptoms 3 weeks after ED attendance were eligible for Step 2. In Step 1, the control intervention was UCA and the experimental intervention was a psycho-educational intervention (WBA/active management advice). In Step 2 the control treatment was reinforcement of the advice provided in Step 1 and the experimental intervention was a package of up to six physiotherapy treatments. The primary outcome was the Neck Disability Index (NDI), which measures severity and frequency of pain and symptoms, and a range of activities including self-care, driving, reading, sleeping and recreation. Secondary outcomes included the mental and physical health-related quality-of-life (HRQoL) subscales of the Short Form questionnaire-12 items (SF-12) and the number of work days lost. A total of 3851 patients were recruited to Step 1 of the trial. 1598 patients attending EDs were randomised to UCA, and 2253 were

  1. Pregabalin versus placebo in targeting pro-nociceptive mechanisms to prevent chronic pain after whiplash injury in at-risk individuals - a feasibility study for a randomised controlled trial.

    Science.gov (United States)

    Nikles, J; Keijzers, G; Mitchell, G; Schug, S; Ware, R; McLean, S A; Connelly, L; Gibson, S; Farrell, S F; Sterling, M

    2018-01-17

    Whiplash-associated disorders (WAD) are an enormous and costly burden to Australian society. Up to 50% of people who experience a whiplash injury will never fully recover. Whiplash is resistant to treatment and no early management approach has yet been shown to prevent chronic pain. The early presence of central sensitization is associated with poor recovery. Pregabalin's effects on central sensitization indicate the potential to prevent or modulate these processes after whiplash injury and to improve health outcomes, but this has not been investigated. This paper describes the protocol for a feasibility study for a randomised controlled trial of pregabalin plus evidence-based advice compared to placebo plus evidence-based advice for individuals with acute whiplash injury who are at risk of poor recovery. This double blind, placebo-controlled randomised feasibility study will examine the feasibility and potential effectiveness of pregabalin and evidence-based advice (intervention) compared to placebo and evidence-based advice (control) for individuals with acute whiplash injury at risk of poor recovery. Thirty participants (15 per group) aged 18-65 years with Grade II WAD, within 48 hours of injury and currently experiencing at least moderate pain (NRS: ≥ 5/10) will be recruited from Emergency Departments of public hospitals in Queensland, Australia. Pregabalin will be commenced at 75 mg bd and titrated up to 300 mg bd as tolerated for 4 weeks followed by 1 week of weaning. The feasibility of trial procedures will be tested, as well as the potential effect of the intervention on the outcomes. The primary outcome of neck pain intensity at 3 months from randomisation will be compared between the treatment groups using standard analysis of variance techniques. Feasibility and potential effectiveness data will inform an appropriately powered full trial, which if successful, will provide an effective and cost-effective intervention for a costly and treatment

  2. Neck collar, "act-as-usual" or active mobilization for whiplash injury? A randomized parallel-group trial

    DEFF Research Database (Denmark)

    Kongsted, Alice; Montvilas, Erisela Qerama; Kasch, Helge

    2007-01-01

    practitioners within 10 days after a whiplash injury and randomized to: 1) immobilization of the cervical spine in a rigid collar followed by active mobilization, 2) advice to "act-as-usual," or 3) an active mobilization program (Mechanical Diagnosis and Therapy). Follow-up was carried out after 3, 6, and 12......-extension trauma to the cervical spine. It is unclear whether this, in some cases disabling, condition can be prevented by early intervention. Active interventions have been recommended but have not been compared with information only. Methods. Participants were recruited from emergency units and general......Study Design. Randomized, parallel-group trial. Objective. To compare the effect of 3 early intervention strategies following whiplash injury. Summary of Background Data. Long-lasting pain and disability, known as chronic whiplash-associated disorder (WAD), may develop after a forced flexion...

  3. Neck collar, "act-as-usual" or active mobilization for whiplash injury? A randomized parallel-group trial

    DEFF Research Database (Denmark)

    Kongsted, Alice; Montvilas, Erisela Qerama; Kasch, Helge

    2007-01-01

    Study Design. Randomized, parallel-group trial. Objective. To compare the effect of 3 early intervention strategies following whiplash injury. Summary of Background Data. Long-lasting pain and disability, known as chronic whiplash-associated disorder (WAD), may develop after a forced flexion......-extension trauma to the cervical spine. It is unclear whether this, in some cases disabling, condition can be prevented by early intervention. Active interventions have been recommended but have not been compared with information only. Methods. Participants were recruited from emergency units and general...... practitioners within 10 days after a whiplash injury and randomized to: 1) immobilization of the cervical spine in a rigid collar followed by active mobilization, 2) advice to "act-as-usual," or 3) an active mobilization program (Mechanical Diagnosis and Therapy). Follow-up was carried out after 3, 6, and 12...

  4. Active intervention in patients with whiplash-associated disorders improves long-term prognosis: a randomized controlled clinical trial.

    Science.gov (United States)

    Rosenfeld, Mark; Seferiadis, Aris; Carlsson, Jane; Gunnarsson, Ronny

    2003-11-15

    Three-year follow-up of a prospective randomized trial in 97 patients exposed to whiplash trauma in motor vehicle collisions. To compare the long-term efficacy of active intervention with that of standard intervention and the effect of early versus delayed initiation of intervention. There is no strong evidence for many treatments for whiplash-associated disorders. Some studies provide weak evidence supporting active intervention. Patients were randomized to an intervention using frequent active cervical rotation complemented by assessment and treatment according to McKenzie's principles or to a standard intervention of initial rest, recommended soft collar, and gradual self-mobilization. To test the time factor, interventions were either made within 96 hours or delayed 14 days from collision. The effects of the two interventions and the time factor on pain intensity, cervical range of motion, and sick leave were analyzed at 6 months and 3 years. Cervical range of motion at 3 years was also compared with that in matched, unexposed individuals. Pain intensity and sick leave were significantly (P whiplash-associated disorders, active intervention is more effective in reducing pain intensity and sick leave, and in retaining/regaining total range of motion than a standard intervention. Active intervention can be carried out as home exercises initiated and supported by appropriately trained health professionals.

  5. Whiplash injuries.

    Science.gov (United States)

    Malanga, Gerard; Peter, Jason

    2005-10-01

    Whiplash injuries are very common and usually are associated with rear-end collisions. However, a whiplash injury can be caused by any event that results in hyperextension and flexion of the cervical spine. These injuries are of serious concern to all consumers due to escalating cost of diagnosis, treatment, insurance, and litigation. Most acute whiplash injury cases respond well to conservative treatments, which result in resolution of symptoms usually within weeks to a few months after the injury occurred. Chronic whiplash injuries often are harder to diagnose and treat and often result in poor outcomes. Current research shows that various structures in the cervical spine receive nociceptive innervation and potentially may be the cause of chronic pain symptoms. One potential pain generator showing promise is the facet or zygapophyseal joints. Various researchers have proven that these joints are injured during whiplash injuries and that diagnosis and temporary pain relief can be obtained with facet joint injections. The initial evaluation of any patient should follow an organized and stepwise approach, and more serious causes of neck pain must first be ruled out through the history, physical examination, and diagnostic testing. Treatment regimens should be evidence-based, focusing on treatments that have proven to be effective in treating acute and chronic whiplash injuries.

  6. The Effectiveness of Conservative Management for Acute Whiplash Associated Disorder (WAD II: A Systematic Review and Meta-Analysis of Randomised Controlled Trials.

    Directory of Open Access Journals (Sweden)

    Taweewat Wiangkham

    Full Text Available To evaluate the effectiveness of conservative management (except drug therapy for acute Whiplash Associated Disorder (WAD II.Systematic review and meta-analysis of Randomised Controlled Trials (RCTs using a pre-defined protocol. Two independent reviewers searched information sources, decided eligibility of studies, and assessed risk of bias (RoB of included trials. Data were extracted by one reviewer and checked by the other. A third reviewer mediated any disagreements throughout. Qualitative trial and RoB data were summarised descriptively. Quantitative syntheses were conducted across trials for comparable interventions, outcome measures and assessment points. Meta-analyses compared effect sizes with random effects, using STATA version 12.PEDro, Medline, Embase, AMED, CINAHL, PsycINFO, and Cochrane Library with manual searching in key journals, reference lists, British National Bibliography for Report Literature, Center for International Rehabilitation Research Information & Exchange, and National Technical Information Service were searched from inception to 15th April 2015. Active researchers in the field were contacted to determine relevant studies.RCTs evaluating acute (10 days interventions, there were no statistically significant differences in all outcome measures between interventions at any time.Conservative and active interventions may be useful for pain reduction in patients with acute WADII. Additionally, cervical horizontal mobility could be improved by conservative intervention. The employment of a behavioural intervention (e.g. act-as-usual, education and self-care including regularly exercise could have benefits for pain reduction and improvement in cervical movement in the coronal and horizontal planes. The evidence was evaluated as low/very low level according to the Grading of Recommendations Assessment, Development and Evaluation system.

  7. Are early MRI findings correlated with long-lasting symptoms following whiplash injury? A prospective trial with 1-year follow-up

    DEFF Research Database (Denmark)

    Kongsted, Alice; Sorensen, Joan; Andersen, Hans

    2008-01-01

    . Clinical follow-ups were performed after 3 and 12 months. Outcome parameters were neck pain, headache, neck disability and working ability. A total of 178 participants had a cervical MRI scan on average 13 days after the injury. Traumatic findings were observed in seven participants. Signs of disc......Neck pain is the cardinal symptom following whiplash injuries. The trauma mechanism could theoretically lead to both soft tissue and bone injury that could be visualised by means of MRI. From previous quite small trials it seems that MRI does not demonstrate significant tissue damage. Large...... prospectively followed cohorts are needed to identify possible clinically relevant MRI findings. The objective of this trial was to evaluate (1) the predictive value of cervical MRI after whiplash injuries and (2) the value of repeating MRI examinations after 3 months including sequences with flexion...

  8. Neck exercises, physical and cognitive behavioural-graded activity as a treatment for adult whiplash patients with chronic neck pain: Design of a randomised controlled trial

    DEFF Research Database (Denmark)

    Ris Hansen, Inge; Søgaard, Karen; Christensen, Robin Daniel Kjersgaard

    2011-01-01

    scale for pain bothersomeness (0-10), SF-36 Mental Component Summary (MCS), TAMPA scale of Kinesiophobia (17-68), Impact of Event Scale (0-45), EuroQol (0-1), craniocervical flexion test (22 mmHg - 30 mmHg), joint position error test and cervical range of movement. The SF36 scales are scored using norm......ABSTRACT: BACKGROUND: Many patients suffer from chronic neck pain following a whiplash injury. A combination of cognitive, behavioural therapy with physiotherapy interventions has been indicated to be effective in the management of patients with chronic whiplash-associated disorders. The objective...... is to present the design of a randomised controlled trial (RCT) aimed at evaluating the effectiveness of a combined individual physical and cognitive behavioural-graded activity program on self-reported general physical function, in addition to neck function, pain, disability and quality of life in patients...

  9. Whiplash and prevention.

    NARCIS (Netherlands)

    2008-01-01

    A whiplash is caused by a sudden and violent movement of the head in relation to the torso. Whiplash injury is a combination of pain in the neck, pain in the head, and other health complaints. Annually, an estimated 30,000 to 50,000 people in the Netherlands incur whiplash due to a traffic crash,

  10. Neck exercises, physical and cognitive behavioural-graded activity as a treatment for adult whiplash patients with chronic neck pain: Design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Hansen Inge

    2011-12-01

    Full Text Available Abstract Background Many patients suffer from chronic neck pain following a whiplash injury. A combination of cognitive, behavioural therapy with physiotherapy interventions has been indicated to be effective in the management of patients with chronic whiplash-associated disorders. The objective is to present the design of a randomised controlled trial (RCT aimed at evaluating the effectiveness of a combined individual physical and cognitive behavioural-graded activity program on self-reported general physical function, in addition to neck function, pain, disability and quality of life in patients with chronic neck pain following whiplash injury compared with a matched control group measured at baseline and 4 and 12 months after baseline. Methods/Design The design is a two-centre, RCT-study with a parallel group design. Included are whiplash patients with chronic neck pain for more than 6 months, recruited from physiotherapy clinics and an out-patient hospital department in Denmark. Patients will be randomised to either a pain management (control group or a combined pain management and training (interventiongroup. The control group will receive four educational sessions on pain management, whereas the intervention group will receive the same educational sessions on pain management plus 8 individual training sessions for 4 months, including guidance in specific neck exercises and an aerobic training programme. Patients and physiotherapists are aware of the allocation and the treatment, while outcome assessors and data analysts are blinded. The primary outcome measures will be Medical Outcomes Study Short Form 36 (SF36, Physical Component Summary (PCS. Secondary outcomes will be Global Perceived Effect (-5 to +5, Neck Disability Index (0-50, Patient Specific Functioning Scale (0-10, numeric rating scale for pain bothersomeness (0-10, SF-36 Mental Component Summary (MCS, TAMPA scale of Kinesiophobia (17-68, Impact of Event Scale (0-45, EuroQol (0

  11. Acute whiplash associated disorders (WAD

    Directory of Open Access Journals (Sweden)

    Kumar S

    2011-04-01

    Full Text Available Khushnum Pastakia, Saravana KumarInternational Centre for Allied Health Evidence, University of South Australia, Adelaide, SA, Australia Date of preparation: 27th January 2011Conflict of interest: None declaredBackground: Whiplash-associated disorder (WAD is the term given for the collection of symptoms affecting the neck that are triggered by an accident with an acceleration–deceleration mechanism such as a motor vehicle accident. The incidence of whiplash injury varies greatly between different parts of the world with significant monetary burden on the individual as well as the wider community.Objective: Which treatments are best for reducing pain and disability experience in acute WADs?Level of evidence: Clinical practice guidelines, systematic reviews, meta-analysis, randomized controlled trials.Search sources: PubMed, Cochrane Library, Medline, EMBASE, AUST health, AMED.Outcomes: From the patient perspective the main outcomes considered are pain and disability.Consumer summary: Whiplash-associated disorders include a range of symptoms related to the neck and head. They commonly occur after motor vehicle accidents or diving mishaps. There is good evidence to suggest that active exercise, acting as usual and combination therapy are the most effective treatment choices in an acute presentation.Keywords: whiplash, neckpain, pain levels, multimodel therapy

  12. Location of whiplash pain (image)

    Science.gov (United States)

    Whiplash is an injury to the soft tissues of the neck. Whiplash injury strains the muscles and ligaments of the ... neck for the first few days following a whiplash injury. The pain can also be felt in ...

  13. Chronic whiplash pain.

    Science.gov (United States)

    Seroussi, Richard; Singh, Virtaj; Fry, Adrielle

    2015-05-01

    Although most patients recover from acute whiplash injuries, those with chronic whiplash syndrome develop signs of central nervous system (CNS) amplification of pain and have a poor prognosis. In this context, specific pain generators from acute whiplash have been identified through clinical, biomechanical, and animal studies. This article gives a clinical perspective on current understanding of these pain generators, including the phenomenon of CNS sensitization. Copyright © 2015 Elsevier Inc. All rights reserved.

  14. SPIRIT 2013 Statement: defining standard protocol items for clinical trials.

    Science.gov (United States)

    Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krle A-Jerić, Karmela; Hrobjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Dore, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

    2015-12-01

    The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

  15. Whiplash Injuries: An Update

    Directory of Open Access Journals (Sweden)

    Robert W Teasell

    1998-01-01

    Full Text Available Whiplash injuries remain a significant public health problem throughout the developed industrialized world, with significant socioeconomic consequences. Studies looking at the natural history of whiplash injuries have suffered from problems of selection bias, retrospective reviewing and unclear outcomes. Etiology continues to be controversial, largely because of the misconception that all soft tissue injuries heal within six weeks. Recent studies have implicated the cervical facet joint as a cause of whiplash injury pain. A recent treatment study that successfully eliminated whiplash-associated facet joint pain demonstrated abnormal psychological profiles secondary to pain which normalized with successful pain elimination. The impact of compensation on recovery remains controversial, while the concept that mild traumatic brain injury occurs in the absence of loss of consciousness has been largely refuted. The Quebec Task Force on Whiplash-Associated Disorders recently published a report in which the scientific literature was exhaustively reviewed and has made recommendations regarding the prevention and treatment of whiplash and its associated disorders. The Quebec Task Force highlighted the paucity of good scientific evidence; however, they still provided consensus treatment guidelines, which have not been validated. There continues to be a need for further research.

  16. Whiplash – en usynlig lidelse

    DEFF Research Database (Denmark)

    Lauritzen, Jette

    2005-01-01

    A disease such as whiplash presents a large number of complex social problems. With the help of medical anthropology it is possible to look at whiplash as a multifaceted concept influenced by the social and cultural norms in Western society. In this way whiplash can be considered to be a socially...

  17. Whiplash Continues Its Challenge.

    Science.gov (United States)

    Jull, Gwendolen

    2016-10-01

    There have been many advances in the management of neck pain disorders, but a personal frustration as a clinician and researcher in the field is that the incidence of full recovery following a whiplash injury as a result of a motor vehicle crash has not increased and, subsequently, the rate of transition to chronic neck pain has not lessened. The commentaries in this special issue reflect the multifaceted nature of whiplash-associated disorders and the wide-ranging research in the field. While management of whiplash, especially the challenge of lessening the rate of transition to chronicity, has yet to be achieved, the picture is becoming clearer. This should give great confidence and some hope to individuals with whiplash-associated disorders who have long-term pain and functional disability that after the next decade of research and clinical development, the outcomes following whiplash are likely to be vastly improved. J Orthop Sports Phys Ther 2016;46(10):815-817. doi:10.2519/jospt.2016.0112.

  18. Late sequelae of whiplash injury with dissection of cervical arteries.

    Science.gov (United States)

    Hauser, Vital; Zangger, Peter; Winter, Yaroslav; Oertel, Wolfgang; Kesselring, Jürg

    2010-01-01

    The objective of our study was to estimate the incidence of posttraumatic dissections of cervical arteries in patients with whiplash injury acquired in a car accident. We performed a retrospective analysis of medical records of 500 patients with whiplash injury acquired in car accidents between 1996 and 2005 and searched for dissections of cervical arteries occurring within 12 months after injury. Eight cases of cervical arterial dissection occurred within 12 months following whiplash injury. In 7 cases (87.5%), the dissection was complicated by brain infarction. The incidence of posttraumatic dissections after whiplash injuries was much higher than the overall incidence of cervical arterial dissections in the general population (1.6 vs. 0.0041%). The risk of cerebrovascular events was still increased 4-12 months after whiplash injury (0.6 vs. 0.003075% in the general population). There is an increased risk of posttraumatic dissection and cerebrovascular events within 12 months after whiplash injury. Car accident is an important risk factor for arterial dissections. The victims of car accidents should be screened for arterial dissections. The results of this study should be more thoroughly investigated in a prospective trial of car accident victims as a risk factor for arterial dissections. Copyright © 2010 S. Karger AG, Basel.

  19. Persistent myalgia following whiplash.

    Science.gov (United States)

    Dommerholt, Jan

    2005-10-01

    Persistent myalgia following whiplash is commonly considered the result of poor psychosocial status, illness behavior, or failing coping skills. However, there is much evidence that persistent myalgia may be due to neurophysiologic mechanisms involving peripheral and central sensitization. Myofascial trigger points may play a crucial role in maintaining sensitization. Recent research suggests that the chemical environment of myofascial trigger points is an important factor. Several consequences are reviewed when central pain mechanisms and myofascial trigger points are included in the differential diagnosis and in the management of patients with persistent pain following whiplash.

  20. [Preliminary study on syndrome differentiation types and acupuncture for whiplash injuries].

    Science.gov (United States)

    Chen, Ye-meng; Li, Hui; Zheng, Xin; Zhang, Qun-ce; Wang, Tian-fang

    2011-04-01

    Whiplash injury is a relatively common injury of clinical acupuncture and moxibustion in the United States. The mechanism and clinical manifestation of whiplash injuries as well as its pathogenesis described in TCM were analyzed in this present article. The authors introduced the TCM syndrome differentiation of whiplash injuries and claimed that both the location and the stage of disease should be considered. For the different injury locations, the meridian musculature differentiation was applied to classify the whiplash injuries as Taiyang, Yangming, Shaoyang and Shaoyin Meridian syndromes. Considering the duration of the injury, qi stagnation and blood stasis types were classified in the acute stage and phlegm accumulation, insufficiency of the liver and kidney and qi and blood deficiencies types were classified during the chronic stage. An acupuncture protocol for whiplash injuries and typical cases were also introduced.

  1. Whiplash-Associated Disorders

    DEFF Research Database (Denmark)

    Ferrara, S. D.; Ananian, V.; Baccino, E.

    2016-01-01

    The manuscript presents the International Guidelines developed by the Working Group on Personal Injury and Damage under the patronage of the International Academy of Legal Medicine (IALM) regarding the Methods of Ascertainment of any suspected Whiplash-Associated Disorders (WAD). The document...

  2. Are altered smooth pursuit eye movements related to chronic pain and disability following whiplash injuries? A prospective trial with one-year follow-up.

    Science.gov (United States)

    Kongsted, Alice; Jørgensen, Lars Vincents; Leboeuf-Yde, Charlotte; Qerama, Erisela; Korsholm, Lars; Bendix, Tom

    2008-05-01

    To evaluate the ability of early smooth pursuit testing to predict chronic whiplash-associated disorders, and to study whether the presence of abnormal smooth pursuit eye movements at one-year follow-up is associated with symptoms at that time. Prospective cohort study with one-year follow-up. The study was carried out at a university research centre and participants were recruited from emergency units and general practitioners. In all, 262 participants were recruited within 10 days from a whiplash injury. Smooth pursuit eye movements were tested with electrooculography (EOG) an average of 12 days after a whiplash trauma and again after one year. Analyses of EOG recordings were computerized. Associations between test results both from baseline and one-year tests and self-reported neck pain, headache, neck disability and working ability one year after the car collision were determined. Results of early eye movement tests were not associated with the prognosis. Reduced smooth pursuit performance when tested in static cervical rotation at the one-year follow-up was significantly associated with higher neck pain intensity at that time (regression coefficient 0.8, 95% confidence interval (CI) 0.04-1.5), but the association was too weak for the test to discriminate between recovered participants and those with lasting symptoms. Although reduced smooth pursuit performance at one-year follow-up was associated with persistent neck pain, smooth pursuit eye movement tests are not useful as predictive or diagnostic tests in whiplash-associated disorders.

  3. Redactions in protocols for drug trials: what industry sponsors concealed.

    Science.gov (United States)

    Marquardsen, Mikkel; Ogden, Michelle; Gøtzsche, Peter C

    2018-04-01

    Objective To describe the redactions in contemporary protocols for industry-sponsored randomised drug trials with patient relevant outcomes and to evaluate whether there was a legitimate rationale for the redactions. Design Cohort study. Under the Freedom of Information Act, we requested access to trial protocols approved by a research ethics committee in Denmark from October 2012 to March 2013. We received 17 consecutive protocols, which had been redacted before we got them, and nine protocols without redactions. In five additional cases, the companies refused to let the committees give us access, and in three other cases, documents were missing. Participants Not applicable. Setting Not applicable. Main outcome measure Amount and nature of redactions in 22 predefined key protocol variables. Results The redactions were most widespread in those sections of the protocol where there is empirical evidence of substantial problems with the trustworthiness of published drug trials: data analysis, handling of missing data, detection and analysis of adverse events, definition of the outcomes, interim analyses and premature termination of the study, sponsor's access to incoming data while the study is running, ownership to the data and investigators' publication rights. The parts of the text that were redacted differed widely, both between companies and within the same company. Conclusions We could not identify any legitimate rationale for the redactions. The current mistrust in industry-sponsored drug trials can only change if the industry offers unconditional access to its trial protocols and other relevant documents and data.

  4. The effect of neck-specific exercise with, or without a behavioral approach, on pain, disability, and self-efficacy in chronic whiplash-associated disorders: a randomized clinical trial.

    Science.gov (United States)

    Ludvigsson, Maria L; Peterson, Gunnel; O'Leary, Shaun; Dedering, Åsa; Peolsson, Anneli

    2015-04-01

    The aim of this study was to compare the effect on self-rated pain, disability, and self-efficacy of 3 interventions for the management of chronic whiplash-associated disorders: physiotherapist-led neck-specific exercise (NSE), physiotherapist-led NSE with the addition of a behavioral approach, or Prescription of Physical Activity (PPA). A total of 216 volunteers with chronic whiplash-associated disorders participated in this randomized, assessor blinded, clinical trial of 3 exercise interventions. Self-rated pain/pain bothersomeness (Visual Analogue Scale), disability (Neck Disability Index), and self-efficacy (Self-Efficacy Scale) were evaluated at baseline and at 3 and 6 months. The proportion of patients reaching substantial reduction in pain bothersomness (at least 50% reduction) was more evident (Pexercise groups at both 3 and 6 months (PSelf-efficacy was only improved in the NSE group without a behavioral approach (P=0.02). However, there were no significant differences in any outcomes between the 2 physiotherapist-led NSE groups. NSE resulted in superior outcomes compared with PPA in this study, but the observed benefits of adding a behavioral approach to the implementation of exercise in this study were inconclusive.

  5. Temporomandibular disorders after whiplash injury

    DEFF Research Database (Denmark)

    Kasch, Helge; Hjorth, Tine; Svensson, Peter

    2002-01-01

    Aims: Whiplash injury to the neck, is often considered a significant risk factor for development of temporomandibular disorders (TMD), and has been proposed to produce internal derangements of the temporomandibular joint (TMJ). Few studies however have examined TMD-related pain in acute whiplash...... patients compared with a matched control group. The aim of the present study was to assess pain and sensorimotor function in the craniofacial region in an unselected group of patients sustaining a motor vehicle accident involving a rear collision. Methods: Prospectively, 19 acute whiplash patients exposed...... obtained at each visit. Results: One whiplash patient and I ankle-injury patient bad jaw pain at the first visit. Palpation scores of the TMJ and the summated palpation scores only tended to be higher in patients sustaining a whiplash injury than in ankle-injury controls at the first visit. However, MPQ...

  6. Driving skills after whiplash.

    Science.gov (United States)

    Gimse, R; Bjørgen, I A; Straume, A

    1997-09-01

    Previous studies have shown that some persons with longlasting problems after whiplash have changed eye movements. These changes have been related to disturbance of the posture control system. The question raised in the present study is whether such disturbances can influence daily life functions connected with balance, position and external movements, such as car driving. A group of 23 persons with disturbed eye movements due to whiplash injury, was tested in a driving simulator, together with a closely matched control group. The results revealed significant differences between the two groups with respect to response times to the traffic signs presented, identification of type of sign, as well as steering precision while the subjects' attention was directed to the process of identifying the signs. Alternative explanations such as driving experience, pain, medication or malingering are at least partly controlled for, but cannot completely be ruled out. A distorted posture control system leading to disturbance of eye movements seems to be the most likely primary causative factor, but these disturbances are most certainly complexly determined. Reduced attention capacity is considered to be a mediating secondary factor. Registration of eye movements may be a useful diagnostic tool to evaluate driving skill after whiplash.

  7. Does cervical kyphosis relate to symptoms following whiplash injury?

    DEFF Research Database (Denmark)

    Johansson, Mats Peter; Baann Liane, Martin Skogheim; Bendix, Tom

    2011-01-01

    is not significantly associated with chronic whiplash associated pain. Moreover, it is a clear clinical implication that pain should not be ascribed to a straight spine on MRI. We suggest that future trials on cervical posture focus upon the presence of kyphotic deformity rather than just on the absence of lordosis....

  8. Initial Assessment of Whiplash Patients

    Directory of Open Access Journals (Sweden)

    R Gunzburg

    2003-01-01

    Full Text Available The article looks at how for severe trauma, the outcome of treatment depends on the initial medical care. This has now also been accepted for whiplash associated disorders, underlining the importance of a proper initial assessment. Once major injury has been excluded and the diagnosis of whiplash associated disorder has been established, the initial treatment of whiplash in the emergency room can be started. The four key points to remember are described, including reassuring the patient about evolution, no soft collar, nonsteroidal anti-inflammatory drugs and early mobilisation.

  9. Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

    Science.gov (United States)

    Kasenda, Benjamin; Schandelmaier, Stefan; Sun, Xin; von Elm, Erik; You, John; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; Busse, Jason W; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Rosenthal, Rachel; Ebrahim, Shanil; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

    2014-07-16

    To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. Cohort of protocols of randomised controlled trial and subsequent full journal publications. Six research ethics committees in Switzerland, Germany, and Canada. 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials. © The DISCO study group 2014.

  10. Blockchain protocols in clinical trials: Transparency and traceability of consent

    Science.gov (United States)

    Benchoufi, Mehdi; Porcher, Raphael; Ravaud, Philippe

    2018-01-01

    Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security, transparency and could be

  11. Blockchain protocols in clinical trials: Transparency and traceability of consent.

    Science.gov (United States)

    Benchoufi, Mehdi; Porcher, Raphael; Ravaud, Philippe

    2017-01-01

    Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients' informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient's consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security, transparency and could be a

  12. Definition, klassifikation og epidemiologi ved whiplash

    DEFF Research Database (Denmark)

    Jensen, Troels Staehelin; Kasch, Helge; Bach, Flemming Winther

    2010-01-01

    A whiplash trauma is caused by an acceleration-deceleration force transferring its energy to the cervical spine. Whiplash-associated disorder (WAD) refers to the symptoms that develop after a whiplash injury. The prognosis is favorable with recovery in over 90% of the injured subjects...

  13. Influence of vestibular rehabilitation on neck pain and cervical range of motion among patients with whiplash-associated disorder: a randomized controlled trial.

    Science.gov (United States)

    Hansson, Eva Ekvall; Persson, Liselott; Malmström, Eva Maj

    2013-09-01

    To describe how vestibular rehabilitation influences pain and range of motion among patients with whiplash-associated disorder and dizziness, and to describe whether pain or range of motion correlated with balance performance or self-perceived dizziness handicap. A total of 29 patients, 20 women and 9 men, age range 22-76 years. Patients with whiplash-associated disorder and dizziness were randomized to either intervention (vestibular rehabilitation) or control. Neck pain intensity, cervical range of motion (CROM), balance and self-perceived dizziness handicap were measured at baseline, 6 weeks and 3 months. There were no differences in neck pain intensity or CROM between the 2 groups either at baseline, 6 weeks or 3 months (p = 0.10-0.89). At baseline, neck pain intensity correlated with CROM (-0.406) and self-perceived dizziness handicap (0.492). CROM correlated with self-perceived dizziness handicap and with 1 balance measure (-0.432). Neck pain intensity did not correlate with balance performance (-0.188-0.049). Neck pain intensity and CROM was not influenced by vestibular rehabilitation. Importantly, the programme did not appear to increase pain or decrease neck motion, as initially thought. Neck pain intensity and CROM correlated with self-perceived dizziness handicap. CROM also correlated with 1 balance measure.

  14. MRI in acute phase of whiplash injury

    Energy Technology Data Exchange (ETDEWEB)

    Fagerlund, M. [Dept. of Diagnostic Radiology, Univ. Hospital of Northern Sweden, Umeaa (Sweden); Bjoernebrink, J. [Dept. of Diagnostic Radiology, Univ. Hospital of Northern Sweden, Umeaa (Sweden); Pettersson, K. [Dept. of Orthopaedic Surgery, Univ. Hospital of Northern Sweden, Umeaa (Sweden); Hildingsson, C. [Dept. of Orthopaedic Surgery, Univ. Hospital of Northern Sweden, Umeaa (Sweden)

    1995-11-01

    A prospective MRI study of 39 whiplash patients was performed and the results were compared with the clinical findings within 15 days after trauma. The MRI parameters included disc bulging either with impingement on the anterior epidural space or with medullary compression, foraminal stenosis, dorsal ligament thickening, osteophyte extension and intramedullary or paravertebral soft tissue injury. All changes were graded visually on a four-point scale (no, some, moderate or extensive changes). After the MRI evaluation was made the clinical findings were analysed by two orthopaedic surgeons using a specially designed protocol. With MRI 29 patients (74 %) showed no or only slight changes, and were thus regarded as normal variations. Of these, 10 of 29 patients (34 %) had as the only symptom pain in the head or in the neck, 19 of 29 patients (66 %) showed neurological changes, either paresthesias, sensory deficits or weakness of upper extremities. In 10 (26 %) patients with moderate or extensive MRI changes, 3 of 10 (33 %) had only head or neck pain, or both, and 7 of 10 (66 %) had neurological changes. Use of MRI in whiplash injury is helpful, but it is not the first-choice radiological examination method. Despite neurological changes, the frequency of true traumatic lesions is low. There is no clear correlation between the patients` subjective symptoms or clinical signs and the findings with MRI. However, MRI can be used to find patients with disk herniation that can be treated surgically. (orig.)

  15. MRI in acute phase of whiplash injury

    International Nuclear Information System (INIS)

    Fagerlund, M.; Bjoernebrink, J.; Pettersson, K.; Hildingsson, C.

    1995-01-01

    A prospective MRI study of 39 whiplash patients was performed and the results were compared with the clinical findings within 15 days after trauma. The MRI parameters included disc bulging either with impingement on the anterior epidural space or with medullary compression, foraminal stenosis, dorsal ligament thickening, osteophyte extension and intramedullary or paravertebral soft tissue injury. All changes were graded visually on a four-point scale (no, some, moderate or extensive changes). After the MRI evaluation was made the clinical findings were analysed by two orthopaedic surgeons using a specially designed protocol. With MRI 29 patients (74 %) showed no or only slight changes, and were thus regarded as normal variations. Of these, 10 of 29 patients (34 %) had as the only symptom pain in the head or in the neck, 19 of 29 patients (66 %) showed neurological changes, either paresthesias, sensory deficits or weakness of upper extremities. In 10 (26 %) patients with moderate or extensive MRI changes, 3 of 10 (33 %) had only head or neck pain, or both, and 7 of 10 (66 %) had neurological changes. Use of MRI in whiplash injury is helpful, but it is not the first-choice radiological examination method. Despite neurological changes, the frequency of true traumatic lesions is low. There is no clear correlation between the patients' subjective symptoms or clinical signs and the findings with MRI. However, MRI can be used to find patients with disk herniation that can be treated surgically. (orig.)

  16. [Whiplash. Epidemiology, diagnosis and treatment].

    Science.gov (United States)

    Lønnberg, F

    2001-04-16

    Recent years have seen an increasing number of car occupants with neck complaints following a car collision and a declining number of persons involved in car crashes--a relationship that is not well understood. Presumably less than 5% will suffer from persistent, (long-lasting), disabling neck pain. Although mostly men are involved in motor vehicle accidents, an equal number of men and women seek emergency care, but it is mostly women, who have persistent (long-lasting) neck complaints after a car collision. In general, there is no documentation of specific injury to the brain or spinal cord from a simple whiplash (WAD 1-3). Whiplash-related neck pain is caused by a distortion of the cervical spine, and, as such, should be interpreted as a benign condition with a good prognosis. Whiplash should be considered a risk factor rather than a medical diagnosis. The association between cause (whiplash mechanism) and effect (symptoms) is poor. Persistent (long-lasting) health problems from a whiplash should be treated like other post-traumatic conditions, and need a bio-psycho-social approach.

  17. Gender, age and ethnicity influence on pain levels and analgesic use in the acute whiplash injury.

    Science.gov (United States)

    Koren, L; Peled, E; Trogan, R; Norman, D; Berkovich, Y; Israelit, S

    2015-06-01

    Initial pain level in the acute whiplash injury is the most consistent predictor of transformation to a chronic pain syndrome. The risk factors for those early pain levels were, to our knowledge, scarcely evaluate to this date. We set to evaluate whether gender, age or ethnicity comprise a risk factor for those initial pain levels. Further, gender, age and ethnicity have been shown to be bias factors in pain management. We investigated if gender, age or ethnicity are bias factor in pain management in the face of a standardized pain treatment protocol in the acute whiplash injury. We reviewed 2,538 patients with acute whiplash injury that were treated at our emergency department (ED). Gender, age and ethnicity were investigated as risk factors for elevated visual analog scale (VAS) scores. Those factors were also investigated as bias in pain medication administration in the face of a standardized analgesic protocol. Women had significantly higher VAS scores (p = 0.009). Age and ethnicity did not influence pain levels. There was no influence of gender or age on pain medication administration. The Jewish patients (the majority in Israel) were administered fewer pain medication (p whiplash injury. Age and ethnicity have less impact on those pain levels. A pain management protocol might reduce bias in pain management in the acute whiplash injury in the ED. The Jewish population tends to be less receptive to pain medication administration.

  18. Are altered smooth pursuit eye movements related to chronic pain and disability following whiplash injuries? A prospective trial with one-year follow-up

    DEFF Research Database (Denmark)

    Kongsted, Alice; Jørgensen, Lars Vincents; Leboeuf-Yde, Charlotte

    2008-01-01

    collision were determined. RESULTS: Results of early eye movement tests were not associated with the prognosis. Reduced smooth pursuit performance when tested in static cervical rotation at the one-year follow-up was significantly associated with higher neck pain intensity at that time (regression...... with electrooculography (EOG) an average of 12 days after a whiplash trauma and again after one year. Analyses of EOG recordings were computerized. Associations between test results both from baseline and one-year tests and self-reported neck pain, headache, neck disability and working ability one year after the car...... coefficient 0.8, 95% confidence interval (CI) 0.04-1.5), but the association was too weak for the test to discriminate between recovered participants and those with lasting symptoms. CONCLUSIONS: Although reduced smooth pursuit performance at one-year follow-up was associated with persistent neck pain, smooth...

  19. Is multimodal care effective for the management of patients with whiplash-associated disorders or neck pain and associated disorders? A systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration.

    Science.gov (United States)

    Sutton, Deborah A; Côté, Pierre; Wong, Jessica J; Varatharajan, Sharanya; Randhawa, Kristi A; Yu, Hainan; Southerst, Danielle; Shearer, Heather M; van der Velde, Gabrielle M; Nordin, Margareta C; Carroll, Linda J; Mior, Silvano A; Taylor-Vaisey, Anne L; Stupar, Maja

    2016-12-01

    Little is known about the effectiveness of multimodal care for individuals with whiplash-associated disorders (WAD) and neck pain and associated disorders (NAD). To update findings of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders and evaluate the effectiveness of multimodal care for the management of patients with WAD or NAD. Systematic review and best-evidence synthesis. We included randomized controlled trials (RCTs), cohort studies, and case-control studies. Self-rated recovery, functional recovery (eg, disability, return to activities, work, or school), pain intensity, health-related quality of life, psychological outcomes (eg, depression, fear), or adverse events. We systematically searched five electronic databases (MEDLINE, EMBASE, CINAHL, PsycINFO, and Cochrane Central Register of Controlled Trials) from 2000 to 2013. RCTs, cohort, and case-control studies meeting our selection criteria were eligible for critical appraisal. Random pairs of independent reviewers critically appraised eligible studies using the Scottish Intercollegiate Guidelines Network criteria. Scientifically admissible studies were summarized using evidence tables and synthesized following best-evidence synthesis principles. We retrieved 2,187 articles, and 23 articles were eligible for critical appraisal. Of those, 18 articles from 14 different RCTs were scientifically admissible. There were a total of 31 treatment arms, including 27 unique multimodal programs of care. Overall, the evidence suggests that multimodal care that includes manual therapy, education, and exercise may benefit patients with grades I and II WAD and NAD. General practitioner care that includes reassurance, advice to stay active, and resumption of regular activities may be an option for the early management of WAD grades I and II. Our synthesis suggests that patients receiving high-intensity health care tend to experience poorer outcomes than those who receive fewer

  20. A Combination of Gestalt Therapy, Rosen Body Work, and Cranio Sacral Therapy did not help in Chronic Whiplash-Associated Disorders (WAD - Results of a Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Søren Ventegodt

    2004-01-01

    Full Text Available The chronic state of whiplash-associated disorder (WAD might be understood as a somatization of existential pain. Intervention aimed to improve quality of life (QOL seemed to be a solution for such situations. The basic idea behind the intervention was holistic, restoring quality of life and relationship with self, in order to diminish tension in the locomotion system, especially the neck. A psychosomatic theory for WAD is proposed. Our treatment was a short 2-day course with teachings in philosophy of life, followed by 6 to 10 individual sessions in gestalt psychotherapy and body therapy (Rosen therapy and Cranio Sacral therapy, followed by a 1-day course approximately 2 months later, closing the intervention. Two independent institutions did the intervention and the assessments. In a randomized, clinically controlled setting, 87 chronic WAD patients were included with a median duration of 37 months from their whiplash accidents. One patient never started. Forty-three had the above intervention (female/male = 36/7, ages 22–49, median 37 years and another 43 were assigned to a nontreated control group (female/male = 35/8, ages 1848, median 38. Six had disability pension and 27 had pending medicolegal issues in each group. Effect variables were pain in neck, arm, and/or head; measures of quality of life and daily activities; as well as general physical or mental health. Wilcoxon test for between-groups comparisons with intention-to-treat analyses was conducted; the square curve paradigm testing for immediate improvements of health and quality of life was also used. The groups were comparable at baseline. From the intervention group, 11 dropped out during the intervention (4 of those later joined the follow-up investigation, 22 of the remaining 32 graduated the course, and 35 of the 43 controls did as well. Approximately 3 months later, we found no clinically relevant or significant increase in any effect measure. The above version of a quality

  1. Is exercise effective for the management of neck pain and associated disorders or whiplash-associated disorders? A systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration.

    Science.gov (United States)

    Southerst, Danielle; Nordin, Margareta C; Côté, Pierre; Shearer, Heather M; Varatharajan, Sharanya; Yu, Hainan; Wong, Jessica J; Sutton, Deborah A; Randhawa, Kristi A; van der Velde, Gabrielle M; Mior, Silvano A; Carroll, Linda J; Jacobs, Craig L; Taylor-Vaisey, Anne L

    2016-12-01

    In 2008, the Neck Pain Task Force (NPTF) recommended exercise for the management of neck pain and whiplash-associated disorders (WAD). However, no evidence was available on the effectiveness of exercise for Grade III neck pain or WAD. Moreover, limited evidence was available to contrast the effectiveness of various types of exercises. To update the findings of the NPTF on the effectiveness of exercise for the management of neck pain and WAD grades I to III. Systematic review and best evidence synthesis. Studies comparing the effectiveness of exercise to other conservative interventions or no intervention. Outcomes of interest included self-rated recovery, functional recovery, pain intensity, health-related quality of life, psychological outcomes, and/or adverse events. We searched eight electronic databases from 2000 to 2013. Eligible studies were critically appraised using the Scottish Intercollegiate Guidelines Network criteria. The results of scientifically admissible studies were synthesized following best-evidence synthesis principles. We retrieved 4,761 articles, and 21 randomized controlled trials (RCTs) were critically appraised. Ten RCTs were scientifically admissible: nine investigated neck pain and one addressed WAD. For the management of recent neck pain Grade I/II, unsupervised range-of-motion exercises, nonsteroidal anti-inflammatory drugs and acetaminophen, or manual therapy lead to similar outcomes. For recent neck pain Grade III, supervised graded strengthening is more effective than advice but leads to similar short-term outcomes as a cervical collar. For persistent neck pain and WAD Grade I/II, supervised qigong and combined strengthening, range-of-motion, and flexibility exercises are more effective than wait list. Additionally, supervised Iyengar yoga is more effective than home exercise. Finally, supervised high-dose strengthening is not superior to home exercises or advice. We found evidence that supervised qigong, Iyengar yoga, and combined

  2. Definition, klassifikation og epidemiologi ved whiplash

    DEFF Research Database (Denmark)

    Jensen, Troels Staehelin; Kasch, Helge; Bach, Flemming Winther

    2010-01-01

    A whiplash trauma is caused by an acceleration-deceleration force transferring its energy to the cervical spine. Whiplash-associated disorder (WAD) refers to the symptoms that develop after a whiplash injury. The prognosis is favorable with recovery in over 90% of the injured subjects. In a fract......A whiplash trauma is caused by an acceleration-deceleration force transferring its energy to the cervical spine. Whiplash-associated disorder (WAD) refers to the symptoms that develop after a whiplash injury. The prognosis is favorable with recovery in over 90% of the injured subjects....... In a fraction of patients, long-term symptoms with pain and cognitive and emotional symptoms may occur, causing long-term disability. The pathophysiology is unclear. Most research groups favor a multifactorial pathophysiology similar to that observed for other chronic pain conditions without a clear nociceptive...

  3. Behandling af gener efter whiplash

    DEFF Research Database (Denmark)

    Rittig-Rasmussen, Bjarne; Kongsted, Alice; Carstensen, Tina

    2010-01-01

    Treatment of whiplash-associated disorders starts with a thorough clinical examination, which may be repeated after 1-3 weeks. For optimal results it is essential that the patient receives clear information about the condition and that any pain is treated effectively with analgesics. Risk factors...

  4. Cost-effectiveness of neck-specific exercise with or without a behavioral approach versus physical activity prescription in the treatment of chronic whiplash-associated disorders: Analyses of a randomized clinical trial.

    Science.gov (United States)

    Landén Ludvigsson, Maria; Peolsson, Anneli; Peterson, Gunnel; Dedering, Åsa; Johansson, Gun; Bernfort, Lars

    2017-06-01

    Fifty percent of people injured by whiplash still report neck pain after 1 year and costs associated with whiplash associated disorders (WAD) are mostly attributed to health service and sick-leave costs in chronic conditions. With increasing health care expenditures the economic impact of interventions needs to be considered. To analyze the cost-effectiveness of physiotherapist-led neck-specific exercise without (NSE) or with a behavioral approach (NSEB), or prescription of physical activity (PPA) in chronic WAD, grade 2 to 3. This is a secondary cost-effectiveness analysis of a multicenter randomized clinical trial of 216 participants with chronic WAD grade 2 to 3. The interventions were physiotherapist-led neck-specific exercise without or with a behavioral approach, or prescription of physical activity for 12 weeks. Incremental cost-effectiveness ratios (ICERs) were determined after 1 year and bootstrapped cost-effectiveness planes and sensitivity analyses of physiotherapy visits were performed. Health care and production loss costs were included and quality-adjusted life years (QALYs) were estimated, using the Euroqol-5D questionnaire. Comparisons with the Short Form-6D, and neck disability index (NDI) were also made. The 1-year follow-up was completed by 170 participants (79%). Both physiotherapist-led groups improved in health related quality of life. The intervention cost alone, per quality-adjusted life year (QALY) gain in the NSE group was US$ 12,067. A trend for higher QALY gains were observed in the NSEB group but the costs were also higher. The ICERs varied depending on questionnaire used, but the addition of a behavioral approach to neck-specific exercise alone was not cost-effective from a societal perspective (ICER primary outcome $127,800 [95% confidence interval [CI], 37,816-711,302]). The sensitivity analyses confirmed the results. The prescription of physical activity did not result in any QALY gain and the societal costs were not lower. Neck

  5. Does cervical kyphosis relate to symptoms following whiplash injury?

    DEFF Research Database (Denmark)

    Johansson, Mats Peter; Baann Liane, Martin Skogheim; Bendix, Tom

    2011-01-01

    The mechanisms for developing long-lasting neck pain after whiplash injuries are still largely unrevealed. In the present study it was investigated whether a kyphotic deformity of the cervical spine, as opposed to a straight or a lordotic spine, was associated with the symptoms at baseline...... appearance of the cervical spine in supine MRI. In relation to symptoms it was seen that a kyphotic deformity was associated with reporting the highest intensities of headache at baseline, but not with an increased risk of long-lasting neck pain or headache. In conclusion, a kyphotic deformity...... is not significantly associated with chronic whiplash associated pain. Moreover, it is a clear clinical implication that pain should not be ascribed to a straight spine on MRI. We suggest that future trials on cervical posture focus upon the presence of kyphotic deformity rather than just on the absence of lordosis....

  6. What factors have influence on persistence of neck pain after a whiplash?

    Science.gov (United States)

    Cobo, Eulogio Pleguezuelos; Mesquida, M Engracia Pérez; Fanegas, Elisabet Palomera; Atanasio, Eva Moreno; Pastor, M Beatriz Samitier; Pont, Cristina Perucho; Prieto, Carlos Matarrubia; Gómez, Genoveva Reverón; Cano, Lluis Guirao

    2010-04-20

    Prospective longitudinal study. To identify prognosis factors that allow us to identify patients with risk of developing chronic symptoms and disabilities after a whiplash injury. The prognosis factors for poor recovery in acute whiplash are not conclusive. We included 557 patients who suffered whiplash injury after road traffic accident and visited the Department of Physical Medicine and Rehabilitation of Mataró Hospital (Spain) for medical evaluation and rehabilitation treatment. The variables were collected following a protocol designed for the study, and all patients were assessed through the Visual Analogue Scale (VAS) for the intensity of neck pain, the Goldberg Depression and Anxiety Scale and the Northwick Park Neck Pain Questionnaire (NPH) for cervical column functionality at initial evaluation and 6 months later. Factors related with VAS 6 months after the whiplash injury were women, age, number of days of cervical column immobilization, previous neck pain, self-employed workers, housewives, pensioners, students, presence of headache or dizziness, and VAS, Goldberg Depression and Anxiety scale, and NPH scores at initial evaluation. In multivaried analysis, it had been found that the variables that had influence on VAS 6 months after the whiplash injury were statistically significant for age, presence of dizziness, self-employed workers, and VAS and NPH scores at initial evaluation. Our findings indicate that factors that allow us to identify patients at risk for poor recovery are age, dizziness, and initial evaluation of neck pain with VAS and cervical column functionality with NPH.

  7. ECONOMIC ASPECTS OF "WHIPLASH" INJURY.

    Science.gov (United States)

    SNOW, G H

    1964-10-01

    The term "whiplash," used to describe a neck injury received in an automobile accident, has no foundation in medical science to support the complaints of persons suing for damages. The term is gaining unwarranted popularity as a term describing an injury, even though there are no clinical or pathological findings to support it."Whiplash" cases today account for an estimated 30 per cent of all injuries in automobile accidents. Direct compensation for damages paid to persons injured in automobile accidents in the United States in 1961 amounted to approximately one billion, seven hundred million dollars. It has been estimated that five hundred and eighty million dollars of that amount was paid in compensation on allegation of neck injuries.

  8. Whiplash and the compensation hypothesis.

    Science.gov (United States)

    Spearing, Natalie M; Connelly, Luke B

    2011-12-01

    Review article. To explain why the evidence that compensation-related factors lead to worse health outcomes is not compelling, either in general, or in the specific case of whiplash. There is a common view that compensation-related factors lead to worse health outcomes ("the compensation hypothesis"), despite the presence of important, and unresolved sources of bias. The empirical evidence on this question has ramifications for the design of compensation schemes. Using studies on whiplash, this article outlines the methodological problems that impede attempts to confirm or refute the compensation hypothesis. Compensation studies are prone to measurement bias, reverse causation bias, and selection bias. Errors in measurement are largely due to the latent nature of whiplash injuries and health itself, a lack of clarity over the unit of measurement (specific factors, or "compensation"), and a lack of appreciation for the heterogeneous qualities of compensation-related factors and schemes. There has been a failure to acknowledge and empirically address reverse causation bias, or the likelihood that poor health influences the decision to pursue compensation: it is unclear if compensation is a cause or a consequence of poor health, or both. Finally, unresolved selection bias (and hence, confounding) is evident in longitudinal studies and natural experiments. In both cases, between-group differences have not been addressed convincingly. The nature of the relationship between compensation-related factors and health is unclear. Current approaches to testing the compensation hypothesis are prone to several important sources of bias, which compromise the validity of their results. Methods that explicitly test the hypothesis and establish whether or not a causal relationship exists between compensation factors and prolonged whiplash symptoms are needed in future studies.

  9. PROPOSAL OF GUIDELINE FOR CLINICAL TRIAL PROTOCOLS WITH HERBAL DRUGS

    Directory of Open Access Journals (Sweden)

    Migdacelys Arboláez Estrada.

    2007-04-01

    Full Text Available SUMMARYCuba has extensive experience about herbal drugs, however only a few products get to the clinical phase of drug development. Our objective was to design new guidelines for clinical trials with herbal drugs.A detailed bibliographic search about regulatory aspects about clinical trials in Cuba and the world was done for development of the guideline. The guideline's proposed format includes: 1 Index, including the classification of the content. 2 Summary, 3 Fifteen chapters, related to the clinical trials. The guideline also propose the inclusion of annexes.A new guideline containing 15 chapters allows for writing more clear and detailed clinical trial protocols. The guideline contains the information required to guide the research staff who is interested in the validation of herbal drugs pharmacological activations from the perspective of clinical trials. RESUMEN Cuba tiene experiencia extensa sobre plantas medicinales, aunque solo algunos productos llegan a una fase clínica del desarrollo. Nuestro objetivo fué diseñar una nueva guía para ensayos clínicos con plantas medicinales.Hemos realizado una detallada búsqueda bibliográfica sobre aspectos reguladores de ensayos clínicos en Cuba y el resto del mundo para el desarrollo de la guía. El formato propuesto de la guia incluye: 1 Índice, incluyendo la clasificación de los contenidos. 2 Resumen, 3 Quince capítulos, relacionados con los ensayos clínicos. La guía también propone la inclusión de anexos.La nueva guía que contiene 15 capítulos que orientan la redacción de protocolos de ensayos clínicos más claros y más detallados. La guía contiene la información requerida para orientar al personal investigador interesado en la validación de la actividad farmacológica de las plantas medicinales desde la perspectiva de los ensayos clínicos.

  10. Bounding the per-protocol effect in randomized trials: An application to colorectal cancer screening

    NARCIS (Netherlands)

    S.A. Swanson (Sonja); Holme (Øyvind); M. Løberg (Magnus); M. Kalager (Mette); M. Bretthauer (Michael); G. Hoff (G.); E. Aas (Eline); M.A. Hernán (M.)

    2015-01-01

    textabstractBackground: The per-protocol effect is the effect that would have been observed in a randomized trial had everybody followed the protocol. Though obtaining a valid point estimate for the per-protocol effect requires assumptions that are unverifiable and often implausible, lower and upper

  11. A randomized trial of microdose leuprolide acetate protocol versus luteal phase ganirelix protocol in predicted poor responders.

    Science.gov (United States)

    DiLuigi, Andrea J; Engmann, Lawrence; Schmidt, David W; Benadiva, Claudio A; Nulsen, John C

    2011-06-30

    We performed a randomized trial to compare IVF outcomes in 54 poor responder patients undergoing a microdose leuprolide acetate (LA) protocol or a GnRH antagonist protocol incorporating a luteal phase E(2) patch and GnRH antagonist in the preceding menstrual cycle. Cancellation rates, number of oocytes retrieved, clinical pregnancy rates (PR), and ongoing PRs were similar between the two groups. Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  12. Redegørelse om whiplash

    DEFF Research Database (Denmark)

    Lønnberg, Frank

    Begrebet whiplash anvendes ofte som om, der er tale om en velafgrænset sygdomsenhed, hvilket ikke er tilfældet. Whiplash er medicinsk set ikke en lidelse eller en diagnose, men en potentiel skadesmekanisme/risikofaktor uden et specifikt symptombillede. Der er ingen sikker sammenhæng imellem...... påvirkning, vævslæsion og symptombillede. Psykologiske faktorer påvirker symptomer og sygdomsoplevelse efter whiplash, ligesom sociokulturelle faktorer har indflydelse på forekomsten af længerevarende symptomer. Relevant klinisk undersøgelse tidligt i forløbet anbefales, aktivering synes at have fordele frem...

  13. Prevention of abdominal wound infection (PROUD trial, DRKS00000390: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Heger Ulrike

    2011-11-01

    Full Text Available Abstract Background Wound infection affects a considerable portion of patients after abdominal operations, increasing health care costs and postoperative morbidity and affecting quality of life. Antibacterial coating has been suggested as an effective measure to decrease postoperative wound infections after laparotomies. The INLINE metaanalysis has recently shown the superiority of a slowly absorbable continuous suture for abdominal closure; with PDS plus® such a suture has now been made available with triclosan antibacterial coating. Methods/Design The PROUD trial is designed as a randomised, controlled, observer, surgeon and patient blinded multicenter superiority trial with two parallel groups and a primary endpoint of wound infection during 30 days after surgery. The intervention group will receive triclosan coated polydioxanone sutures, whereas the control group will receive the standard polydioxanone sutures; abdominal closure will otherwise be standardized in both groups. Statistical analysis is based on intention-to-treat population via binary logistic regression analysis, the total sample size of n = 750 is sufficient to ensure alpha = 5% and power = 80%, an interim analysis will be carried out after data of 375 patients are available. Discussion The PROUD trial will yield robust data to determine the effectiveness of antibacterial coating in one of the standard sutures for abdominal closure and potentially lead to amendment of current guidelines. The exploration of clinically objective parameters as well as quality of life holds immediate relevance for clinical management and the pragmatic trial design ensures high external validity. Trial Registration The trial protocol has been registered with the German Clinical Trials Register (DRKS00000390.

  14. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials.

    Science.gov (United States)

    Chan, An-Wen; Tetzlaff, Jennifer M; Gøtzsche, Peter C; Altman, Douglas G; Mann, Howard; Berlin, Jesse A; Dickersin, Kay; Hróbjartsson, Asbjørn; Schulz, Kenneth F; Parulekar, Wendy R; Krleza-Jeric, Karmela; Laupacis, Andreas; Moher, David

    2013-01-08

    High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.

  15. Testing the activitystat hypothesis: a randomised controlled trial protocol.

    Science.gov (United States)

    Gomersall, Sjaan; Maher, Carol; Norton, Kevin; Dollman, Jim; Tomkinson, Grant; Esterman, Adrian; English, Coralie; Lewis, Nicole; Olds, Tim

    2012-10-08

    The activitystat hypothesis proposes that when physical activity or energy expenditure is increased or decreased in one domain, there will be a compensatory change in another domain to maintain an overall, stable level of physical activity or energy expenditure. To date, there has been no experimental study primarily designed to test the activitystat hypothesis in adults. The aim of this trial is to determine the effect of two different imposed exercise loads on total daily energy expenditure and physical activity levels. This study will be a randomised, multi-arm, parallel controlled trial. Insufficiently active adults (as determined by the Active Australia survey) aged 18-60 years old will be recruited for this study (n=146). Participants must also satisfy the Sports Medicine Australia Pre-Exercise Screening System and must weigh less than 150 kg. Participants will be randomly assigned to one of three groups using a computer-generated allocation sequence. Participants in the Moderate exercise group will receive an additional 150 minutes of moderate to vigorous physical activity per week for six weeks, and those in the Extensive exercise group will receive an additional 300 minutes of moderate to vigorous physical activity per week for six weeks. Exercise targets will be accumulated through both group and individual exercise sessions monitored by heart rate telemetry. Control participants will not be given any instructions regarding lifestyle. The primary outcome measures are activity energy expenditure (doubly labeled water) and physical activity (accelerometry). Secondary measures will include resting metabolic rate via indirect calorimetry, use of time, maximal oxygen consumption and several anthropometric and physiological measures. Outcome measures will be conducted at baseline (zero weeks), mid- and end-intervention (three and six weeks) with three (12 weeks) and six month (24 week) follow-up. All assessors will be blinded to group allocation. This protocol

  16. Partner randomized controlled trial: study protocol and coaching intervention

    Directory of Open Access Journals (Sweden)

    Garbutt Jane M

    2012-04-01

    Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications

  17. Some observations on whiplash injuries.

    Science.gov (United States)

    Evans, R W

    1992-11-01

    Motor vehicle accidents with a whiplash mechanism of injury are one of the most common causes of neck injuries, with an incidence of perhaps 1 million per year in the United States. Proper adjustment of head restraints can reduce the incidence of neck pain in rear-end collisions by 24%. Persistent neck pain is more common in women by a ratio of 70:30. Whiplash injuries usually result in neck pain owing to myofascial trauma, which has been documented in both animal and human studies. Headaches, reported in 82% of patients acutely, are usually of the muscle contraction type, often associated with greater occipital neuralgia and less often temporomandibular joint syndrome. Occasionally migraine headaches can be precipitated. Dizziness often occurs and can result from vestibular, central, and cervical injury. More than one third of patients acutely complain of paresthesias, which frequently are caused by trigger points and thoracic outlet syndrome and less commonly by cervical radiculopathy. Some studies have indicated that a postconcussion syndrome can develop from a whiplash injury. Interscapular and low back pain are other frequent complaints. Although most patients recover within 3 months after the accident, persistent neck pain and headaches after 2 years are reported by more than 30% and 10% of patients. Risk factors for a less favorable recovery include older age, the presence of interscapular or upper back pain, occipital headache, multiple symptoms or paresthesias at presentation, reduced range of movement of the cervical spine, the presence of an objective neurologic deficit, preexisting degenerative osteoarthritic changes; and the upper middle occupational category. There is only a minimal association of a poor prognosis with the speed or severity of the collision and the extent of vehicle damage. Whiplash injuries result in long-term disability with upward of 6% of patients not returning to work after 1 year. Although litigation is very common and always

  18. Patient-reported outcome (PRO assessment in clinical trials: a systematic review of guidance for trial protocol writers.

    Directory of Open Access Journals (Sweden)

    Melanie Calvert

    Full Text Available Evidence suggests there are inconsistencies in patient-reported outcome (PRO assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers.We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013 for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts. 162 unique PRO-specific protocol recommendations were extracted from included documents. A further 10 PRO recommendations were identified relating to supporting trial documentation. Only 5/162 (3% recommendations appeared in ≥50% of guidance documents reviewed, indicating a lack of consistency.PRO-specific protocol guidelines were difficult to access, lacked consistency and may be challenging to implement in practice. There is a need to develop easily accessible consensus-driven PRO protocol guidance. Guidance should be aimed at ensuring key PRO information is routinely included in

  19. Development of a manualized protocol of massage therapy for clinical trials in osteoarthritis

    Directory of Open Access Journals (Sweden)

    Ali Ather

    2012-10-01

    Full Text Available Abstract Background Clinical trial design of manual therapies may be especially challenging as techniques are often individualized and practitioner-dependent. This paper describes our methods in creating a standardized Swedish massage protocol tailored to subjects with osteoarthritis of the knee while respectful of the individualized nature of massage therapy, as well as implementation of this protocol in two randomized clinical trials. Methods The manualization process involved a collaborative process between methodologic and clinical experts, with the explicit goals of creating a reproducible semi-structured protocol for massage therapy, while allowing some latitude for therapists’ clinical judgment and maintaining consistency with a prior pilot study. Results The manualized protocol addressed identical specified body regions with distinct 30- and 60-min protocols, using standard Swedish strokes. Each protocol specifies the time allocated to each body region. The manualized 30- and 60-min protocols were implemented in a dual-site 24-week randomized dose-finding trial in patients with osteoarthritis of the knee, and is currently being implemented in a three-site 52-week efficacy trial of manualized Swedish massage therapy. In the dose-finding study, therapists adhered to the protocols and significant treatment effects were demonstrated. Conclusions The massage protocol was manualized, using standard techniques, and made flexible for individual practitioner and subject needs. The protocol has been applied in two randomized clinical trials. This manualized Swedish massage protocol has real-world utility and can be readily utilized both in the research and clinical settings. Trial registration Clinicaltrials.gov NCT00970008 (18 August 2009

  20. The Role of Exercise and Patient Education in the Noninvasive Management of Whiplash.

    Science.gov (United States)

    Rebbeck, Trudy

    2017-07-01

    Synopsis The majority of people with whiplash-associated disorder do not have neurological deficit or fracture and are therefore largely managed with nonsurgical interventions such as exercise, patient education, and behavioral-based interventions. To date, clinical guidelines, systematic reviews, and the results of high-quality randomized controlled trials recommend exercise and patient education as the primary interventions for people in both acute and chronic stages after injury. However, the relatively weak evidence and small effect sizes in individual trials have led authors of some systematic reviews to reach equivocal recommendations for either exercise or patient education, and led policy makers and funders to question whether the more expensive intervention (exercise) should be funded at all. Physical therapists, one of the most commonly consulted professionals treating individuals with whiplash-associated disorder, need to look beyond the evidence for insights as to what role patient education and exercise should play in the future management of whiplash. This clinical commentary therefore will review the evidence for exercise, patient education, and behavioral-based interventions for whiplash and provide clinical insight as to the future role that exercise and patient education should play in the management of this complex condition. Possible subgroups of patients who may best respond to exercise will be explored using stratification based on impairments, treatment response, and risk/prognostic factors. J Orthop Sports Phys Ther 2017;47(7):481-491. Epub 16 Jun 2017. doi:10.2519/jospt.2017.7138.

  1. Cervical vertigo and dizziness after whiplash injury.

    Science.gov (United States)

    Endo, Kenji; Ichimaru, Katsuji; Komagata, Mashashi; Yamamoto, Kengo

    2006-06-01

    Whiplash injury is not only limited to neck injury but also brainstem injury that does not involve direct damage to the neck or head. The symptoms of whiplash injury are polymorphous, with the most common complaints being cervical pain, headache and scapulodynia. Vertigo and dizziness are also reported in 25-50% of the cases. In otoneurologic studies, magnetic resonance angiography (MRA) is used for the evaluation of vertebrobasilar hemodynamics in patients who complain of dizziness and vertigo. It is reported that vertebrobasilar artery insufficiency (VBI) leads to brainstem and cerebellar ischemia and infarction following cervical manipulation. Here we examined the correlation between vertigo or dizziness and the right and left side difference in vertebral arteries after whiplash injury using MRA. We studied 20 patients who complained of neck pain with vertigo or dizziness after whiplash injury and 13 healthy volunteers as a control. In the control group, abnormal MRA findings in the vertebral arteries such as occlusion, stenosis or slow blood flow were seen in 77% of the cases. In the patient group, abnormal MRA findings were seen in 60%. The side difference in blood flow was 3.5+/-2.5 cm/s in the control group and 6.1+/-3.0 cm/s in the patient group. Our findings suggest that some subjects with persistent vertigo or dizziness after whiplash injury are more likely to have VBI on MRA. VBI might be an important background factor to evoke cervical vertigo or dizziness after whiplash injury. The side difference between the two vertebral arteries could cause a circulation disorder in the vertebrobasilar system after whiplash injury. However, the VBI on MRA itself was also seen in the control group, and thus it is not clear whether it is due to whiplash injury in the patient group.

  2. Cervical vertigo and dizziness after whiplash injury

    OpenAIRE

    Endo, Kenji; Ichimaru, Katsuji; Komagata, Mashashi; Yamamoto, Kengo

    2006-01-01

    Whiplash injury is not only limited to neck injury but also brainstem injury that does not involve direct damage to the neck or head. The symptoms of whiplash injury are polymorphous, with the most common complaints being cervical pain, headache and scapulodynia. Vertigo and dizziness are also reported in 25–50% of the cases. In otoneurologic studies, magnetic resonance angiography (MRA) is used for the evaluation of vertebrobasilar hemodynamics in patients who complain of dizziness and verti...

  3. Reporting on blinding in trial protocols and corresponding publications was often inadequate but rarely contradictory

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Pildal, Julie; Chan, An-Wen

    2009-01-01

    OBJECTIVE: To compare the reporting on blinding in protocols and articles describing randomized controlled trials. STUDY DESIGN AND SETTING: We studied 73 protocols of trials approved by the scientific/ethical committees for Copenhagen and Frederiksberg, 1994 and 1995, and their corresponding...... publications. RESULTS: Three out of 73 trials (4%) reported blinding in the protocol that contradicted that in the publication (e.g., "open" vs. "double blind"). The proportion of "double-blind" trials with a clear description of the blinding of participants increased from 11 out of 58 (19%) when based...... on publications alone to 39 (67%) when adding the information in the protocol. The similar proportions for the blinding of health care providers were 2 (3%) and 22 (38%); and for the blinding of data collectors, they were 8 (14%) and 14 (24%). In 52 of 58 publications (90%), it was unclear whether all patients...

  4. Use of botulinum toxin-A for musculoskeletal pain in patients with whiplash associated disorders [ISRCTN68653575

    Directory of Open Access Journals (Sweden)

    Juan Francisco J

    2004-02-01

    Full Text Available Abstract Background Whiplash associated disorder is commonly linked to motor vehicle accidents and sports injuries. Cervical injury is attributed to rapid extension followed by neck flexion. The exact pathophysiology of whiplash is uncertain but probably involves some degree of aberrant muscle spasms and may produce a wide range of symptoms. The most commonly prescribed pharmacological agents for initial treatment of whiplash-associated pain are oral muscle relaxants and nonsteroidal anti-inflammatory drugs. However, potential systemic adverse effects limit these agents. Physical interventions such as mobilization, manipulation, and exercises have proved beneficial for pain and dysfunction but only on a time-limited basis. Little evidence suggests that physical therapy specifically aimed at the musculature (e.g., transcutaneous electrical nerve stimulation, ultrasonography, heat, ice, and acupuncture improves prognosis in acute whiplash associated disorder. A new approach to treatment is the use of botulinum toxin, which acts to reduce muscle spasms. Methods/design This is a prospective, randomized, controlled clinical trial and botulinum toxin-A (Botox® injections will be compared with placebo injections. The primary objective is to determine the efficacy of Botox® in the management of musculoskeletal pain in whiplash associated disorders. Discussion Botulinum toxin type-A toxin has been studied in small trials on whiplash associated disorder patients and has generally been found to relieve pain and improve range of motion. Specifically, we seek to assess the efficacy of Botox® in reducing pain and to improve the cervical spine range of movement, during the 6-month trial period.

  5. Evaluating Protocol Lifecycle Time Intervals in HIV/AIDS Clinical Trials

    Science.gov (United States)

    Schouten, Jeffrey T.; Dixon, Dennis; Varghese, Suresh; Cope, Marie T.; Marci, Joe; Kagan, Jonathan M.

    2014-01-01

    Background Identifying efficacious interventions for the prevention and treatment of human diseases depends on the efficient development and implementation of controlled clinical trials. Essential to reducing the time and burden of completing the clinical trial lifecycle is determining which aspects take the longest, delay other stages, and may lead to better resource utilization without diminishing scientific quality, safety, or the protection of human subjects. Purpose In this study we modeled time-to-event data to explore relationships between clinical trial protocol development and implementation times, as well as identify potential correlates of prolonged development and implementation. Methods We obtained time interval and participant accrual data from 111 interventional clinical trials initiated between 2006 and 2011 by NIH’s HIV/AIDS Clinical Trials Networks. We determined the time (in days) required to complete defined phases of clinical trial protocol development and implementation. Kaplan-Meier estimates were used to assess the rates at which protocols reached specified terminal events, stratified by study purpose (therapeutic, prevention) and phase group (pilot/phase I, phase II, and phase III/ IV). We also examined several potential correlates to prolonged development and implementation intervals. Results Even though phase grouping did not determine development or implementation times of either therapeutic or prevention studies, overall we observed wide variation in protocol development times. Moreover, we detected a trend toward phase III/IV therapeutic protocols exhibiting longer developmental (median 2 ½ years) and implementation times (>3years). We also found that protocols exceeding the median number of days for completing the development interval had significantly longer implementation. Limitations The use of a relatively small set of protocols may have limited our ability to detect differences across phase groupings. Some timing effects

  6. Economic and Health-Related Quality of Life Outcomes of Whiplash Associated Disorders.

    Science.gov (United States)

    Pink, Joshua; Petrou, Stavros; Williamson, Esther; Williams, Mark; Lamb, Sarah E

    2016-09-01

    This study examines the links between severity of whiplash associated disorder and costs and health outcomes. The study aims to estimate the economic costs and health-state utilities associated with disability levels and recovery trajectories after acute whiplash injury. Data used were from the Managing Injuries of the Neck Trial, which collected information on 3851 people over a 12-month period after acute whiplash injury. Effects of whiplash associated disorder severity on economic costs (measured from a societal perspective and separately from a health and personal social services perspective) were estimated using two-part regression models, comprising probability of incurring a cost and the total cost, given one was incurred. Effects on health-state utilities (measured using the EQ-5D and SF-6D) were estimated using ordinary least squares regression, and two-part models as for costs. There was a direct relationship between severity of disability after acute whiplash injury and economic costs. Between baseline and 4 months, average societal costs for those with no disability were £99.55 (UK£, 2009 prices), increasing to £668.53 for those with complete disability. Average societal costs for the whole sample were £234.15 over the first 4 months, decreasing to £127.51 between 8 and 12 months. Conversely, utility scores decreased with increased disability. The average EQ-5D utility score was 0.934 at 4 months for those with no disability, decreasing to 0.033 for those with complete disability. The average EQ-5D utility score for the whole sample increased from 0.587 immediately post-injury to 0.817 at 12 months. Relative costs and disutilities generated by the multivariate models are also presented by disability level and recovery trajectory. These results provide estimates of the costs and health-state utilities associated with disability levels and recovery trajectories after acute whiplash injury. They can be used to inform estimates of the cost

  7. What is the comparative effectiveness of current standard treatment, against an individually tailored behavioural programme delivered either on the Internet or face-to-face for people with acute whiplash associated disorder? A randomized controlled trial.

    Science.gov (United States)

    Bring, Annika; Åsenlöf, Pernilla; Söderlund, Anne

    2016-05-01

    To investigate the comparative effectiveness of current standard treatment, against an individually tailored behavioural programme delivered via the Internet or face-to-face for people with acute whiplash associated disorders. A multicentre, randomized, three-group design, with concealed allocation. A total of 55 participants (37 female), age 18-65, with acute Whiplash Associated Disorder (Grade I-II), recruited at two emergency clinics in Sweden. Before randomization all participants received standard self-care instructions. The Internet and face-to-face groups followed a seven-week behavioural programme involving individual tailoring, via email (Internet group), or in sessions at a physical therapy unit (face-to-face group). The control group only received the self-care instructions. Pain-related disability, pain intensity, self-efficacy in daily activities, catastrophizing and fear of movement/(re)injury. Assessments were performed at baseline (2-4 weeks postinjury) and at three, six and 12 months postintervention. Both the Internet (n = 16) and face-to-face (n = 14) group showed a larger decrease in pain-related disability than the control group (n = 16); -12 and -11, respectively, compared with -5 in the control group at 12-months follow-up. Significant differences between the groups in overall treatment effect were shown in all outcomes except pain intensity. All groups improved significantly over time in all outcomes, except for fear of movement/(re)injury and catastrophizing in the control group. An individually tailored behavioural programme improved biopsychosocial factors in patients with whiplash associated disorders up to 12 months after treatment. Internet-delivered intervention was as effective as clinic-based face-to-face therapy sessions. © The Author(s) 2015.

  8. Use of cervical collar after whiplash injuries.

    Science.gov (United States)

    Józefiak-Wójtowicz, Anna; Stolarczyk, Artur; Deszczyński, Jarosław Michał; Materek, Magdalena; Pietras, Marta; Bażant, Katarzyna

    2014-08-08

    Whiplash injuries, also known as neck sprains and strains, are currently some of the most common injuries of the cervical spine. Mechanism of injury is still controversial and current treatment methods do not provide satisfactory results. In this article we present QTF classification of related disorders, epidemiological data and treatment methods. We described basic principles of using a soft collar, goals and effects of collar use and potential complications ensuing from immobilization. Authors reviewed publications comparing the effects of collar use with other methods of treatment and physiotherapy following whiplash injury.

  9. Whiplash

    Science.gov (United States)

    ... cervical muscles, and nerve roots. Symptoms such as neck pain may be present directly after the injury or ... be delayed for several days. In addition to neck pain, other symptoms may include neck stiffness, injuries to ...

  10. From Protocols to Publications: A Study in Selective Reporting of Outcomes in Randomized Trials in Oncology

    Science.gov (United States)

    Raghav, Kanwal Pratap Singh; Mahajan, Sminil; Yao, James C.; Hobbs, Brian P.; Berry, Donald A.; Pentz, Rebecca D.; Tam, Alda; Hong, Waun K.; Ellis, Lee M.; Abbruzzese, James; Overman, Michael J.

    2015-01-01

    Purpose The decision by journals to append protocols to published reports of randomized trials was a landmark event in clinical trial reporting. However, limited information is available on how this initiative effected transparency and selective reporting of clinical trial data. Methods We analyzed 74 oncology-based randomized trials published in Journal of Clinical Oncology, the New England Journal of Medicine, and The Lancet in 2012. To ascertain integrity of reporting, we compared published reports with their respective appended protocols with regard to primary end points, nonprimary end points, unplanned end points, and unplanned analyses. Results A total of 86 primary end points were reported in 74 randomized trials; nine trials had greater than one primary end point. Nine trials (12.2%) had some discrepancy between their planned and published primary end points. A total of 579 nonprimary end points (median, seven per trial) were planned, of which 373 (64.4%; median, five per trial) were reported. A significant positive correlation was found between the number of planned and nonreported nonprimary end points (Spearman r = 0.66; P < .001). Twenty-eight studies (37.8%) reported a total of 65 unplanned end points; 52 (80.0%) of which were not identified as unplanned. Thirty-one (41.9%) and 19 (25.7%) of 74 trials reported a total of 52 unplanned analyses involving primary end points and 33 unplanned analyses involving nonprimary end points, respectively. Studies reported positive unplanned end points and unplanned analyses more frequently than negative outcomes in abstracts (unplanned end points odds ratio, 6.8; P = .002; unplanned analyses odd ratio, 8.4; P = .007). Conclusion Despite public and reviewer access to protocols, selective outcome reporting persists and is a major concern in the reporting of randomized clinical trials. To foster credible evidence-based medicine, additional initiatives are needed to minimize selective reporting. PMID:26304898

  11. From Protocols to Publications: A Study in Selective Reporting of Outcomes in Randomized Trials in Oncology.

    Science.gov (United States)

    Raghav, Kanwal Pratap Singh; Mahajan, Sminil; Yao, James C; Hobbs, Brian P; Berry, Donald A; Pentz, Rebecca D; Tam, Alda; Hong, Waun K; Ellis, Lee M; Abbruzzese, James; Overman, Michael J

    2015-11-01

    The decision by journals to append protocols to published reports of randomized trials was a landmark event in clinical trial reporting. However, limited information is available on how this initiative effected transparency and selective reporting of clinical trial data. We analyzed 74 oncology-based randomized trials published in Journal of Clinical Oncology, the New England Journal of Medicine, and The Lancet in 2012. To ascertain integrity of reporting, we compared published reports with their respective appended protocols with regard to primary end points, nonprimary end points, unplanned end points, and unplanned analyses. A total of 86 primary end points were reported in 74 randomized trials; nine trials had greater than one primary end point. Nine trials (12.2%) had some discrepancy between their planned and published primary end points. A total of 579 nonprimary end points (median, seven per trial) were planned, of which 373 (64.4%; median, five per trial) were reported. A significant positive correlation was found between the number of planned and nonreported nonprimary end points (Spearman r = 0.66; P medicine, additional initiatives are needed to minimize selective reporting. © 2015 by American Society of Clinical Oncology.

  12. Staying well after depression: trial design and protocol

    Directory of Open Access Journals (Sweden)

    Duggan Danielle S

    2010-03-01

    Full Text Available Abstract Background Depression is often a chronic relapsing condition, with relapse rates of 50-80% in those who have been depressed before. This is particularly problematic for those who become suicidal when depressed since habitual recurrence of suicidal thoughts increases likelihood of further acute suicidal episodes. Therefore the question how to prevent relapse is of particular urgency in this group. Methods/Design This trial compares Mindfulness-Based Cognitive Therapy (MBCT, a novel form of treatment combining mindfulness meditation and cognitive therapy for depression, with both Cognitive Psycho-Education (CPE, an equally plausible cognitive treatment but without meditation, and treatment as usual (TAU. It will test whether MBCT reduces the risk of relapse in recurrently depressed patients and the incidence of suicidal symptoms in those with a history of suicidality who do relapse. It recruits participants, screens them by telephone for main inclusion and exclusion criteria and, if they are eligible, invites them to a pre-treatment session to assess eligibility in more detail. This trial allocates eligible participants at random between MBCT and TAU, CPE and TAU, and TAU alone in a ratio of 2:2:1, stratified by presence of suicidal ideation or behaviour and current anti-depressant use. We aim to recruit sufficient participants to allow for retention of 300 following attrition. We deliver both active treatments in groups meeting for two hours every week for eight weeks. We shall estimate effects on rates of relapse and suicidal symptoms over 12 months following treatment and assess clinical status immediately after treatment, and three, six, nine and twelve months thereafter. Discussion This will be the first trial of MBCT to investigate whether MCBT is effective in preventing relapse to depression when compared with a control psychological treatment of equal plausibility; and to explore the use of MBCT for the most severe recurrent

  13. Whiplash and post-traumatic stress disorder

    NARCIS (Netherlands)

    Jaspers, JPC

    1998-01-01

    Purpose : This study examined the comorbidity of whiplash and post-traumatic stress disorder (PTSD) following motor vehicle accidents. A treatment strategy in cases with both disorders is proposed. Method: A review of the literature on psychological consequences of motor vehicle accidents and on

  14. [Whiplash lesions and temporomandibular joint disorders].

    Science.gov (United States)

    Gola, R; Richard, O; Guyot, L; Cheynet, F

    2004-11-01

    Attributing dysfunction of the temporomandibular joint (TMJ) to whiplash injury is a difficult problem to solve. TMJ disorders do not seem to be secondary to direct articular trauma but rather caused by a postural disorder of the cervical spine. Occlusal disorders and stress further complicate the picture. Four clinical cases illustrate a new hypothetical approach.

  15. Whiplash and post-traumatic stress disorder

    NARCIS (Netherlands)

    Jaspers, JPC

    Purpose : This study examined the comorbidity of whiplash and post-traumatic stress disorder (PTSD) following motor vehicle accidents. A treatment strategy in cases with both disorders is proposed. Method: A review of the literature on psychological consequences of motor vehicle accidents and on

  16. Which interventions are cost-effective for the management of whiplash-associated and neck pain-associated disorders? A systematic review of the health economic literature by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration.

    Science.gov (United States)

    van der Velde, Gabrielle; Yu, Hainan; Paulden, Mike; Côté, Pierre; Varatharajan, Sharanya; Shearer, Heather M; Wong, Jessica J; Randhawa, Kristi; Southerst, Danielle; Mior, Silvano; Sutton, Deborah; Jacobs, Craig; Taylor-Vaisey, Anne

    2016-12-01

    Whiplash-associated disorders (WAD) and neck pain and associated disorders (NAD) are prevalent conditions that impact society and impose a significant economic burden on health-care systems. Health economic evidence on WAD and NAD interventions has been sparse: only three economic evaluations of interventions for NAD were identified by the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders (NPTF). An updated overview is needed to inform health-care policy and guidelines. This study aimed to determine the cost-effectiveness of interventions for grades I-III WAD and NAD in children and adults. Systematic review of health economic literature, best-evidence synthesis. We systematically searched CINAHL, the Cochrane economic databases (Health Technology Assessment, NHS Economic Evaluation Database), EconLit, EMBASE, MEDLINE, PsycINFO, and Tufts CEA Registry from 2000 to 2015 for economic evaluations of WAD and NAD interventions. We appraised relevant evaluations using the Scottish Intercollegiate Guidelines Network Methodology Criteria for Economic Evaluations. We extracted data, including mean costs (standardized to 2013 Canadian dollars [CAD]) and quality-adjusted life years (QALYs), from studies with adequate methodological quality. We recalculated cost-effectiveness statistics based on the standardized currency using a willingness-to-pay of CAD $50,000 per additional QALY. Funding was provided by the Ministry of Finance. Our search identified 1,616 citations. Six studies fulfilled our selection criteria, including three studies previously reviewed by the NPTF. Structured education appears cost-effective for adults with WAD. For adults with NAD, acupuncture added to routine medical care; manual therapy; multimodal care that includes manual therapy; advice and exercise; and psychological care using cognitive-behavioral therapy appear cost-effective. In contrast, adding manual therapy or diathermy to advice and exercise; multimodal

  17. The Bipolar Interactive Psychoeducation (BIPED study: trial design and protocol

    Directory of Open Access Journals (Sweden)

    Jones Ian

    2009-08-01

    Full Text Available Abstract Background Bipolar disorders affect between 3–5% of the population and are associated with considerable lifelong impairment. Since much of the morbidity associated with bipolar disorder is caused by recurrent depressive symptoms, which are often only poorly responsive to antidepressants, there is a need to develop alternative, non-pharmacological interventions. Psychoeducational interventions have emerged as promising long-term therapeutic options for bipolar disorder. Methods/design The study is an exploratory, individually randomised controlled trial. The intervention known as 'Beating Bipolar' is a psychoeducational programme which is delivered via a novel web-based system. We will recruit 100 patients with a diagnosis of DSM-IV bipolar disorder (including type I and type II currently in clinical remission. The primary outcome is quality of life. This will be compared for those patients who have participated in the psychoeducational programme with those who received treatment as usual. Quality of life will be assessed immediately following the intervention as well as 10 months after randomisation. Secondary outcomes include current depressive and manic symptoms, number of episodes of depression and mania/hypomania experienced during the follow-up period, global functioning, functional impairment and insight. An assessment of costs and a process evaluation will also be conducted which will explore the feasibility and acceptability of the intervention as well as potential barriers to effectiveness. Discussion Bipolar disorder is common, under-recognised and often poorly managed. It is a chronic, life-long, relapsing condition which has an enormous impact on the individual and the economy. This trial will be the first to explore the effectiveness of a novel web-based psychoeducational intervention for patients with bipolar disorder which has potential to be easily rolled out to patients. Trial registration Current Controlled Trials

  18. Protocol adherence for continuously titrated interventions in randomized trials: an overview of the current methodology and case study

    Directory of Open Access Journals (Sweden)

    F. Lauzier

    2017-07-01

    Full Text Available Abstract Background The standard definition for protocol adherence is the proportion of all scheduled doses that are delivered. In clinical research, this definition has several limitations when evaluating protocol adherence in trials that study interventions requiring continuous titration. Discussion Building upon a specific case study, we analyzed a recent trial of a continuously titrated intervention to assess the impact of different definitions of protocol deviations on the interpretation of protocol adherence. The OVATION pilot trial was an open-label randomized controlled trial of higher (75–80 mmHg versus lower (60–65 mmHg mean arterial pressure (MAP targets for vasopressor therapy in shock. In this trial, potential protocol deviations were defined as MAP values outside the targeted range for >4 consecutive hours during vasopressor therapy without synchronous and consistent adjustments of vasopressor doses. An adjudication committee reviewed each potential deviation to determine if it was clinically-justified or not. There are four reasons for this contextual measurement and reporting of protocol adherence. First, between-arm separation is a robust measure of adherence to complex protocols. Second, adherence assessed by protocol deviations varies in function of the definition of deviations and the frequency of measurements. Third, distinguishing clinically-justified vs. not clinically-justified protocol deviations acknowledges clinically sensible bedside decision-making and offers a clear terminology before the trial begins. Finally, multiple metrics exist to report protocol deviations, which provides different information but complementary information on protocol adherence. Conclusions In trials of interventions requiring continuous titration, metrics used for defining protocol deviations have a considerable impact on the interpretation of protocol adherence. Definitions for protocol deviations should be prespecified and correlated

  19. Protocol adherence for continuously titrated interventions in randomized trials: an overview of the current methodology and case study.

    Science.gov (United States)

    Lauzier, F; Adhikari, N K; Seely, A; Koo, K K Y; Belley-Côté, E P; Burns, K E A; Cook, D J; D'Aragon, F; Rochwerg, B; Kho, M E; Oczkowksi, S J W; Duan, E H; Meade, M O; Day, A G; Lamontagne, F

    2017-07-17

    The standard definition for protocol adherence is the proportion of all scheduled doses that are delivered. In clinical research, this definition has several limitations when evaluating protocol adherence in trials that study interventions requiring continuous titration. Building upon a specific case study, we analyzed a recent trial of a continuously titrated intervention to assess the impact of different definitions of protocol deviations on the interpretation of protocol adherence. The OVATION pilot trial was an open-label randomized controlled trial of higher (75-80 mmHg) versus lower (60-65 mmHg) mean arterial pressure (MAP) targets for vasopressor therapy in shock. In this trial, potential protocol deviations were defined as MAP values outside the targeted range for >4 consecutive hours during vasopressor therapy without synchronous and consistent adjustments of vasopressor doses. An adjudication committee reviewed each potential deviation to determine if it was clinically-justified or not. There are four reasons for this contextual measurement and reporting of protocol adherence. First, between-arm separation is a robust measure of adherence to complex protocols. Second, adherence assessed by protocol deviations varies in function of the definition of deviations and the frequency of measurements. Third, distinguishing clinically-justified vs. not clinically-justified protocol deviations acknowledges clinically sensible bedside decision-making and offers a clear terminology before the trial begins. Finally, multiple metrics exist to report protocol deviations, which provides different information but complementary information on protocol adherence. In trials of interventions requiring continuous titration, metrics used for defining protocol deviations have a considerable impact on the interpretation of protocol adherence. Definitions for protocol deviations should be prespecified and correlated with between-arm separation, if it can be measured.

  20. The Evidence for Brain Injury in Whiplash Injuries

    Directory of Open Access Journals (Sweden)

    Michael P. Alexander

    2003-01-01

    Full Text Available The evidence that brain damage can occur in injuries that produce whiplash is reviewed. The clinical phenomena for the two injuries are the same. Pure whiplash injury implies no, or minimal head contact, but many patients also have head contact against a head rest or the steering wheel or windshield. The relative severity of the neck injury and the head injury distinguishes whiplash from mild closed head injury. If there is brain injury is some patients with whiplash, it, by definition, falls at the mildest end of the concussion spectrum. The relationship between these two injuries is examined.

  1. Acupuncture for dry eye: a randomised controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Kim Ae-Ran

    2009-12-01

    Full Text Available Abstract Background Dry eye is usually managed by conventional medical interventions such as artificial tears, anti-inflammatory drugs and surgical treatment. However, since dry eye is one of the most frequent ophthalmologic disorders, safer and more effective methods for its treatment are necessary, especially for vulnerable patients. Acupuncture has been widely used to treat patients with dry eye. Our aim is to evaluate the effectiveness and safety of acupuncture for this condition. Methods/Design A randomised, patient-assessor blinded, sham (non-acupuncture point, shallow acupuncture controlled study was established. Participants allocated to verum acupuncture and sham acupuncture groups will be treated three times weekly for three weeks for a total of nine sessions per participant. Seventeen points (GV23; bilateral BL2, GB4, TE23, Ex1 (Taiyang, ST1 and GB20; and left SP3, LU9, LU10 and HT8 for men, right for women have been selected for the verum acupuncture; for the sham acupuncture, points have been selected that do not coincide with a classical acupuncture point and that are located close to the verum points, except in the case of the rim of the eye. Ocular surface disease index, tear film breakup time, the Schirmer I test, medication quantification scale and general assessment of improvement will be used as outcome variables for evaluating the effectiveness of acupuncture. Safety will also be assessed at every visit. Primary and secondary outcomes will be assessed four weeks after screening. All statistical analyses will be performed using analysis of covariance. Discussion The results of this trial will be used as a basis for clarifying the efficacy of acupuncture for dry eye. Trial registration ClinicalTrials.gov NCT00969280.

  2. Staying well after depression: trial design and protocol.

    Science.gov (United States)

    Williams, J Mark G; Russell, Ian T; Crane, Catherine; Russell, Daphne; Whitaker, Chris J; Duggan, Danielle S; Barnhofer, Thorsten; Fennell, Melanie J V; Crane, Rebecca; Silverton, Sarah

    2010-03-19

    Depression is often a chronic relapsing condition, with relapse rates of 50-80% in those who have been depressed before. This is particularly problematic for those who become suicidal when depressed since habitual recurrence of suicidal thoughts increases likelihood of further acute suicidal episodes. Therefore the question how to prevent relapse is of particular urgency in this group. This trial compares Mindfulness-Based Cognitive Therapy (MBCT), a novel form of treatment combining mindfulness meditation and cognitive therapy for depression, with both Cognitive Psycho-Education (CPE), an equally plausible cognitive treatment but without meditation, and treatment as usual (TAU). It will test whether MBCT reduces the risk of relapse in recurrently depressed patients and the incidence of suicidal symptoms in those with a history of suicidality who do relapse. It recruits participants, screens them by telephone for main inclusion and exclusion criteria and, if they are eligible, invites them to a pre-treatment session to assess eligibility in more detail. This trial allocates eligible participants at random between MBCT and TAU, CPE and TAU, and TAU alone in a ratio of 2:2:1, stratified by presence of suicidal ideation or behaviour and current anti-depressant use. We aim to recruit sufficient participants to allow for retention of 300 following attrition. We deliver both active treatments in groups meeting for two hours every week for eight weeks. We shall estimate effects on rates of relapse and suicidal symptoms over 12 months following treatment and assess clinical status immediately after treatment, and three, six, nine and twelve months thereafter. This will be the first trial of MBCT to investigate whether MCBT is effective in preventing relapse to depression when compared with a control psychological treatment of equal plausibility; and to explore the use of MBCT for the most severe recurrent depression--that in people who become suicidal when depressed.

  3. Surgical Trial in Lobar Intracerebral Haemorrhage (STICH II Protocol

    Directory of Open Access Journals (Sweden)

    Rowan Elise N

    2011-05-01

    Full Text Available Abstract Background Within the spectrum of spontaneous intracerebral haemorrhage there are some patients with large or space occupying haemorrhage who require surgery for neurological deterioration and others with small haematomas who should be managed conservatively. There is equipoise about the management of patients between these two extremes. In particular there is some evidence that patients with lobar haematomas and no intraventricular haemorrhage might benefit from haematoma evacuation. The STICH II study will establish whether a policy of earlier surgical evacuation of the haematoma in selected patients will improve outcome compared to a policy of initial conservative treatment. Methods/Design an international multicentre randomised parallel group trial. Only patients for whom the treating neurosurgeon is in equipoise about the benefits of early craniotomy compared to initial conservative treatment are eligible. All patients must have a CT scan confirming spontaneous lobar intracerebral haemorrhage (≤1 cm from the cortex surface of the brain and 10-100 ml in volume. Any clotting or coagulation problems must be corrected and randomisation must take place within 48 hours of ictus. With 600 patients, the study will be able to demonstrate a 12% benefit from surgery (2p Stratified randomisation is undertaken using a central 24 hour randomisation service accessed by telephone or web. Patients randomised to early surgery should have the operation within 12 hours. Information about the status (Glasgow Coma Score and focal signs of all patients through the first five days of their trial progress is also collected in addition to another CT scan at about five days (+/- 2 days. Outcome is measured at six months via a postal questionnaire to the patient. Primary outcome is death or severe disability defined using a prognosis based 8 point Glasgow Outcome Scale. Secondary outcomes include: Mortality, Rankin, Barthel, EuroQol, and Survival. Trial

  4. Single dental implant retained mandibular complete dentures – influence of the loading protocol: study protocol for a randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background Over the years, there has been a strong consensus in dentistry that at least two implants are required to retain a complete mandibular denture. It has been shown in several clinical trials that one single median implant can retain a mandibular overdenture sufficiently well for up to 5 years without implant failures, when delayed loading was used. However, other trials have reported conflicting results with in part considerable failure rates when immediate loading was applied. Therefore it is the purpose of the current randomized clinical trial to test the hypothesis that immediate loading of a single mandibular midline implant with an overdenture will result in a comparable clinical outcome as using the standard protocol of delayed loading. Methods/design This prospective nine-center randomized controlled clinical trial is still ongoing. The final patient will complete the trial in 2016. In total, 180 edentulous patients between 60 and 89 years with sufficient complete dentures will receive one median implant in the edentulous mandible, which will retain the existing complete denture using a ball attachment. Loading of the median implant is either immediately after implant placement (experimental group) or delayed by 3 months of submerged healing at second-stage surgery (control group). Follow-up of patients will be performed for 24 months after implant loading. The primary outcome measure is non-inferiority of implant success rate of the experimental group compared to the control group. The secondary outcome measures encompass clinical, technical and subjective variables. The study was funded by the Deutsche Forschungsgemeinschaft (German research foundation, KE 477/8-1). Discussion This multi-center clinical trial will give information on the ability of a single median implant to retain a complete mandibular denture when immediately loaded. If viable, this treatment option will strongly improve everyday dental practice. Trial registration The trial

  5. FIT for FUNCTION: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Richardson, Julie; Tang, Ada; Guyatt, Gordon; Thabane, Lehana; Xie, Feng; Sahlas, Demetrios; Hart, Robert; Fleck, Rebecca; Hladysh, Genevieve; Macrae, Louise

    2018-01-15

    The current state of evidence suggests that community-based exercise programs are beneficial in improving impairment, function, and health status, and are greatly needed for persons with stroke. However, limitations of these studies include risk of bias, feasibility, and cost issues. This single-blinded, randomized controlled trial (RCT) of 216 participants with stroke will compare the effectiveness of a 12-week YMCA community-based wellness program (FIT for FUNCTION) specifically designed for community-dwelling persons with stroke to persons who receive a standard YMCA membership. The primary outcome will be community reintegration using the Reintegration to Normal Living Index at 12 and 24 weeks. Secondary outcomes include measurement of physical activity level using the Rapid Assessment of Physical Activity and accelerometry; balance using the Berg Balance Scale; lower extremity function using the Short Physical Performance Battery; exercise capacity using the 6-min walk test; grip strength and isometric knee extension strength using hand held dynamometry; and health-related quality of life using the European Quality of Life 5-Dimension Questionnaire. We are also assessing cardiovascular health and lipids; glucose and inflammatory markers will be collected following 12-h fast for total cholesterol, insulin, glucose, and glycated hemoglobin. Self-efficacy for physical activity will be assessed with a single question and self-efficacy for managing chronic disease will be assessed using the Stanford 6-item Scale. The Patient Activation Measure will be used to assess the patient's level of knowledge, skill, and confidence for self-management. Healthcare utilization and costs will be evaluated. Group, time, and group × time interaction effects will be estimated using generalized linear models for continuous variables, including relevant baseline variables as covariates in the analysis that differ appreciably between groups at baseline. Cost data will be treated

  6. Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial-PROSPECT: protocol for a feasibility randomized pilot trial.

    Science.gov (United States)

    Johnstone, Jennie; Meade, Maureen; Marshall, John; Heyland, Daren K; Surette, Michael G; Bowdish, Dawn Me; Lauzier, Francois; Thebane, Lehana; Cook, Deborah J

    2015-01-01

    Probiotics are defined as live microorganisms that may confer health benefits when ingested. Meta-analysis of probiotic trials suggests a 25 % lower ventilator-associated pneumonia (VAP) and 18 % lower infection rates overall when administered to patients in the intensive care unit (ICU). However, prior trials are small, largely single center, and at high risk of bias. Before a large rigorous trial is launched, testing whether probiotics confer benefit, harm, or have no impact, a pilot trial is needed. The aim of the PROSPECT Pilot Trial is to determine the feasibility of performing a larger trial in mechanically ventilated critically ill patients investigating Lactobacillus rhamnosus GG. A priori, we determined that the feasibility of the larger trial would be based on timely recruitment, high protocol adherence, minimal contamination, and an acceptable VAP rate. Patients ≥18 years old in the ICU who are anticipated to receive mechanical ventilation for ≥72 hours will be included. Patients are excluded if they are at increased risk of probiotic-associated infection, have strict enteral medication contraindications, are pregnant, previously enrolled in a related trial, or are receiving palliative care. Following informed consent, patients are randomized in variable unspecified block sizes in a fixed 1:1 ratio, stratified by ICU, and medical, surgical, or trauma admitting diagnosis. Patients receive 1 × 10 10 colony forming units of L. rhamnosus GG (Culturelle, Locin Industries Ltd) or an identical placebo suspended in tap water administered twice daily via nasogastric tube in the ICU. Clinical and research staff, patients, and families are blinded. The primary outcomes for this pilot trial are the following: (1) recruitment success, (2) ≥90 % protocol adherence, (3) ≤5 % contamination, and (4) ~10 % VAP rate. Additional clinical outcomes are VAP, other infections, diarrhea (total, antibiotic associated, and Clostridium difficile), ICU and

  7. External validation of a clinical prediction rule to predict full recovery and ongoing moderate/severe disability following acute whiplash injury.

    Science.gov (United States)

    Ritchie, Carrie; Hendrikz, Joan; Jull, Gwendolen; Elliott, James; Sterling, Michele

    2015-04-01

    Retrospective secondary analysis of data. To investigate the external validity of the whiplash clinical prediction rule (CPR). We recently derived a whiplash CPR to consolidate previously established prognostic factors for poor recovery from a whiplash injury and predicted 2 recovery pathways. Prognostic factors for full recovery were being less than 35 years of age and having an initial Neck Disability Index (NDI) score of 32% or less. Prognostic factors for ongoing moderate/severe pain and disability were being 35 years of age or older, having an initial NDI score of 40% or more, and the presence of hyperarousal symptoms. Validation is required to confirm the reproducibility and accuracy of this CPR. Clinician feedback on the usefulness of the CPR is also important to gauge acceptability. A secondary analysis of data from 101 individuals with acute whiplash-associated disorder who had previously participated in either a randomized controlled clinical trial or prospective cohort study was performed using accuracy statistics. Full recovery was defined as NDI score at 6 months of 10% or less, and ongoing moderate/severe pain and disability were defined as an NDI score at 6 months of 30% or greater. In addition, a small sample of physical therapists completed an anonymous survey on the clinical acceptability and usability of the tool. Results The positive predictive value of ongoing moderate/severe pain and disability was 90.9% in the validation cohort, and the positive predictive value of full recovery was 80.0%. Surveyed physical therapists reported that the whiplash CPR was simple, understandable, would be easy to use, and was an acceptable prognostic tool. External validation of the whiplash CPR confirmed the reproducibility and accuracy of this dual-pathway tool for individuals with acute whiplash-associated disorder. Further research is needed to assess prospective validation, the impact of inclusion on practice, and to examine the efficacy of linking treatment

  8. Sensitivity Analysis of Per-Protocol Time-to-Event Treatment Efficacy in Randomized Clinical Trials

    Science.gov (United States)

    Gilbert, Peter B.; Shepherd, Bryan E.; Hudgens, Michael G.

    2013-01-01

    Summary Assessing per-protocol treatment effcacy on a time-to-event endpoint is a common objective of randomized clinical trials. The typical analysis uses the same method employed for the intention-to-treat analysis (e.g., standard survival analysis) applied to the subgroup meeting protocol adherence criteria. However, due to potential post-randomization selection bias, this analysis may mislead about treatment efficacy. Moreover, while there is extensive literature on methods for assessing causal treatment effects in compliers, these methods do not apply to a common class of trials where a) the primary objective compares survival curves, b) it is inconceivable to assign participants to be adherent and event-free before adherence is measured, and c) the exclusion restriction assumption fails to hold. HIV vaccine efficacy trials including the recent RV144 trial exemplify this class, because many primary endpoints (e.g., HIV infections) occur before adherence is measured, and nonadherent subjects who receive some of the planned immunizations may be partially protected. Therefore, we develop methods for assessing per-protocol treatment efficacy for this problem class, considering three causal estimands of interest. Because these estimands are not identifiable from the observable data, we develop nonparametric bounds and semiparametric sensitivity analysis methods that yield estimated ignorance and uncertainty intervals. The methods are applied to RV144. PMID:24187408

  9. Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols

    DEFF Research Database (Denmark)

    Chan, A.W.; Hrobjartsson, A.; Jorgensen, K.J.

    2008-01-01

    OBJECTIVE: To evaluate how often sample size calculations and methods of statistical analysis are pre-specified or changed in randomised trials. DESIGN: Retrospective cohort study. Data source Protocols and journal publications of published randomised parallel group trials initially approved...... in 1994-5 by the scientific-ethics committees for Copenhagen and Frederiksberg, Denmark (n=70). MAIN OUTCOME MEASURE: Proportion of protocols and publications that did not provide key information about sample size calculations and statistical methods; proportion of trials with discrepancies between...... of handling missing data was described in 16 protocols and 49 publications. 39/49 protocols and 42/43 publications reported the statistical test used to analyse primary outcome measures. Unacknowledged discrepancies between protocols and publications were found for sample size calculations (18/34 trials...

  10. Development of a dynamic quality assurance testing protocol for multisite clinical trial DCE-CT accreditation

    Energy Technology Data Exchange (ETDEWEB)

    Driscoll, B. [Department of Radiation Physics, Princess Margaret Cancer Center, 610 University Avenue, Toronto, Ontario M5G 2M9 (Canada); Keller, H. [Department of Radiation Physics, Princess Margaret Cancer Center, 610 University Avenue, Toronto, Ontario M5G 2M9, Canada and Department of Radiation Oncology, University of Toronto, 150 College Street, Toronto, Ontario M5S 3E2 (Canada); Jaffray, D.; Coolens, C. [Department of Radiation Physics, Princess Margaret Cancer Center, 610 University Avenue, Toronto, Ontario M5G 2M9 (Canada); Department of Radiation Oncology, University of Toronto, 150 College Street, Toronto, Ontario M5S 3E2 (Canada); Techna Institute, University Health Network, 124-100 College Street, Toronto, Ontario M5G 1L5 (Canada)

    2013-08-15

    Purpose: Credentialing can have an impact on whether or not a clinical trial produces useful quality data that is comparable between various institutions and scanners. With the recent increase of dynamic contrast enhanced-computed tomography (DCE-CT) usage as a companion biomarker in clinical trials, effective quality assurance, and control methods are required to ensure there is minimal deviation in the results between different scanners and protocols at various institutions. This paper attempts to address this problem by utilizing a dynamic flow imaging phantom to develop and evaluate a DCE-CT quality assurance (QA) protocol.Methods: A previously designed flow phantom, capable of producing predictable and reproducible time concentration curves from contrast injection was fully validated and then utilized to design a DCE-CT QA protocol. The QA protocol involved a set of quantitative metrics including injected and total mass error, as well as goodness of fit comparison to the known truth concentration curves. An additional region of interest (ROI) sensitivity analysis was also developed to provide additional details on intrascanner variability and determine appropriate ROI sizes for quantitative analysis. Both the QA protocol and ROI sensitivity analysis were utilized to test variations in DCE-CT results using different imaging parameters (tube voltage and current) as well as alternate reconstruction methods and imaging techniques. The developed QA protocol and ROI sensitivity analysis was then applied at three institutions that were part of clinical trial involving DCE-CT and results were compared.Results: The inherent specificity of robustness of the phantom was determined through calculation of the total intraday variability and determined to be less than 2.2 ± 1.1% (total calculated output contrast mass error) with a goodness of fit (R{sup 2}) of greater than 0.99 ± 0.0035 (n= 10). The DCE-CT QA protocol was capable of detecting significant deviations from

  11. Kinematics of a Head-Neck Model Simulating Whiplash

    Science.gov (United States)

    Colicchia, Giuseppe; Zollman, Dean; Wiesner, Hartmut; Sen, Ahmet Ilhan

    2008-01-01

    A whiplash event is a relative motion between the head and torso that occurs in rear-end automobile collisions. In particular, the large inertia of the head results in a horizontal translation relative to the thorax. This paper describes a simulation of the motion of the head and neck during a rear-end (whiplash) collision. A head-neck model that…

  12. Perceived Cognitive Deficits, Emotional Distress and Disability following Whiplash Injury

    Directory of Open Access Journals (Sweden)

    Michael JL Sullivan

    2002-01-01

    Full Text Available OBJECTIVES: To describe the pattern of perceived cognitive deficits in patients with whiplash injury, to examine the relation between perceived cognitive deficits and disability, and to examine the determinants of perceived cognitive deficits in patients with whiplash injury.

  13. [Biofeedback treatment for acute whiplash patients].

    Science.gov (United States)

    Gálvez-Hernández, Carmen Lizette; Rodríguez-Ortiz, María Dolores; Del Río-Portilla, Yolanda

    2016-01-01

    The aim of this study is to evaluate the physiological and psychological effect after an electromyographic biofeedback treatment in combination with progressive muscular relaxation training in patients with acute whiplash. Twelve patients with acute whiplash volunteered to participate in a quasi-experimental design and a control group. Two months maximum after car accident, severity levels II and I. previous history of persistent pain or serious previous injury. The groups were randomly divided in two (treatment and waiting list groups). We used electromyographic measures of the trapezius muscles with psychometric tests: Beck Anxiety and Depression Inventory; Oswestry Pain Disability Questionnaire; Visual Analog Scale of Pain; TAMPA Scale for Kinesiophobia. The treatment consisted in electromyographic biofeedback after progressive muscular relaxation training. There were significant intra-group differences before and after treatment in muscular symmetry and subjective pain perception in the treatment group. We achieved a significant change (clinical and statistical) in subjective pain perception and muscular symmetry. This study highlights the importance of multidisciplinary work in acute pain patients and the effectiveness of clinical psychophysiological strategies with acute whiplash patients.

  14. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat

    DEFF Research Database (Denmark)

    Schroll, Jeppe Bennekou; Penninga, Elisabeth I; Gøtzsche, Peter C

    2016-01-01

    BACKGROUND: Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs) from the European Medicines Agency through the Freedom of Information Act. The CSRs describe......Med and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about...

  15. Standardized terminology for clinical trial protocols based on top-level ontological categories.

    Science.gov (United States)

    Heller, B; Herre, H; Lippoldt, K; Loeffler, M

    2004-01-01

    This paper describes a new method for the ontologically based standardization of concepts with regard to the quality assurance of clinical trial protocols. We developed a data dictionary for medical and trial-specific terms in which concepts and relations are defined context-dependently. The data dictionary is provided to different medical research networks by means of the software tool Onto-Builder via the internet. The data dictionary is based on domain-specific ontologies and the top-level ontology of GOL. The concepts and relations described in the data dictionary are represented in natural language, semi-formally or formally according to their use.

  16. Thoracic dysfunction in whiplash associated disorders: A systematic review

    Science.gov (United States)

    Smith, Richard; Tyros, Isaak; Falla, Deborah; Rushton, Alison

    2018-01-01

    Background Research investigating Whiplash Associated Disorder (WAD) has largely focused on the cervical spine yet symptoms can be widespread. Thoracic spine pain prevalence is reported ~66%; perhaps unsurprising given the forceful stretch/eccentric loading of posterior structures of the spine, and the thoracic spine’s contribution to neck mobility/function. Approximately 50% WAD patients develop chronic pain and disability resulting in high levels of societal and healthcare costs. It is time to look beyond the cervical spine to fully understand anatomical dysfunction in WAD and provide new directions for clinical practice and research. Purpose To evaluate the scope and nature of dysfunction in the thoracic region in patients with WAD. Methods A systematic review and data synthesis was conducted according to a pre-defined, registered (PROSPERO, CRD42015026983) and published protocol. All forms of observational study were included. A sensitive topic-based search strategy was designed from inception to 1/06/16. Databases, grey literature and registers were searched using a study population terms and key words derived from scoping search. Two reviewers independently searched information sources, assessed studies for inclusion, extracted data and assessed risk of bias. A third reviewer checked for consistency and clarity. Extracted data included summary data: sample size and characteristics, outcomes, and timescales to reflect disorder state. Risk of bias was assessed using the Newcastle-Ottawa Scale. Data were tabulated to allow enabling a semi-qualitative comparison and grouped by outcome across studies. Strength of the overall body of evidence was assessed using a modified GRADE. Results Thirty eight studies (n>50,000) which were conducted across a range of countries were included. Few authors responded to requests for further data (5 of 9 contacted). Results were reported in the context of overall quality and were presented for measures of pain or dysfunction and

  17. A Test-Retest Reliability Study of the Whiplash Disability Questionnaire in Patients With Acute Whiplash-Associated Disorders

    DEFF Research Database (Denmark)

    Stupar, Maja; Côté, Pierre; Beaton, Dorcas E

    2015-01-01

    OBJECTIVE: The purpose of this study was to determine the test-retest reliability and the Minimal Detectable Change (MDC) of the Whiplash Disability Questionnaire (WDQ) in individuals with acute whiplash-associated disorders (WADs). METHODS: We performed a test-retest reliability study. We includ...

  18. Correlations between coping styles and symptom expectation for whiplash injury.

    Science.gov (United States)

    Ferrari, Robert; Russell, Anthony S

    2010-11-01

    In pain conditions, active coping has been found to be associated with less severe depression, increased activity level, and less functional impairment. Studies indicate that Canadians have a high expectation for chronic pain following whiplash injury. Expectation of recovery has been shown to predict recovery in whiplash victims. The objective of this study was to compare both the expectations and the coping style for whiplash injury in injury-naive subjects. The Vanderbilt Pain Management Inventory was administered to university students. Subjects who had not yet experienced whiplash injury were given a vignette concerning a neck sprain (whiplash injury) in a motor vehicle collision and were asked to indicate how likely they were to have thoughts or behaviors indicated in the coping style questionnaire. Subjects also completed expectation questionnaires regarding whiplash injury. Subjects (57%) held an expectation of chronic pain after whiplash injury. The mean active coping style score was 28.5±6.6 (40 is the maximum score for active coping). The mean passive coping style score was 28.5±6.6 (50 is the maximum score for passive coping). Those with high passive coping styles had a higher mean expectation score. The correlation between passive coping style score and expectation score was 0.62, while the correlation between active coping style score and expectation was -0.48. Both expectations and coping styles may interact or be co-modifiers in the outcomes of whiplash injury in whiplash victims. Further studies of coping style as an etiologic factor in the chronic whiplash syndrome are needed.

  19. Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials.

    Directory of Open Access Journals (Sweden)

    Benjamin Kasenda

    2016-06-01

    Full Text Available Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i the existence and types of publication agreements in trial protocols, (ii the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii the frequency of co-authorship by industry employees.We used a retrospective cohort of randomized clinical trials (RCTs based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5% mentioned an agreement regarding publication of results. Of these 456, 393 (86.2% documented an industry partner's right to disapprove or at least review proposed manuscripts; 39 (8.6% agreements were without constraints of publication. The remaining 24 (5.3% protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0% trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]. Of 71 agreements reported in publications, 52 (73.2% were concordant with those documented in the protocol. In 14 of 37 (37.8% publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements.Publication agreements constraining academic authors' independence are common. Journal articles seldom report on publication agreements, and, if they do

  20. Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials

    Science.gov (United States)

    Kasenda, Benjamin; von Elm, Erik; You, John J.; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J.; Stegert, Mihaela; Olu, Kelechi K.; Tikkinen, Kari A. O.; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M.; Mertz, Dominik; Akl, Elie A.; Bassler, Dirk; Busse, Jason W.; Nordmann, Alain; Gloy, Viktoria; Ebrahim, Shanil; Schandelmaier, Stefan; Sun, Xin; Vandvik, Per O.; Johnston, Bradley C.; Walter, Martin A.; Burnand, Bernard; Hemkens, Lars G.; Bucher, Heiner C.; Guyatt, Gordon H.; Briel, Matthias

    2016-01-01

    Background Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. Methods and Findings We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner’s right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements. Conclusions Publication agreements constraining academic authors’ independence are common. Journal articles seldom report on

  1. A combination of gestalt therapy, Rosen Body Work, and Cranio Sacral therapy did not help in chronic whiplash-associated disorders (WAD)--results of a randomized clinical trial.

    Science.gov (United States)

    Ventegodt, Søren; Merrick, Joav; Andersen, Niels Jørgen; Bendix, Tom

    2004-12-10

    The chronic state of whiplash-associated disorder (WAD) might be understood as a somatization of existential pain. Intervention aimed to improve quality of life (QOL) seemed to be a solution for such situations. The basic idea behind the intervention was holistic, restoring quality of life and relationship with self, in order to diminish tension in the locomotion system, especially the neck. A psychosomatic theory for WAD is proposed. Our treatment was a short 2-day course with teachings in philosophy of life, followed by 6-10 individual sessions in gestalt psychotherapy and body therapy (Rosen therapy and Cranio Sacral therapy), followed by a 1-day course approximately 2 months later, closing the intervention. Two independent institutions did the intervention and the assessments. In a randomized, clinically controlled setting, 87 chronic WAD patients were included with a median duration of 37 months from their whiplash accidents. One patient never started. Forty-three had the above intervention (female/male = 36/7, ages 22-49, median 37 years) and another 43 were assigned to a nontreated control group (female/male = 35/8, ages 18-48, median 38). Six had disability pension and 27 had pending medicolegal issues in each group. Effect variables were pain in neck, arm, and/or head; measures of quality of life and daily activities; as well as general physical or mental health. Wilcoxon test for between-groups comparisons with intention-to-treat analyses was conducted; the square curve paradigm testing for immediate improvements of health and quality of life was also used. The groups were comparable at baseline. From the intervention group, 11 dropped out during the intervention (4 of those later joined the follow-up investigation), 22 of the remaining 32 graduated the course, and 35 of the 43 controls did as well. Approximately 3 months later, we found no clinically relevant or significant increase in any effect measure. The above version of a quality of life

  2. Initiating change locally in bullying and aggression through the school environment (INCLUSIVE) trial: update to cluster randomised controlled trial protocol.

    Science.gov (United States)

    Bonell, Chris; Mathiot, Anne; Allen, Elizabeth; Bevilacqua, Leonardo; Christie, Deborah; Elbourne, Diana; Fletcher, Adam; Grieve, Richard; Legood, Rosa; Scott, Stephen; Warren, Emily; Wiggins, Meg; Viner, Russell M

    2017-05-25

    Systematic reviews suggest that multi-component interventions are effective in reducing bullying victimisation and perpetration. We are undertaking a phase III randomised trial of the INCLUSIVE multi-component intervention. This trial aims to assess the effectiveness and cost-effectiveness of the INCLUSIVE intervention in reducing aggression and bullying victimisation in English secondary schools. This paper updates the original trial protocol published in 2014 (Trials 15:381, 2014) and presents the changes in the process evaluation protocol and the secondary outcome data collection. The methods are summarised as follows. cluster randomised trial. 40 state secondary schools. Outcomes assessed among the cohort of students at the end of year 7 (n = 6667) at baseline. INCLUSIVE is a multi-component school intervention including a social and emotional learning curriculum, changes to school environment (an action group comprising staff and students reviews local data on needs to review rules and policies and determine other local actions) and staff training in restorative practice. The intervention will be delivered by schools supported in the first two years by educational facilitators independent of the research team, with a third intervention year involving no external facilitation but all other elements. Comparator: normal practice. Primary: Two primary outcomes at student level assessed at baseline and at 36 months: 1. Aggressive behaviours in school: Edinburgh Study of Youth Transitions and Crime school misbehaviour subscale (ESYTC) 2. Bullying and victimisation: Gatehouse Bullying Scale (GBS) Secondary outcomes assessed at baseline, 24 and 36 months will include measures relating to the economic evaluation, psychosocial outcomes in students and staff and school-level truancy and exclusion rates. 20 schools per arm will provide 90% power to identify an effect size of 0.25 SD with a 5% significance level. Randomisation: eligible consenting schools were

  3. Protocol for the Osteoporosis Choice trial. A pilot randomized trial of a decision aid in primary care practice

    Directory of Open Access Journals (Sweden)

    Tulledge-Scheitel Sidna M

    2009-12-01

    Full Text Available Abstract Background Bisphosphonates can reduce fracture risk in patients with osteoporosis, but many at-risk patients do not start or adhere to these medications. The aims of this study are to: (1 preliminarily evaluate the effect of an individualized 10-year osteoporotic fracture risk calculator and decision aid (OSTEOPOROSIS CHOICE for postmenopausal women at risk for osteoporotic fractures; and (2 assess the feasibility and validity (i.e., absence of contamination of patient-level randomization (vs. cluster randomization in pilot trials of decision aid efficacy. Methods/Design This is a protocol for a parallel, 2-arm, randomized trial to compare an intervention group receiving OSTEOPOROSIS CHOICE to a control group receiving usual primary care. Postmenopausal women with bone mineral density T-scores of STEOPOROSIS CHOICE on five outcomes: (a patient knowledge regarding osteoporosis risk factors and treatment; (b quality of the decision-making process for both the patient and clinician; (c patient and clinician acceptability and satisfaction with the decision aid; (d rate of bisphosphonate use and adherence, and (e trial processes (e.g., ability to recruit participants, collect patient outcomes. To capture these outcomes, we will use patient and clinician surveys following each visit and video recordings of the clinical encounters. These video recordings will also allow us to determine the extent to which clinicians previously exposed to the decision aid were able to recreate elements of the decision aid with control patients (i.e., contamination. Pharmacy prescription profiles and follow-up phone interviews will assess medication start and adherence at 6 months. Discussion This pilot trial will provide evidence of feasibility, validity of patient randomization, and preliminary efficacy of a novel approach -- decision aids -- to improving medication adherence for postmenopausal women at risk of osteoporotic fractures. The results will inform

  4. Grade II whiplash injuries to the neck: what is the benefit for patients treated by different physical therapy modalities?

    Science.gov (United States)

    Dehner, Christoph; Elbel, Martin; Strobel, Philipp; Scheich, Matthias; Schneider, Florian; Krischak, Gert; Kramer, Michael

    2009-01-01

    Background In a majority of cases, whiplash injuries are a domain of conservative therapy. Nevertheless it remains unclear whether physical therapy is of medical or economic benefit in patients with whiplash injuries. Methods Seventy patients with acute Quebec Task Force (QTF) grade II whiplash injuries were randomized to two therapy groups and received either active (APT) or passive (PPT) physical therapy. Patients were compared with regard to pain and range of motion with data obtained in an earlier study from a group with grade II whiplash injuries in which the therapy recommendation had been "act as usual" (AAU; n = 20). The above-mentioned parameters were assessed at 24 hours and two months after the injury. Furthermore patients' period of disability was documented after two months. Results After two months, patients in both the APT and PPT groups showed significant improvement in the median period of disability (active: 14 days; passive: 14 days) compared to the AAU group (49 days). No group difference was observed with regard to median improvement in range of motion (active: 120°; passive: 108°; activity as usual: 70°). The median pain reduction was significantly greater in the APT group (50.5) than in the PPT (39.2) or AAU group (28.8). Conclusion Our data show that active physical therapy results in enhanced pain reduction and shortening of post-injury disability. Therefore, active physical therapy should be considered the treatment of choice in patients with QTF grade II whiplash injuries. Trial registration The study complied with applicable German law and with the principles of the Helsinki Declaration and was approved by the institutional ethics commission. PMID:19149880

  5. Grade II whiplash injuries to the neck: what is the benefit for patients treated by different physical therapy modalities?

    Directory of Open Access Journals (Sweden)

    Krischak Gert

    2009-01-01

    Full Text Available Abstract Background In a majority of cases, whiplash injuries are a domain of conservative therapy. Nevertheless it remains unclear whether physical therapy is of medical or economic benefit in patients with whiplash injuries. Methods Seventy patients with acute Quebec Task Force (QTF grade II whiplash injuries were randomized to two therapy groups and received either active (APT or passive (PPT physical therapy. Patients were compared with regard to pain and range of motion with data obtained in an earlier study from a group with grade II whiplash injuries in which the therapy recommendation had been "act as usual" (AAU; n = 20. The above-mentioned parameters were assessed at 24 hours and two months after the injury. Furthermore patients' period of disability was documented after two months. Results After two months, patients in both the APT and PPT groups showed significant improvement in the median period of disability (active: 14 days; passive: 14 days compared to the AAU group (49 days. No group difference was observed with regard to median improvement in range of motion (active: 120°; passive: 108°; activity as usual: 70°. The median pain reduction was significantly greater in the APT group (50.5 than in the PPT (39.2 or AAU group (28.8. Conclusion Our data show that active physical therapy results in enhanced pain reduction and shortening of post-injury disability. Therefore, active physical therapy should be considered the treatment of choice in patients with QTF grade II whiplash injuries. Trial registration The study complied with applicable German law and with the principles of the Helsinki Declaration and was approved by the institutional ethics commission.

  6. Whiplash Syndrome Reloaded: Digital Echoes of Whiplash Syndrome in the European Internet Search Engine Context.

    Science.gov (United States)

    Noll-Hussong, Michael

    2017-03-27

    In many Western countries, after a motor vehicle collision, those involved seek health care for the assessment of injuries and for insurance documentation purposes. In contrast, in many less wealthy countries, there may be limited access to care and no insurance or compensation system. The purpose of this infodemiology study was to investigate the global pattern of evolving Internet usage in countries with and without insurance and the corresponding compensation systems for whiplash injury. We used the Internet search engine analytics via Google Trends to study the health information-seeking behavior concerning whiplash injury at national population levels in Europe. We found that the search for "whiplash" is strikingly and consistently often associated with the search for "compensation" in countries or cultures with a tort system. Frequent or traumatic painful injuries; diseases or disorders such as arthritis, headache, radius, and hip fracture; depressive disorders; and fibromyalgia were not associated similarly with searches on "compensation." In this study, we present evidence from the evolving viewpoint of naturalistic Internet search engine analytics that the expectations for receiving compensation may influence Internet search behavior in relation to whiplash injury. ©Michael Noll-Hussong. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 27.03.2017.

  7. Correction: PAIS: paracetamol (acetaminophen in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN74418480

    Directory of Open Access Journals (Sweden)

    Kappelle L Jaap

    2008-11-01

    Full Text Available Abstract Background The Paracetamol (Acetaminophen In Stroke (PAIS study is a phase III multicenter, double blind, randomized, placebo-controlled clinical trial of high-dose acetaminophen in patients with acute stroke. The trial compares treatment with a daily dose of 6 g acetaminophen, started within 12 hours after the onset of symptoms, with matched placebo. The purpose of this study is to assess whether treatment with acetaminophen for 3 days will result in improved functional outcome through a modest reduction in body temperature and prevention of fever. The previously planned statistical analysis based on a dichotomization of the scores on the modified Rankin Scale (mRS may not make the most efficient use of the available baseline information. Therefore, the planned primary analysis of the PAIS study has been changed from fixed dichotomization of the mRS to a sliding dichotomy analysis. Methods Instead of taking a single definition of good outcome for all patients, the definition is tailored to each individual patient's baseline prognosis on entry into the trial. Conclusion The protocol change was initiated because of both advances in statistical approaches and to increase the efficiency of the trial by improving statistical power. Trial Registration Current Controlled Trials [ISCRTN74418480

  8. Whiplash causes increased laxity of cervical capsular ligament.

    Science.gov (United States)

    Ivancic, Paul C; Ito, Shigeki; Tominaga, Yasuhiro; Rubin, Wolfgang; Coe, Marcus P; Ndu, Anthony B; Carlson, Erik J; Panjabi, Manohar M

    2008-02-01

    Previous clinical studies have identified the cervical facet joint, including the capsular ligaments, as sources of pain in whiplash patients. The goal of this study was to determine whether whiplash caused increased capsular ligament laxity by applying quasi-static loading to whiplash-exposed and control capsular ligaments. A total of 66 capsular ligament specimens (C2/3 to C7/T1) were prepared from 12 cervical spines (6 whiplash-exposed and 6 control). The whiplash-exposed spines had been previously rear impacted at a maximum peak T1 horizontal acceleration of 8 g. Capsular ligaments were elongated at 1mm/s in increments of 0.05 mm until a tensile force of 5 N was achieved and subsequently returned to neutral position. Four pre-conditioning cycles were performed and data from the load phase of the fifth cycle were used for subsequent analyses. Ligament elongation was computed at tensile forces of 0, 0.25, 0.5, 0.75, 1.0, 2.5, and 5.0 N. Two factor, non-repeated measures ANOVA (Pwhiplash-exposed and control groups and between spinal levels. Average elongation of the whiplash-exposed capsular ligaments was significantly greater than that of the control ligaments at tensile forces of 0 and 5 N. No significant differences between spinal levels were observed. Capsular ligament injuries, in the form of increased laxity, may be one component perpetuating chronic pain and clinical instability in whiplash patients.

  9. A Randomized Trial Comparing Two Tongue-Pressure Resistance Training Protocols for Post-Stroke Dysphagia.

    Science.gov (United States)

    Steele, Catriona M; Bayley, Mark T; Peladeau-Pigeon, Melanie; Nagy, Ahmed; Namasivayam, Ashwini M; Stokely, Shauna L; Wolkin, Talia

    2016-06-01

    The objective of this study was to compare the outcomes of two tongue resistance training protocols. One protocol ("tongue-pressure profile training") emphasized the pressure-timing patterns that are typically seen in healthy swallows by focusing on gradual pressure release and saliva swallowing tasks. The second protocol ("tongue-pressure strength and accuracy training") emphasized strength and accuracy in tongue-palate pressure generation and did not include swallowing tasks. A prospective, randomized, parallel allocation trial was conducted. Of 26 participants who were screened for eligibility, 14 received up to 24 sessions of treatment. Outcome measures of posterior tongue strength, oral bolus control, penetration-aspiration and vallecular residue were made based on videofluoroscopy analysis by blinded raters. Complete data were available for 11 participants. Significant improvements were seen in tongue strength and post-swallow vallecular residue with thin liquids, regardless of treatment condition. Stage transition duration (a measure of the duration of the bolus presence in the pharynx prior to swallow initiation, which had been chosen to capture impairments in oral bolus control) showed no significant differences. Similarly, significant improvements were not seen in median scores on the penetration-aspiration scale. This trial suggests that tongue strength can be improved with resistance training for individuals with tongue weakness following stroke. We conclude that improved penetration-aspiration does not necessarily accompany improvements in tongue strength; however, tongue-pressure resistance training does appear to be effective for reducing thin liquid vallecular residue.

  10. Do head-restraints protect the neck from whiplash injuries?

    Science.gov (United States)

    Morris, F

    1989-01-01

    Over an 11-month period a study was made of all patients presenting to an accident and emergency department who had sustained whiplash as a result of rear-bumper impacts. The patients were analysed with respect to the presence of head-restraints in their vehicles. A significant increase in the incidence of whiplash was found in patients whose vehicles did not have head-restraints fitted. Legislation requiring all passenger cars to have head-restraints fitted as standard would have a major impact in reducing the number of whiplash injuries sustained in rear bumper impacts. PMID:2712983

  11. Physiotherapy in a whiplash injury: a case report

    Directory of Open Access Journals (Sweden)

    C. Van Eck

    2008-01-01

    Full Text Available Study Design: Case ReportObjectives: To describe physiotherapy intervention in an individual with asuspected whiplash injury.Background: The patient was a 29-year old male with complaints of neckpain and tightness following a motor vehicle accident. Methods and Measures: The focus of the case study is physiotherapyassessment and intervention in a stage II whiplash injury. Results: Following intervention, positive changes occurred in outcome measures such as pain, work status and activities of daily living. Conclusion: Physiotherapy intervention is successful in addressing whiplash associated disorders.

  12. A prospective study of 39 patients with whiplash injury

    DEFF Research Database (Denmark)

    Karlsborg, M; Smed, A; Jespersen, H

    1997-01-01

    INTRODUCTION: The acute symptoms after whiplash traumas can be explained by the neck sprain, but the pathogenesis of the 'late whiplash syndrome' and the reason why only some people have persistent symptoms more than 6 months is still unknown. MATERIAL AND METHODS: Thirty-four consecutive cases...... of whiplash injury were examined clinically three times; within 14 days, after 1 month and finally 7 months postinjury. In addition, MRI of the brain and the cervical spine, neuropsychological tests and motor evoked potentials (MEP) were done one month postinjury and repeated after 6 months, if abnormalities...

  13. The effects of a tailored intensive care unit delirium prevention protocol: A randomized controlled trial.

    Science.gov (United States)

    Moon, Kyoung-Ja; Lee, Sun-Mi

    2015-09-01

    A decreased incidence of delirium following the application of non-pharmacologic intervention protocols to several patient populations has been previously reported. However, few studies have been conducted to examine the effects of their application to intensive care unit (ICU) patients. To examine the effects of applying a tailored delirium preventive protocol, developed by the authors, to ICU patients by analyzing its effects on delirium incidence, in-hospital mortality, ICU readmission, and length of ICU stay in a Korean hospital. A single-blind randomized controlled trial. A 1049-bed general hospital with a 105-bed ICU. Sixty and 63 ICU patients were randomly assigned to the intervention and control groups, respectively. The researchers applied the delirium prevention protocol to the intervention group every day for the first 7 days of ICU hospitalization. Delirium incidence, mortality, and re-admission to the ICU during the same hospitalization period were analyzed by logistic regression analysis; the 7- and 30-day in-hospital mortality by Kaplan-Meier survival and Cox proportional hazard regression analysis; and length of ICU stay was assessed by linear regression analysis. Application of the protocol had no significant effect on delirium incidence, in-hospital mortality, re-admission to the ICU, or length of ICU stay. Whereas the risk of 30-day in-hospital mortality was not significantly lower in the intervention than in the control group (OR: 0.33; 95% CI: 0.10-1.09), we found a significantly decreased 7-day in-hospital mortality in the intervention group after protocol application (HR: 0.09; 95% CI: 0.01-0.72). Application of a tailored delirium prevention protocol to acute stage patients during the first 7 days of ICU hospitalization appeared to reduce the 7-day in-hospital risk of mortality only for this patient population. Copyright © 2015 Elsevier Ltd. All rights reserved.

  14. The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Scherer, Roberta W; Drye, Lea; Mintzer, Jacobo; Lanctôt, Krista; Rosenberg, Paul; Herrmann, Nathan; Padala, Prasad; Brawman-Mintzer, Olga; Burke, William; Craft, Suzanne; Lerner, Alan J; Levey, Allan; Porsteinsson, Anton; van Dyck, Christopher H

    2018-01-18

    Alzheimer's disease (AD) is characterized not only by cognitive and functional decline, but also often by the presence of neuropsychiatric symptoms. Apathy, which can be defined as a lack of motivation, is one of the most prevalent neuropsychiatric symptoms in AD and typically leads to a worse quality of life and greater burden for caregivers. Treatment options for apathy in AD are limited, but studies have examined the use of the amphetamine, methylphenidate. The Apathy in Dementia Methylphenidate Trial (ADMET) found that treatment of apathy in AD with methylphenidate was associated with significant improvement in apathy in two of three outcome measures, some evidence of improvement in global cognition, and minimal adverse events. However, the trial only enrolled 60 participants who were followed for only 6 weeks. A larger, longer-lasting trial is required to confirm these promising findings. The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2) is a phase III, placebo-controlled, masked, 6-month, multi-center, randomized clinical trial targeted to enroll 200 participants with AD and apathy. Participants are randomly assigned 1:1 to 20 mg methylphenidate per day prepared as four over-encapsulated tablets or to matching placebo. The primary outcomes include (1) the mean difference in the Neuropsychiatric Inventory Apathy subscale scores measured as change from baseline to 6 months, and (2) the odds of having a given rating or better on the modified AD Cooperative Study Clinical Global Impression of Change ratings at month 6 compared with the baseline rating. Other outcomes include change in cognition, safety, and cost-effectiveness measured at monthly follow-up visits up to 6 months. Given the prevalence of apathy in AD and its impact on both patients and caregivers, an intervention to alleviate apathy would be of great benefit to society. ADMET 2 follows on the promising results from the original ADMET to evaluate the efficacy of methylphenidate as a

  15. Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Foglia, Elizabeth E; Owen, Louise S; Thio, Marta; Ratcliffe, Sarah J; Lista, Gianluca; Te Pas, Arjan; Hummler, Helmut; Nadkarni, Vinay; Ades, Anne; Posencheg, Michael; Keszler, Martin; Davis, Peter; Kirpalani, Haresh

    2015-03-15

    Extremely preterm infants require assistance recruiting the lung to establish a functional residual capacity after birth. Sustained inflation (SI) combined with positive end expiratory pressure (PEEP) may be a superior method of aerating the lung compared with intermittent positive pressure ventilation (IPPV) with PEEP in extremely preterm infants. The Sustained Aeration of Infant Lungs (SAIL) trial was designed to study this question. This multisite prospective randomized controlled unblinded trial will recruit 600 infants of 23 to 26 weeks gestational age who require respiratory support at birth. Infants in both arms will be treated with PEEP 5 to 7 cm H2O throughout the resuscitation. The study intervention consists of performing an initial SI (20 cm H20 for 15 seconds) followed by a second SI (25 cm H2O for 15 seconds), and then PEEP with or without IPPV, as needed. The control group will be treated with initial IPPV with PEEP. The primary outcome is the combined endpoint of bronchopulmonary dysplasia or death at 36 weeks post-menstrual age. www.clinicaltrials.gov , Trial identifier NCT02139800 , Registered 13 May 2014.

  16. Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Callahan Christopher M

    2012-06-01

    Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared

  17. The Depression in Visual Impairment Trial (DEPVIT: trial design and protocol

    Directory of Open Access Journals (Sweden)

    Margrain Tom H

    2012-07-01

    Full Text Available Abstract Background The prevalence of depression in people with a visual disability is high but screening for depression and referral for treatment is not yet an integral part of visual rehabilitation service provision. One reason for this may be that there is no good evidence about the effectiveness of treatments in this patient group. This study is the first to evaluate the effect of depression treatments on people with a visual impairment and co morbid depression. Methods /design The study is an exploratory, multicentre, individually randomised waiting list controlled trial. Participants will be randomised to receive Problem Solving Therapy (PST, a ‘referral to the GP’ requesting treatment according to the NICE’s ‘stepped care’ recommendations or the waiting list arm of the trial. The primary outcome measure is change (from randomisation in depressive symptoms as measured by the Beck’s Depression Inventory (BDI-II at 6 months. Secondary outcomes include change in depressive symptoms at 3 months, change in visual function as measured with the near vision subscale of the VFQ-48 and 7 item NEI-VFQ at 3 and 6 months, change in generic health related quality of life (EQ5D, the costs associated with PST, estimates of incremental cost effectiveness, and recruitment rate estimation. Discussion Depression is prevalent in people with disabling visual impairment. This exploratory study will establish depression screening and referral for treatment in visual rehabilitation clinics in the UK. It will be the first to explore the efficacy of PST and the effectiveness of NICE’s ‘stepped care’ approach to the treatment of depression in people with a visual impairment. Trial registration ISRCTN46824140

  18. The Chronic Kidney Disease Water Intake Trial: Protocol of a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    William F. Clark

    2017-08-01

    Full Text Available Background: In observational studies, drinking more water associates with a slower rate of kidney function decline; whether the same is true in a randomized controlled trial is unknown. Objective: To examine the 1-year effect of a higher vs usual water intake on estimated glomerular filtration rate (eGFR in patients with chronic kidney disease. Design: Parallel-group randomized controlled trial. Setting: Nine centers in Ontario, Canada. Enrollment and randomization occurred between May 2013 and May 2016; follow-up for the primary outcome will continue until June 2017. Participants: Adults (n = 631 with stage 3 chronic kidney disease (eGFR 30-60 mL/min/1.73 m 2 and microalbuminuria. Intervention: The high water intake group was coached to increase their oral water intake by 1.0 to 1.5 L/day (depending on sex and weight, over and above usual consumed beverages, for a period of 1 year. The control group was coached to maintain their usual water intake during this time. Measures: Participants provided 24-hour urine samples at baseline and at 6 and 12 months after randomization; urine samples were analyzed for volume, creatinine, osmolality, and the albumin-to-creatinine ratio. Blood samples were obtained at baseline and at 3- to 6-month intervals after randomization, and analyzed for creatinine, copeptin, osmolality, and electrolytes. Other measures collected included health-related quality of life, blood pressure, body mass index, and diet. Primary outcome: The between-group change in eGFR from baseline (prerandomization to 12 months after randomization. Secondary outcomes: Change in plasma copeptin concentration, 24-hour urine albumin-to-creatinine ratio, measured creatinine clearance, estimated 5-year risk of kidney failure (using the 4-variable Kidney Failure Risk Equation, and health-related quality of life. Planned analysis: The primary analysis will follow an intention-to-treat approach. The between-group change in eGFR will be compared using

  19. South African Research Ethics Committee Review of Standards of Prevention in HIV Vaccine Trial Protocols.

    Science.gov (United States)

    Essack, Zaynab; Wassenaar, Douglas R

    2018-04-01

    HIV prevention trials provide a prevention package to participants to help prevent HIV acquisition. As new prevention methods are proven effective, this raises ethical and scientific design complexities regarding the prevention package or standard of prevention. Given its high HIV incidence and prevalence, South Africa has become a hub for HIV prevention research. For this reason, it is critical to study the implementation of relevant ethical-legal frameworks for such research in South Africa. This qualitative study used in-depth interviews to explore the practices and perspectives of eight members of South African research ethics committees (RECs) who have reviewed protocols for HIV vaccine trials. Their practices and perspectives are compared with ethics guideline requirements for standards of prevention.

  20. Nitrates and bone turnover (NABT) - trial to select the best nitrate preparation: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Bucur, Roxana C; Reid, Lauren S; Hamilton, Celeste J; Cummings, Steven R; Jamal, Sophie A

    2013-09-08

    comparisons with the best' approach for data analyses, as this strategy allows practical considerations of ease of use and tolerability to guide selection of the preparation for future studies. Data from this protocol will be used to develop a randomized, controlled trial of nitrates to prevent osteoporotic fractures. ClinicalTrials.gov Identifier: NCT01387672. Controlled-Trials.com: ISRCTN08860742.

  1. Sociale, økonomiske og kulturelle aspekter ved whiplash

    DEFF Research Database (Denmark)

    Rasmussen, Claus; Stenager, Elsebeth; Nielsen, Claus Vinther

    2010-01-01

    The sequelae following whiplash injuries (WL) entail considerable human costs and expenses for both treatment and social services, especially public income benefits. Frequently, many players are involved after WL and good intersectional collaboration is therefore essential to counter the WL...

  2. The risk assessment score in acute whiplash injury predicts outcome and reflects biopsychosocial factors

    DEFF Research Database (Denmark)

    Kasch, Helge; Qerama, Erisela; Kongsted, Alice

    2011-01-01

    One-year prospective study of 141 acute whiplash patients (WLP) and 40 acute ankle-injured controls.......One-year prospective study of 141 acute whiplash patients (WLP) and 40 acute ankle-injured controls....

  3. Increased neck muscle activity and impaired balance among females with whiplash-related chronic neck pain

    DEFF Research Database (Denmark)

    Juul-Kristensen, Birgit; Clausen, Brian; Ris Hansen, Inge

    2013-01-01

    To investigate neck muscle activity and postural control in patients with whiplash-associated disorder compared with healthy controls.......To investigate neck muscle activity and postural control in patients with whiplash-associated disorder compared with healthy controls....

  4. Temporomandibular disorders after whiplash injury: a controlled, prospective study.

    Science.gov (United States)

    Kasch, Helge; Hjorth, Tine; Svensson, Peter; Nyhuus, Lone; Jensen, Troels S

    2002-01-01

    Whiplash injury to the neck is often considered a significant risk factor for development of temporomandibular disorders (TMD), and has been proposed to produce internal derangements of the temporomandibular joint (TMJ). Few studies, however, have examined TMD-related pain in acute whiplash patients compared with a matched control group. The aim of the present study was to assess pain and sensorimotor function in the craniofacial region in an unselected group of patients sustaining a motor vehicle accident involving a rear collision. Prospectively, 19 acute whiplash patients exposed to a motor vehicle accident involving a rear collision participated in a study of TMD. The control group consisted of 20 age- and gender-matched ankle-injury patients. Participants were seen within 4 weeks and again at 6 months post-injury. The masticatory system was examined in accordance with the research diagnostic criteria. Participants underwent structured interviews, filled out the McGill Pain Questionnaire (MPQ), and had their masticatory system examined by a trained dentist, blinded to their diagnosis. Pain detection threshold (PDT) to pressure stimuli, and maximal voluntary occlusal force (MVOF) were obtained at each visit. One whiplash patient and 1 ankle-injury patient had jaw pain at the first visit. Palpation scores of the TMJ and the summated palpation scores only tended to be higher in patients sustaining a whiplash injury than in ankle-injury controls at the first visit. However, MPQ, TMD symptoms and signs, MVOF and PDT were not significantly different in whiplash-injury and ankle-injury patients after 4 weeks and 6 months. TMD pain after whiplash injury and ankle injury is rare, suggesting that whiplash injury is not a major risk factor for the development of TMD problems. Further studies are needed to identify which other factors may contribute to TMD pain.

  5. On associations between different factors and whiplash injury

    OpenAIRE

    Berglund, Anita

    2002-01-01

    The overall aim of this thesis was to evaluate associations between different factors and whiplash injury (defined as a soft tissue injury to the neck without fracture or dislocation), focusing on risk of initial and future complaints. The objectives in Paper 1 and II was to determine whether exposure to a rear-end collision, with or without whiplash injury, is associated with future neck or shoulder pain (Paper 1) and other health complaints, besides neck pain (Paper II). T...

  6. Underestimation of Severity of Previous Whiplash Injuries

    Science.gov (United States)

    Naqui, SZH; Lovell, SJ; Lovell, ME

    2008-01-01

    INTRODUCTION We noted a report that more significant symptoms may be expressed after second whiplash injuries by a suggested cumulative effect, including degeneration. We wondered if patients were underestimating the severity of their earlier injury. PATIENTS AND METHODS We studied recent medicolegal reports, to assess subjects with a second whiplash injury. They had been asked whether their earlier injury was worse, the same or lesser in severity. RESULTS From the study cohort, 101 patients (87%) felt that they had fully recovered from their first injury and 15 (13%) had not. Seventy-six subjects considered their first injury of lesser severity, 24 worse and 16 the same. Of the 24 that felt the violence of their first accident was worse, only 8 had worse symptoms, and 16 felt their symptoms were mainly the same or less than their symptoms from their second injury. Statistical analysis of the data revealed that the proportion of those claiming a difference who said the previous injury was lesser was 76% (95% CI 66–84%). The observed proportion with a lesser injury was considerably higher than the 50% anticipated. CONCLUSIONS We feel that subjects may underestimate the severity of an earlier injury and associated symptoms. Reasons for this may include secondary gain rather than any proposed cumulative effect. PMID:18201501

  7. MRI of car occupants with whiplash injury

    Energy Technology Data Exchange (ETDEWEB)

    Voyvodic, F [Dept. of Radiology, Flinders Medical Centre, Bedford Park, SA (Australia); Dolinis, J [National Injury Surveillance Unit, Bedford Park, SA (Australia); [National Health and Medical Research Council Road Accident Research Unit, Univ. of Adelaide, SA (Australia); Moore, V M [National Health and Medical Research Council Road Accident Research Unit, Univ. of Adelaide, SA (Australia); Ryan, G A [National Health and Medical Research Council Road Accident Research Unit, Univ. of Adelaide, SA (Australia); Slavotinek, J P [Dept. of Radiology, Flinders Medical Centre, Bedford Park, SA (Australia); Whyte, A M [Ashford Hospital Specialist Centre, SA (Australia); Hoile, R D [Ashford Hospital Specialist Centre, SA (Australia); Taylor, G W [National Health and Medical Research Council Road Accident Research Unit, Univ. of Adelaide, SA (Australia)

    1997-01-01

    Our purpose was to document and investigate the prognostic significance of features seen on MRI of patients with whiplash injury following relatively minor road traffic crashes. MRI was obtained shortly and at 6 months after the crash using a 0.5 T imager. The images were assessed independently by two radiologists for evidence of fracture or other injury; loss of lordosis and spondylosis were also recorded. Clinical examinations were used to assess the status of patients initially and at 6 months. The results of the independent MRI and clinical investigations were then examined for association using statistical tests. Initial MRI was performed on 29 patients, of whom 19 had repeat studies at 6 months; 48 examinations were thus examined. Apart from spondylosis and loss of lordosis, only one abnormality was detected: an intramedullary lesion consistent with a small cyst or syrinx. There were no statistically significant associations between the outcome of injury and spondylosis or loss of lordosis. No significant changes were found when comparing the initial and follow-up MRI. It appears that MRI of patients with relatively less severe whiplash symptoms reveals a low frequency of abnormalities, apart from spondylosis and loss of lordosis, which have little short-term prognostic value. Routine investigation of such patients with MRI is not justified in view of the infrequency of abnormalities detected, the lack of prognostic value and the high cost of the procedure. (orig.). With 1 fig., 1 tab.

  8. MRI of car occupants with whiplash injury

    International Nuclear Information System (INIS)

    Voyvodic, F.; Dolinis, J.; Moore, V.M.; Ryan, G.A.; Slavotinek, J.P.; Whyte, A.M.; Hoile, R.D.; Taylor, G.W.

    1997-01-01

    Our purpose was to document and investigate the prognostic significance of features seen on MRI of patients with whiplash injury following relatively minor road traffic crashes. MRI was obtained shortly and at 6 months after the crash using a 0.5 T imager. The images were assessed independently by two radiologists for evidence of fracture or other injury; loss of lordosis and spondylosis were also recorded. Clinical examinations were used to assess the status of patients initially and at 6 months. The results of the independent MRI and clinical investigations were then examined for association using statistical tests. Initial MRI was performed on 29 patients, of whom 19 had repeat studies at 6 months; 48 examinations were thus examined. Apart from spondylosis and loss of lordosis, only one abnormality was detected: an intramedullary lesion consistent with a small cyst or syrinx. There were no statistically significant associations between the outcome of injury and spondylosis or loss of lordosis. No significant changes were found when comparing the initial and follow-up MRI. It appears that MRI of patients with relatively less severe whiplash symptoms reveals a low frequency of abnormalities, apart from spondylosis and loss of lordosis, which have little short-term prognostic value. Routine investigation of such patients with MRI is not justified in view of the infrequency of abnormalities detected, the lack of prognostic value and the high cost of the procedure. (orig.). With 1 fig., 1 tab

  9. Increasing walking in patients with intermittent claudication: Protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    O'Carroll Ronan E

    2010-10-01

    Full Text Available Abstract Background People with intermittent claudication are at increased risk of death from heart attack and stroke compared to matched controls. Surgery for intermittent claudication is for symptom management and does not reduce the risk of cardiovascular morbidity and mortality. Increasing physical activity can reduce claudication symptoms and may improve cardiovascular health. This paper presents the pilot study protocol for a randomised controlled trial to test whether a brief psychological intervention leads to increased physical activity, improvement in quality of life, and a reduction in the demand for surgery, for patients with intermittent claudication. Methods/Design We aim to recruit 60 patients newly diagnosed with intermittent claudication, who will be randomised into two groups. The control group will receive usual care, and the treatment group will receive usual care and a brief 2-session psychological intervention to modify illness and walking beliefs and develop a walking action plan. The primary outcome will be walking, measured by pedometer. Secondary outcomes will include quality of life and uptake of surgery for symptom management. Participants will be followed up after (a 4 months, (b 1 year and (c 2 years. Discussion This study will assess the acceptability and efficacy of a brief psychological intervention to increase walking in patients with intermittent claudication, both in terms of the initiation, and maintenance of behaviour change. This is a pilot study, and the results will inform the design of a larger multi-centre trial. Trial Registration Current Controlled Trials ISRCTN28051878

  10. Peer-led healthy lifestyle program in supportive housing: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Cabassa, Leopoldo J; Stefancic, Ana; O'Hara, Kathleen; El-Bassel, Nabila; Lewis-Fernández, Roberto; Luchsinger, José A; Gates, Lauren; Younge, Richard; Wall, Melanie; Weinstein, Lara; Palinkas, Lawrence A

    2015-09-02

    The risk for obesity is twice as high in people with serious mental illness (SMI) compared to the general population. Racial and ethnic minority status contribute additional health risks. The aim of this study is to describe the protocol of a Hybrid Trial Type 1 design that will test the effectiveness and examine the implementation of a peer-led healthy lifestyle intervention in supportive housing agencies serving diverse clients with serious mental illness who are overweight or obese. The Hybrid Trial Type 1 design will combine a randomized effectiveness trial with a mixed-methods implementation study. The effectiveness trial will test the health impacts of a peer-led healthy lifestyle intervention versus usual care in supportive housing agencies. The healthy lifestyle intervention is derived from the Group Lifestyle Balanced Program, lasts 12 months, and will be delivered by trained peer specialists. Repeated assessments will be conducted at baseline and at 6, 12, and 18 months post randomization. A mixed-methods (e.g., structured interviews, focus groups, surveys) implementation study will be conducted to examine multi-level implementation factors and processes that can inform the use of the healthy lifestyle intervention in routine practice, using data from agency directors, program managers, staff, and peer specialists before, during, and after the implementation of the effectiveness trial. This paper describes the use of a hybrid research design that blends effectiveness trial methodologies and implementation science rarely used when studying the physical health of people with SMI and can serve as a model for integrating implementation science and health disparities research. Rigorously testing effectiveness and exploring the implementation process are both necessary steps to establish the evidence for large-scale delivery of peer-led healthy lifestyle intervention to improve the physical health of racial/ethnic minorities with SMI. www

  11. Validation of a new questionnaire to assess the impact of Whiplash Associated Disorders: The Whiplash Activity and participation List (WAL)

    NARCIS (Netherlands)

    Stenneberg, Martijn S.; Schmitt, Maarten A.; van Trijffel, Emiel; Schröder, Carin D.; Lindeboom, Robert

    2015-01-01

    Valid questionnaires for measuring functional limitations in patients with Whiplash Associated Disorders (WAD) are lacking, since existing measures are not suitable for addressing the specific limitations of these patients and because of cross contamination between theoretical constructs. The

  12. Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Wilson Graeme B

    2012-09-01

    delivery, and retention in the study population, to inform power calculations for a definitive trial. The health-economics component will establish how cost-effectiveness will be assessed, and examine which data on health service resource use should be collected in a main trial. Participants’ views on instruments and procedures will be sought to confirm their acceptability. Discussion The study will produce a full trial protocol with robust sample-size calculations to extend evidence on effectiveness of screening and brief intervention. Trial Registration Current Controlled Trials ISRCTN43218782

  13. The "Healthy Habits, Healthy Girls" randomized controlled trial for girls: study design, protocol, and baseline results.

    Science.gov (United States)

    Leme, Ana Carolina Barco; Philippi, Sonia Tucunduva

    2015-07-01

    The purpose of this article is to describe the study design, protocol, and baseline results of the "Healthy Habits, Healthy Girls" program. The intervention is being evaluated through a randomized controlled trial in 10 public schools in the city of São Paulo, Brazil. Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months: body mass index, waist circumference, dietary intake, nutrition, physical activity, social cognitive mediators, physical activity level, sedentary behaviors, self-rated physical status, and overall self-esteem. According to the baseline results, 32.4% and 23.4% of girls were overweight in the intervention and control groups, respectively, and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time (TV, computer, mobile devices). There were no significant differences between the groups for most of the variables, except age (p = 0.000) and waist circumference (p = 0.014). The study showed a gap in the Brazilian literature on protocols for randomized controlled trials to prevent obesity among youth. The current study may thus be an important initial contribution to the field.

  14. A quality analysis of clinical anaesthesia study protocols from the Chinese clinical trials registry according to the SPIRIT statement.

    Science.gov (United States)

    Yang, Lei; Chen, Shouming; Yang, Di; Li, Jiajin; Wu, Taixiang; Zuo, Yunxia

    2018-05-15

    To learn about the overall quality of clinical anaesthesia study protocols from the Chinese Clinical Trials Registry and to discuss the way to improve study protocol quality. We defined completeness of each sub-item in SPIRIT as N/A (not applicable) or with a score of 0, 1, or 2. For each protocol, we calculated the proportion of adequately reported items (score = 2 and N/A) and unreported items (score = 0). Protocol quality was determined according to the proportion of reported items, with values >50% indicating high quality. Protocol quality was determined according to the proportion of reported items. For each sub-item in SPIRIT, we calculated the adequately reported rate (percentage of all protocols with score 2 and NA on one sub-item) as well as the unreported rate (percentage of all protocols with score 0 on one sub-item). Total 126 study protocols were available for assessment. Among these, 88.1% were assessed as being of low quality. By comparison, the percentage of low-quality protocols was 88.9% after the publication of the SPIRIT statement. Among the 51 SPIRIT sub-items, 18 sub-items had an unreported rate above 90% while 16 had a higher adequately reported rate than an unreported rate. The overall quality of clinical anaesthesia study protocols registered in the ChiCTR was poor. A mandatory protocol upload and self-check based on the SPIRIT statement during the trial registration process may improve protocol quality in the future.

  15. Whiplash Syndrome Reloaded: Digital Echoes of Whiplash Syndrome in the European Internet Search Engine Context

    Science.gov (United States)

    2017-01-01

    Background In many Western countries, after a motor vehicle collision, those involved seek health care for the assessment of injuries and for insurance documentation purposes. In contrast, in many less wealthy countries, there may be limited access to care and no insurance or compensation system. Objective The purpose of this infodemiology study was to investigate the global pattern of evolving Internet usage in countries with and without insurance and the corresponding compensation systems for whiplash injury. Methods We used the Internet search engine analytics via Google Trends to study the health information-seeking behavior concerning whiplash injury at national population levels in Europe. Results We found that the search for “whiplash” is strikingly and consistently often associated with the search for “compensation” in countries or cultures with a tort system. Frequent or traumatic painful injuries; diseases or disorders such as arthritis, headache, radius, and hip fracture; depressive disorders; and fibromyalgia were not associated similarly with searches on “compensation.” Conclusions In this study, we present evidence from the evolving viewpoint of naturalistic Internet search engine analytics that the expectations for receiving compensation may influence Internet search behavior in relation to whiplash injury. PMID:28347974

  16. Telerehabilitation Versus Traditional Care Following Total Hip Replacement: A Randomized Controlled Trial Protocol.

    Science.gov (United States)

    Nelson, Mark; Bourke, Michael; Crossley, Kay; Russell, Trevor

    2017-03-02

    Total hip replacement (THR) is the gold standard treatment for severe hip osteoarthritis. Effectiveness of physical rehabilitation for THR patients following discharge from hospital is supported by evidence; however, barriers such as geographical location and transport can limit access to appropriate health care. One solution to this issue is using an alternative model of care using telerehabilitation technology to deliver rehabilitation programs directly into patients' homes. A telerehabilitation model may also have potential health care cost savings for health care providers. This study aims to determine if a telerehabilitation model of care delivered remotely is as effective as face-to-face rehabilitation in the THR population and cost effective for health care providers and patients. A total of 70 people undergoing THR will be recruited to participate in a randomized, single-blind, controlled noninferiority clinical trial. The trial will compare a technology-based THR rehabilitation program to in-person care. On discharge from hospital, participants randomized to the in-person group will receive usual care, defined as a paper home exercise program (HEP) targeting strengthening exercises for quadriceps, hip abductors, extensors, and flexors; they will be advised to perform their HEP 3 times per day. At 2, 4, and 6 weeks postoperatively, they will receive a 30-minute in-person physiotherapy session with a focus on gait retraining and reviewing and progressing their HEP. The telerehabilitation protocol will involve a program similar in content to the in-person rehabilitation program, except delivery will be directly into the homes of the participants via telerehabilitation technology on an iPad. Outcomes will be evaluated preoperatively, day of discharge from in-patient physiotherapy, 6 weeks and 6 months postoperatively. The primary outcome will be the quality of life subscale of the hip disability and osteoarthritis outcome score, measured at 6 weeks. Both

  17. The Diabetes Remission Clinical Trial (DiRECT): protocol for a cluster randomised trial.

    Science.gov (United States)

    Leslie, Wilma S; Ford, Ian; Sattar, Naveed; Hollingsworth, Kieren G; Adamson, Ashley; Sniehotta, Falko F; McCombie, Louise; Brosnahan, Naomi; Ross, Hazel; Mathers, John C; Peters, Carl; Thom, George; Barnes, Alison; Kean, Sharon; McIlvenna, Yvonne; Rodrigues, Angela; Rehackova, Lucia; Zhyzhneuskaya, Sviatlana; Taylor, Roy; Lean, Mike E J

    2016-02-16

    Despite improving evidence-based practice following clinical guidelines to optimise drug therapy, Type 2 diabetes (T2DM) still exerts a devastating toll from vascular complications and premature death. Biochemical remission of T2DM has been demonstrated with weight loss around 15kg following bariatric surgery and in several small studies of non-surgical energy-restriction treatments. The non-surgical Counterweight-Plus programme, running in Primary Care where obesity and T2DM are routinely managed, produces >15 kg weight loss in 33% of all enrolled patients. The Diabetes UK-funded Counterpoint study suggested that this should be sufficient to reverse T2DM by removing ectopic fat in liver and pancreas, restoring first-phase insulin secretion. The Diabetes Remission Clinical Trial (DiRECT) was designed to determine whether a structured, intensive, weight management programme, delivered in a routine Primary Care setting, is a viable treatment for achieving durable normoglycaemia. Other aims are to understand the mechanistic basis of remission and to identify psychological predictors of response. Cluster-randomised design with GP practice as the unit of randomisation: 280 participants from around 30 practices in Scotland and England will be allocated either to continue usual guideline-based care or to add the Counterweight-Plus weight management programme, which includes primary care nurse or dietitian delivery of 12-20weeks low calorie diet replacement, food reintroduction, and long-term weight loss maintenance. Main inclusion criteria: men and women aged 20-65 years, all ethnicities, T2DM 0-6years duration, BMI 27-45 kg/m(2). Tyneside participants will undergo Magnetic Resonance (MR) studies of pancreatic and hepatic fat, and metabolic studies to determine mechanisms underlying T2DM remission. Co-primary endpoints: weight reduction ≥ 15 kg and HbA1c <48 mmol/mol at one year. Further follow-up at 2 years. This study will establish whether a structured weight

  18. Telemedical support for prehospital Emergency Medical Service (TEMS trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Stevanovic, Ana; Beckers, Stefan Kurt; Czaplik, Michael; Bergrath, Sebastian; Coburn, Mark; Brokmann, Jörg Christian; Hilgers, Ralf-Dieter; Rossaint, Rolf

    2017-01-26

    Increasing numbers of emergency calls, shortages of Emergency Medical Service (EMS), physicians, prolonged emergency response times and regionally different quality of treatment by EMS physicians require improvement of this system. Telemedical solutions have been shown to be beneficial in different emergency projects, focused on specific disease patterns. Our previous pilot studies have shown that the implementation of a holistic prehospital EMS teleconsultation system, between paramedics and experienced tele-EMS physicians, is safe and feasible in different emergency situations. We aim to extend the clinical indications for this teleconsultation system. We hypothesize that the use of a tele-EMS physician is noninferior regarding the occurrence of system-induced patient adverse events and superior regarding secondary outcome parameters, such as the quality of guideline-conforming treatment and documentation, when compared to conventional EMS-physician treatment. Three thousand and ten patients will be included in this single-center, open-label, randomized controlled, noninferiority trial with two parallel arms. According to the inclusion criteria, all emergency cases involving adult patients who require EMS-physician treatment, excluding life-threatening cases, will be randomly assigned by the EMS dispatching center into two groups. One thousand five hundred and five patients in the control group will be treated by a conventional EMS physician on scene, and 1505 patients in the intervention group will be treated by paramedics who are concurrently instructed by the tele-EMS physicians at the teleconsultation center. The primary outcome measure will include the rate of treatment-specific adverse events in relation to the kind of EMS physician used. The secondary outcome measures will record the specific treatment-associated quality indicators. The evidence underlines the better quality of service using telemedicine networks between medical personnel and medical

  19. The Role of the Trigemino Cervical Complex in Chronic Whiplash Associated Headache: A Cross Sectional Study.

    Science.gov (United States)

    Watson, Dean H; Drummond, Peter D

    2016-06-01

    To investigate signs of central sensitization in a cohort of patients with chronic whiplash associated headache (CWAH). Central sensitization is one of the mechanisms leading to chronicity of primary headache, and thus might contribute to CWAH. However, the pathophysiological mechanism of CWAH is poorly understood and whether it is simply an expression of the primary headache or has a distinct pathogenesis remains unclear. Thus, the factors involved in the genesis of CWAH require further investigation. Twenty-two patients with CWAH (20 females, 2 males; age 25-50 years, mean age 36.3 years) and 25 asymptomatic participants (13 females, 12 males; age 18-50 years, mean age 35.6 years) rated glare and light-induced discomfort in response to light from an ophthalmoscope. Hyperalgesia evoked by a pressure algometer was assessed bilaterally on the forehead, temples, occipital base, and the middle phalanx of the third finger. The number, latency, area under the curve, and recovery cycle of nociceptive blink reflexes elicited by a supraorbital electrical stimulus were also recorded. Eight and 6 CWAH patients had migrainous and tension-type headache (TTH) profiles, respectively; the remainder had features attributable to both migraine and TTH. Patients in the whiplash group reported significantly greater light-induced pain than controls (8.48 ± .35 vs 6.66 ± .43 on a 0-10 scale; P = .001). The CWAH patients reported significantly lower pressure pain thresholds at all sites. For stimuli delivered at 20 second intervals, whiplash patients were more responsive than controls (4.8 ± .6 blinks vs 3.0 ± .6 blinks in a block of 10 stimuli; P = .036). While R2 latencies and the area under the curve for the 20 second interval trials were comparable in both groups, there was a significant reduction of the area under the curve from the first to the second of the 2-second interval trials only in controls (99 ± 8% of baseline in whiplash patients vs 68

  20. Comparison between publicly accessible publications, registries, and protocols of phase III trials indicated persistence of selective outcome reporting.

    Science.gov (United States)

    Zhang, Sheng; Liang, Fei; Li, Wenfeng

    2017-11-01

    The decision to make protocols of phase III randomized controlled trials (RCTs) publicly accessible by leading journals was a landmark event in clinical trial reporting. Here, we compared primary outcomes defined in protocols with those in publications describing the trials and in trial registration. We identified phase III RCTs published between January 1, 2012, and June 30, 2015, in The New England Journal of Medicine, The Lancet, The Journal of the American Medical Association, and The BMJ with available protocols. Consistency in primary outcomes between protocols and registries (articles) was evaluated. We identified 299 phase III RCTs with available protocols in this analysis. Out of them, 25 trials (8.4%) had some discrepancy for primary outcomes between publications and protocols. Types of discrepancies included protocol-defined primary outcome reported as nonprimary outcome in publication (11 trials, 3.7%), protocol-defined primary outcome omitted in publication (10 trials, 3.3%), new primary outcome introduced in publication (8 trials, 2.7%), protocol-defined nonprimary outcome reported as primary outcome in publication (4 trials, 1.3%), and different timing of assessment of primary outcome (4 trials, 1.3%). Out of trials with discrepancies in primary outcome, 15 trials (60.0%) had discrepancies that favored statistically significant results. Registration could be seen as a valid surrogate of protocol in 237 of 299 trials (79.3%) with regard to primary outcome. Despite unrestricted public access to protocols, selective outcome reporting persists in a small fraction of phase III RCTs. Only studies from four leading journals were included, which may cause selection bias and limit the generalizability of this finding. Copyright © 2017 Elsevier Inc. All rights reserved.

  1. Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background Psychological stress occurs when an individual perceives that environmental demands tax or exceed his or her adaptive capacity. Its association with severe health and emotional diseases, points out the necessity to find new efficient strategies to treat it. Moreover, psychological stress is a very personal problem and requires training focused on the specific needs of individuals. To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new paradigm for e-health - Interreality - that integrates contextualized assessment and treatment within a hybrid environment, bridging the physical and the virtual worlds. According to this premise, the aim of this study is to investigate the advantages of using advanced technologies, in combination with cognitive behavioral therapy (CBT), based on a protocol for reducing psychological stress. Methods/Design The study is designed as a randomized controlled trial. It includes three groups of approximately 50 subjects each who suffer from psychological stress: (1) the experimental group, (2) the control group, (3) the waiting list group. Participants included in the experimental group will receive a treatment based on cognitive behavioral techniques combined with virtual reality, biofeedback and mobile phone, while the control group will receive traditional stress management CBT-based training, without the use of new technologies. The wait-list group will be reassessed and compared with the two other groups five weeks after the initial evaluation. After the reassessment, the wait-list patients will randomly receive one of the two other treatments. Psychometric and physiological outcomes will serve as quantitative dependent variables, while subjective reports of participants will be used as the qualitative dependent variable. Discussion What we would like to show with the present trial is that bridging virtual experiences, used to learn coping skills and emotional regulation, with real

  2. Mecasin treatment in patients with amyotrophic lateral sclerosis: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Kim, Sungha; Kim, Jae Kyoun; Son, Mi Ju; Kim, Dongwoung; Song, Bongkeun; Son, Ilhong; Kang, Hyung Won; Lee, Jongdeok; Kim, Sungchul

    2018-04-13

    Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease that causes paralysis of limb, swallowing, and breathing muscles. Riluzole, the Food and Drug Administration-approved drug for ALS, provides minimal benefit, prolonging patient life by only 2-3 months. Previous studies have found a neuro-protective and anti-neuroinflammatory effect of Mecasin, with retrospective studies providing suggestive evidence for a beneficial effect of Mecasin. The aim of this study was to develop a protocol to determine the proper dosage of Mecasin. This is a phase II-A, multi-center, randomized study with three arms. Thirty-six patients with ALS will be randomly assigned to one of three groups, each receiving the standard treatment with 100 mg of riluzole in addition to one of 1.6 g of Mecasin, 2.4 g of Mecasin, or a placebo. The Primary outcome is the Korean version of the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised result after 12 weeks of treatment. Secondary outcomes include results of the Short Form Health Survey-8, Medical Research Council Scale, Visual Analogue Scale for Pain, Hamilton Rating Scale for Depression, Fatigue Severity Scale, Patient Global Impression of Change, pulmonary function test, forced expiratory volume in 1 s and its ratio to forced vital capacity, creatine kinase, and body weight. The frequencies of total adverse events and serious adverse events will be described and documented. The trial protocol has been approved by the Institutional Review Board of the Wonkwang University Gwangju and Sanbon Hospital (2016-5-4 and 2016-34-01, respectively). An Investigational New Drug status (30731) was granted by the Korea Food and Drug Administration. This trial will aim to identify the optimal dosage of Mecasin. Additionally, it will test the efficacy and safety of Mecasin in conjunction with standard treatment, riluzole, for alleviating the functional decline in patients with ALS. Korean National Clinical Trial Registry CRIS; KCT

  3. Use acupuncture to treat functional constipation: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Li Ying

    2012-07-01

    Full Text Available Abstract Background Whether acupuncture is effective for patients with functional constipation is still unclear. Therefore, we report the protocol of a randomized controlled trial of using acupuncture to treat functional constipation. Design A randomized, controlled, four-arm design, large-scale trial is currently undergoing in China. Seven hundred participants are randomly assigned to three acupuncture treatment groups and Mosapride Citrate control group in a 1:1:1:1 ratio. Participants in acupuncture groups receive 16 sessions of acupuncture treatment, and are followed up for a period of 9 weeks after randomization. The acupuncture groups are: (1 Back-Shu and Front-Mu acupoints of Large Intestine meridians (Shu-Mu points group; (2 He-Sea and Lower He-Sea acupoints of Large Intestine meridians (He points group; (3 Combining used Back-Shu, Front-Mu, He-Sea, and Lower He-Sea acupoints of Large Intestine meridians (Shu-Mu-He points group. The control group is Mosapride Citrate group. The primary outcome is frequency of defecation per week at the fourth week after randomization. The secondary outcomes include Bristol stool scale, the extent of difficulty during defecating, MOS 36-item Short Form health survey (SF-36, Self-Rating Anxiety Scale (SAS, and Self-rating Depression Scale (SDS. The first two of second outcomes are measured 1 week before randomization and 2, 4, and 8 weeks after randomization. Other second outcomes are measured 1 week before randomization and 2 and 4 weeks after randomization, but SF-36 is measured at randomization and 4 weeks after randomization. Discussion The result of this trial (which will be available in 2012 will confirm whether acupuncture is effective to treat functional constipation and whether traditional acupuncture theories play an important role in it. Trials registration Clinical Trials.gov NCT01411501

  4. A protocol for a pragmatic randomized controlled trial evaluating outcomes of emergency nurse practitioner service.

    Science.gov (United States)

    Jennings, Natasha; Gardner, Glenn; O'Reilly, Gerard

    2014-09-01

    To evaluate emergency nurse practitioner service effectiveness on outcomes related to quality of care and service responsiveness. Increasing service pressures in the emergency setting have resulted in the adoption of service innovation models; the most common and rapidly expanding of these is the emergency nurse practitioner. The delivery of high quality patient care in the emergency department is one of the most important service indicators to be measured in health services today. The rapid uptake of emergency nurse practitioner service in Australia has outpaced the capacity to evaluate this model in outcomes related to safety and quality of patient care. Pragmatic randomized controlled trial at one site with 260 participants. This protocol describes a definitive prospective randomized controlled trial, which will examine the impact of emergency nurse practitioner service on key patient care and service indicators. The study control will be standard emergency department care. The intervention will be emergency nurse practitioner service. The primary outcome measure is pain score reduction and time to analgesia. Secondary outcome measures are waiting time, number of patients who did not wait, length of stay in the emergency department and representations within 48 hours. Scant research enquiry evaluating emergency nurse practitioner service on patient effectiveness and service responsiveness exists currently. This study is a unique trial that will test the effectiveness of the emergency nurse practitioner service on patients who present to the emergency department with pain. The research will provide an opportunity to further evaluate emergency nurse practitioner models of care and build research capacity into the workforce. Trial registration details: Australian and New Zealand Clinical Trials Registry dated 18th August 2013, ACTRN12613000933752. © 2014 John Wiley & Sons Ltd.

  5. Occupational therapy discharge planning for older adults: A protocol for a randomised trial and economic evaluation

    Directory of Open Access Journals (Sweden)

    Wales Kylie

    2012-07-01

    Full Text Available Abstract Background Decreased functional ability is common in older adults after hospitalisation. Lower levels of functional ability increase the risk of hospital readmission and nursing care facility admission. Discharge planning across the hospital and community interface is suggested to increase functional ability and decrease hospital length of stay and hospital readmission. However evidence is limited and the benefits of occupational therapists providing this service has not been investigated. This randomised trial will investigate the clinical effectiveness of a discharge planning program in reducing functional difficulties of older adults post-discharge. This trial will also examine the cost of the intervention and cost effectiveness when compared to in-hospital discharge planning. Methods/design 400 participants admitted to participating hospitals will be recruited. Participants will be 70 years of age and over, have no significant cognitive impairment and be independently mobile at discharge. This study protocol was approved by the ethics committee of Ryde Rehabilitation Human Research Ethics Committee, Western Sydney Local Health District (Westmead Campus Human Research Ethics Committee, Alfred Health Human Research ethics committee for the randomised trial and NSW Population and Health Service Human Research Ethics Committee for data linkage. Participants will provide informed written consent. Participants will be randomly allocated to the intervention or control group. The intervention group will receive discharge planning therapies primarily within their home environment while the control group will receive an in-hospital consultation, both provided by trained occupational therapists. Primary outcome measures will be the Nottingham Extended Activities of Daily Living Scale (NEADL and the Late Life Disability Index (LLDI which will measure functional independence, and participation and limitation in daily life activities

  6. A Randomized trial of an Asthma Internet Self-management Intervention (RAISIN): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Morrison, Deborah; Wyke, Sally; Thomson, Neil C; McConnachie, Alex; Agur, Karolina; Saunderson, Kathryn; Chaudhuri, Rekha; Mair, Frances S

    2014-05-24

    The financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website 'Living well with asthma' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes. The study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status). Piloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of

  7. Pregnancy outcome of “delayed start” GnRH antagonist protocol versus GnRH antagonist protocol in poor responders: A clinical trial study

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    Abbas Aflatoonian

    2017-08-01

    Full Text Available Background: Management of poor-responding patients is still major challenge in assisted reproductive techniques (ART. Delayed-start GnRH antagonist protocol is recommended to these patients, but little is known in this regards. Objective: The goal of this study was assessment of delayed-start GnRH antagonist protocol in poor responders, and in vitro fertilization (IVF outcomes. Materials and Methods: This randomized clinical trial included sixty infertile women with Bologna criteria for ovarian poor responders who were candidate for IVF. In case group (n=30, delayed-start GnRH antagonist protocol administered estrogen priming followed by early follicular-phase GnRH antagonist treatment for 7 days before ovarian stimulation with gonadotropin. Control group (n=30 treated with estrogen priming antagonist protocol. Finally, endometrial thickness, the rates of oocytes maturation, , embryo formation, and pregnancy were compared between two groups. Results: Rates of implantation, chemical, clinical, and ongoing pregnancy in delayed-start cycles were higher although was not statistically significant. Endometrial thickness was significantly higher in case group. There were no statistically significant differences in the rates of oocyte maturation, embryo formation, and IVF outcomes between two groups. Conclusion: There is no significant difference between delayed-start GnRH antagonist protocol versus GnRH antagonist protocol.

  8. Supporting Policy In health with Research: an Intervention Trial (SPIRIT)—protocol for a stepped wedge trial

    Science.gov (United States)

    2014-01-01

    Introduction Governments in different countries have committed to better use of evidence from research in policy. Although many programmes are directed at assisting agencies to better use research, there have been few tests of the effectiveness of such programmes. This paper describes the protocol for SPIRIT (Supporting Policy In health with Research: an Intervention Trial), a trial designed to test the effectiveness of a multifaceted programme to build organisational capacity for the use of research evidence in policy and programme development. The primary aim is to determine whether SPIRIT results in an increase in the extent to which research and research expertise is sought, appraised, generated and used in the development of specific policy products produced by health policy agencies. Methods and analysis A stepped wedge cluster randomised trial involving six health policy agencies located in Sydney, Australia. Policy agencies are the unit of randomisation and intervention. Agencies were randomly allocated to one of three start dates (steps) to receive the 1-year intervention programme, underpinned by an action framework. The SPIRIT intervention is tailored to suit the interests and needs of each agency and includes audit, feedback and goal setting; a leadership programme; staff training; the opportunity to test systems to assist in the use of research in policies; and exchange with researchers. Outcome measures will be collected at each agency every 6 months for 30 months (starting at the beginning of step 1). Ethics and dissemination Ethics approval was granted by the University of Western Sydney Human Research and Ethics Committee HREC Approval H8855. The findings of this study will be disseminated broadly through peer-reviewed publications and presentations at conferences and used to inform future strategies. PMID:24989620

  9. Which dressing do donor site wounds need?: study protocol for a randomized controlled trial

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    Ubbink Dirk T

    2011-10-01

    Full Text Available Abstract Background Donor site wounds after split-skin grafting are rather 'standard' wounds. At present, lots of dressings and topical agents for donor site wounds are commercially available. This causes large variation in the local care of these wounds, while the optimum 'standard' dressing for local wound care is unclear. This protocol describes a trial in which we investigate the effectiveness of various treatment options for these donor site wounds. Methods A 14-center, six-armed randomized clinical trial is being carried out in the Netherlands. An a-priori power analysis and an anticipated dropout rate of 15% indicates that 50 patients per group are necessary, totaling 300 patients, to be able to detect a 25% quicker mean time to complete wound healing. Randomization has been computerized to ensure allocation concealment. Adult patients who need a split-skin grafting operation for any reason, leaving a donor site wound of at least 10 cm2 are included and receive one of the following dressings: hydrocolloid, alginate, film, hydrofiber, silicone dressing, or paraffin gauze. No combinations of products from other intervention groups in this trial are allowed. Optimum application and changes of these dressings are pursued according to the protocol as supplied by the dressing manufacturers. Primary outcomes are days to complete wound healing and pain (using a Visual Analogue Scale. Secondary outcomes are adverse effects, scarring, patient satisfaction, and costs. Outcome assessors unaware of the treatment allocation will assess whether or not an outcome has occurred. Results will be analyzed according to the intention to treat principle. The first patient was randomized October 1, 2009. Discussion This study will provide comprehensive data on the effectiveness of different treatment options for donor site wounds. The dressing(s that will prevail in effectiveness, satisfaction and costs will be promoted among clinicians dealing with such

  10. Acupuncture Antiarrhythmic Effects on Drug Refractory Persistent Atrial Fibrillation: Study Protocol for a Randomized, Controlled Trial

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    Jimin Park

    2015-01-01

    Full Text Available Background. Atrial fibrillation (AF is the most common form of arrhythmia. Several trials have suggested that acupuncture may prevent AF. However, the efficacy of acupuncture for AF prevention has not been well investigated. Therefore, we designed a prospective, two-parallel-armed, participant and assessor blinded, randomized, sham-controlled clinical trial to investigate acupuncture in persistent AF (ACU-AF. Methods. A total of 80 participants will be randomly assigned to active acupuncture or sham acupuncture groups in a 1 : 1 ratio. Both groups will take the same antiarrhythmic medication during the study period. Patients will receive 10 sessions of acupuncture treatment once a week for 10 weeks. The primary endpoint is AF recurrence rate. Secondary endpoints are left atrium (LA and left atrial appendage (LAA changes in function and volume, and inflammatory biomarker changes. Ethics. This study protocol was approved by the institutional review boards (IRBs of Kyung Hee University Hospital (number 1335-04. This trial is registered with clinicaltrials.gov NCT02110537.

  11. Safety of intrathecal transplantation of human umbilical cord mesenchymal stem cells for treating hereditary cerebellar ataxia: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Yi-hua An

    2016-01-01

    Trial registration: ClinicalTrials.gov identifier: NCT01489267; registered on 30 October 2011. The study protocol has been approved by the ethics committee of the General Hospital of Chinese Armed Police Forces, China (approval No. 201117.

  12. Trends in the number and the quality of trial protocols involving children submitted to a French Institutional Review Board

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    Isabelle Gautier

    2017-08-01

    Full Text Available Abstract Background There is a great need for high quality clinical research for children. The European Pediatric Regulation aimed to improve the quality of clinical trials in order to increase the availability of treatments for children. The main purpose of this study was to assess the evolution of both the number and the quality of pediatric trial protocols that were submitted to a French Institutional Review Board (IRB00009118 before and after the initiation of the EU Pediatric Regulation. Methods All protocols submitted to the IRB00009118 between 2003 and 2014 and conducting research on subjects under eighteen years of age were eligible. The quality of randomized clinical trials was assessed according to the guidelines developed by the Enhancing the QUAlity and Transparency Of health Research (EQUATOR Network and ranked using the Jadad score. Results Out of 622 protocols submitted to the Institutional Review Board (IRB, 21% (133/622 included children. Among these 133 pediatric protocols, the number of submitted pediatric protocols doubled between the two studied periods. From 2003 to 2008, 47 protocols including 21 institutionally sponsored were submitted to the IRB and from 2009 until 2014, 86 protocols including 48 institutionally sponsored were submitted. No significant trend was observed on the quality of RCTs. The overall median score of RCTs on the Jadad scale was high (3.5, 70.0% of protocols had a Jadad score ≥ 3, and 30.0% had a score < 3. Conclusion Following the EU Pediatric Regulation, the number of pediatric protocols submitted to the IRB00009118 tends to increase, but no change was noticed regarding their quality.

  13. Whiplash causes increased laxity of cervical capsular ligament

    Science.gov (United States)

    Ivancic, Paul C.; Ito, Shigeki; Tominaga, Yasuhiro; Rubin, Wolfgang; Coe, Marcus P.; Ndu, Anthony B.; Carlson, Erik J.; Panjabi, Manohar M.

    2009-01-01

    Background Previous clinical studies have identified the cervical facet joint, including the capsular ligaments, as sources of pain in whiplash patients. The goal of this study was to determine whether whiplash caused increased capsular ligament laxity by applying quasi-static loading to whiplash-exposed and control capsular ligaments. Methods A total of 66 capsular ligament specimens (C2/3 to C7/T1) were prepared from 12 cervical spines (6 whiplash-exposed and 6 control). The whiplash-exposed spines had been previously rear impacted at a maximum peak T1 horizontal acceleration of 8 g. Capsular ligaments were elongated at 1 mm/s in increments of 0.05 mm until a tensile force of 5 N was achieved and subsequently returned to neutral position. Four pre-conditioning cycles were performed and data from the load phase of the fifth cycle were used for subsequent analyses. Ligament elongation was computed at tensile forces of 0, 0.25, 0.5, 0.75, 1.0, 2.5, and 5.0 N. Two factor, non-repeated measures ANOVA (Pwhiplash-exposed and control groups and between spinal levels. Findings Average elongation of the whiplash-exposed capsular ligaments was significantly greater than that of the control ligaments at tensile forces of 0 and 5 N. No significant differences between spinal levels were observed. Interpretation Capsular ligament injuries, in the form of increased laxity, may be one component perpetuating chronic pain and clinical instability in whiplash patients. PMID:17959284

  14. Comparing 2 Whiplash Grading Systems to Predict Clinical Outcomes.

    Science.gov (United States)

    Croft, Arthur C; Bagherian, Alireza; Mickelsen, Patrick K; Wagner, Stephen

    2016-06-01

    Two whiplash severity grading systems have been developed: Quebec Task Force on Whiplash-Associated Disorders (QTF-WAD) and the Croft grading system. The majority of clinical studies to date have used the modified grading system published by the QTF-WAD in 1995 and have demonstrated some ability to predict outcome. But most studies include only injuries of lower severity (grades 1 and 2), preventing a broader interpretation. The purpose of this study was assess the ability of these grading systems to predict clinical outcome within the context of a broader injury spectrum. This study evaluated both grading systems for their ability to predict the bivalent outcome, recovery, within a sample of 118 whiplash patients who were part of a previous case-control designed study. Of these, 36% (controls) had recovered, and 64% (cases) had not recovered. The discrete bivariate distribution between recovery status and whiplash grade was analyzed using the 2-tailed cross-tabulation statistics. Applying the criteria of the original 1993 Croft grading system, the subset comprised 1 grade 1 injury, 32 grade 2 injuries, 53 grade 3 injuries, and 32 grade 4 injuries. Applying the criteria of the modified (QTF-WAD) grading system, there were 1 grade 1 injury, 89 grade 2 injuries, and 28 grade 3 injuries. Both whiplash grading systems correlated negatively with recovery; that is, higher severity grades predicted a lower probability of recovery, and statistically significant correlations were observed in both, but the Croft grading system substantially outperformed the QTF-WAD system on this measure. The Croft grading system for whiplash injury severity showed a better predictive measure for recovery status from whiplash injuries as compared with the QTF-WAD grading system.

  15. Prevalence of whiplash trauma in TMD patients: a systematic review.

    Science.gov (United States)

    Häggman-Henrikson, B; Rezvani, M; List, T

    2014-01-01

    The purpose of this systematic review was to describe the prevalence of whiplash trauma in patients with temporomandibular disorders (TMDs) and to describe clinical signs and symptoms in comorbid TMD/whiplash compared with TMD localised to the facial region. A systematic literature search of the PubMed, Cochrane Library and Bandolier databases was carried out for articles published from 1 January 1966 to 31 December 2012. The systematic search identified 129 articles. After the initial screening of abstracts, 32 articles were reviewed in full text applying inclusion and exclusion criteria. Six studies on the prevalence of neck trauma in patients with TMD met the inclusion criteria and were included in the review. Two of the authors evaluated the methodological quality of the included studies. The reported prevalence of whiplash trauma ranged from 8·4% to 70% (median 35%) in TMD populations, compared with 1·7-13% in the non-TMD control groups. Compared with patients with TMD localised to the facial region, TMD patients with a history of whiplash trauma reported more TMD symptoms, such as limited jaw opening and more TMD pain, and also more headaches and stress symptoms. In conclusion, the prevalence of whiplash trauma is higher in patients with TMD compared with non-TMD controls. Furthermore, patients with comorbid TMD/whiplash present with more jaw pain and more severe jaw dysfunction compared with TMD patients without a history of head-neck trauma. These results suggest that whiplash trauma might be an initiating and/or aggravating factor as well as a comorbid condition for TMD. © 2014 John Wiley & Sons Ltd.

  16. The effect of 3 different exercise approaches on neck muscle endurance, kinesiophobia, exercise compliance, and patient satisfaction in chronic whiplash.

    Science.gov (United States)

    Peterson, Gunnel E; Landén Ludvigsson, Maria H; O'Leary, Shaun P; Dedering, Åsa M; Wallman, Thorne; Jönsson, Margaretha I N; Peolsson, Anneli L C

    2015-09-01

    The purpose of this study was to compare the effects of 3 different exercise approaches on neck muscle endurance (NME), kinesiophobia, exercise compliance, and patient satisfaction in patients with chronic whiplash. This prospective randomized clinical trial included 216 individuals with chronic whiplash. Participants were randomized to 1 of 3 exercise interventions: neck-specific exercise (NSE), NSE combined with a behavioral approach (NSEB), or prescribed physical activity (PPA). Measures of ventral and dorsal NME (endurance time in seconds), perceived pain after NME testing, kinesiophobia, exercise compliance, and patient satisfaction were recorded at baseline and at the 3- and 6-month follow-ups. Compared with individuals in the prescribed physical activity group, participants in the NSE and NSEB groups exhibited greater gains in dorsal NME (P = .003), greater reductions in pain after NME testing (P = .03), and more satisfaction with treatment (P .07). Among patients with chronic whiplash, a neck-specific exercise intervention (with or without a behavioral approach) appears to improve NME. Participants were more satisfied with intervention including neck-specific exercises than with the prescription of general exercise. Copyright © 2015 National University of Health Sciences. Published by Elsevier Inc. All rights reserved.

  17. A Research Synthesis of Therapeutic Interventions for Whiplash-Associated Disorder: Part 1 – Overview and Summary

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    Robert W Teasell

    2010-01-01

    Full Text Available Whiplash-associated disorder (WAD represents a significant public health problem, resulting in a substantial socioeconomic burden throughout the industrialized world, wherever costs are documented. While many treatments have been advocated for patients with WAD, scientific evidence of their effectiveness is often lacking. A systematic review was conducted to evaluate the strength of evidence supporting various WAD therapies. Multiple databases (including Web of Science, EMBASE and PubMed were searched to identify all studies published from January 1980 through March 2009 that evaluated the effectiveness of any clearly defined treatment for acute (less than two weeks, subacute (two to 12 weeks or chronic (longer than 12 weeks WAD. The present article, the first in a five-part series, provides an overview of the review methodology as well as a summary and discussion of the review’s main findings. Eighty-three studies met the inclusion criteria, 40 of which were randomized controlled trials. The majority of studies (n=47 evaluated treatments initiated in the chronic stage of the disorder, while 23 evaluated treatments for acute WAD and 13 assessed therapies for subacute WAD. Exercise and mobilization programs for acute and chronic WAD had the strongest supporting evidence, although many questions remain regarding the relative effectiveness of various protocols. At present, there is insufficient evidence to support any treatment for subacute WAD. For patients with chronic WAD who do not respond to conventional treatments, it appears that radiofrequency neurotomy may be the most effective treatment option. The present review found a relatively weak but growing research base on which one could make recommendations for patients at any stage of the WAD continuum. Further research is needed to determine which treatments are most effective at reducing the disabling symptoms associated with WAD.

  18. Family planning to promote physical activity: a randomized controlled trial protocol.

    Science.gov (United States)

    Quinlan, Alison; Rhodes, Ryan E; Blanchard, Chris M; Naylor, Patti-Jean; Warburton, Darren E R

    2015-10-05

    Physical activity is associated with the reduction of several chronic conditions in adults. Additionally, physical activity is extremely important for children for their development and cognitive functioning and also to create a physically active lifestyle that continues into adulthood. Despite the known benefits of physical activity, only one in five adults are achieving the public health recommendations of 150 minutes of moderate-to-vigorous physical activity per week and only 13 % of boys and 6 % of girls between the ages of 5 and 17 years are meeting the guidelines of 60 minutes per day. This study aims to evaluate whether a planning condition improves adherence to regular physical activity compared to an education-only control condition among families. Families are eligible if there is at least one child between the ages of 6 and 12 years who is not meeting the Canadian Physical Activity Guidelines. A six-month longitudinal randomized controlled trial will be used to compare the two conditions. Materials will be delivered at baseline with 'booster' sessions at six weeks and three months. Participants will be assessed at baseline and at six months with a fitness test, as well as questionnaires and accelerometery at baseline, six weeks, three months and six months. A total of 137 families have been recruited thus far from Greater Victoria. This study is ongoing and recruitment will continue until December 2015 with the target goal of reaching 160 families. This protocol describes the implementation of a randomized controlled trial that utilizes planning strategies to try and increase physical activity among families. Research findings could be useful in public health in providing effective strategies to families to help decrease sedentary lifestyles. Additionally, findings may help to inform future interventions aimed at increasing physical activity among families. This trial was registered on June 5, 2012 with the Clinical Trials Registry maintained by the

  19. The Interface of Clinical Decision-Making With Study Protocols for Knowledge Translation From a Walking Recovery Trial.

    Science.gov (United States)

    Hershberg, Julie A; Rose, Dorian K; Tilson, Julie K; Brutsch, Bettina; Correa, Anita; Gallichio, Joann; McLeod, Molly; Moore, Craig; Wu, Sam; Duncan, Pamela W; Behrman, Andrea L

    2017-01-01

    Despite efforts to translate knowledge into clinical practice, barriers often arise in adapting the strict protocols of a randomized, controlled trial (RCT) to the individual patient. The Locomotor Experience Applied Post-Stroke (LEAPS) RCT demonstrated equal effectiveness of 2 intervention protocols for walking recovery poststroke; both protocols were more effective than usual care physical therapy. The purpose of this article was to provide knowledge-translation tools to facilitate implementation of the LEAPS RCT protocols into clinical practice. Participants from 2 of the trial's intervention arms: (1) early Locomotor Training Program (LTP) and (2) Home Exercise Program (HEP) were chosen for case presentation. The two cases illustrate how the protocols are used in synergy with individual patient presentations and clinical expertise. Decision algorithms and guidelines for progression represent the interface between implementation of an RCT standardized intervention protocol and clinical decision-making. In each case, the participant presents with a distinct clinical challenge that the therapist addresses by integrating the participant's unique presentation with the therapist's expertise while maintaining fidelity to the LEAPS protocol. Both participants progressed through an increasingly challenging intervention despite their own unique presentation. Decision algorithms and exercise progression for the LTP and HEP protocols facilitate translation of the RCT protocol to the real world of clinical practice. The two case examples to facilitate translation of the LEAPS RCT into clinical practice by enhancing understanding of the protocols, their progression, and their application to individual participants.Video Abstract available for more insights from the authors (see Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A147).

  20. Acupuncture, Counseling, and Usual care for Depression (ACUDep: study protocol for a randomized controlled trial

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    MacPherson Hugh

    2012-11-01

    Full Text Available Abstract Background The evidence on the effect of acupuncture or counseling for depression is not conclusive yet is sufficient to warrant further research. Our aim is to conduct a full-scale RCT to determine the clinical and cost effectiveness of acupuncture and counseling compared to usual care alone. We will explore the experiences and perspectives of patients and practitioners. Methods/Design Randomized controlled trial with three parallel arms: acupuncture plus usual care, counseling plus usual care, and usual care alone, in conjunction with a nested qualitative study using in-depth interviews with purposive samples of trial participants. Participants: Patients aged over 18 years diagnosed with depression or mood disorder by their GP and with a score of 20 or above on the Beck Depression Inventory (BDI-II. Randomization: Computer randomization by York Trials Unit to acupuncture, counseling, and usual care alone in proportions of 2:2:1, respectively, with secure allocation concealment. Interventions: Patients allocated to acupuncture and counseling groups receive the offer of up to 12 weekly sessions. Both interventions allow flexibility to address patient variation, yet are constrained within defined protocols. Acupuncture is based on traditional Chinese medicine and counseling is non-directive within the humanistic tradition. Outcome: The PHQ-9 is the primary outcome measure, collected at baseline, 3, 6, 9, and 12 months. Also measured is BDI-II, SF-36 Bodily pain subscale, and EQ-5D. Texted mood scores are collected weekly over the first 15 weeks. Health-related resource use is collected over 12 months. Analysis: The sample size target was for 640 participants, calculated for an effect size of 0.32 on the PHQ-9 when comparing acupuncture with counseling given 90% power, 5% significance, and 20% loss to follow-up. Analysis of covariance will be used on an intention-to-treat basis. Thematic analysis will be used for qualitative data. We will

  1. Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension.

    Science.gov (United States)

    Calvert, Melanie; Kyte, Derek; Mercieca-Bebber, Rebecca; Slade, Anita; Chan, An-Wen; King, Madeleine T; Hunn, Amanda; Bottomley, Andrew; Regnault, Antoine; Chan, An-Wen; Ells, Carolyn; O'Connor, Daniel; Revicki, Dennis; Patrick, Donald; Altman, Doug; Basch, Ethan; Velikova, Galina; Price, Gary; Draper, Heather; Blazeby, Jane; Scott, Jane; Coast, Joanna; Norquist, Josephine; Brown, Julia; Haywood, Kirstie; Johnson, Laura Lee; Campbell, Lisa; Frank, Lori; von Hildebrand, Maria; Brundage, Michael; Palmer, Michael; Kluetz, Paul; Stephens, Richard; Golub, Robert M; Mitchell, Sandra; Groves, Trish

    2018-02-06

    Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence to inform shared decision making, labeling claims, clinical guidelines, and health policy; however, the PRO content of clinical trial protocols is often suboptimal. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was published in 2013 and aims to improve the completeness of trial protocols by providing evidence-based recommendations for the minimum set of items to be addressed, but it does not provide PRO-specific guidance. To develop international, consensus-based, PRO-specific protocol guidance (the SPIRIT-PRO Extension). The SPIRIT-PRO Extension was developed following the Enhancing Quality and Transparency of Health Research (EQUATOR) Network's methodological framework for guideline development. This included (1) a systematic review of existing PRO-specific protocol guidance to generate a list of potential PRO-specific protocol items (published in 2014); (2) refinements to the list and removal of duplicate items by the International Society for Quality of Life Research (ISOQOL) Protocol Checklist Taskforce; (3) an international stakeholder survey of clinical trial research personnel, PRO methodologists, health economists, psychometricians, patient advocates, funders, industry representatives, journal editors, policy makers, ethicists, and researchers responsible for evidence synthesis (distributed by 38 international partner organizations in October 2016); (4) an international Delphi exercise (n = 137 invited; October 2016 to February 2017); and (5) consensus meeting (n = 30 invited; May 2017). Prior to voting, consensus meeting participants were informed of the results of the Delphi exercise and given data from structured reviews evaluating the PRO protocol content of 3 defined samples of trial protocols. The systematic review identified 162 PRO-specific protocol recommendations from 54 sources. The ISOQOL Taskforce (n

  2. Modulation of Cervical Facet Joint Nociception and Pain Attenuates Physical and Psychological Features of Chronic Whiplash: A Prospective Study.

    Science.gov (United States)

    Smith, Ashley Dean; Jull, Gwendolen; Schneider, Geoff M; Frizzell, Bevan; Hooper, Robert A; Sterling, Michele

    2015-09-01

    To investigate changes in clinical (physical and psychological) features of individuals with chronic whiplash-associated disorder who had previously undergone cervical radiofrequency neurotomy at the time point when the effects of radiofrequency neurotomy had dissipated and pain returned. Prospective cohort observational trial of consecutive patients. Tertiary spinal intervention centre in Calgary, Alberta, Canada. A total of 53 consecutive individuals with chronic whiplash-associated disorder. Individuals underwent radiofrequency neurotomy and were assessed before radiofrequency neurotomy, at 1 and 3 months postprocedure, and then after the return of pain (approximately 10 months postprocedure). Quantitative sensory tests (pressure; thermal pain thresholds; brachial plexus provocation test), nociceptive flexion reflex, and motor function (cervical range of movement; craniocervical flexion test) were measured. Self-reported disability, psychological distress, pain catastrophization, and posttraumatic stress disorder symptoms also were measured. Upon the return of pain after radiofrequency neurotomy, levels of disability increased (P .22). There were no significant changes in pressure hyperalgesia (P > .054) or craniocervical flexion test performance (P > .07) after the return of pain. Psychological distress and pain catastrophizing increased significantly after the return of pain (P .13). However, there was no difference in number or severity of posttraumatic stress symptoms after the return of pain (P > .30). Physical and psychological features of chronic whiplash-associated disorder are modulated dynamically with cervical radiofrequency neurotomy. These findings indicate that peripheral nociception is involved in the manifestations of chronic whiplash-associated disorder in this cohort of individuals. Copyright © 2015 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

  3. Study protocol for the evaluation of an Infant Simulator based program delivered in schools: a pragmatic cluster randomised controlled trial

    OpenAIRE

    Brinkman, Sally A; Johnson, Sarah E; Lawrence, David; Codde, James P; Hart, Michael B; Straton, Judith AY; Silburn, Sven

    2010-01-01

    Abstract Background This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such programs, there is no published evidence of their long-term impact. The aim of this trial is to evaluate the Virtual Infant Parenting (VIP) program by investigating pre-c...

  4. Lovastatin for adult patients with dengue: protocol for a randomised controlled trial

    Science.gov (United States)

    2012-01-01

    Background Dengue is the most important vector-borne viral infection of man, with approximately 2 billion people living in areas at risk. Infection results in a range of manifestations from asymptomatic infection through to life-threatening shock and haemorrhage. One of the hallmarks of severe dengue is vascular endothelial disruption. There is currently no specific therapy and clinical management is limited to supportive care. Statins are a class of drug initially developed for lipid lowering. There has been considerable recent interest in their effects beyond lipid lowering. These include anti-inflammatory effects at the endothelium. In addition, it is possible that lovastatin may have an anti-viral effect against dengue. Observational data suggest that the use of statins may improve outcomes for such conditions as sepsis and pneumonia. This paper describes the protocol for a randomised controlled trial investigating a short course of lovastatin therapy in adult patients with dengue. Methods/design A randomised, double-blind, placebo-controlled trial will investigate the effects of lovastatin therapy in the treatment of dengue. The trial will be conducted in two phases with an escalation of dose between phases if an interim safety review is satisfactory. This is an exploratory study focusing on safety and there are no data on which to base a sample size calculation. A target sample size of 300 patients in the second phase, enrolled over two dengue seasons, was chosen based on clinical judgement and feasibility considerations. In a previous randomised trial in dengue, about 10% and 30% of patients experienced at least one serious adverse event or adverse event, respectively. With 300 patients, we will have 80% power to detect an increase of 12% (from 10% to 22%) or 16% (from 30% to 46%) in the frequency of adverse events. Furthermore, this sample size ensures some power to explore the efficacy of statins. Discussion The development of a dengue therapeutic that can

  5. HEART: heart exercise and remote technologies: A randomized controlled trial study protocol

    Directory of Open Access Journals (Sweden)

    Kira Geoffrey

    2011-05-01

    Full Text Available Abstract Background Cardiovascular disease (CVD is the leading cause of death worldwide. Cardiac rehabilitation (CR is aimed at improving health behaviors to slow or reverse the progression of CVD disease. Exercise is a central element of CR. Technologies such as mobile phones and the Internet (mHealth offer potential to overcome many of the psychological, physical, and geographical barriers that have been associated with lack of participation in exercise-based CR. We aim to trial the effectiveness of a mobile phone delivered exercise-based CR program to increase exercise capacity and functional outcomes compared with usual CR care in adults with CVD. This paper outlines the rationale and methods of the trial. Methods A single-blinded parallel two-arm randomized controlled trial is being conducted. A total of 170 people will be randomized at 1:1 ratio either to receive a mHealth CR program or usual care. Participants are identified by CR nurses from two metropolitan hospitals in Auckland, New Zealand through outpatient clinics and existing databases. Consenting participants are contacted to attend a baseline assessment. The intervention consists of a theory-based, personalized, automated package of text and video message components via participants' mobile phones and the Internet to increase exercise behavior, delivered over six months. The control group will continue with usual CR. Data collection occurs at baseline and 24 weeks (post-intervention. The primary outcome is change in maximal oxygen uptake from baseline to 24 weeks. Secondary outcomes include post-intervention measures on self-reported physical activity (IPAQ, cardiovascular risk factors (systolic blood pressure, weight, and waist to hip ratio, health related quality of life (SF-36, and cost-effectiveness. Discussion This manuscript presents the protocol for a randomized controlled trial of a mHealth exercise-based CR program. Results of this trial will provide much needed

  6. Increasing girls’ physical activity during an organised youth sport basketball program: a randomised controlled trial protocol

    Science.gov (United States)

    2014-01-01

    Background Participation in organised youth sports (OYS) has been recommended as an opportunity to increase young peoples’ moderate-to-vigorous physical activity (MVPA) levels. Participants, however, spend a considerable proportion of time during OYS inactive. The purpose of this study, therefore, was to investigate whether coaches who attended coach education sessions (where education on increasing MVPA and decreasing inactivity during training was delivered) can increase players’ MVPA during training sessions over a 5-day basketball program compared to coaches who did not receive coach education sessions. Methods/design A convenience sample of 80 female players and 8 coaches were recruited into the UWS School Holiday Basketball Program in Greater Western Sydney, Australia. A two-arm, parallel-group randomised controlled trial was employed to investigate whether coaches who attended 2 coach education sessions (compared with a no-treatment control) can increase their players’ MVPA during training sessions over a 5-day basketball program. Objectively measured physical activity, directly observed lesson context and leader behaviour, player motivation, players’ perceived autonomy support, and coaching information (regarding training session planning, estimations on player physical activity and lesson context during training, perceived ability to modify training sessions, perceived importance of physical activity during training, intention to increase physical activity/reduce inactivity, and likelihood of increasing physical activity/reducing inactivity) were assessed at baseline (day 1) and at follow-up (day 5). Linear mixed models will be used to analyse between arm differences in changes from baseline to follow-up on all outcomes. Discussion The current trial protocol describes, to our knowledge, the first trial conducted in an OYS context to investigate the efficacy of an intervention, relative to a control, in increasing MVPA. This study’s findings will

  7. Evaluating the optimal timing of surgical antimicrobial prophylaxis: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Mujagic, Edin; Zwimpfer, Tibor; Marti, Walter R; Zwahlen, Marcel; Hoffmann, Henry; Kindler, Christoph; Fux, Christoph; Misteli, Heidi; Iselin, Lukas; Lugli, Andrea Kopp; Nebiker, Christian A; von Holzen, Urs; Vinzens, Fabrizio; von Strauss, Marco; Reck, Stefan; Kraljević, Marko; Widmer, Andreas F; Oertli, Daniel; Rosenthal, Rachel; Weber, Walter P

    2014-05-24

    Surgical site infections are the most common hospital-acquired infections among surgical patients. The administration of surgical antimicrobial prophylaxis reduces the risk of surgical site infections . The optimal timing of this procedure is still a matter of debate. While most studies suggest that it should be given as close to the incision time as possible, others conclude that this may be too late for optimal prevention of surgical site infections. A large observational study suggests that surgical antimicrobial prophylaxis should be administered 74 to 30 minutes before surgery. The aim of this article is to report the design and protocol of a randomized controlled trial investigating the optimal timing of surgical antimicrobial prophylaxis. In this bi-center randomized controlled trial conducted at two tertiary referral centers in Switzerland, we plan to include 5,000 patients undergoing general, oncologic, vascular and orthopedic trauma procedures. Patients are randomized in a 1:1 ratio into two groups: one receiving surgical antimicrobial prophylaxis in the anesthesia room (75 to 30 minutes before incision) and the other receiving surgical antimicrobial prophylaxis in the operating room (less than 30 minutes before incision). We expect a significantly lower rate of surgical site infections with surgical antimicrobial prophylaxis administered more than 30 minutes before the scheduled incision. The primary outcome is the occurrence of surgical site infections during a 30-day follow-up period (one year with an implant in place). When assuming a 5% surgical site infection risk with administration of surgical antimicrobial prophylaxis in the operating room, the planned sample size has an 80% power to detect a relative risk reduction for surgical site infections of 33% when administering surgical antimicrobial prophylaxis in the anesthesia room (with a two-sided type I error of 5%). We expect the study to be completed within three years. The results of this

  8. [Development of clinical trial education program for pharmaceutical science students through small group discussion and role-playing using protocol].

    Science.gov (United States)

    Imakyure, Osamu; Shuto, Hideki; Nishikawa, Fumi; Hagiwara, Yoshifuka; Inoue, Sachiko; Koyanagi, Taeko; Hirakawa, Masaaki; Kataoka, Yasufumi

    2010-08-01

    The acquirement of basic knowledge of clinical trials and professional attitude in their practices is a general instructional objective in the Model Core Curriculum for Pharmaceutical Education. Unfortunately, the previous program of clinical trial education was not effective in the acquirement of a professional attitude in their practices. Then, we developed the new clinical trial education program using protocol through small group discussion (SGD) and roll-playing. Our program consists of 7 steps of practical training. In step 1, the students find some problems after presentation of the protocol including case and prescription. In step 2, they analyse the extracted problems and share the information obtained in SGD. In steps 3 and 5, five clinical case scenarios are presented to the students and they discuss which case is suitable for entry to the clinical trial or which case corresponds to the discontinuance criteria in the present designed protocol. In steps 4 and 6, the roll-playing is performed by teachers and students as doctors and clinical research coordinators (CRC) respectively. Further, we conducted a trial practice based on this program for the students. In the student's self-evaluation into five grades, the average score of the skill acquisition level in each step was 3.8-4.7 grade. Our clinical trial education program could be effective in educating the candidates for CRC or clinical pharmacists.

  9. Isometric muscle fatigue of the paravertebral and upper extremity muscles after whiplash injury.

    Science.gov (United States)

    Rastovic, Pejana; Gojanovic, Marija Definis; Berberovic, Marina; Pavlovic, Marko; Lesko, Josip; Galic, Gordan; Pandza, Maja

    2017-01-01

    Whiplash-associated disorders (WAD) result from injury of neck structures that most often occur during traffic accidents as a result of rapid acceleration-deceleration. The dominant symptoms manifest in the musculoskeletal system and include increased fatigue. Because of the frequency of whiplash injuries, a simple, cheap and useful diagnostic tool is needed to differentiate whiplash injury from healthy patients or those faking symptoms. To determine muscle fatigue in patients with whiplash injury in six body positions. Analytical cross-sectional study. Emergency center, university hospital. We studied patients with whiplash injury from vehicular traffic accidents who presented to the emergency center within 6 hours of sustaining the injury. We determined whiplash injury grade according to the Quebec Task Force (QTF) classification and measured isometric muscle endurance in six different body positions. Control subjects for each patient were matched by age, gender and anthropomorphic characteristics. Cut-off values were determined to distinguish patients with whiplash injury from controls and for determination of injury grade . QTF grade, time to muscle fatigue in seconds. From September 2013 to September 2016, we enrolled 75 patients with whiplash injury and 75 matching control subjects. In all six positions, the patients with whiplash injury felt muscle fatigue faster than equivalent controls (P whiplash injury grade in all six positions (P whiplash injury and grade. The size of the sample was small. An objective parameter such as electromyography is needed to confirm isometric muscle fatigue.

  10. Validity and internal consistency of a whiplash-specific disability measure.

    Science.gov (United States)

    Pinfold, Melanie; Niere, Ken R; O'Leary, Elizabeth F; Hoving, Jan Lucas; Green, Sally; Buchbinder, Rachelle

    2004-02-01

    Cross-sectional study of patients with whiplash-associated disorders investigating the internal consistency, factor structure, response rates, and presence of floor and ceiling effects of the Whiplash Disability Questionnaire (WDQ). The aim of this study was to confirm the appropriateness of the proposed WDQ items. Whiplash injuries are a common cause of pain and disability after motor vehicle accidents. Neck disability questionnaires are often used in whiplash studies to assess neck pain but lack content validity for patients with whiplash-associated disorders. The newly developed WDQ measures functional limitations associated with whiplash injury and was designed after interviews with 83 patients with whiplash in a previous study. Researchers sought expert opinion on items of the WDQ, and items were then tested on a clinical whiplash population. Data were inspected to determine floor and ceiling effects, response rates, factor structure, and internal consistency. Packages of questionnaires were distributed to 55 clinicians, whose patients with whiplash completed and returned 101 questionnaires to researchers. No substantial floor or ceiling effects were identified on inspection of data. The overall floor effect was 12%, and the overall ceiling effect was 4%. Principal component analysis identified one broad factor that accounted for 65% of the variance in responses. Internal consistency was high; Cronbach's alpha = 0.96. Results of the study supported the retention of the 13 proposed items in a whiplash-specific disability questionnaire. Dependent on the results of further psychometric testing, the WDQ is likely to be an appropriate outcome measure for patients with whiplash.

  11. A blinded randomised placebo-controlled trial investigating the efficacy of morphine analgesia for procedural pain in infants: Trial protocol.

    Science.gov (United States)

    Slater, Rebeccah; Hartley, Caroline; Moultrie, Fiona; Adams, Eleri; Juszczak, Ed; Rogers, Richard; Norman, Jane E; Patel, Chetan; Stanbury, Kayleigh; Hoskin, Amy; Green, Gabrielle

    2016-11-15

    Infant pain has both immediate and long-term negative consequences, yet in clinical practice it is often undertreated. To date, few pain-relieving drugs have been tested in infants. Morphine is a potent analgesic that provides effective pain relief in adults, but there is inconclusive evidence for its effectiveness in infants. The purpose of this study is to establish whether oral morphine provides effective analgesia for procedural pain in infants. A blinded, placebo-controlled, parallel-group randomized, phase II, clinical trial will be undertaken to determine whether morphine sulphate administered orally prior to clinically-required retinopathy of prematurity (ROP) screening and heel lancing provides effective analgesia. 
156 infants between 34 and 42 weeks' gestational age who require a clinical heel lance and ROP screening on the same test occasion will be included in the trial. Infants will be randomised to receive either a single dose of morphine sulphate (100 μg/kg) or placebo. Each infant will be monitored for 48 hours and safety data will be collected during the 24 hours following drug administration. The primary outcome will be the Premature Infant Pain Profile-revised (PIPP-R) score 30 seconds after ROP screening. The co-primary outcome will be the magnitude of nociceptive-specific brain activity evoked by a clinically-required heel lance. Infant clinical stability will be assessed by comparing the number of episodes of bradycardia, tachycardia, desaturation and apnoea, and changes in respiratory support requirements in the 24-hour periods before and after the clinical intervention. In addition, drug safety will be assessed by considering the occurrence of apnoeic and hypotensive episodes requiring intervention in the 24-hour period following drug administration. This study has been published as an Accepted Protocol Summary by The Lancet .

  12. Psychiatric morbidity in patients with chronic whiplash-associated disorder.

    Science.gov (United States)

    Kivioja, Jouko; Själin, Mikael; Lindgren, Urban

    2004-06-01

    Prospective cohort with age- and gender-matched controls. To compare psychiatric morbidity between two groups: patients having chronic symptoms after a whiplash injury and patients who recovered completely. Psychiatric morbidity may influence the outcome of somatic diseases, and it has been suggested that psychological factors are often involved in the development of chronic symptoms after whiplash injuries, but there is no study assessing psychiatric morbidity in whiplash-associated disorder (WAD) using the Structured Clinical Interview for DSM-IV. We studied a consecutive sample of 278 patients with a whiplash injury. Eighty-five had persisting neck pain after 1 year, and 38 of these participated in this study. For each patient with chronic neck pain at the 1 year follow-up, a gender- and age-matched recovered patient was selected from the study cohort of 278 cases. Psychiatric morbidity was determined using the Structured Clinical Interview for DSM-IV (SCID). The interview was conducted at 1 year after the accident (360 days, SD 2 days). The chronic WAD group had a significantly (P factor for chronic symptoms after a whiplash injury. The development of chronic symptoms after awhiplash injury seems to be associated with psychiatric vulnerability.

  13. Transcranial direct current stimulation for depression in Alzheimer's disease: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Narita, Zui; Yokoi, Yuma

    2017-06-19

    Patients with Alzheimer's disease frequently elicit neuropsychiatric symptoms as well as cognitive deficits. Above all, depression is one of the most common neuropsychiatric symptoms in Alzheimer's disease but antidepressant drugs have not shown significant beneficial effects on it. Moreover, electroconvulsive therapy has not ensured its safety for potential severe adverse events although it does show beneficial clinical effect. Transcranial direct current stimulation can be the safe alternative of neuromodulation, which applies weak direct electrical current to the brain. Although transcranial direct current stimulation has plausible evidence for its effect on depression in young adult patients, no study has explored it in older subjects with depression in Alzheimer's disease. Therefore, we present a study protocol designed to evaluate the safety and clinical effect of transcranial direct current stimulation on depression in Alzheimer's disease in subjects aged over 65 years. This is a two-arm, parallel-design, randomized controlled trial, in which patients and assessors will be blinded. Subjects will be randomized to either an active or a sham transcranial direct current stimulation group. Participants in both groups will be evaluated at baseline, immediately, and 2 weeks after the intervention. This study investigates the safety and effect of transcranial direct current stimulation that may bring a significant impact on both depression and cognition in patients with Alzheimer's disease, and may be useful to enhance their quality of life. ClinicalTrials.gov, NCT02351388 . Registered on 27 January 2015. Last updated on 30 May 2016.

  14. Dry needling in a manual physiotherapy and therapeutic exercise protocol for patients with chronic mechanical shoulder pain of unspecific origin: a protocol for a randomized control trial.

    Science.gov (United States)

    Tejera-Falcón, Emma; Toledo-Martel, Nuria Del Carmen; Sosa-Medina, Francisco Manuel; Santana-González, Fátima; Quintana-de la Fe, Miriam Del Pino; Gallego-Izquierdo, Tomás; Pecos-Martín, Daniel

    2017-09-18

    Shoulder pain of musculoskeletal origin is the main cause of upper limb pain of non-traumatic origin. Despite being one of the most common reasons for consultation, there is no established protocol for treatment due to the complexity of its etiology. However, it has been shown that the presence of myofascial trigger points on the shoulder muscles is a common condition associated with patients suffering from shoulder pain. This protocol has been created which describes the design of a randomized controlled trial to evaluate the effectiveness of the inclusion of dry needling (DN) within a protocol of manual physiotherapy and therapeutic exercise in the treatment of chronic shoulder pain of unspecific origin. Thirty-six participants aged 18-65 years will be recruited having mechanical chronic shoulder pain on unspecific origin and meeting the inclusion criteria. These will be randomized to one of two interventions, (i) DN, manual physiotherapy and therapeutic exercise or (ii) sham DN, manual physiotherapy and therapeutic exercise. The protocol will cover 6 weeks of treatment, with a 6-month follow-up. Our main outcome measure will be the Visual Analogue Scale for pain. This is the first study to combine the use of DN, manual physiotherapy and an exercise program with a 6-month follow-up, thus becoming a new contribution to the treatment of chronic shoulder pain, while new lines of research may be established to help determine the effects of DN on chronic shoulder pain and the frequency and proper dosage. International Standard Randomized Controlled Trial Number Register: ISRCTN30604244 ( http://www.controlled-trials.com ) 29 June 2016.

  15. Hepatitis C - Assessment to Treatment Trial (HepCATT) in primary care: study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Roberts, Kirsty; Macleod, John; Metcalfe, Chris; Simon, Joanne; Horwood, Jeremy; Hollingworth, William; Marlowe, Sharon; Gordon, Fiona H; Muir, Peter; Coleman, Barbara; Vickerman, Peter; Harrison, Graham I; Waldron, Cherry-Ann; Irving, William; Hickman, Matthew

    2016-07-29

    Public Health England (PHE) estimates that there are upwards of 160,000 individuals in England and Wales with chronic hepatitis C virus (HCV) infection, but until now only around 100,000 laboratory diagnoses have been reported to PHE and of these 28,000 have been treated. Targeted case-finding in primary care is estimated to be cost-effective; however, there has been no robust randomised controlled trial evidence available of specific interventions. Therefore, this study aims to develop and conduct a complex intervention within primary care and to evaluate this approach using a cluster randomised controlled trial. A total of 46 general practices in South West England will be randomised in a 1:1 ratio to receive either a complex intervention comprising: educational training on HCV for the practice; poster and leaflet display in the practice waiting rooms to raise awareness and encourage opportunistic testing; a HCV risk prediction algorithm based on information on possible risk markers in the electronic patient record run using Audit + software (BMJ Informatica). The audit will then be used to recall and offer patients a HCV test. Control practices will follow usual care. The effectiveness of the intervention will be measured by comparing number and rates of HCV testing, the number and proportion of patients testing positive, onward referral, rates of specialist assessment and treatment in control and intervention practices. Intervention costs and health service utilisation will be recorded to estimate the NHS cost per new HCV diagnosis and new HCV patient initiating treatment. Longer-term cost-effectiveness of the intervention in improving quality-adjusted life years (QALYs) will be extrapolated using a pre-existing dynamic health economic model. Patients' and health care workers' experiences and acceptability of the intervention will be explored through semi-structured qualitative interviews. This trial has the potential to make an important impact on patient

  16. Impact of using a local protocol in preoperative testing: blind randomized clinical trial.

    Science.gov (United States)

    Santos, Mônica Loureiro; Iglesias, Antônio Carlos

    2017-01-01

    to evaluate the impact of the use of a local protocol of preoperative test requests in reducing the number of exams requested and in the occurrence of changes in surgical anesthetic management and perioperative complications. we conducted a randomized, blinded clinical trial at the Gaffrée and Guinle University Hospital with 405 patients candidates for elective surgery randomly divided into two groups, according to the practice of requesting preoperative exams: a group with non-selectively requested exams and a protocol group with exams requested according to the study protocol. Studied exams: complete blood count, coagulogram, glycemia, electrolytes, urea and creatinine, ECG and chest X-ray. Primary outcomes: changes in surgical anesthetic management caused by abnormal exams, reduction of the number of exams requested after the use of the protocol and perioperative complications. there was a significant difference (pgrupos segundo a prática de solicitação de exames pré-operatórios: grupo Rotina com exames solicitados de maneira não seletiva e grupo Protocolo com exames solicitados de acordo com o protocolo em estudo. Exames em estudo: hemograma, coagulograma, glicemia, eletrólitos, ureia e creatinina, ECG e radiografia de tórax. Desfechos primários: alterações na conduta anestésico-cirúrgica motivadas por exames anormais, redução do número de exames solicitados após o uso do protocolo e complicações perioperatórias. foi observada diferença significativa (pgrupos (14,9% x 29,1%) e redução de 57,3% no número de exames pedidos entre os dois grupos (pgrupos. Na análise multivariada hemograma e coagulograma foram os únicos exames capazes de modificar a conduta anestésico-cirúrgica. o protocolo proposto foi efetivo em eliminar um quantitativo significativo de exames complementares sem indicação clínica, sem que houvesse aumento na morbidade e mortalidades perioperatórias.

  17. Evaluation of a physical activity intervention for new parents: protocol paper for a randomized trial

    Directory of Open Access Journals (Sweden)

    Alison Quinlan

    2017-11-01

    Full Text Available Abstract Background Identifying critical life transitions in people’s physical activity behaviors may illuminate the most opportune intervention apertures for chronic disease prevention. A substantive evidence base now indicates that parenthood is one of these critical transition points for physical activity decline. This study will examine whether a brief theory-based intervention can prevent a decline in physical activity among new parents over 6 months following intervention. This study protocol represents the first dyad-based physical activity initiative in the parenthood literature involving both mothers and fathers; prior research has focused on only mothers or only fathers (albeit limited, and has shown only short-term changes in physical activity. This study will be investigating whether a theory-based physical activity intervention can maintain or improve moderate to vigorous intensity physical activity measured via accelerometry of new parents over a 6 month period following intervention compared to a control group. Methods This study is a 6-month longitudinal randomized controlled trial. Parents are measured at baseline (2 months postpartum with two assessment points at 6 weeks (3.5 months postpartum and 3 months (5 months postpartum and a final follow-up assessment at 6 months (8 months postpartum. The content of the theory-based intervention was derived from the results of our prior longitudinal trial of new parents using an adapted theory of planned behavior framework to predict changes in physical activity. Results A total of 152 couples have been recruited to date. Sixteen couples dropped out after baseline and a total of 88 couples have completed their 6-month measures. Discussion If the intervention proves successful, couple-based physical activity promotion efforts among parents could be a promising avenue to pursue to help mitigate the declines of physical activity levels during parenthood. These findings could inform

  18. Prednisolone and acupuncture in Bell's palsy: study protocol for a randomized, controlled trial

    Directory of Open Access Journals (Sweden)

    Wang Kangjun

    2011-06-01

    Full Text Available Abstract Background There are a variety of treatment options for Bell's palsy. Evidence from randomized controlled trials indicates corticosteroids can be used as a proven therapy for Bell's palsy. Acupuncture is one of the most commonly used methods to treat Bell's palsy in China. Recent studies suggest that staging treatment is more suitable for Bell's palsy, according to different path-stages of this disease. The aim of this study is to compare the effects of prednisolone and staging acupuncture in the recovery of the affected facial nerve, and to verify whether prednisolone in combination with staging acupuncture is more effective than prednisolone alone for Bell's palsy in a large number of patients. Methods/Design In this article, we report the design and protocol of a large sample multi-center randomized controlled trial to treat Bell's palsy with prednisolone and/or acupuncture. In total, 1200 patients aged 18 to 75 years within 72 h of onset of acute, unilateral, peripheral facial palsy will be assessed. There are six treatment groups, with four treated according to different path-stages and two not. These patients are randomly assigned to be in one of the following six treatment groups, i.e. 1 placebo prednisolone group, 2 prednisolone group, 3 placebo prednisolone plus acute stage acupuncture group, 4 prednisolone plus acute stage acupuncture group, 5 placebo prednisolone plus resting stage acupuncture group, 6 prednisolone plus resting stage acupuncture group. The primary outcome is the time to complete recovery of facial function, assessed by Sunnybrook system and House-Brackmann scale. The secondary outcomes include the incidence of ipsilateral pain in the early stage of palsy (and the duration of this pain, the proportion of patients with severe pain, the occurrence of synkinesis, facial spasm or contracture, and the severity of residual facial symptoms during the study period. Discussion The result of this trial will assess the

  19. A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol.

    Science.gov (United States)

    Block, Gladys; Azar, Kristen Mj; Block, Torin J; Romanelli, Robert J; Carpenter, Heather; Hopkins, Donald; Palaniappan, Latha; Block, Clifford H

    2015-01-21

    In the United States, 86 million adults have pre-diabetes. Evidence-based interventions that are both cost effective and widely scalable are needed to prevent diabetes. Our goal was to develop a fully automated diabetes prevention program and determine its effectiveness in a randomized controlled trial. Subjects with verified pre-diabetes were recruited to participate in a trial of the effectiveness of Alive-PD, a newly developed, 1-year, fully automated behavior change program delivered by email and Web. The program involves weekly tailored goal-setting, team-based and individual challenges, gamification, and other opportunities for interaction. An accompanying mobile phone app supports goal-setting and activity planning. For the trial, participants were randomized by computer algorithm to start the program immediately or after a 6-month delay. The primary outcome measures are change in HbA1c and fasting glucose from baseline to 6 months. The secondary outcome measures are change in HbA1c, glucose, lipids, body mass index (BMI), weight, waist circumference, and blood pressure at 3, 6, 9, and 12 months. Randomization and delivery of the intervention are independent of clinic staff, who are blinded to treatment assignment. Outcomes will be evaluated for the intention-to-treat and per-protocol populations. A total of 340 subjects with pre-diabetes were randomized to the intervention (n=164) or delayed-entry control group (n=176). Baseline characteristics were as follows: mean age 55 (SD 8.9); mean BMI 31.1 (SD 4.3); male 68.5%; mean fasting glucose 109.9 (SD 8.4) mg/dL; and mean HbA1c 5.6 (SD 0.3)%. Data collection and analysis are in progress. We hypothesize that participants in the intervention group will achieve statistically significant reductions in fasting glucose and HbA1c as compared to the control group at 6 months post baseline. The randomized trial will provide rigorous evidence regarding the efficacy of this Web- and Internet-based program in reducing or

  20. Streamlining tasks and roles to expand treatment and care for HIV: randomised controlled trial protocol

    Directory of Open Access Journals (Sweden)

    van Vuuren Cloete

    2008-04-01

    Full Text Available Abstract Background A major barrier to accessing free government-provided antiretroviral treatment (ART in South Africa is the shortage of suitably skilled health professionals. Current South African guidelines recommend that only doctors should prescribe ART, even though most primary care is provided by nurses. We have developed an effective method of educational outreach to primary care nurses in South Africa. Evidence is needed as to whether primary care nurses, with suitable training and managerial support, can initiate and continue to prescribe and monitor ART in the majority of ART-eligible adults. Methods/design This is a protocol for a pragmatic cluster randomised trial to evaluate the effectiveness of a complex intervention based on and supporting nurse-led antiretroviral treatment (ART for South African patients with HIV/AIDS, compared to current practice in which doctors are responsible for initiating ART and continuing prescribing. We will randomly allocate 31 primary care clinics in the Free State province to nurse-led or doctor-led ART. Two groups of patients aged 16 years and over will be included: a 7400 registering with the programme with CD4 counts of ≤ 350 cells/mL (mainly to evaluate treatment initiation and b 4900 already receiving ART (to evaluate ongoing treatment and monitoring. The primary outcomes will be time to death (in the first group and viral suppression (in the second group. Patients' survival, viral load and health status indicators will be measured at least 6-monthly for at least one year and up to 2 years, using an existing province-wide clinical database linked to the national death register. Trial registration Controlled Clinical Trials ISRCTN46836853

  1. Electroacupuncture for tapering off long-term benzodiazepine use: study protocol of randomized controlled trial.

    Science.gov (United States)

    Yeung, Wing-Fai; Chung, Ka-Fai; Zhang, Zhang-Jin; Chan, Wai-Chi; Zhang, Shi-Ping; Ng, Roger Man-Kin; Chan, Connie Lai-Wah; Ho, Lai-Ming; Yu, Yee-Man; Lao, Li-Xing

    2017-03-31

    Conventional approaches for benzodiazepine tapering have their limitations. Anecdotal studies have shown that acupuncture is a potential treatment for facilitating successful benzodiazepine tapering. As of today, there was no randomized controlled trial examining its efficacy and safety. The purpose of the study is to evaluate the efficacy of using electroacupuncture as an adjunct treatment to gradual tapering of benzodiazepine doses in complete benzodiazepine cessation in long-term benzodiazepine users. The study protocol of a randomized, assessor- and subject-blinded, controlled trial is presented. One hundred and forty-four patients with histories of using benzodiazepines in ≥50% of days for more than 3 months will be randomly assigned in a 1:1 ratio to receive either electroacupuncture or placebo electroacupuncture combined with gradual benzodiazepine tapering schedule. Both experimental and placebo treatments will be delivered twice per week for 4 weeks. Major assessments will be conducted at baseline, week 6 and week 16 post-randomization. Primary outcome is the cessation rate of benzodiazepine use. Secondary outcomes include the percentage change in the doses of benzodiazepine usage and the severity of withdrawal symptoms experienced based on the Benzodiazepine Withdrawal Symptom Questionnaire, insomnia as measured by the Insomnia Severity Index, and anxiety and depressive symptoms as evaluated by the Hospital Anxiety and Depression Scale. Adverse events will also be measured at each study visit. Results of this study will provide high quality evidence of the efficacy and safety of electroacupuncture as an adjunct treatment for benzodiazepine tapering in long-term users. ClinicalTrials.gov NCT02475538 .

  2. Do Subjects with Whiplash-Associated Disorders Respond Differently in the Short-Term to Manual Therapy and Exercise than Those with Mechanical Neck Pain?

    Science.gov (United States)

    Castaldo, Matteo; Catena, Antonella; Chiarotto, Alessandro; Fernández-de-Las-Peñas, César; Arendt-Nielsen, Lars

    2017-04-01

    To compare the short-term effects of manual therapy and exercise on pain, related disability, range of motion, and pressure pain thresholds between subjects with mechanical neck pain and whiplash-associated disorders. Twenty-two subjects with mechanical neck pain and 28 with whiplash-associated disorders participated. Clinical and physical outcomes including neck pain intensity, neck-related disability, and pain area, as well as cervical range of motion and pressure pain thresholds over the upper trapezius and tibialis anterior muscles, were obtained at baseline and after the intervention by a blinded assessor. Each subject received six sessions of manual therapy and specific neck exercises. Mixed-model repeated measures analyses of covariance (ANCOVAs) were used for the analyses. Subjects with whiplash-associated disorders exhibited higher neck-related disability ( P  = 0.021), larger pain area ( P  = 0.003), and lower pressure pain thresholds in the tibialis anterior muscle ( P  = 0.009) than those with mechanical neck pain. The adjusted ANCOVA revealed no between-group differences for any outcome (all P  > 0.15). A significant main effect of time was demonstrated for clinical outcomes and cervical range of motion with both groups experiencing similar improvements (all P   0.222). The current clinical trial found that subjects with mechanical neck pain and whiplash-associated disorders exhibited similar clinical and neurophysiological responses after a multimodal physical therapy intervention, suggesting that although greater signs of central sensitization are present in subjects with whiplash-associated disorders, this does not alter the response in the short term to manual therapy and exercises. © 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  3. Whiplash-associated disorder: musculoskeletal pain and related clinical findings

    Science.gov (United States)

    Sterling, Michele

    2011-01-01

    The aim of this paper was to review the physical and psychological processes associated with whiplash-associated disorders. There is now much scientific data available to indicate the presence of disturbed nociceptive processing, stress system responses, muscle and motor changes as well as psychological factors in both acute and chronic whiplash-associated disorders. Some of these factors seem to be associated with the transition from acute to chronic pain and have demonstrated prognostic capacity. Further investigation is required to determine if these processes can be modified and if modification will lead to improved outcomes for this condition. The burden of whiplash injuries, the high rate of transition to chronicity, and evidence of limited effects of current management on transition rates demand new directions in evaluation and management. The understanding of processes underlying this condition is improving and this lays the foundation for the development of more effective management approaches. PMID:23115472

  4. Why blame is a factor in recovery from whiplash injury.

    Science.gov (United States)

    Ferrari, R; Russell, A S

    2001-03-01

    The biopsychosocial model of chronic whiplash continues to evolve. An aspect of the medicolegal and social dilemma of whiplash that has been largely unresearched is the impression in clinical practice of how seldom drivers who caused the collision present with chronic whiplash symptoms. There are potential biological (injury threshold and mechanism), psychological, and social explanations for this observation, and these flow from the same biopsychosocial model that addresses the progression from acute to chronic pain. This article explores each of these factors as they relate to the disparate experiences of the driver at-fault ('blamed') for the collision, and the not-at-fault driver ('innocent victim'). Recent research lends further support to the hypothesis that a biopsychosocial model best explains this phenomenon. Copyright DUMMY.

  5. Predicting recovery from whiplash injury in the primary care setting.

    Science.gov (United States)

    Ferrari, Robert

    2014-08-01

    The effect of expectation of recovery on the recovery rate of whiplash patients in the primary care setting is not known. Whiplash patients were assessed in a primary care setting within 1 week of their collision for their expectations of recovery and were re-examined 3 months later for recovery. Initial expectations of recovery predicted recovery. According to adjusted odds ratios, subjects who expected 'to get better slowly' had a recovery rate that was nearly 1.9 times that of subjects with poor recovery expectations. Subjects who expected 'to get better soon' had a recovery rate that was 2.6 times greater than either of those with poor recovery expectations. In the primary care setting, asking patients with whiplash about their expectations of recovery is a useful predictor of their outcome.

  6. Examining the impact of genetic testing for type 2 diabetes on health behaviors: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Voils Corrine I

    2012-08-01

    Full Text Available Abstract Background We describe the study design, procedures, and development of the risk counseling protocol used in a randomized controlled trial to evaluate the impact of genetic testing for diabetes mellitus (DM on psychological, health behavior, and clinical outcomes. Methods/Design Eligible patients are aged 21 to 65 years with body mass index (BMI ≥27 kg/m2 and no prior diagnosis of DM. At baseline, conventional DM risk factors are assessed, and blood is drawn for possible genetic testing. Participants are randomized to receive conventional risk counseling for DM with eye disease counseling or with genetic test results. The counseling protocol was pilot tested to identify an acceptable graphical format for conveying risk estimates and match the length of the eye disease to genetic counseling. Risk estimates are presented with a vertical bar graph denoting risk level with colors and descriptors. After receiving either genetic counseling regarding risk for DM or control counseling on eye disease, brief lifestyle counseling for prevention of DM is provided to all participants. Discussion A standardized risk counseling protocol is being used in a randomized trial of 600 participants. Results of this trial will inform policy about whether risk counseling should include genetic counseling. Trial registration ClinicalTrials.gov Identifier NCT01060540

  7. Alcohol handrubbing and chlorhexidine handwashing protocols for routine hospital practice: A randomized clinical trial of protocol efficacy and time effectiveness

    NARCIS (Netherlands)

    Chow, Angela; Arah, Onyebuchi A.; Chan, Siew-Pang; Poh, Bee-Fong; Krishnan, Prabha; Ng, Woei-Kian; Choudhury, Saugata; Chan, Joey; Ang, Brenda

    2012-01-01

    Background: The World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) recommend the use of alcohol handrubs to prevent health care-associated infections. However, the efficacy and time effectiveness of different alcohol handrubbing protocols have yet to be

  8. Determining the Optimal Protocol for Measuring an Albuminuria Class Transition in Clinical Trials in Diabetic Kidney Disease

    DEFF Research Database (Denmark)

    Kröpelin, Tobias F; de Zeeuw, Dick; Remuzzi, Giuseppe

    2016-01-01

    Albuminuria class transition (normo- to micro- to macroalbuminuria) is used as an intermediate end point to assess renoprotective drug efficacy. However, definitions of such class transition vary between trials. To determine the most optimal protocol, we evaluated the approaches used in four...... effect increased (decreased precision) with stricter end point definitions, resulting in a loss of statistical significance. In conclusion, the optimal albuminuria transition end point for use in drug intervention trials can be determined with a single urine collection for albuminuria assessment per...... clinical trials testing the effect of renin-angiotensin-aldosterone system intervention on albuminuria class transition in patients with diabetes: the BENEDICT, the DIRECT, the ALTITUDE, and the IRMA-2 Trial. The definition of albuminuria class transition used in each trial differed from the definitions...

  9. An attempt of early detection of poor outcome after whiplash

    Directory of Open Access Journals (Sweden)

    Sebastien LAPORTE

    2016-10-01

    Full Text Available The main concern with whiplash is that a large proportion of whiplash patients experience disabling symptoms or whiplash associated disorders (WAD for months if not years following the accident. Therefore, identifying early prognostic factors of WAD development is important as WAD have widespread clinical and economic consequences.In order to tackle that question, our study was specifically aimed at combining several methods of investigation in the same WAD patients at the acute stage and six months later. Our longitudinal, open, prospective, multi-center study included 38 whiplash patients, and 13 healthy volunteers matched for age, gender, and socio-economic status with the whiplash group. Whiplash patients were evaluated 15 to 21 days after road accident, and 6 months later. At each appointment, patients underwent a neuropsychological evaluation, a full clinical neurological examination, neurophysiological and postural tests, oto-neurological tests, cervical spine cord Magnetic Resonance Imaging (MRI with tractography (DTI. At 6-month, whiplash patients were categorized into two subgroups based on the results of the Diagnostic and Statistical Manual of Mental Disorders as having either favourable or unfavourable progression (an unfavourable classification corresponding to the presence of Post-Concussion Symptom PCS and we searched retrospectively for early prognostic factors of WAD predicting the passage to chronicity. We found that patients displaying high level of catastrophizing at the acute stage and /or post-traumatic stress disorder associated with either abnormalities in head or trunk kinematics, abnormal test of the otolithic function and at the Equitest or a combination of these syndromes, turned to chronicity. That is, the association of a neuropsychological disorder with a somatic one was sufficient to explain the passage to chronicity. This study suggests that low-grade whiplash patients should be submitted as early as possible

  10. Hyperextension strain of ''whiplash'' injuries to the cervical spine

    International Nuclear Information System (INIS)

    Griffiths, H.J.; Olson, P.N.; Everson, L.I.; Winemiller, M.

    1995-01-01

    A full cervical spine radiographic series (including flexion and extension views) was reviewed in 40 patients with clinically proven ''whiplash'' injuries and compared to the radiographs in 105 normal controls. The level and degree of kinking or kyphosis, subluxation, and the difference in the amount of fanning between spinous processes on flexion and extension films were measured in each patient. Localized kinking greater than 10 and over 12 mm of fanning, often occurring at the level below the kinking or kyphosis, occurred mainly in the group of whiplash patients (sensitivity 81%, specificity 76%, accuracy 80%). (orig./VHE)

  11. An Attempt of Early Detection of Poor Outcome after Whiplash

    Science.gov (United States)

    Laporte, Sebastien; Wang, Danping; Lecompte, Jennyfer; Blancho, Sophie; Sandoz, Baptiste; Feydy, Antoine; Lindberg, Pavel; Adrian, Julien; Chiarovano, Elodie; de Waele, Catherine; Vidal, Pierre-Paul

    2016-01-01

    The main concern with whiplash is that a large proportion of whiplash patients experience disabling symptoms or whiplash-associated disorders (WAD) for months if not years following the accident. Therefore, identifying early prognostic factors of WAD development is important as WAD have widespread clinical and economic consequences. In order to tackle that question, our study was specifically aimed at combining several methods of investigation in the same WAD patients at the acute stage and 6 months later. Our longitudinal, open, prospective, multi-center study included 38 whiplash patients, and 13 healthy volunteers matched for age, gender, and socio-economic status with the whiplash group. Whiplash patients were evaluated 15–21 days after road accident, and 6 months later. At each appointment, patients underwent a neuropsychological evaluation, a full clinical neurological examination, neurophysiological and postural tests, oto-neurological tests, cervical spine cord magnetic resonance imaging (MRI) with tractography (DTI). At 6 months, whiplash patients were categorized into two subgroups based on the results of the Diagnostic and Statistical Manual of Mental Disorders as having either favorable or unfavorable progression [an unfavorable classification corresponding to the presence of post-concussion symptom (PCS)] and we searched retrospectively for early prognostic factors of WAD predicting the passage to chronicity. We found that patients displaying high level of catastrophizing at the acute stage and/or post-traumatic stress disorder associated with either abnormalities in head or trunk kinematics, abnormal test of the otolithic function and at the Equitest or a combination of these syndromes, turned to chronicity. This study suggests that low-grade whiplash patients should be submitted as early as possible after the trauma to neuropsychological and motor control tests in a specialized consultation. In addition, they should be evaluated by a neuro

  12. [Literature review of whiplash injuries of the cervical spine].

    Science.gov (United States)

    Pavić, Roman

    2011-01-01

    The paper presents the latest information in world literature on whiplash injury of the cervical spine. This injury has been noted through history, mentioned as early as Ancient Egypt, and prevalent in the 19 century, the time before using the car, until today. The mechanism of injury is described, as well as treatment, and news in view of the frequency of injuries in different parts of the world and the impact of socio-cultural, economic, ethnic and geographic factors. Impacts of traffic laws, automobile production and automobile seats that would indicate the possibility of prevention as a result of a whiplash injury of the cervical spine are also presented.

  13. Hyperextension strain of ``whiplash`` injuries to the cervical spine

    Energy Technology Data Exchange (ETDEWEB)

    Griffiths, H.J. [Dept. of Radiology, Univ. of Minnesota Hospital and Clinic, Minneapolis, MN (United States); Olson, P.N. [Dept. of Radiology, Univ. of Minnesota Hospital and Clinic, Minneapolis, MN (United States); Everson, L.I. [Dept. of Radiology, Univ. of Minnesota Hospital and Clinic, Minneapolis, MN (United States); Winemiller, M. [Dept. of Radiology, Univ. of Minnesota Hospital and Clinic, Minneapolis, MN (United States)

    1995-05-01

    A full cervical spine radiographic series (including flexion and extension views) was reviewed in 40 patients with clinically proven ``whiplash`` injuries and compared to the radiographs in 105 normal controls. The level and degree of kinking or kyphosis, subluxation, and the difference in the amount of fanning between spinous processes on flexion and extension films were measured in each patient. Localized kinking greater than 10 and over 12 mm of fanning, often occurring at the level below the kinking or kyphosis, occurred mainly in the group of whiplash patients (sensitivity 81%, specificity 76%, accuracy 80%). (orig./VHE)

  14. Physical activity as a treatment for depression: the TREAD randomised trial protocol

    Directory of Open Access Journals (Sweden)

    Lawlor Debbie A

    2010-11-01

    Full Text Available Abstract Background Depression is one of the most common reasons for consulting a General Practitioner (GP within the UK. Whilst antidepressants have been shown to be clinically effective, many patients and healthcare professionals would like to access other forms of treatment as an alternative or adjunct to drug therapy for depression. A recent systematic review presented some evidence that physical activity could offer one such option, although further investigation is needed to test its effectiveness within the context of the National Health Service. The aim of this paper is to describe the protocol for a randomised, controlled trial (RCT designed to evaluate an intervention developed to increase physical activity as a treatment for depression within primary care. Methods/design The TREAD study is a pragmatic, multi-centre, two-arm RCT which targets patients presenting with a new episode of depression. Patients were approached if they were aged 18-69, had recently consulted their GP for depression and, where appropriate, had been taking antidepressants for less than one month. Only those patients with a confirmed diagnosis of a depressive episode as assessed by the Clinical Interview Schedule-Revised (CIS-R, a Beck Depression Inventory (BDI score of at least 14 and informed written consent were included in the study. Eligible patients were individually randomised to one of two treatment groups; usual GP care or usual GP care plus facilitated physical activity. The primary outcome of the trial is clinical symptoms of depression assessed using the BDI four months after randomisation. A number of secondary outcomes are also measured at the 4-, 8- and 12-month follow-up points including quality of life, attitude to and involvement in physical activity and antidepressant use/adherence. Outcomes will be analysed on an intention-to-treat (ITT basis and will use linear and logistic regression models to compare treatments. Discussion The results of

  15. Functional rehabilitation of upper limb apraxia in poststroke patients: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Pérez-Mármol, Jose Manuel; García-Ríos, M Carmen; Barrero-Hernandez, Francisco J; Molina-Torres, Guadalupe; Brown, Ted; Aguilar-Ferrándiz, María Encarnación

    2015-11-05

    expected to clarify the effectiveness of a combined functional rehabilitation approach compared to a conservative intervention for improving upper limb movement and function in poststroke patients. Clinical Trial Gov number NCT02199093 . The protocol registration was received 23 July 2014. Participant enrollment began on 1 May 2014. The trial is expected to be completed in March 2016.

  16. The FiCTION dental trial protocol – filling children’s teeth: indicated or not?

    Science.gov (United States)

    2013-01-01

    ; incidence of caries in primary and permanent teeth, patient quality of life, cost-effectiveness, acceptability of treatment strategies to patients and parents and their experiences, and dentists’ preferences. Discussion FiCTION will provide evidence for the most clinically-effective and cost-effective approach to managing caries in children’s primary teeth in Primary Care. This will support general dental practitioners in treatment decision making for child patients to minimize pain and infection in primary teeth. The trial is currently recruiting patients. Trial registration Protocol ID: NCTU: ISRCTN77044005 PMID:23725316

  17. Evaluation of a physical activity intervention for new parents: protocol paper for a randomized trial.

    Science.gov (United States)

    Quinlan, Alison; Rhodes, Ryan E; Beauchamp, Mark R; Symons Downs, Danielle; Warburton, Darren E R; Blanchard, Chris M

    2017-11-09

    Identifying critical life transitions in people's physical activity behaviors may illuminate the most opportune intervention apertures for chronic disease prevention. A substantive evidence base now indicates that parenthood is one of these critical transition points for physical activity decline. This study will examine whether a brief theory-based intervention can prevent a decline in physical activity among new parents over 6 months following intervention. This study protocol represents the first dyad-based physical activity initiative in the parenthood literature involving both mothers and fathers; prior research has focused on only mothers or only fathers (albeit limited), and has shown only short-term changes in physical activity. This study will be investigating whether a theory-based physical activity intervention can maintain or improve moderate to vigorous intensity physical activity measured via accelerometry of new parents over a 6 month period following intervention compared to a control group. This study is a 6-month longitudinal randomized controlled trial. Parents are measured at baseline (2 months postpartum) with two assessment points at 6 weeks (3.5 months postpartum) and 3 months (5 months postpartum) and a final follow-up assessment at 6 months (8 months postpartum). The content of the theory-based intervention was derived from the results of our prior longitudinal trial of new parents using an adapted theory of planned behavior framework to predict changes in physical activity. A total of 152 couples have been recruited to date. Sixteen couples dropped out after baseline and a total of 88 couples have completed their 6-month measures. If the intervention proves successful, couple-based physical activity promotion efforts among parents could be a promising avenue to pursue to help mitigate the declines of physical activity levels during parenthood. These findings could inform public health materials and practitioners. This trial has been

  18. Management of whiplash injuries presenting to accident and emergency departments in Wales

    Science.gov (United States)

    Logan, A; Holt, M

    2003-01-01

    Methods: Questionnaires were sent to 76 full time accident and emergency staff across Wales inquiring into their management of soft tissue sprains/strains of the neck and soft collar use. Results: The overall response rate was 74% (SHO 70%, registrar 65%, consultant 100%). Half of consultants and more than half of the middle grade and junior staff reported soft collar use in this condition. As required wear was most commonly recommended and instructions for use ranged from one day only to until the patient was pain free. Conclusion: The study recommends treatment protocols for whiplash injuries prescribing regular analgesia, early home exercises with the help of an advice sheet, and physiotherapy if symptoms persist. PMID:12835348

  19. Peer mentorship to promote effective pain management in adolescents: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Hayes Loran P

    2011-05-01

    Full Text Available Abstract Background This protocol is for a study of a new program to improve outcomes in children suffering from chronic pain disorders, such as fibromyalgia, recurrent headache, or recurrent abdominal pain. Although teaching active pain self-management skills through cognitive-behavioral therapy (CBT or a complementary program such as hypnotherapy or yoga has been shown to improve pain and functioning, children with low expectations of skill-building programs may lack motivation to comply with therapists' recommendations. This study will develop and test a new manualized peer-mentorship program which will provide modeling and reinforcement by peers to other adolescents with chronic pain (the mentored participants. The mentorship program will encourage mentored participants to engage in therapies that promote the learning of pain self-management skills and to support the mentored participants' practice of these skills. The study will examine the feasibility of this intervention for both mentors and mentored participants, and will assess the preliminary effectiveness of this program on mentored participants' pain and functional disability. Methods This protocol will recruit adolescents ages 12-17 with chronic pain and randomly assign them to either peer mentorship or a treatment-as-usual control group. Mentored participants will be matched with peer mentors of similar age (ages 14-18 who have actively participated in various treatment modalities through the UCLA Pediatric Pain Program and have learned to function successfully with a chronic pain disorder. The mentors will present information to mentored participants in a supervised and monitored telephone interaction for 2 months to encourage participation in skill-building programs. The control group will receive usual care but without the mentorship intervention. Mentored and control subjects' pain and functioning will be assessed at 2 months (end of intervention for mentored participants and

  20. The notion of a “whiplash culture”: a review of the evidence

    Science.gov (United States)

    Haneline, Michael T.

    2009-01-01

    Objective Most whiplash patients eventually recover, although some are left with ongoing pain and impairment. Why some develop long-term symptoms after whiplash, whereas others do not, is largely unknown. One explanation blames the cultural expectations of the population wherein the injury occurred, engendering the moniker whiplash culture. The purpose of this review was to locate and discuss studies that were used as a basis for developing the whiplash culture concept and to evaluate its plausibility. Methods The PubMed database was searched using combinations of the terms whiplash culture, whiplash OR WAD, and chronic OR late OR long term. Search dates spanned from 1950 to June 2008. Filters were set to only retrieve English-language citations. Articles that dealt with the whiplash culture were selected and examined to determine which studies had been used to create the concept. Results Nineteen articles discussed the cultural aspects of whiplash and were explored to determine which were used as a basis for the whiplash culture. Eight studies were found that met this final criterion. Conclusion There are many unanswered questions about the basis of chronic whiplash, and the notion of a whiplash culture is controversial. Chronic whiplash symptoms are surely not caused entirely by cultural issues, yet they are probably not entirely physical. Presumably, a tissue injury component exists in most chronic whiplash-associated disorder victims that becomes aggravated in those who are susceptible to biopsychosocial factors. As with many other controversial health care topics, the answer to the debate probably lies somewhere in the middle. PMID:19703667

  1. What occupant kinematics and neuromuscular responses tell us about whiplash injury.

    Science.gov (United States)

    Siegmund, Gunter P

    2011-12-01

    Literature-based review. To review the published data on occupant kinematic and neuromuscular responses during low-speed impacts and analyze how these data inform our understanding of whiplash injury. A stereotypical kinematic and neuromuscular response has been observed in human subjects exposed to rear-end impacts. Combined with various models of injury, these response data have been used to develop anti-whiplash seats that prevent whiplash injury in many, but not all, individuals exposed to a rear-end crash. Synthesis of the literature. Understanding of the occupant kinematics and neuromuscular responses, combined with data from various seat-related interventions, have shown that differential motion between the superior and inferior ends of the cervical spine is responsible for many whiplash injuries. The number of whiplash injuries not prevented by current anti-whiplash seats suggests than further work remains, possibly related to designing seats that respond dynamically to the occupant and collision properties. Neck muscles alter the head and neck kinematics during the interval in which injury likely occurs, even in initially relaxed occupants. It remains unclear whether muscle activation mitigates or exacerbates whiplash injury. If muscle activation mitigates injury, then advance warning could be used to help occupant tense their muscles before impact. Alternatively, if muscle activation exacerbates whiplash injury, then a loud preimpact sound that uncouples the startle and postural components of the muscle response could reduce peak muscle activation during a whiplash exposure. Our improved understanding of whiplash injury has led to anti-whiplash seats that have prevented many whiplash injuries. Further work remains to optimize these and possibly other systems to further reduce the number of whiplash injuries.

  2. Effectiveness of a transdiagnostic internet-based protocol for the treatment of emotional disorders versus treatment as usual in specialized care: study protocol for a randomized controlled trial.

    Science.gov (United States)

    González-Robles, Alberto; García-Palacios, Azucena; Baños, Rosa; Riera, Antonio; Llorca, Ginés; Traver, Francisco; Haro, Gonzalo; Palop, Vicente; Lera, Guillem; Romeu, José Enrique; Botella, Cristina

    2015-10-31

    Emotional disorders (depression and anxiety disorders) are highly prevalent mental health problems. Although evidence showing the effectiveness of disorder-specific treatments exists, high comorbidity rates among emotional disorders limit the utility of these protocols. This has led some researchers to focus their interest on transdiagnostic interventions, a treatment perspective that might be more widely effective across these disorders. Also, the current way of delivering treatments makes it difficult provide assistance to all of the population in need. The use of the Internet in the delivery of evidence-based treatments may help to disseminate treatments among the population. In this study, we aim to test the effectiveness of EmotionRegulation, a new transdiagnostic Internet-based protocol for unipolar mood disorders, five anxiety disorders (panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder and anxiety disorder not otherwise specified), and obsessive-compulsive disorder in comparison to treatment as usual as provided in Spanish public specialized mental health care. We will also study its potential impact on basic temperament dimensions (neuroticism/behavioral inhibition and extraversion/behavioral activation). Expectations and opinions of patients about this protocol will also be studied. The study is a randomized controlled trial. 200 participants recruited in specialized care will be allocated to one of two treatment conditions: a) EmotionRegulation or b) treatment as usual. Primary outcome measures will be the BAI and the BDI-II. Secondary outcomes will include a specific measure of the principal disorder, and measures of neuroticism/behavioral inhibition and extraversion/behavioral activation. Patients will be assessed at baseline, post-treatment, and 3- and 12-month follow-ups. Intention to treat and per protocol analyses will be performed. Although the effectiveness of face-to-face transdiagnostic protocols has been

  3. Music therapy in Huntington's disease: a protocol for a multi-center randomized controlled trial.

    Science.gov (United States)

    van Bruggen-Rufi, Monique; Vink, Annemieke; Achterberg, Wilco; Roos, Raymund

    2016-07-26

    Huntington's disease is a progressive, neurodegenerative disease with autosomal dominant inheritance, characterized by motor disturbances, cognitive decline and behavioral and psychological symptoms. Since there is no cure, all treatment is aimed at improving quality of life. Music therapy is a non-pharmacological intervention, aiming to improve the quality of life, but its use and efficacy in patients with Huntington's disease has hardly been studied. In this article, a protocol is described to study the effects of music therapy in comparison with a control intervention to improve quality of life through stimulating expressive and communicative skills. By targeting these skills we assume that the social-cognitive functioning will improve, leading to a reduction in behavioral problems, resulting in an overall improvement of the quality of life in patients with Huntington's disease. The study is designed as a multi-center single-blind randomised controlled intervention trial. Sixty patients will be randomised using centre-stratified block-permuted randomisation. Patients will be recruited from four long-term care facilities specialized in Huntington's disease-care in The Netherlands. The outcome measure to assess changes in expressive and communication skills is the Behaviour Observation Scale Huntington and changes in behavior will be assessed by the Problem Behaviour Assesment-short version and by the BOSH. Measurements take place at baseline, then 8, 16 (end of intervention) and 12 weeks after the last intervention (follow-up). This randomized controlled study will provide greater insight into the effectiveness of music therapy on activities of daily living, social-cognitive functioning and behavior problems by improving expressive and communication skills, thus leading to a better quality of life for patients with Huntington's disease. Netherlands Trial Register: NTR4904 , registration date Nov. 15, 2014.

  4. Balance circuit classes to improve balance among rehabilitation inpatients: a protocol for a randomised controlled trial.

    Science.gov (United States)

    Treacy, Daniel; Schurr, Karl; Sherrington, Catherine

    2013-07-20

    -based physiotherapy at the study site as well as across other rehabilitation inpatient settings. The protocol for this study is registered with the Australian New Zealand, Clinical Trials Registry: ACTRN=12611000412932.

  5. Shared decision making for stroke prevention in atrial fibrillation: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Kunneman, Marleen; Branda, Megan E; Noseworthy, Peter A; Linzer, Mark; Burnett, Bruce; Dick, Sara; Spencer-Bonilla, Gabriela; Fernandez, Cara A; Gorr, Haeshik; Wambua, Mike; Keune, Shelly; Zeballos-Palacios, Claudia; Hargraves, Ian; Shah, Nilay D; Montori, Victor M

    2017-09-29

    Nonvalvular atrial fibrillation (AF) is a common ongoing health problem that places patients at risk of stroke. Whether and how a patient addresses this risk depends on each patient's goals, context, and values. Consequently, leading cardiovascular societies recommend using shared decision making (SDM) to individualize antithrombotic treatment in patients with AF. The aim of this study is to assess the extent to which the ANTICOAGULATION CHOICE conversation tool promotes high-quality SDM and influences anticoagulation uptake and adherence in patients with AF at risk of strokes. This study protocol describes a multicenter, encounter-level, randomized trial to assess the effect of using the ANTICOAGULATION CHOICE conversation tool in the clinical encounter, compared to usual care. The participating centers include an academic hospital system, a suburban community group practice, and an urban safety net hospital, all in Minnesota, USA. Patients with ongoing nonvalvular AF at risk of strokes (CHA 2 DS 2 -VASc score ≥ 1 in men, or ≥ 2 in women) will be eligible for participation. We aim to include 999 patients and their clinicians. The primary outcome is the quality of SDM as perceived by participants, and as assessed by a post-encounter survey that ascertains (a) knowledge transfer, (b) concordance of the decision made, (c) quality of communication, and (d) satisfaction with the decision-making process. Recordings of encounters will be reviewed to assess the extent of patient involvement and how participants use the tool (fidelity). Anticoagulant use, choice of agent, and adherence will be drawn from patients' medical and pharmacy records. Strokes and bleeding events will be drawn from patient records. This study will provide a valid and precise measure of the effect of the ANTICOAGULATION CHOICE conversation tool on SDM quality and processes, and on the treatment choices and adherence to therapy among AF patients at risk of stroke. ClinicalTrials.gov, NCT

  6. A trial of a job-specific workers' health surveillance program for construction workers: study protocol

    Directory of Open Access Journals (Sweden)

    Sluiter Judith K

    2011-09-01

    Full Text Available Abstract Background Dutch construction workers are offered periodic health examinations. This care can be improved by tailoring this workers health surveillance (WHS to the demands of the job and adjust the preventive actions to the specific health risks of a worker in a particular job. To improve the quality of the WHS for construction workers and stimulate relevant job-specific preventive actions by the occupational physician, we have developed a job-specific WHS. The job-specific WHS consists of modules assessing both physical and psychological requirements. The selected measurement instruments chosen, are based on their appropriateness to measure the workers' capacity and health requirements. They include a questionnaire and biometrical tests, and physical performance tests that measure physical functional capabilities. Furthermore, our job-specific WHS provides occupational physicians with a protocol to increase the worker-behavioural effectiveness of their counselling and to stimulate job-specific preventive actions. The objective of this paper is to describe and clarify our study to evaluate the behavioural effects of this job-specific WHS on workers and occupational physicians. Methods/Design The ongoing study of bricklayers and supervisors is a nonrandomised trial to compare the outcome of an intervention (job-specific WHS group (n = 206 with that of a control (WHS group (n = 206. The study includes a three-month follow-up. The primary outcome measure is the proportion of participants who have undertaken one or more of the preventive actions advised by their occupational physician in the three months after attending the WHS. A process evaluation will be carried out to determine context, reach, dose delivered, dose received, fidelity, and satisfaction. The present study is in accordance with the TREND Statement. Discussion This study will allow an evaluation of the behaviour of both the workers and occupational physician regarding the

  7. Increasing organ donation via anticipated regret (INORDAR: protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    O'Carroll Ronan E

    2012-03-01

    Full Text Available Abstract Background Throughout the world there is an insufficient supply of donor organs to meet the demand for organ transplantations. This paper presents a protocol for a randomised controlled trial, testing whether a simple, theory-based anticipated regret manipulation leads to a significant increase in posthumous organ donor registrations. Methods We will use a between-groups, prospective randomised controlled design. A random sample of 14,520 members of the adult Scottish general public will be contacted via post. These participants will be randomly allocated into 1 of the 4 conditions. The no questionnaire control (NQC group will simply receive a letter and donor registration form. The questionnaire control (QC arm will receive a questionnaire measuring their emotions and non-cognitive affective attitudes towards organ donation. The theory of planned behavior (TPB group will complete the emotions and affective attitudes questionnaire plus additional items assessing their cognitive attitudes towards organ donation, perceived control over registration and how they think significant others view this action. Finally, the anticipated regret (AR group will complete the same indices as the TPB group, plus two additional anticipated regret items. These items will assess the extent to which the participant anticipates regret for not registering as an organ donor in the near future. The outcome variable will be NHS Blood and Transplant verified registrations as an organ donor within 6 months of receiving our postal intervention. Discussion This study will assess whether simply asking people to reflect on the extent to which they may anticipate regret for not registering as an organ donor increases organ donor registration 6 months later. If successful, this simple and easy to administer theory-based intervention has the potential to save lives and money for the NHS by reducing the number of people receiving treatments such as dialysis. This

  8. Targeted full energy and protein delivery in critically ill patients: a study protocol for a pilot randomised control trial (FEED Trial

    Directory of Open Access Journals (Sweden)

    Kate Fetterplace

    2018-02-01

    Full Text Available Abstract Background Current guidelines for the provision of protein for critically ill patients are based on incomplete evidence, due to limited data from randomised controlled trials. The present pilot randomised controlled trial is part of a program of work to expand knowledge about the clinical effects of protein delivery to critically ill patients. The primary aim of this pilot study is to determine whether an enteral feeding protocol using a volume target, with additional protein supplementation, delivers a greater amount of protein and energy to mechanically ventilated critically ill patients than a standard nutrition protocol. The secondary aims are to evaluate the potential effects of this feeding strategy on muscle mass and other patient-centred outcomes. Methods This prospective, single-centred, pilot, randomised control trial will include 60 participants who are mechanically ventilated and can be enterally fed. Following informed consent, the participants receiving enteral nutrition in the intensive care unit (ICU will be allocated using a randomisation algorithm in a 1:1 ratio to the intervention (high-protein daily volume-based feeding protocol, providing 25 kcal/kg and 1.5 g/kg protein or standard care (hourly rate-based feeding protocol providing 25 kcal/kg and 1 g/kg protein. The co-primary outcomes are the average daily protein and energy delivered to the end of day 15 following randomisation. The secondary outcomes include change in quadriceps muscle layer thickness (QMLT from baseline (prior to randomisation to ICU discharge and other nutritional and patient-centred outcomes. Discussion This trial aims to examine whether a volume-based feeding protocol with supplemental protein increases protein and energy delivery. The potential effect of such increases on muscle mass loss will be explored. These outcomes will assist in formulating larger randomised control trials to assess mortality and morbidity. Trial registration

  9. Engaging Moms on Teen Indoor Tanning Through Social Media: Protocol of a Randomized Controlled Trial.

    Science.gov (United States)

    Pagoto, Sherry L; Baker, Katie; Griffith, Julia; Oleski, Jessica L; Palumbo, Ashley; Walkosz, Barbara J; Hillhouse, Joel; Henry, Kimberly L; Buller, David B

    2016-11-29

    . This trial will deliver social media content grounded in theory and will test it in a randomized design with state-of-the-art measures. This will contribute much needed insights on how to employ social media for health behavior change and disease prevention both for indoor tanning and other health risk behaviors and inform future social media efforts by public health and health care organizations. Clinicaltrials.gov NCT02835807; https://clinicaltrials.gov/ct2/show/NCT02835807 (Archived by WebCite at http://www.webcitation.org/6mDMICcCE). ©Sherry L Pagoto, Katie Baker, Julia Griffith, Jessica L Oleski, Ashley Palumbo, Barbara J Walkosz, Joel Hillhouse, Kimberly L Henry, David B Buller. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 29.11.2016.

  10. Physical activity as a treatment for depression: the TREAD randomised trial protocol.

    Science.gov (United States)

    Baxter, Helen; Winder, Rachel; Chalder, Melanie; Wright, Christine; Sherlock, Sofie; Haase, Anne; Wiles, Nicola J; Montgomery, Alan A; Taylor, Adrian H; Fox, Ken R; Lawlor, Debbie A; Peters, Tim J; Sharp, Deborah J; Campbell, John; Lewis, Glyn

    2010-11-12

    Depression is one of the most common reasons for consulting a General Practitioner (GP) within the UK. Whilst antidepressants have been shown to be clinically effective, many patients and healthcare professionals would like to access other forms of treatment as an alternative or adjunct to drug therapy for depression. A recent systematic review presented some evidence that physical activity could offer one such option, although further investigation is needed to test its effectiveness within the context of the National Health Service.The aim of this paper is to describe the protocol for a randomised, controlled trial (RCT) designed to evaluate an intervention developed to increase physical activity as a treatment for depression within primary care. The TREAD study is a pragmatic, multi-centre, two-arm RCT which targets patients presenting with a new episode of depression. Patients were approached if they were aged 18-69, had recently consulted their GP for depression and, where appropriate, had been taking antidepressants for less than one month. Only those patients with a confirmed diagnosis of a depressive episode as assessed by the Clinical Interview Schedule-Revised (CIS-R), a Beck Depression Inventory (BDI) score of at least 14 and informed written consent were included in the study. Eligible patients were individually randomised to one of two treatment groups; usual GP care or usual GP care plus facilitated physical activity. The primary outcome of the trial is clinical symptoms of depression assessed using the BDI four months after randomisation. A number of secondary outcomes are also measured at the 4-, 8- and 12-month follow-up points including quality of life, attitude to and involvement in physical activity and antidepressant use/adherence. Outcomes will be analysed on an intention-to-treat (ITT) basis and will use linear and logistic regression models to compare treatments. The results of the trial will provide information about the effectiveness of

  11. Person-centered care planning and service engagement: a study protocol for a randomized controlled trial.

    Science.gov (United States)

    Stanhope, Victoria; Tondora, Janis; Davidson, Larry; Choy-Brown, Mimi; Marcus, Steven C

    2015-04-22

    interpretation of outcomes. The aim of this study is to generate valuable guidance for state systems engaged in scale-up and transformation efforts. Targeted staff selection for training to support sustainability will serve to provide further insight into important intervention implementation strategies. Person-centered care planning has the potential to enhance the impact of all evidence-based and recovery-oriented practices and bring practice into line with the emerging national guidelines in health care reform. This trial was registered with ClinicalTrials.gov (Identifier: NCT02299492) on 21 November 2014 as New York University Protocol Record PCCP-13-9762, Person-Centered Care Planning and Service Engagement.

  12. Promoting psychosocial well-being following stroke: study protocol for a randomized, controlled trial.

    Science.gov (United States)

    Kirkevold, Marit; Kildal Bragstad, Line; Bronken, Berit A; Kvigne, Kari; Martinsen, Randi; Gabrielsen Hjelle, Ellen; Kitzmüller, Gabriele; Mangset, Margrete; Angel, Sanne; Aadal, Lena; Eriksen, Siren; Wyller, Torgeir B; Sveen, Unni

    2018-04-03

    Stroke is a major public health threat globally. Psychosocial well-being may be affected following stroke. Depressive symptoms, anxiety, general psychological distress and social isolation are prevalent. Approximately one third report depressive symptoms and 20% report anxiety during the first months or years after the stroke. Psychosocial difficulties may impact significantly on long-term functioning and quality of life, reduce the effects of rehabilitation services and lead to higher mortality rates. The aim of the study is to evaluate the effect of a previously developed and feasibility tested dialogue-based psychosocial intervention aimed at promoting psychosocial well-being and coping following stroke among stroke survivors with and without aphasia. The study will be conducted as a multicenter, randomized, single blind controlled trial with one intervention and one control arm. It will include a total of 330 stroke survivors randomly allocated into either an intervention group (dialogue-based intervention to promote psychosocial well-being) or a control group (usual care). Participants in the intervention group will receive eight individual sessions of supported dialogues in their homes during the first six months following an acute stroke. The primary outcome measure will be psychosocial well-being measured by the General Health Questionnaire (GHQ). Secondary outcome measures will be quality of life (SAQoL), sense of coherence (SOC), and depression (Yale). Process evaluation will be conducted in a longitudinal mixed methods study by individual qualitative interviews with 15-20 participants in the intervention and control groups, focus group interviews with the intervention personnel and data collectors, and a comprehensive analysis of implementation fidelity. The intervention described in this study protocol is based on thorough development and feasibility work, guided by the UK medical research council framework for developing and testing complex

  13. The FiCTION dental trial protocol - filling children's teeth: indicated or not?

    Science.gov (United States)

    Innes, Nicola P T; Clarkson, Jan E; Speed, Chris; Douglas, Gail V A; Maguire, Anne

    2013-06-01

    permanent teeth, patient quality of life, cost-effectiveness, acceptability of treatment strategies to patients and parents and their experiences, and dentists’ preferences. FiCTION will provide evidence for the most clinically-effective and cost-effective approach to managing caries in children's primary teeth in Primary Care. This will support general dental practitioners in treatment decision making for child patients to minimize pain and infection in primary teeth. The trial is currently recruiting patients. Protocol ID: NCTU: ISRCTN77044005.

  14. Psychosocial therapy for Parkinson's-related dementia: study protocol for the INVEST randomised controlled trial.

    Science.gov (United States)

    McCormick, Sheree A; McDonald, Kathryn R; Vatter, Sabina; Orgeta, Vasiliki; Poliakoff, Ellen; Smith, Sarah; Silverdale, Monty A; Fu, Bo; Leroi, Iracema

    2017-06-19

    Parkinson's disease (PD) with mild cognitive impairment (MCI-PD) or dementia (PDD) and dementia with Lewy bodies (DLB) are characterised by motor and 'non-motor' symptoms which impact on quality of life. Treatment options are generally limited to pharmacological approaches. We developed a psychosocial intervention to improve cognition, quality of life and companion burden for people with MCI-PD, PDD or DLB. Here, we describe the protocol for a single-blind randomised controlled trial to assess feasibility, acceptability and tolerability of the intervention and to evaluate treatment implementation. The interaction among the intervention and selected outcome measures and the efficacy of this intervention in improving cognition for people with MCI-PD, PDD or DLB will also be explored. Dyads will be randomised into two treatment arms to receive either 'treatment as usual' (TAU) or cognitive stimulation therapy specifically adapted for Parkinson's-related dementias (CST-PD), involving 30 min sessions delivered at home by the study companion three times per week over 10 weeks. A mixed-methods approach will be used to collect data on the operational aspects of the trial and treatment implementation. This will involve diary keeping, telephone follow-ups, dyad checklists and researcher ratings. Analysis will include descriptive statistics summarising recruitment, acceptability and tolerance of the intervention, and treatment implementation. To pilot an outcome measure of efficacy, we will undertake an inferential analysis to test our hypothesis that compared with TAU, CST-PD improves cognition. Qualitative approaches using thematic analysis will also be applied. Our findings will inform a larger definitive trial. Ethical opinion was granted (REC reference: 15/YH/0531). Findings will be published in peer-reviewed journals and at conferences. We will prepare reports for dissemination by organisations involved with PD and dementia. ISRCTN (ISRCTN11455062). © Article author

  15. Chronic Neck Pain and Whiplash: A Case-Control Study of the Relationship between Acute Whiplash Injuries and Chronic Neck Pain

    Directory of Open Access Journals (Sweden)

    Michael D Freeman

    2006-01-01

    Full Text Available The authors undertook a case-control study of chronic neck pain and whiplash injuries in nine states in the United States to determine whether whiplash injuries contributed significantly to the population of individuals with chronic neck and other spine pain.

  16. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis.

    Directory of Open Access Journals (Sweden)

    Jeppe Bennekou Schroll

    2016-08-01

    Full Text Available Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs from the European Medicines Agency through the Freedom of Information Act. The CSRs describe the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials.We received the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on PubMed and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were "bothersome," a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal, which meant that one trial had more withdrawals due to adverse events in the placebo group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc filters, though six of

  17. Clinical Trials

    Medline Plus

    Full Text Available ... Trial Protocol Each clinical trial has a master plan called a protocol (PRO-to-kol). This plan explains how the trial will work. The trial ... clinical trial; and detailed information about the treatment plan. Eligibility Criteria A clinical trial's protocol describes what ...

  18. UK Dermatology Clinical Trials Network’s STOP GAP trial (a multicentre trial of prednisolone versus ciclosporin for pyoderma gangrenosum: protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Craig Fiona F

    2012-04-01

    Full Text Available Abstract Background Pyoderma gangrenosum (PG is a rare inflammatory skin disorder characterised by painful and rapidly progressing skin ulceration. PG can be extremely difficult to treat and patients often require systemic immunosuppression. Recurrent lesions of PG are common, but the relative rarity of this condition means that there is a lack of published evidence regarding its treatment. A systematic review published in 2005 found no randomised controlled trials (RCTs relating to the treatment of PG. Since this time, one small RCT has been published comparing infliximab to placebo, but none of the commonly used systemic treatments for PG have been formally assessed. The UK Dermatology Clinical Trials Network’s STOP GAP Trial has been designed to address this lack of trial evidence. Methods The objective is to assess whether oral ciclosporin is more effective than oral prednisolone for the treatment of PG. The trial design is a two-arm, observer-blind, parallel-group, randomised controlled trial comparing ciclosporin (4 mg/kg/day to prednisolone (0.75 mg/kg/day. A total of 140 participants are to be recruited over a period of 4 years, from up to 50 hospitals in the UK and Eire. Primary outcome of velocity of healing at 6 weeks is assessed blinded to treatment allocation (using digital images of the ulcers. Secondary outcomes include: (i time to healing; (ii global assessment of improvement; (iii PG inflammation assessment scale score; (iv self-reported pain; (v health-related quality of life; (vi time to recurrence; (vii treatment failures; (viii adverse reactions to study medications; and (ix cost effectiveness/utility. Patients with a clinical diagnosis of PG (excluding granulomatous PG; measurable ulceration (that is, not pustular PG; and patients aged over 18 years old who are able to give informed consent are included in the trial. Randomisation is by computer generated code using permuted blocks of randomly varying size

  19. Burnout in Patients with Chronic Whiplash-Associated Disorders

    Science.gov (United States)

    Clementz, Gunilla; Borsbo, Bjorn; Norrbrink, Cecilia

    2012-01-01

    This study sought to assess burnout and its relation to pain, disability, mood and health-related quality of life in a group of patients with chronic whiplash-associated disorders (WAD). Forty-five patients with chronic WAD ([greater than or equal to] 3 months) referred to a multidisciplinary rehabilitation centre were included. A questionnaire…

  20. Role of spinal inhibitory mechanisms in whiplash injuries.

    Science.gov (United States)

    Lo, Yew-Long; Tan, Yam-Eng; Fook-Chong, Stephanie; Boolsambatra, Pensie; Yue, Wai-Mun; Chan, Ling-Ling; Tan, Seang-Beng

    2007-06-01

    Whiplash injury, commonly encountered in road traffic accidents, is a major cause of morbidity. Its pathophysiology is not well understood, and diagnosis remains clinical. Imaging and electrophysiological methods have not provided objective diagnostic evidence. Availability of a sensitive and specific diagnostic method would be of high clinical interest. We studied 20 consecutive patients with chronic whiplash injury. Despite persistent symptoms, most had minimal neurological findings. Cutaneous silent period (CSP), a nociceptive spinal inhibitory electromyographic reflex, showed 90% sensitivity and 90% specificity for its diagnosis. In contrast, only two patients (10%) had abnormal transcranial magnetic stimulation findings, and another two (10%) showed abnormal electromyography. Magnetic resonance imaging (MRI) showed cervical cord abnormalities in only two of 20 (10%) patients. None of the patients had abnormal somatosensory evoked potential studies. Our findings suggest that neurological dysfunction of whiplash may occur at several possible spinal cord localities in the CSP functional pathway. The use of this simple, quick, and sensitive method is advocated in the diagnostic work up of whiplash injury.

  1. Telephone versus usual care in management of acute whiplash ...

    African Journals Online (AJOL)

    Whiplash associated disorder (WAD) is a common and costly condition, and recommended management includes advice to “act as usual” and exercise. Providing this treatment through a telephonic intervention may help to improve access to care, and reduce costs. This pilot study assessed: (1) the effectiveness of a ...

  2. Late whiplash syndrome: a clinical and magnetic resonance imaging study.

    Science.gov (United States)

    Bonuccelli, U; Pavese, N; Lucetti, C; Renna, M R; Gambaccini, G; Bernardini, S; Canapicchi, R; Carrozzi, L; Murri, L

    1999-01-01

    Cervical hyperextension injuries are common and are associated with significant morbidity. Clinically two syndromes are described: "acute" whiplash syndrome and "late" whiplash syndrome (in which the patients are still symptomatic after six months despite normal physical and radiological examination). In order to clarify the pathology of the persistent pain in late whiplash syndrome we performed a cervical spine magnetic resonance imaging (MRI) in 33 consecutive patients suffering from this condition. Twenty-six patients (78.8%) showed MRI abnormalities, the most common MRI finding (57.6%) was pre-existent spondylosis. Indeed, the group of patients with spondylosis and other MRI changes had higher clinical scores than those without MRI abnormalities as measured by a three-point grading system based upon the symptoms and signs shown. Several MRI changes, most of them already demonstrable by standard X-ray were seen among 33 patients suffering from late whiplash syndrome. Although no one of these findings appears to be specific and certainly related to the previous neck injury, they could represent a risk factor for a longer pain duration.

  3. Acute and chronic whiplash disorders--a review.

    Science.gov (United States)

    Sterner, Ylva; Gerdle, Björn

    2004-09-01

    This review examines acute and chronic whiplash-associated disorders to facilitate assessment, treatment and rehabilitation for further research and evidence-based practices. A review of the literature. Whiplash-associated disorders account for a large proportion of the overall impairment and disability caused by traffic injuries. Rarely can a definite injury be determined in the acute (or chronic) phase. Crash-related factors have been identified, and several trauma mechanisms possibly causing different injuries have been described. Most whiplash trauma will not cause injury, and the majority of patients (92-95%) will return to work. Litigation is not a major factor. Cognitive impairments are not the same as brain injury. Variables such as pain intensity, restricted motion, neurological symptoms and signs, together with central nervous system symptoms can be used to predict a situation with risk of remaining complaints. Influences of other factors--the same as for other chronic pain conditions--also exist. Persistent/chronic pain is not merely acute pain that persists over time; changes occur at different levels of the pain transmission system. Chronic whiplash-associated disorders are associated with problems concerning social functioning, daily anxieties and satisfaction with different aspects of life. Adequate information, advice and pain medication together with active interventions might be more effective in the acute stage. Early multidisciplinary rehabilitation focusing on cognitive-behavioural changes might be of value. To develop specific treatment and rehabilitation, it is important to identify homogenous subgroups.

  4. Prognosis of patients with whiplash-associated disorders consulting physiotherapy

    DEFF Research Database (Denmark)

    Bohman, Tony; Côté, Pierre; Boyle, Eleanor

    2012-01-01

    BACKGROUND: Patients with whiplash-associated disorders (WAD) have a generally favourable prognosis, yet some develop longstanding pain and disability. Predicting who will recover from WAD shortly after a traffic collision is very challenging for health care providers such as physical therapists....

  5. Delayed onset of fatal basilar thrombotic embolus after whiplash injury

    DEFF Research Database (Denmark)

    Viktrup, L; Knudsen, G M; Hansen, S H

    1995-01-01

    in a collision. CASE DESCRIPTION: After whiplash trauma in a car accident, a 50-year-old taxi driver suffered from headache and episodic visual disturbances. Two months after the accident he suddenly lost consciousness and was admitted to the hospital. A CT scan performed at that time was indicative of basilar...

  6. Altered Regional Cerebral Blood Flow in Chronic Whiplash Associated Disorders

    NARCIS (Netherlands)

    Vállez García, David; Doorduin, Janine; Willemsen, Antoon T.M.; Dierckx, Rudi A.j.o.; Otte, Andreas

    There is increasing evidence of central hyperexcitability in chronic whiplash-associated disorders (cWAD). However, little is known about how an apparently simple cervical spine injury can induce changes in cerebral processes. The present study was designed (1) to validate previous results showing

  7. Long-term Labour Market Performance of Whiplash Claimants

    DEFF Research Database (Denmark)

    Leth-Petersen, Søren; Rotger, Gabriel Pons

    financial incentive to not reduce earnings. This suggests that moderate injuries tend to be chronic, and that compensation-seeking behaviour is not the main explanation for this group. We find that claimants with chronic WADs used more health care in the year prior to the whiplash than claimants with non...

  8. Long term labour market performance of whiplash claimants

    DEFF Research Database (Denmark)

    Leth-Petersen, Søren; Rotger, Gabriel Pons

    2009-01-01

    financial incentive to not reduce earnings. This suggests that moderate injuries tend to be chronic, and that compensation-seeking behaviour is not the main explanation for this group. We find that claimants with chronic WADs used more health care in the year prior to the whiplash than claimants with non...

  9. Neck ligament strength is decreased following whiplash trauma

    Directory of Open Access Journals (Sweden)

    Rubin Wolfgang

    2006-12-01

    Full Text Available Abstract Background Previous clinical studies have documented successful neck pain relief in whiplash patients using nerve block and radiofrequency ablation of facet joint afferents, including capsular ligament nerves. No previous study has documented injuries to the neck ligaments as determined by altered dynamic mechanical properties due to whiplash. The goal of the present study was to determine the dynamic mechanical properties of whiplash-exposed human cervical spine ligaments. Additionally, the present data were compared to previously reported control data. The ligaments included the anterior and posterior longitudinal, capsular, and interspinous and supraspinous ligaments, middle-third disc, and ligamentum flavum. Methods A total of 98 bone-ligament-bone specimens (C2–C3 to C7-T1 were prepared from six cervical spines following 3.5, 5, 6.5, and 8 g rear impacts and pre- and post-impact flexibility testing. The specimens were elongated to failure at a peak rate of 725 (SD 95 mm/s. Failure force, elongation, and energy absorbed, as well as stiffness were determined. The mechanical properties were statistically compared among ligaments, and to the control data (significance level: P Results For all whiplash-exposed ligaments, the average failure elongation exceeded the average physiological elongation. The highest average failure force of 204.6 N was observed in the ligamentum flavum, significantly greater than in middle-third disc and interspinous and supraspinous ligaments. The highest average failure elongation of 4.9 mm was observed in the interspinous and supraspinous ligaments, significantly greater than in the anterior longitudinal ligament, middle-third disc, and ligamentum flavum. The average energy absorbed ranged from 0.04 J by the middle-third disc to 0.44 J by the capsular ligament. The ligamentum flavum was the stiffest ligament, while the interspinous and supraspinous ligaments were most flexible. The whiplash

  10. Education of patients after whiplash injury: is oral advice any better than a pamphlet?

    DEFF Research Database (Denmark)

    Kongsted, Alice; Qerama, Erisela; Kasch, Helge

    2008-01-01

    STUDY DESIGN: Randomized parallel-group trial with 1-year follow-up. OBJECTIVE: To evaluate whether education of patients communicated orally by a specially trained nurse is superior to giving patients a pamphlet after a whiplash injury. SUMMARY OF BACKGROUND DATA: Long-lasting pain and physical......, headache, disability, and return to work. Recovery was defined as scoring pain 0 or 1 (0-10 point scale) and not being off sick at the time of the follow-ups. RESULTS: After 3, 6, and 12 months 60%, 58%, and 66%, respectively of the participants had recovered. Group differences were nonsignificant on all...... outcome parameters, even though the outcome tended to be better for the group receiving personal advice. CONCLUSION: Prognosis did not differ between patients who received personal education and those who got a pamphlet. However, a systematic tendency toward better outcome with personal communicated...

  11. UK Dermatology Clinical Trials Network's STOP GAP trial (a multicentre trial of prednisolone versus ciclosporin for pyoderma gangrenosum): protocol for a randomised controlled trial.

    Science.gov (United States)

    Craig, Fiona F; Thomas, Kim S; Mitchell, Eleanor J; Williams, Hywel C; Norrie, John; Mason, James M; Ormerod, Anthony D

    2012-04-28

    Pyoderma gangrenosum (PG) is a rare inflammatory skin disorder characterised by painful and rapidly progressing skin ulceration. PG can be extremely difficult to treat and patients often require systemic immunosuppression. Recurrent lesions of PG are common, but the relative rarity of this condition means that there is a lack of published evidence regarding its treatment. A systematic review published in 2005 found no randomised controlled trials (RCTs) relating to the treatment of PG. Since this time, one small RCT has been published comparing infliximab to placebo, but none of the commonly used systemic treatments for PG have been formally assessed. The UK Dermatology Clinical Trials Network's STOP GAP Trial has been designed to address this lack of trial evidence. The objective is to assess whether oral ciclosporin is more effective than oral prednisolone for the treatment of PG. The trial design is a two-arm, observer-blind, parallel-group, randomised controlled trial comparing ciclosporin (4 mg/kg/day) to prednisolone (0.75 mg/kg/day). A total of 140 participants are to be recruited over a period of 4 years, from up to 50 hospitals in the UK and Eire. Primary outcome of velocity of healing at 6 weeks is assessed blinded to treatment allocation (using digital images of the ulcers). Secondary outcomes include: (i) time to healing; (ii) global assessment of improvement; (iii) PG inflammation assessment scale score; (iv) self-reported pain; (v) health-related quality of life; (vi) time to recurrence; (vii) treatment failures; (viii) adverse reactions to study medications; and (ix) cost effectiveness/utility. Patients with a clinical diagnosis of PG (excluding granulomatous PG); measurable ulceration (that is, not pustular PG); and patients aged over 18 years old who are able to give informed consent are included in the trial. Randomisation is by computer generated code using permuted blocks of randomly varying size, stratified by lesion size, and

  12. Post-Exercise Protein Trial: Interactions between Diet and Exercise (PEPTIDE): study protocol for randomized controlled trial.

    Science.gov (United States)

    Alghannam, Abdullah F; Tsintzas, Kostas; Thompson, Dylan; Bilzon, James; Betts, James A

    2014-11-24

    Performing regular exercise is known to manifest a number of health benefits that mainly relate to cardiovascular and muscular adaptations to allow for greater oxygen extraction and utilization. There is increasing evidence that nutrient intake can affect the adaptive response to a single exercise bout, and that protein feeding is important to facilitate this process. Thus, the exercise-nutrient interaction may potentially lead to a greater response to training. The role of post-exercise protein ingestion in enhancing the effects of running-based endurance exercise training relative to energy-matched carbohydrate intervention remains to be established. Additionally, the influence of immediate versus overnight protein ingestion in mediating these training effects is currently unknown. The current protocol aims to establish whether post-exercise nutrient intake and timing would influence the magnitude of improvements during a prescribed endurance training program. The project involves two phases with each involving two treatment arms applied in a randomized investigator-participant double-blind parallel group design. For each treatment, participants will be required to undergo six weeks of running-based endurance training. Immediately post-exercise, participants will be prescribed solutions providing 0.4 grams per kilogram of body mass (g · kg(-1)) of whey protein hydrolysate plus 0.4 g · kg(-1) sucrose, relative to an isocaloric sucrose control (0.8 g · kg(-1); Phase I). In Phase II, identical protein supplements will be provided (0.4 + 0.4 g · kg(-1) · h(-1) of whey protein hydrolysate and sucrose, respectively), with the timing of ingestion manipulated to compare immediate versus overnight recovery feedings. Anthropometric, expired gas, venous blood and muscle biopsy samples will be obtained at baseline and following the six-week training period. By investigating the role of nutrition in enhancing the effects of endurance exercise training, we will provide

  13. PTSD Symptoms Mediate the Effect of Attachment on Pain and Somatisation after Whiplash Injury

    OpenAIRE

    Andersen, Tonny Elmose; Elklit, Ask; Brink, Ole

    2013-01-01

    Introduction: The development of persistent pain post-whiplash injury is still an unresolved mystery despite the fact that approximately 50% of individuals reporting whiplash develop persistent pain. There is agreement that high initial pain and PTSD symptoms are indicators of a poor prognosis after whiplash injury. Recently attachment insecurity has been proposed as a vulnerability factor for both pain and PTSD. In order to guide treatment it is important to examine possible mechanisms which...

  14. Intensive group training protocol versus guideline physiotherapy for patients with chronic low back pain: a randomised controlled trial

    OpenAIRE

    van der Roer, Nicole; van Tulder, Maurits; Barendse, Johanna; Knol, Dirk; van Mechelen, Willem; de Vet, Henrica

    2008-01-01

    Intensive group training using principles of graded activity has been proven to be effective in occupational care for workers with chronic low back pain. Objective of the study was to compare the effects of an intensive group training protocol aimed at returning to normal daily activities and guideline physiotherapy for primary care patients with non-specific chronic low back pain. The study was designed as pragmatic randomised controlled trial with a setup of 105 primary care physiotherapist...

  15. Behavioral counseling to prevent childhood obesity – study protocol of a pragmatic trial in maternity and child health care

    OpenAIRE

    Mustila, Taina; Keskinen, Päivi; Luoto, Riitta

    2012-01-01

    Abstract Background Prevention is considered effective in combating the obesity epidemic. Prenatal environment may increase offspring's risk for obesity. A child starts to adopt food preferences and other behavioral habits affecting weight gain during preschool years. We report the study protocol of a pragmatic lifestyle intervention aiming at primary prevention of childhood obesity. Methods/Design A non-randomized controlled pragmatic trial in maternity and child health care clinics. The con...

  16. Supportive Mental Health Self-Monitoring among Smartphone Users with Psychological Distress: Protocol for a Fully Mobile Randomized Controlled Trial

    OpenAIRE

    Till Beiwinkel; Stefan Hey; Olaf Bock; Wulf Rössler; Wulf Rössler; Wulf Rössler

    2017-01-01

    Mobile health (mHealth) could be widely used in the population to improve access to psychological treatment. In this paper, we describe the development of a mHealth intervention on the basis of supportive self-monitoring and describe the protocol for a randomized controlled trial to evaluate its effectiveness among smartphone users with psychological distress. Based on power analysis, a representative quota sample of N = 186 smartphone users will be recruited, with an over-sampling of persons...

  17. Efficacy of Mobile Serious Games in Increasing HIV Risk Perception in Swaziland: A Randomized Control Trial (SGprev Trial) Research Protocol.

    Science.gov (United States)

    Lukhele, Bhekumusa Wellington; Musumari, Patou; El-Saaidi, Christina; Techasrivichien, Teeranee; Suguimoto, S Pilar; Ono Kihara, Masako; Kihara, Masahiro

    2016-11-22

    -list control group at 4-weeks post-intervention. We will use standardized regression coefficients to calculate the effect of the intervention on our primary outcome with P values. We will conduct both intention to treat and as treated analysis. This study is funded by Hayao Nakayama Foundation for Science & Technology and Culture; Grant number H26-A2-41. The research and development approval has been obtained from Kyoto University Graduate School and Faculty of Medicine Ethics Committee, Japan, and Swaziland's Ministry of Health Ethics and Scientific committee. Results are expected in February 2017. This study will provide evidence on the efficiency of a mobile phone interactive game in increasing HIV risk perception in Swaziland. Our findings may also be generalizable to similar settings in SSA. University Hospital Medical Information Network Clinical Trial Registry ID number (UMIN-CTR):UMIN000021781; URL:https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025103 (Archived by WebCite at http://www.webcitation.org/6hOphB11a). ©Bhekumusa Wellington Lukhele, Patou Musumari, Christina El-Saaidi, Teeranee Techasrivichien, S. Pilar Suguimoto, Masako Ono Kihara, Masahiro Kihara. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 22.11.2016.

  18. Postural control deficit in acute QTF grade II whiplash injuries.

    Science.gov (United States)

    Dehner, Christoph; Heym, Birgit; Maier, Dirk; Sander, Silvia; Arand, Markus; Elbel, Martin; Hartwig, Erich; Kramer, Michael

    2008-07-01

    Experimental in vivo study. The objective was to investigate the balance control in patients with acute QTF grade II whiplash injuries of the cervical spine. Tetra-ataxiametric posturography in chronic pain patients after whiplash injuries of the cervical spine has revealed an impaired regulation of balance. However, so far it is unclear if this is caused by the accident or other factors that are associated with the pain chronification process. 40 patients with acute QTF grade II whiplash injuries and 40 healthy matched controls were examined on a posturography platform. The stability index ST(Sigma) and the Fourier analysis FA(Sigma) (0.10-1.00Hz) were established for eight standing positions and sum scores were calculated. The pain index was established using a visual analog scale ranging from 0 to 100. A follow-up examination was conducted for the patients after 2 months. The patients with acute whiplash injuries of the cervical spine achieved significantly poorer results for both ST(Sigma) and FA(Sigma) than the healthy controls. There were no differences between the eight standing positions for both ST(Sigma) and FA(Sigma). After 2 months, 17 patients had no change in the pain development, 21 patients showed an improvement in pain intensity and 2 patients had deteriorated. The subgroup of patients with improvement in pain intensity showed a significant improvement in balance control concerning the FA(Sigma) compared to patients with unchanged pain intensity. Patients with acute whiplash injuries have a reduced balance control as compared to matched controls. This study gives an indication that post-traumatic neck pain is associated with impairments of postural control.

  19. Improving pain treatment with a smartphone app: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Suso-Ribera, Carlos; Mesas, Ángela; Medel, Javier; Server, Anna; Márquez, Esther; Castilla, Diana; Zaragozá, Irene; García-Palacios, Azucena

    2018-02-27

    Chronic pain has become a major health problem across the world, especially in older adults. Unfortunately, the effectiveness of medical interventions is modest. Some have argued that assessment strategies should be improved if the impact of medical interventions is to be improved. Ecological momentary assessment using smartphones is now considered the gold standard in monitoring in health settings, including chronic pain. However, to the best of our knowledge, there is no randomized controlled trial to show that telemonitoring using a smartphone app can indeed improve the effectiveness of medical treatments in adults with chronic pain. The goal of this study will be to explore the effects of using a smartphone app for telemonitoring adults with chronic pain. The study will be a randomized controlled trial with three groups: treatment as usual (TAU), TAU+app, and TAU+app+alarms. All groups will receive the adequate treatment for their pain, which will be prescribed the first day of study according to clinical guidelines. Assessment in the TAU group will be the usual at the Pain Clinic, that is, a paper-and-pencil evaluation at the onset of treatment (beginning of study) and at follow up (end of study, 30 days later). The other two groups (TAU+app and TAU+app+alarms) will be assessed daily using Pain Monitor, a smartphone app developed by our multidisciplinary team. Telemonitoring will only be made in the TAU+app+alarms group. For this group, physicians at the Pain Clinic may decide to adjust pain treatment in response to alarms. Telemonitoring is not the usual practice at the Pain Clinic and will not occur in the other two groups (TAU and TAU+app), so no changes in treatment are expected in these groups after the first appointment. The total sample size will be 150, with 50 patients in each group. The assessment protocol will be the same in all groups and will include pain intensity and side effects of the medication (primary outcomes), together with several pain

  20. The Risk Assessment Score in acute whiplash injury predicts outcome and reflects bio-psycho-social factors

    DEFF Research Database (Denmark)

    Kasch, Helge; Qerama, Erisela; Kongsted, Alice

    2011-01-01

    One-year prospective study of 141 acute whiplash patients (WLP) and 40 acute ankle-injured controls.......One-year prospective study of 141 acute whiplash patients (WLP) and 40 acute ankle-injured controls....

  1. Catastrophizing and perceived injustice: risk factors for the transition to chronicity after whiplash injury.

    Science.gov (United States)

    Sullivan, Michael J L; Adams, Heather; Martel, Marc-Olivier; Scott, Whitney; Wideman, Timothy

    2011-12-01

    The article will summarize research that has supported the role of pain catastrophizing and perceived injustice as risk factors for problematic recovery after whiplash injury. This article focuses on two psychological variables that have been shown to impact on recovery trajectories after whiplash injury; namely pain catastrophizing and perceived injustice. Research has shown that psychological variables play a role in determining the trajectory of recovery after whiplash injury. This article will focus on two psychological variables that have been shown to impact on recovery trajectories after whiplash injury; namely pain catastrophizing and perceived injustice. The article will summarize research that has supported the role of pain catastrophizing and perceived injustice as risk factors for problematic recovery after whiplash injury. Several investigations have shown that measures of catastrophizing and perceived injustice prospectively predict problematic trajectories of recovery after whiplash injury. Basic research points to the potential roles of expectancies, attention, coping and endogenous opioid dysregulation as possible avenues through which catastrophizing might heighten the probability of the persistence of pain after whiplash injury. Although research has yet to systematically address the mechanisms by which perceived injustice might contribute to prolonged disability in individuals with whiplash injuries, there are grounds for suggesting the potential contributions of catastrophizing, pain behavior and anger. A challenge for future research will be the development and evaluation of risk factor-targeted interventions aimed at reducing catastrophizing and perceived injustice to improve recovery trajectories after whiplash injury.

  2. Study protocol for the evaluation of an Infant Simulator based program delivered in schools: a pragmatic cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Hart Michael B

    2010-10-01

    Full Text Available Abstract Background This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such programs, there is no published evidence of their long-term impact. The aim of this trial is to evaluate the Virtual Infant Parenting (VIP program by investigating pre-conceptual health and risk behaviours, teen pregnancy and the resultant birth outcomes, early child health and maternal health. Methods and Design Fifty-seven schools (86% of 66 eligible secondary schools in Perth, Australia were recruited to the clustered (by school randomised trial, with even randomisation to the intervention and control arms. Between 2003 and 2006, the VIP program was administered to 1,267 participants in the intervention schools, while 1,567 participants in the non-intervention schools received standard curriculum. Participants were all female and aged between 13-15 years upon recruitment. Pre and post-intervention questionnaires measured short-term impact and participants are now being followed through their teenage years via data linkage to hospital medical records, abortion clinics and education records. Participants who have a live birth are interviewed by face-to-face interview. Kaplan-Meier survival analysis and proportional hazards regression will test for differences in pregnancy, birth and abortion rates during the teenage years between the study arms. Discussion This protocol paper provides a detailed overview of the trial design as well as initial results in the form of participant flow. The authors describe the intervention and its delivery within the natural school setting and discuss the practical issues in the conduct of the trial, including recruitment. The trial is pragmatic and will directly inform those who provide

  3. Evaluating Data Abstraction Assistant, a novel software application for data abstraction during systematic reviews: protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ian J. Saldanha

    2016-11-01

    abstraction approaches. Trial registration The trial is registered at National Information Center on Health Services Research and Health Care Technology (NICHSR under Registration # HSRP20152269: https://wwwcf.nlm.nih.gov/hsr_project/view_hsrproj_record.cfm?NLMUNIQUE_ID=20152269&SEARCH_FOR=Tianjing%20Li . All items from the World Health Organization Trial Registration Data Set are covered at various locations in this protocol. Protocol version and date: This is version 2.0 of the protocol, dated September 6, 2016. As needed, we will communicate any protocol amendments to the Institutional Review Boards (IRBs of Johns Hopkins Bloomberg School of Public Health (JHBSPH and Brown University. We also will make appropriate as-needed modifications to the NICHSR website in a timely fashion.

  4. Electroacupuncture to treat gastroesophageal reflux disease: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Han, Gajin; Leem, Jungtae; Lee, Hojung; Lee, Junhee

    2016-05-17

    Gastroesophageal reflux disease lowers the quality of life and increases medical costs. Electroacupuncture has been used to ease symptoms and improve gastrointestinal motility in patients with gastroesophageal reflux disease. The main purposes of this study are to evaluate the efficacy and safety of this procedure. This is a protocol for a randomized, patient-blinded, assessor-blinded, sham-controlled trial. Sixty participants with symptoms of gastroesophageal reflux disease, who have previously undergone standard treatment, will be recruited from August 2015 at Kyung Hee University Korean Medicine Hospital. The participants will be allocated to either the electroacupuncture (n = 30) or the sham electroacupuncture group (n = 30); the allocation will be concealed from both the participants and the assessors. The EA group will undergo penetrating acupuncture at 18 fixed points and two optional points chosen using the pattern identification for gastroesophageal reflux disease. Electrical stimulation will be applied at some of the acupoints. The sham electroacupuncture group will undergo nonpenetrating acupuncture without electrical stimulation at 18 nonspecific points, each of which will be only 2 cm away from the true acupoints used in the electroacupuncture group. In both groups, the procedure will be performed using the Park device. The treatment will last for 6 weeks (with two sessions each week), and the outcome will be evaluated at baseline, 3 weeks, and 6 weeks. The primary outcome will be the proportion of responders with adequate symptom relief, whereas the secondary outcomes will comprise the results of the Nepean dyspepsia index; the Korean gastrointestinal symptom rating scale; the EQ-5D™; levels of gastrin, motilin, and inflammatory cytokines; the perceived stress scale; the qi-stagnation questionnaire; the patient global impression of change; and the spleen qi deficiency questionnaire. The results of this trial will provide information

  5. EXERCISE in pediatric autologous stem cell transplant patients: a randomized controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Chamorro-Viña Carolina

    2012-09-01

    Full Text Available Abstract Background Hematopoietic stem cell transplantation is an intensive therapy used to improve survivorship and cure various oncologic diseases. However, this therapy is associated with high mortality rates and numerous negative side-effects. The recovery of the immune system is a special concern and plays a key role in the success of this treatment. In healthy populations it is known that exercise plays an important role in immune system regulation, but little is known about the role of exercise in the hematological and immunological recovery of children undergoing hematopoietic stem cell transplant. The primary objective of this randomized-controlled trial (RCT is to study the effect of an exercise program (in- and outpatient on immune cell recovery in patients undergoing an autologous stem cell transplantation. The secondary objective is to determine if an exercise intervention diminishes the usual deterioration in quality of life, physical fitness, and the acquisition of a sedentary lifestyle. Methods This RCT has received approval from The Conjoint Health Research Ethics Board (CHREB of the University of Calgary (Ethics ID # E-24476. Twenty-four participants treated for a malignancy with autologous stem cell transplant (5 to 18 years in the Alberta Children’s Hospital will be randomly assigned to an exercise or control group. The exercise group will participate in a two-phase exercise intervention (in- and outpatient from hospitalization until 10 weeks after discharge. The exercise program includes strength, flexibility and aerobic exercise. During the inpatient phase this program will be performed 5 times/week and will be supervised. The outpatient phase will combine a supervised session with two home-based exercise sessions with the use of the Wii device. The control group will follow the standard protocol without any specific exercise program. A range of outcomes, including quantitative and functional recovery of immune system

  6. Optimising conservative management of chronic low back pain: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Simson, Katherine J; Miller, Clint T; Ford, Jon; Hahne, Andrew; Main, Luana; Rantalainen, Timo; Teo, Wei-Peng; Teychenne, Megan; Connell, David; Trudel, Guy; Zheng, Guoyan; Thickbroom, Gary; Belavy, Daniel L

    2017-04-20

    Lower back pain is a global health issue affecting approximately 80% of people at some stage in their life. The current literature suggests that any exercise is beneficial for reducing back pain. However, as pain is a subjective evaluation and physical deficits are evident in low back pain, using it as the sole outcome measure to evaluate superiority of an exercise protocol for low back pain treatment is insufficient. The overarching goal of the current clinical trial is to implement two common, conservative intervention approaches and examine their impact on deficits in chronic low back pain. Forty participants, 25-45 years old with chronic (>3 months), non-specific low back pain will be recruited. Participants will be randomised to receive either motor control and manual therapy (n = 20) or general strength and conditioning (n = 20) exercise treatments for 6 months. The motor control/manual therapy group will receive twelve 30-min sessions, ten in the first 3 months (one or two per week) and two in the last 3 months. The general exercise group will attend two 1-hour sessions weekly for 3 months, and one or two a week for the following 3 months. Primary outcome measures are average lumbar spine intervertebral disc T2 relaxation time and changes in thickness of the transversus abdominis muscle on a leg lift using magnetic resonance imaging (MRI). Secondary outcomes include muscle size and fat content, vertebral body fat content, intervertebral disc morphology and water diffusion measured by MRI, body composition using dual energy X-ray absorptiometry, physical function through functional tests, changes in corticospinal excitability and cortical motor representation of the spinal muscles using transcranial magnetic stimulation and self-reported measure of pain symptoms, health and disability. Outcome measures will be conducted at baseline, at the 3-month follow-up and at 6 months at the end of intervention. Pain, depressive symptomology and emotions will be

  7. A trial of a job-specific workers' health surveillance program for construction workers: study protocol.

    Science.gov (United States)

    Boschman, Julitta S; van der Molen, Henk F; van Duivenbooden, Cor; Sluiter, Judith K; Frings-Dresen, Monique H W

    2011-09-29

    Dutch construction workers are offered periodic health examinations. This care can be improved by tailoring this workers health surveillance (WHS) to the demands of the job and adjust the preventive actions to the specific health risks of a worker in a particular job. To improve the quality of the WHS for construction workers and stimulate relevant job-specific preventive actions by the occupational physician, we have developed a job-specific WHS. The job-specific WHS consists of modules assessing both physical and psychological requirements. The selected measurement instruments chosen, are based on their appropriateness to measure the workers' capacity and health requirements. They include a questionnaire and biometrical tests, and physical performance tests that measure physical functional capabilities. Furthermore, our job-specific WHS provides occupational physicians with a protocol to increase the worker-behavioural effectiveness of their counselling and to stimulate job-specific preventive actions. The objective of this paper is to describe and clarify our study to evaluate the behavioural effects of this job-specific WHS on workers and occupational physicians. The ongoing study of bricklayers and supervisors is a nonrandomised trial to compare the outcome of an intervention (job-specific WHS) group (n = 206) with that of a control (WHS) group (n = 206). The study includes a three-month follow-up. The primary outcome measure is the proportion of participants who have undertaken one or more of the preventive actions advised by their occupational physician in the three months after attending the WHS. A process evaluation will be carried out to determine context, reach, dose delivered, dose received, fidelity, and satisfaction. The present study is in accordance with the TREND Statement. This study will allow an evaluation of the behaviour of both the workers and occupational physician regarding the preventive actions undertaken by them within the scope of a job

  8. Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Arabi, Yaseen M; Alothman, Adel; Balkhy, Hanan H; Al-Dawood, Abdulaziz; AlJohani, Sameera; Al Harbi, Shmeylan; Kojan, Suleiman; Al Jeraisy, Majed; Deeb, Ahmad M; Assiri, Abdullah M; Al-Hameed, Fahad; AlSaedi, Asim; Mandourah, Yasser; Almekhlafi, Ghaleb A; Sherbeeni, Nisreen Murad; Elzein, Fatehi Elnour; Memon, Javed; Taha, Yusri; Almotairi, Abdullah; Maghrabi, Khalid A; Qushmaq, Ismael; Al Bshabshe, Ali; Kharaba, Ayman; Shalhoub, Sarah; Jose, Jesna; Fowler, Robert A; Hayden, Frederick G; Hussein, Mohamed A

    2018-01-30

    It had been more than 5 years since the first case of Middle East Respiratory Syndrome coronavirus infection (MERS-CoV) was recorded, but no specific treatment has been investigated in randomized clinical trials. Results from in vitro and animal studies suggest that a combination of lopinavir/ritonavir and interferon-β1b (IFN-β1b) may be effective against MERS-CoV. The aim of this study is to investigate the efficacy of treatment with a combination of lopinavir/ritonavir and recombinant IFN-β1b provided with standard supportive care, compared to treatment with placebo provided with standard supportive care in patients with laboratory-confirmed MERS requiring hospital admission. The protocol is prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. Hospitalized adult patients with laboratory-confirmed MERS will be enrolled in this recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The trial is initially designed to include 2 two-stage components. The first two-stage component is designed to adjust sample size and determine futility stopping, but not efficacy stopping. The second two-stage component is designed to determine efficacy stopping and possibly readjustment of sample size. The primary outcome is 90-day mortality. This will be the first randomized controlled trial of a potential treatment for MERS. The study is sponsored by King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. Enrollment for this study began in November 2016, and has enrolled thirteen patients as of Jan 24-2018. ClinicalTrials.gov, ID: NCT02845843 . Registered on 27 July 2016.

  9. Risk Factors of Poor Prognosis after Whiplash Injury

    Directory of Open Access Journals (Sweden)

    Samy Suissa

    2003-01-01

    Full Text Available Whiplash, a common injury following motor vehicle crashes, is associated with high costs and a prognosis that is variable and difficult to predict. In this paper, we review findings from the Quebec cohort epidemiological study on predictive factors of recovery from whiplash injury after a motor vehicle crash. We formed a population-based incident cohort of all 4,759 individuals who sustained a whiplash injury resulting from a motor vehicle crash in the province of Québec, Canada, in 1987, and followed these patients for up to seven years. The data were obtained from the universal automobile insurance plan (SAAQ that covers all seven million residents of the Province for all vehicular-related injuries. From this cohort, we formed the cohort of 3,014 for whom a police report was completed. For this cohort, we obtained data on crash-related factors directly from the police report. We also formed the cohort of 2,627 subjects who had strictly a whiplash injury, without associated injuries. For this cohort, the data on signs and symptoms were obtained from the medical charts kept by the SAAQ. For both cohorts, data on the outcome, the recovery time from whiplash, was obtained from the SAAQ databases. The crash-related cohort study found that socio-demographic factors associated with a longer recovery from whiplash include older age, female sex, having dependents and not being employed full time and that each decreases the rate of recovery by 14 to 16 per cent. Factors related to the crash conditions indicate that being in a truck or bus, with a decrease of 52% in the rate of recovery, being a passenger in the vehicle (15%, colliding with a moving vehicle (16%, and a side or frontal collision (15% all decrease the rate of recovery. We introduce a combined risk score that predicts longer recovery. In the cohort of subjects with signs and symptoms, the median recovery time was 32 days and 12% of subjects had still not recovered after 6 months. The signs

  10. Study protocol for a randomized controlled trial: tongue strengthening exercises in head and neck cancer patients, does exercise load matter?

    Science.gov (United States)

    Van Nuffelen, Gwen; Van den Steen, Leen; Vanderveken, Olivier; Specenier, Pol; Van Laer, Carl; Van Rompaey, Diane; Guns, Cindy; Mariën, Steven; Peeters, Marc; Van de Heyning, Paul; Vanderwegen, Jan; De Bodt, Marc

    2015-09-04

    Reduced tongue strength is an important factor contributing to early and late dysphagia in head and neck cancer patients previously treated with chemoradiotherapy. The evidence is growing that tongue strengthening exercises can improve tongue strength and swallowing function in both healthy and dysphagic subjects. However, little is known about the impact of specific features of an exercise protocol for tongue strength on the actual outcome (strength or swallowing function). Previous research originating in the fields of sports medicine and physical rehabilitation shows that the degree of exercise load is an influential factor for increasing muscle strength in the limb skeletal muscles. Since the tongue is considered a muscular hydrostat, it remains to be proven whether the same concepts will apply. This ongoing randomized controlled trial in chemoradiotherapy-treated patients with head and neck cancer investigates the effect of three tongue strengthening exercise protocols, with different degrees of exercise load, on tongue strength and swallowing. At enrollment, 51 patients whose dysphagia is primarily related to reduced tongue strength are randomly assigned to a training schedule of 60, 80, or 100% of their maximal tongue strength. Patients are treated three times a week for 8 weeks, executing 120 repetitions of the assigned exercise once per training day. Exercise load is progressively adjusted every 2 weeks. Patients are evaluated before, during and after treatment by means of tongue strength measurements, fiber-optic endoscopic evaluation of swallowing and quality-of-life questionnaires. This randomized controlled trial is the first to systematically investigate the effect of different exercise loads in tongue strengthening exercise protocols. The results will allow the development of more efficacious protocols. Current Controlled Trials ISRCTN14447678.

  11. A Feasibility Randomised Controlled Trial of the New Orleans Intervention for Infant Mental Health: A Study Protocol

    Directory of Open Access Journals (Sweden)

    Rachel Pritchett

    2013-01-01

    Full Text Available Child maltreatment is associated with life-long social, physical, and mental health problems. Intervening early to provide maltreated children with safe, nurturing care can improve outcomes. The need for prompt decisions about permanent placement (i.e., regarding adoption or return home is internationally recognised. However, a recent Glasgow audit showed that many maltreated children “revolve” between birth families and foster carers. This paper describes the protocol of the first exploratory randomised controlled trial of a mental health intervention aimed at improving placement permanency decisions for maltreated children. This trial compares an infant's mental health intervention with the new enhanced service as usual for maltreated children entering care in Glasgow. As both are new services, the trial is being conducted from a position of equipoise. The outcome assessment covers various fields of a child’s neurodevelopment to identify problems in any ESSENCE domain. The feasibility, reliability, and developmental appropriateness of all outcome measures are examined. Additionally, the potential for linkage with routinely collected data on health and social care and, in the future, education is explored. The results will inform a definitive randomised controlled trial that could potentially lead to long lasting benefits for the Scottish population and which may be applicable to other areas of the world. This trial is registered with ClinicalTrials.gov (NC01485510.

  12. Effectiveness of Chinese massage therapy (Tui Na) for chronic low back pain: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Yang, Mingxiao; Feng, Yue; Pei, Hong; Deng, Shufang; Wang, Minyu; Xiao, Xianjun; Zheng, Hui; Lai, Zhenhong; Chen, Jiao; Li, Xiang; He, Xiaoguo; Liang, Fanrong

    2014-10-29

    Low back pain is a common, disabling musculoskeletal disorder in both developing and developed countries. Although often recommended, the potential efficacy of massage therapy in general, and Chinese massage (tuina) in particular, for relief of chronic low back pain (CLBP) has not been fully established due to inadequate sample sizes, low methodological quality, and subclinical dosing regimens of trials to date. Thus, the purpose of this randomized controlled trial (RCT) is to evaluate the comparative effectiveness of tuina massage therapy versus conventional analgesics for CLBP. The present study is a single center, two-arm, open-label RCT. A total of 150 eligible CLBP patients will be randomly assigned to either a tuina treatment group or a conventional drug control group in a 1:1 ratio. Patients in the tuina group receive a 20 minutes, 4-step treatment protocol which includes both structural and relaxation massage, administered in 20 sessions over a period of 4 weeks. Patients in the conventional drug control group are instructed to take a specific daily dose of ibuprofen. The primary outcome measure is the change from baseline back pain and function, measured by Roland-Morris Disability Questionnaire, at two months. Secondary outcome measures include the visual analogue scale, Japanese orthopedic association score (JOAS), and McGill pain questionnaire. The design and methodological rigor of this trial will allow for collection of valuable data to evaluate the efficacy of a specific tuina protocol for treating CLBP. This trial will therefore contribute to providing a solid foundation for clinical treatment of CLBP, as well as future research in massage therapy. This trial was registered with ClinicalTrials.gov of the National Institute of Health on 22 October 2013 (http://NCT01973010).

  13. Study protocol for the evaluation of an Infant Simulator based program delivered in schools: a pragmatic cluster randomised controlled trial.

    Science.gov (United States)

    Brinkman, Sally A; Johnson, Sarah E; Lawrence, David; Codde, James P; Hart, Michael B; Straton, Judith A Y; Silburn, Sven

    2010-10-21

    This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such programs, there is no published evidence of their long-term impact. The aim of this trial is to evaluate the Virtual Infant Parenting (VIP) program by investigating pre-conceptual health and risk behaviours, teen pregnancy and the resultant birth outcomes, early child health and maternal health. Fifty-seven schools (86% of 66 eligible secondary schools) in Perth, Australia were recruited to the clustered (by school) randomised trial, with even randomisation to the intervention and control arms. Between 2003 and 2006, the VIP program was administered to 1,267 participants in the intervention schools, while 1,567 participants in the non-intervention schools received standard curriculum. Participants were all female and aged between 13-15 years upon recruitment. Pre and post-intervention questionnaires measured short-term impact and participants are now being followed through their teenage years via data linkage to hospital medical records, abortion clinics and education records. Participants who have a live birth are interviewed by face-to-face interview. Kaplan-Meier survival analysis and proportional hazards regression will test for differences in pregnancy, birth and abortion rates during the teenage years between the study arms. This protocol paper provides a detailed overview of the trial design as well as initial results in the form of participant flow. The authors describe the intervention and its delivery within the natural school setting and discuss the practical issues in the conduct of the trial, including recruitment. The trial is pragmatic and will directly inform those who provide Infant Simulator based programs in school settings. ISRCTN24952438.

  14. Does knowledge of seat design and whiplash injury mechanisms translate to understanding outcomes?

    Science.gov (United States)

    Ivancic, Paul C

    2011-12-01

    Review of whiplash injury mechanisms and effects of anti-whiplash systems including active head restraint (AHR) and Whiplash Protection System (WHIPS). This article provides an overview of previous biomechanical and epidemiological studies of AHR and WHIPS and investigates whether seat design and biomechanical knowledge of proposed whiplash injury mechanisms translates to understanding outcomes of rear crash occupants. In attempt to reduce whiplash injuries, some newer automobiles incorporate anti-whiplash systems such as AHR or WHIPS. During a rear crash, mechanically based systems activate by occupant momentum pressing into the seatback whereas electronically based systems activate using crash sensors and an electronic control unit linked to the head restraint. To investigate the effects of AHR and WHIPS on occupant responses including head and neck loads and motions, biomechanical studies of simulated rear crashes have been performed using human volunteers, mathematical models, crash dummies, whole cadavers, and hybrid cadaveric/surrogate models. Epidemiological studies have evaluated the effects of AHR and WHIPS on reducing whiplash injury claims and lessening subjective complaints of neck pain after rear crashes. RESULTS.: Biomechanical studies indicate that AHR and WHIPS reduced the potential for some whiplash injuries but did not completely eliminate the injury risk. Epidemiological outcomes indicate reduced whiplash injury claims or subjective complaints of crash-related neck pain between 43 and 75% due to AHR and between 21% and 49% due to WHIPS as compared to conventional seats and head restraints. Yielding energy-absorbing seats aim to reduce occupant loads and accelerations whereas AHRs aim to provide early head support to minimize head and neck motions. Continued objective biomechanical and epidemiological studies of anti-whiplash systems together with industry, governmental, and clinical initiatives will ultimately lead to reduced whiplash injuries

  15. An examination of coping styles and expectations for whiplash injury in Germany: comparison with Canadian data.

    Science.gov (United States)

    Ferrari, Robert; Pieschl, Stephanie

    2011-09-01

    Cross-sectional cohort study: to examine concurrent expectations and coping style for whiplash injury in injury-naive subjects in Germany. Studies suggest the recovery rate from whiplash injury may be faster in Germany than in Canada. Canadians have a high expectation for chronic pain following whiplash injury and Germans do not. Expectation of recovery not only predicts recovery in whiplash victims but is also known to correlate with coping style. The Vanderbilt Pain Management Inventory was administered to university students and staff in Germany. Subjects who had not yet experienced whiplash injury were given a vignette concerning a neck sprain (whiplash injury) in a motor vehicle collision and were asked to indicate how likely they were to have thoughts or behaviours indicated in the coping style questionnaire. Subjects also completed expectation questionnaires regarding whiplash injury. Sixteen percent of subjects held an expectation of chronic neck or back pain after whiplash injury. The mean active coping style score was 27.4±3.6 (40 is the maximum score for active coping). The mean passive coping style score was 27.0±6.3 (50 is the maximum score for passive coping). Coping style scores and patterns were not different from those previously observed in Canadian studies, but there was no correlation between expectations and coping style among German subjects, a finding that differs from Canadian studies. Although expectations and coping styles may interact or be co-modifiers in the outcomes of whiplash injury in Canadian whiplash victims, in Germany, despite having similar coping styles to Canadians, the lack of expectation for chronic pain may be protective from the effect of passive coping styles. Further studies of coping style as an aetiologic factor in the chronic whiplash syndrome are needed.

  16. Late whiplash syndrome: a clinical science approach to evidence-based diagnosis and management.

    Science.gov (United States)

    Poorbaugh, Keith; Brismée, Jean-Michel; Phelps, Valerie; Sizer, Phillip S

    2008-01-01

    The purpose of this article is to narrow the gap that exists in the clinical application of scientific research and empiric evidence for the evaluation and management of late whiplash. Considering that 14% to 42% of patients are left with chronic symptoms following whiplash injury, it is unlikely that only minor self-limiting injuries result from the typical rear-end impact. As psychosocial issues play a role in the development of persistent whiplash symptoms, discerning the organic conditions from the biopsychosocial factors remains a challenge to clinicians. The term "whiplash" represents the multiple factors associated with the event, injury, and clinical syndrome that are the end-result of a sudden acceleration-deceleration trauma to the head and neck. However, contentions surround the nature of soft-tissue injuries that occur with most motor vehicle accidents and whether these injuries are significant enough to result in chronic pain and limitations. The stark contrast in litigation for whiplash that exists among industrialized nations and less developed countries suggests another factor that could influence one's interpretation of symptoms' chronicity associated with Late Whiplash Syndrome. There are no gold standard tests or imaging techniques that can objectify whiplash-associated disorders. A lack of supporting evidence and disparity in medico-legal issues have created distinct camps in the scientific interpretations and clinical management of late whiplash. It is likely that efforts in research and/or clinical practice will begin to explain the disparity between acute and chronic whiplash syndrome. Recent evidence suggests that Late Whiplash Syndrome should be considered from a different context. The purpose of this article is to expound on several of the significant findings in the literature and offer clinical applications for evaluation and management of Late Whiplash Syndrome.

  17. The PD COMM trial: a protocol for the process evaluation of a randomised trial assessing the effectiveness of two types of SLT for people with Parkinson's disease.

    Science.gov (United States)

    Masterson-Algar, Patricia; Burton, Christopher R; Brady, Marian C; Nicoll, Avril; Clarke, Carl E; Rick, Caroline; Hughes, Max; Au, Pui; Smith, Christina H; Sackley, Catherine M

    2017-08-29

    The PD COMM trial is a phase III multi-centre randomised controlled trial whose aim is to evaluate the effectiveness and cost-effectiveness of two approaches to speech and language therapy (SLT) compared with no SLT intervention (control) for people with Parkinson's disease who have self-reported or carer-reported problems with their speech or voice. Our protocol describes the process evaluation embedded within the outcome evaluation whose aim is to evaluate what happened at the time of the PD COMM intervention implementation and to provide findings that will assist in the interpretation of the PD COMM trial results. Furthermore, the aim of the PD COMM process evaluation is to investigate intervention complexity within a theoretical model of how the trialled interventions might work best and why. Drawing from the Normalization Process Theory and frameworks for implementation fidelity, a mixed method design will be used to address process evaluation research questions. Therapists' and participants' perceptions and experiences will be investigated via in-depth interviews. Critical incident reports, baseline survey data from therapists, treatment record forms and home practice diaries also will be collected at relevant time points throughout the running of the PD COMM trial. Process evaluation data will be analysed independently of the outcome evaluation before the two sets of data are then combined. To date, there are a limited number of published process evaluation protocols, and few are linked to trials investigating rehabilitation therapies. Providing a strong theoretical framework underpinning design choices and being tailored to meet the complex characteristics of the trialled interventions, our process evaluation has the potential to provide valuable insight into which components of the interventions being delivered in PD COMM worked best (and what did not), how they worked well and why. ISRCTN Registry, ISRCTN12421382 . Registered on 18 April 2016.

  18. Investigation of the Study Characteristics Affecting Clinical Trial Quality Using the Protocol Deviations Leading to Exclusion of Subjects From the Per Protocol Set Data in Studies for New Drug Application: A Retrospective Analysis.

    Science.gov (United States)

    Kohara, Norihito; Kaneko, Masayuki; Narukawa, Mamoru

    2018-01-01

    The concept of the risk-based approach has been introduced as an effort to secure the quality of clinical trials. In the risk-based approach, identification and evaluation of risk in advance are considered important. For recently completed clinical trials, we investigated the relationship between study characteristics and protocol deviations leading to the exclusion of subjects from Per Protocol Set (PPS) efficacy analysis. New drugs approved in Japan in the fiscal year 2014-2015 were targeted in the research. The reasons for excluding subjects from the PPS efficacy analysis were described in 102 trials out of 492 in the summary of new drug application documents, which was publicly disclosed after the drug's regulatory approval. The author extracted these reasons along with the numbers of the cases and the study characteristics of each clinical trial. Then, the direct comparison, univariate regression analysis, and multivariate regression analysis was carried out based on the exclusion rate. The study characteristics for which exclusion of subjects from the PPS efficacy analysis were frequently observed was multiregional clinical trials in study region; inhalant and external use in administration route; Anti-infective for systemic use; Respiratory system, Dermatologicals, and Nervous system in therapeutic drug under the Anatomical Therapeutic Chemical Classification. In the multivariate regression analysis, the clinical trial variables of inhalant, Respiratory system, or Dermatologicals were selected as study characteristics leading to a higher exclusion rate. The characteristics of the clinical trial that is likely to cause protocol deviations that will affect efficacy analysis were suggested. These studies should be considered for specific attention and priority observation in the trial protocol or its monitoring plan and execution, such as a clear description of inclusion/exclusion criteria in the protocol, development of training materials to site staff, and

  19. Electroacupuncture versus sham electroacupuncture for urinary retention in poststroke patients: study protocol for a multicenter, randomized controlled trial.

    Science.gov (United States)

    Shin, Seungwon; Lee, Jiwon; Yoo, Junghee; Lim, Sung Min; Lee, Euiju

    2016-04-12

    This study protocol evaluates the effectiveness of adjuvant electroacupuncture (EA) for urinary retention in poststroke patients undergoing conventional treatments, in comparison with that of a sham control. A multicenter, blinded, randomized controlled trial will be conducted in three hospitals in the Republic of Korea. We are recruiting 54 stroke survivors (aged >19 years), who were diagnosed with urinary retention based on the results of two consecutive post-void residual (PVR) tests, and dividing them randomly into two arms: the EA and Park-sham control groups. They will receive ten sessions of EA or sham treatment for 2 weeks. The participants will be blinded with non-penetrating needles and fake sounds of EA stimulators. The daily PVR ratio will be primarily measured at baseline and at the end of the study to statistically test the effectiveness of EA for poststroke urinary retention. Then, the Korean version of the Qualiveen Questionnaire, the Korean version of the International Prostate Symptom Score, and the blinding index will be assessed. After each EA session or sham EA, adverse events will be reported to evaluate the safety of EA. Results will be analyzed by using the independent t-test or Mann-Whitney U test, based on both intention-to-treat and per-protocol principles. The findings will provide clinical evidence for the effectiveness of EA treatment to improve urinary retention in stroke survivors. This study protocol was registered in ClinicalTrials.gov (NCT02472288) on 10 June 2015.

  20. Ultrasound guided injection of dexamethasone versus placebo for treatment of plantar fasciitis: protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Gilheany Mark F

    2010-07-01

    Full Text Available Abstract Background Plantar fasciitis is the most commonly reported cause of chronic pain beneath the heel. Management of this condition commonly involves the use of corticosteroid injection in cases where less invasive treatments have failed. However, despite widespread use, only two randomised trials have tested the effect of this treatment in comparison to placebo. These trials currently offer the best available evidence by which to guide clinical practice, though both were limited by methodological issues such as insufficient statistical power. Therefore, the aim of this randomised trial is to compare the effect of ultrasound-guided corticosteroid injection versus placebo for treatment of plantar fasciitis. Methods The trial will be conducted at the La Trobe University Podiatry Clinic and will recruit 80 community-dwelling participants. Diagnostic ultrasound will be used to diagnose plantar fasciitis and participants will be required to meet a range of selection criteria. Participants will be randomly allocated to one of two treatment arms: (i ultrasound-guided injection of the plantar fascia with 1 mL of 4 mg/mL dexamethasone sodium phosphate (experimental group, or (ii ultrasound-guided injection of the plantar fascia with 1 mL normal saline (control group. Blinding will be applied to participants and the investigator performing procedures, measuring outcomes and analysing data. Primary outcomes will be pain measured by the Foot Health Status Questionnaire and plantar fascia thickness measured by ultrasound at 4, 8 and 12 weeks. All data analyses will be conducted on an intention-to-treat basis. Conclusion This will be a randomised trial investigating the effect of dexamethasone injection on pre-specified treatment outcomes in people with plantar fasciitis. Within the parameters of this protocol, the trial findings will be used to make evidence-based recommendations regarding the use of corticosteroid injection for treatment of this

  1. The evaluation of complex clinical trial protocols: resources available to research ethics committees and the use of clinical trial registries--a case study.

    Science.gov (United States)

    Homedes, Núria; Ugalde, Antonio

    2015-06-01

    To assess the potential role of clinical trial (CT) registries and other resources available to research ethics committees (RECs) in the evaluation of complex CT protocols in low-income and middle-income countries. Using a case study approach, the authors examined the decision-making process of a REC in Argentina and its efforts to use available resources to decide on a complex protocol. We also analysed the information in the USA and other CT registries and consulted 24 CT experts in seven countries. Information requested by the Argentinean REC from other national RECs and ethics' experts was not useful to verify the adequacy of the REC's decision whether or not to approve the CT. The responses from the national regulatory agency and the sponsor were not helpful either. The identification of international resources that could assist was beyond the REC's capability. The information in the USA and other CT registries is limited, and at times misleading; and its accuracy is not verified by register keepers. RECs have limited access to experts and institutions that could assist them in their deliberations. Sponsors do not always answer RECs' request for information to properly conduct the ethical and methodological assessment of CT protocols. The usefulness of the CT registries is curtailed by the lack of appropriate codes and by data errors. Information about reasons for rejection, withdrawal or suspension of the trial should be included in the registries. Establishing formal channels of communication among national and foreign RECs and with independent international reference centres could strengthen the ethical review of CT protocols. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  2. An Evidence-Based Approach to the Treatment of Acute Whiplash Injury

    Directory of Open Access Journals (Sweden)

    Les Barnsley

    2003-01-01

    Full Text Available This review has two components. The first is a selective, narrative background of some of the issues surrounding acute whiplash. The latter part is a more systematic review of the available evidence concerning the management of acute whiplash as it stood in March 2001.

  3. A cross-cultural comparison between Canada and Germany of symptom expectation for whiplash injury.

    Science.gov (United States)

    Ferrari, Robert; Lang, Christoph

    2005-02-01

    Symptom expectation for whiplash injury has been shown to be low in countries with low rates of chronic whiplash when compared with countries like Canada, where chronic whiplash is common. The objective of the current study is to compare the frequency and nature of expected "whiplash" symptoms in Germany with that in Canada. A symptom checklist was administered to two subject groups selected from local companies in Germany and Canada. Subjects were asked to imagine having suffered a neck sprain (whiplash injury) with no loss of consciousness in a motor vehicle collision and to check which, of a variety of symptoms, they would expect might arise from the injury. For symptoms they anticipated, they were asked to select the period of time they expected those symptoms to persist. In both groups, the pattern of acute symptoms anticipated closely resembled the symptoms of acute whiplash victims, but 50% of Canadians also anticipated symptoms to last months or years, whereas few German subjects selected any symptoms as likely to persist. In Germany, despite the documented occurrence of neck sprain symptoms in individuals following motor vehicle collisions, there is a very low rate of expectation of any sequelae from this injury. The current or previous aspects of society that underlie this remain uncertain. This lack of expectation of chronicity in Germany may, in part, determine the low prevalence of the chronic whiplash syndrome there. Further studies of symptom expectation as an etiologic factor in the chronic whiplash syndrome are needed.

  4. Validity and internal consistency of a whiplash-specific disability measure

    NARCIS (Netherlands)

    Pinfold, Melanie; Niere, Ken R.; O'Leary, Elizabeth F.; Hoving, Jan Lucas; Green, Sally; Buchbinder, Rachelle

    2004-01-01

    STUDY DESIGN: Cross-sectional study of patients with whiplash-associated disorders investigating the internal consistency, factor structure, response rates, and presence of floor and ceiling effects of the Whiplash Disability Questionnaire (WDQ). OBJECTIVES: The aim of this study was to confirm the

  5. Prognostic factors of whiplash-associated disorders: a systematic review of prospective cohort studies

    NARCIS (Netherlands)

    Scholten-Peeters, Gwendolijne G.M; Verhagen, Arianne P; Bekkering, Geertruida E; van der Windt, Daniëlle A W M; Barnsley, Les; Oostendorp, Rob A B; Hendriks, Erik J M

    2003-01-01

    We present a systematic review of prospective cohort studies. Our aim was to assess prognostic factors associated with functional recovery of patients with whiplash injuries. The failure of some patients to recover following whiplash injury has been linked to a number of prognostic factors. However,

  6. Prognostic factors of whiplash-associated disorders: a systematic review of prospective cohort studies.

    NARCIS (Netherlands)

    Scholten-Peeters, G.G.M.; Verhagen, A.P.; Bekkering, G.E.; Windt, D.A.W.M. van der; Barnsley, L.; Oostendorp, R.A.B.; Hendriks, E.

    2003-01-01

    We present a systematic review of prospective cohort studies. Our aim was to assess prognostic factors associated with functional recovery of patients with whiplash injuries. The failure of some patients to recover following whiplash injury has been linked to a number of prognostic factors. However,

  7. Effectiveness of a healthy lifestyle intervention for low back pain and osteoarthritis of the knee: protocol and statistical analysis plan for two randomised controlled trials

    Directory of Open Access Journals (Sweden)

    Kate M. O’Brien

    Full Text Available ABSTRACT Background These trials are the first randomised controlled trials of telephone-based weight management and healthy lifestyle interventions for low back pain and knee osteoarthritis. This article describes the protocol and statistical analysis plan. Method These trials are parallel randomised controlled trials that investigate and compare the effect of a telephone-based weight management and healthy lifestyle intervention for improving pain intensity in overweight or obese patients with low back pain or knee osteoarthritis. The analysis plan was finalised prior to initiation of analyses. All data collected as part of the trial were reviewed, without stratification by group, and classified by baseline characteristics, process of care and trial outcomes. Trial outcomes were classified as primary and secondary outcomes. Appropriate descriptive statistics and statistical testing of between-group differences, where relevant, have been planned and described. Conclusions A protocol for standard analyses was developed for the results of two randomised controlled trials. This protocol describes the data, and the pre-determined statistical tests of relevant outcome measures. The plan demonstrates transparent and verifiable use of the data collected. This a priori protocol will be followed to ensure rigorous standards of data analysis are strictly adhered to.

  8. Effectiveness of a healthy lifestyle intervention for low back pain and osteoarthritis of the knee: protocol and statistical analysis plan for two randomised controlled trials

    Science.gov (United States)

    O’Brien, Kate M.; Williams, Amanda; Wiggers, John; Wolfenden, Luke; Yoong, Serene; Campbell, Elizabeth; Kamper, Steven J.; McAuley, James; Attia, John; Oldmeadow, Chris; Williams, Christopher M.

    2016-01-01

    ABSTRACT Background These trials are the first randomised controlled trials of telephone-based weight management and healthy lifestyle interventions for low back pain and knee osteoarthritis. This article describes the protocol and statistical analysis plan. Method These trials are parallel randomised controlled trials that investigate and compare the effect of a telephone-based weight management and healthy lifestyle intervention for improving pain intensity in overweight or obese patients with low back pain or knee osteoarthritis. The analysis plan was finalised prior to initiation of analyses. All data collected as part of the trial were reviewed, without stratification by group, and classified by baseline characteristics, process of care and trial outcomes. Trial outcomes were classified as primary and secondary outcomes. Appropriate descriptive statistics and statistical testing of between-group differences, where relevant, have been planned and described. Conclusions A protocol for standard analyses was developed for the results of two randomised controlled trials. This protocol describes the data, and the pre-determined statistical tests of relevant outcome measures. The plan demonstrates transparent and verifiable use of the data collected. This a priori protocol will be followed to ensure rigorous standards of data analysis are strictly adhered to. PMID:27683839

  9. Evaluating a community-based early childhood education and development program in Indonesia: study protocol for a pragmatic cluster randomized controlled trial with supplementary matched control group

    NARCIS (Netherlands)

    Pradhan, M.; Brinkman, S.A.; Beatty, A.; Maika, A.; Satriawan, E.; de Ree, J.; Hasan, A.

    2013-01-01

    Background This paper presents the study protocol for a pragmatic cluster randomized controlled trial (RCT) with a supplementary matched control group. The aim of the trial is to evaluate a community-based early education and development program launched by the Government of Indonesia. The program

  10. Evaluating a community-based early childhood education and development program in Indonesia: study protocol for a pragmatic cluster randomized controlled trial with supplementary matched control group

    NARCIS (Netherlands)

    Pradhan, M.P.; Brinkman, S.A.; Beatty, A.; Maika, A.; Satriawan, E.; de Ree, J.; Hasan, A.

    2013-01-01

    Background: This paper presents the study protocol for a pragmatic cluster randomized controlled trial (RCT) with a supplementary matched control group. The aim of the trial is to evaluate a community-based early education and development program launched by the Government of Indonesia. The program

  11. Implementation and results of an integrated data quality assurance protocol in a randomized controlled trial in Uttar Pradesh, India.

    Science.gov (United States)

    Gass, Jonathon D; Misra, Anamika; Yadav, Mahendra Nath Singh; Sana, Fatima; Singh, Chetna; Mankar, Anup; Neal, Brandon J; Fisher-Bowman, Jennifer; Maisonneuve, Jenny; Delaney, Megan Marx; Kumar, Krishan; Singh, Vinay Pratap; Sharma, Narender; Gawande, Atul; Semrau, Katherine; Hirschhorn, Lisa R

    2017-09-07

    There are few published standards or methodological guidelines for integrating Data Quality Assurance (DQA) protocols into large-scale health systems research trials, especially in resource-limited settings. The BetterBirth Trial is a matched-pair, cluster-randomized controlled trial (RCT) of the BetterBirth Program, which seeks to improve quality of facility-based deliveries and reduce 7-day maternal and neonatal mortality and maternal morbidity in Uttar Pradesh, India. In the trial, over 6300 deliveries were observed and over 153,000 mother-baby pairs across 120 study sites were followed to assess health outcomes. We designed and implemented a robust and integrated DQA system to sustain high-quality data throughout the trial. We designed the Data Quality Monitoring and Improvement System (DQMIS) to reinforce six dimensions of data quality: accuracy, reliability, timeliness, completeness, precision, and integrity. The DQMIS was comprised of five functional components: 1) a monitoring and evaluation team to support the system; 2) a DQA protocol, including data collection audits and targets, rapid data feedback, and supportive supervision; 3) training; 4) standard operating procedures for data collection; and 5) an electronic data collection and reporting system. Routine audits by supervisors included double data entry, simultaneous delivery observations, and review of recorded calls to patients. Data feedback reports identified errors automatically, facilitating supportive supervision through a continuous quality improvement model. The five functional components of the DQMIS successfully reinforced data reliability, timeliness, completeness, precision, and integrity. The DQMIS also resulted in 98.33% accuracy across all data collection activities in the trial. All data collection activities demonstrated improvement in accuracy throughout implementation. Data collectors demonstrated a statistically significant (p = 0.0004) increase in accuracy throughout

  12. Text messaging reminders for influenza vaccine in primary care: protocol for a cluster randomised controlled trial (TXT4FLUJAB).

    Science.gov (United States)

    Herrett, Emily; van Staa, Tjeerd; Free, Caroline; Smeeth, Liam

    2014-05-02

    The UK government recommends that at least 75% of people aged under 64 with certain conditions receive an annual influenza vaccination. Primary care practices often fall short of this target and strategies to increase vaccine uptake are required. Text messaging reminders are already used in 30% of practices to remind patients about vaccination, but there has been no trial addressing their effectiveness in increasing influenza vaccine uptake in the UK. The aims of the study are (1) to develop the methodology for conducting cluster randomised trials of text messaging interventions utilising routine electronic health records and (2) to assess the effectiveness of using a text messaging influenza vaccine reminder in achieving an increase in influenza vaccine uptake in patients aged 18-64 with chronic conditions, compared with standard care. This cluster randomised trial will recruit general practices across three settings in English primary care (Clinical Practice Research Datalink, ResearchOne and London iPLATO text messaging software users) and randomise them to either standard care or a text messaging campaign to eligible patients. Flu vaccine uptake will be ascertained using routinely collected, anonymised electronic patient records. This protocol outlines the proposed study design and analysis methods. This study will determine the effectiveness of text messaging vaccine reminders in primary care in increasing influenza vaccine uptake, and will strengthen the methodology for using electronic health records in cluster randomised trials of text messaging interventions. This trial was approved by the Surrey Borders Ethics Committee (13/LO/0872). The trial results will be disseminated at national conferences and published in a peer-reviewed medical journal. The results will also be distributed to the Primary Care Research Network and to all participating general practices. This study is registered at controlled-trials.com ISRCTN48840025, July 2013.

  13. Tachikawa project for prevention of posttraumatic stress disorder with polyunsaturated fatty acid (TPOP): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Matsuoka, Yutaka; Nishi, Daisuke; Yonemoto, Naohiro; Hamazaki, Kei; Matsumura, Kenta; Noguchi, Hiroko; Hashimoto, Kenji; Hamazaki, Tomohito

    2013-01-05

    Preclinical and clinical studies suggest that supplementation with omega-3 fatty acids after trauma might reduce subsequent posttraumatic stress disorder (PTSD). To date, we have shown in an open trial that PTSD symptoms in critically injured patients can be reduced by taking omega-3 fatty acids, hypothesized to stimulate hippocampal neurogenesis. The primary aim of the present randomized controlled trial is to examine the efficacy of omega-3 fatty acid supplementation in the secondary prevention of PTSD following accidental injury, as compared with placebo. This paper describes the rationale and protocol of this trial. The Tachikawa Project for Prevention of Posttraumatic Stress Disorder with Polyunsaturated Fatty Acid (TPOP) is a double-blinded, parallel group, randomized controlled trial to assess whether omega-3 fatty acid supplementation can prevent PTSD symptoms among accident-injured patients consecutively admitted to an intensive care unit. We plan to recruit accident-injured patients and follow them prospectively for 12 weeks. Enrolled patients will be randomized to either the omega-3 fatty acid supplement group (1,470 mg docosahexaenoic acid and 147 mg eicosapentaenoic acid daily) or placebo group. Primary outcome is score on the Clinician-Administered PTSD Scale (CAPS). We will need to randomize 140 injured patients to have 90% power to detect a 10-point difference in mean CAPS scores with omega-3 fatty acid supplementation compared with placebo. Secondary measures are diagnosis of PTSD and major depressive disorder, depressive symptoms, physiologic response in the experiment using script-driven imagery and acoustic stimulation, serum brain-derived neurotrophic factor, health-related quality of life, resilience, and aggression. Analyses will be by intent to treat. The trial was initiated on December 13 2008, with 104 subjects randomized by November 30 2012. This study promises to be the first trial to provide a novel prevention strategy for PTSD among

  14. Remotely-Supervised Transcranial Direct Current Stimulation (tDCS for Clinical Trials: Guidelines for Technology and Protocols

    Directory of Open Access Journals (Sweden)

    Leigh E Charvet

    2015-03-01

    Full Text Available The effect of transcranial direct current stimulation (tDCS is cumulative. Treatment protocols typically require multiple consecutive sessions spanning weeks or months. However, traveling to clinic for a tDCS session can present an obstacle to subjects and their caregivers. With modified devices and headgear, tDCS treatment can be administered remotely under clinical supervision, potentially enhancing recruitment, throughput, and convenience. Here we propose standards and protocols for clinical trials utilizing remotely-supervised tDCS with the goal of providing safe, reproducible and well-tolerated stimulation therapy outside of the clinic. The recommendations include: 1 training of staff in tDCS treatment and supervision, 2 assessment of the user’s capability to participate in tDCS remotely, 3 ongoing training procedures and materials including assessments of the user and/or caregiver, 4 simple and fail-safe electrode preparation techniques and tDCS headgear, 5 strict dose control for each session, 6 ongoing monitoring to quantify compliance (device preparation, electrode saturation/placement, stimulation protocol, with corresponding corrective steps as required, 7 monitoring for treatment-emergent adverse effects, 8 guidelines for discontinuation of a session and/or study participation including emergency failsafe procedures tailored to the treatment population’s level of need. These guidelines are intended to provide a minimal level of methodological rigor for clinical trials seeking to apply tDCS outside a specialized treatment center. We outline indication-specific applications (Attention Deficit Hyperactivity Disorder, Depression, Multiple Sclerosis, Palliative Care following these recommendations that support a standardized framework for evaluating the tolerability and reproducibility of remote-supervised tDCS that, once established, will allow for translation of tDCS clinical trials to a greater size and range of patient populations.

  15. A clinical trial protocol to treat massive Africanized honeybee (Apis mellifera) attack with a new apilic antivenom.

    Science.gov (United States)

    Barbosa, Alexandre Naime; Boyer, Leslie; Chippaux, Jean-Philippe; Medolago, Natalia Bronzatto; Caramori, Carlos Antonio; Paixão, Ariane Gomes; Poli, João Paulo Vasconcelos; Mendes, Mônica Bannwart; Dos Santos, Lucilene Delazari; Ferreira, Rui Seabra; Barraviera, Benedito

    2017-01-01

    Envenomation caused by multiple stings from Africanized honeybees Apis mellifera constitutes a public health problem in the Americas. In 2015, the Brazilian Ministry of Health reported 13,597 accidents (incidence of seven cases per 100,000 inhabitants) with 39 deaths (lethality of 0.25%). The toxins present in the venom, which include melittin and phospholipase A 2 , cause lesions in diverse organs and systems that may be fatal. As there has been no specific treatment to date, management has been symptomatic and supportive only. In order to evaluate the safety and neutralizing capacity of a new apilic antivenom, as well as to confirm its lowest effective dose, a clinical protocol was developed to be applied in a multicenter, non-randomized and open phase I/II clinical trial. Twenty participants with more than five stings, aged more than 18 years, of both sexes, who have not previously received the heterologous serum against bee stings, will be included for 24 months. The proposed dose was based on the antivenom neutralizing capacity and the number of stings. Treatment will be administered only in a hospital environment and the participants will be evaluated for a period up to 30 days after discharge for clinical and laboratory follow-up. This protocol, approved by the Brazilian regulatory agencies for ethics (National Commission for Ethics on Research - CONEP) and sanitation (National Health Surveillance Agency - ANVISA), is a guideline constituted by specific, adjuvant, symptomatic and complementary treatments, in addition to basic orientations for conducting a clinical trial involving heterologous sera. This is the first clinical trial protocol designed specifically to evaluate the preliminary efficacy and safety of a new antivenom against stings from the Africanized honeybee Apis mellifera . The results will support future studies to confirm a new treatment for massive bee attack that has a large impact on public health in the Americas.

  16. Multicentre trial of a perioperative protocol to reduce mortality in patients with peptic ulcer perforation

    DEFF Research Database (Denmark)

    Møller, M H; Adamsen, S; Thomsen, R W

    2011-01-01

    Morbidity and mortality rates in patients with perforated peptic ulcer (PPU) remain substantial. The aim of the present study was to evaluate the effect of a multimodal and multidisciplinary perioperative care protocol on mortality in patients with PPU.......Morbidity and mortality rates in patients with perforated peptic ulcer (PPU) remain substantial. The aim of the present study was to evaluate the effect of a multimodal and multidisciplinary perioperative care protocol on mortality in patients with PPU....

  17. Resource use and costs of type 2 diabetes patients receiving managed or protocolized primary care: a controlled clinical trial.

    Science.gov (United States)

    van der Heijden, Amber A W A; de Bruijne, Martine C; Feenstra, Talitha L; Dekker, Jacqueline M; Baan, Caroline A; Bosmans, Judith E; Bot, Sandra D M; Donker, Gé A; Nijpels, Giel

    2014-06-25

    care was significantly associated with better process in terms of diabetes care, fewer secondary care consultations and lower health care costs. The same trends were seen for protocolized care, however they were not statistically significant. Current Controlled trials: ISRCTN66124817.

  18. Otological and vestibular symptoms in patients with low grade (Quebec grades one and two) whiplash injury.

    Science.gov (United States)

    Rowlands, R G; Campbell, I K; Kenyon, G S

    2009-02-01

    To establish the prevalence of new vestibular and otological symptoms in a group of patients who had sustained a low grade (Quebec grades one or two) whiplash injury. A retrospective review of the case records of 109 patients undergoing assessment by a single practitioner for the purposes of compiling a medicolegal report on their whiplash injury. Four patients complained of short-lived, non-specific dizziness symptoms in the acute phase following their original injury. There were no reports of vertigo, tinnitus or hearing loss after a mean period of 149 days following the whiplash injury. No patients reported otological or persistent vestibular symptoms in the acute phase following their whiplash injury. This suggests that caution should be exercised when attributing these symptoms to such an injury. Before whiplash injuries are admitted as an aetiological factor in the development of such symptoms, other causes should be excluded.

  19. How Do We Meet the Challenge of Whiplash?

    Science.gov (United States)

    Elliott, James M; Walton, David M

    2017-07-01

    A previous special issue of JOSPT (October 2016) discussed whiplash in terms of the clinical problems and current research surrounding prevention, biomechanics of injury, emergent care, imaging advancements, recovery pathways and prognosis, pathogenesis of posttrauma pain, acute and chronic management, and new predictive clinical tools. While great strides have been made in the field of whiplash and are continuing in earnest, a key group of clinicians and academics have recognized that inconsistent outcomes in published literature hamper our ability to meaningfully synthesize research findings, leading to results of systematic reviews that provide very few concrete clinical recommendations. We are optimistic that improved outcomes for people with whiplash-associated disorder (WAD) are attainable in the near future, as interdisciplinary research efforts continue to align internationally, new mechanisms are identified and explored, and advanced statistical techniques allow complex questions to be answered in clinically meaningful ways. J Orthop Sports Phys Ther 2017;47(7):444-446. doi:10.2519/jospt.2017.0106.

  20. The fear-avoidance model in whiplash injuries.

    Science.gov (United States)

    Nieto, Rubén; Miró, Jordi; Huguet, Anna

    2009-05-01

    The aim of this work was to study whether fear of movement, and pain catastrophizing predict pain related-disability and depression in sub-acute whiplash patients. Moreover, we wanted to test if fear of movement is a mediator in the relation between catastrophizing and pain-related disability/depression as has been suggested by the fear-avoidance model [Vlaeyen JWS, Kole-Snijders AMJ, Boeren RGB, van Eek H. Fear of movement/(re)injury in chronic low back pain and its relation to behavioral performance. Pain 1995;62:363-72]. The convenience sample used was of 147 sub-acute whiplash patients (pain duration less than 3 months). Two stepwise regression analyses were performed using fear of movement and catastrophizing as the independent variables, and disability and depression as the dependent variables. After controlling for descriptive variables and pain characteristics, catastrophizing and fear of movement were found to be predictors of disability and depression. Pain intensity was a predictor of disability but not of depression. The mediation effect of fear of movement in the relationships between catastrophizing and disability, and between catastrophizing and depression was also supported. The results of this study are in accordance with the fear-avoidance model, and support a biopsychosocial perspective for whiplash disorders.

  1. Recruitment bias in chronic pain research: whiplash as a model.

    Science.gov (United States)

    Nijs, Jo; Inghelbrecht, Els; Daenen, Liesbeth; Hachimi-Idrissi, Said; Hens, Luc; Willems, Bert; Roussel, Nathalie; Cras, Patrick; Wouters, Kristien; Bernheim, Jan

    2011-11-01

    In science findings which cannot be extrapolated to other settings are of little value. Recruitment methods vary widely across chronic whiplash studies, but it remains unclear whether this generates recruitment bias. The present study aimed to examine whether the recruitment method accounts for differences in health status, social support, and personality traits in patients with chronic whiplash-associated disorders (WAD). Two different recruitment methods were compared: recruiting patients through a local whiplash patient support group (group 1) and local hospital emergency department (group 2). The participants (n=118) filled in a set of questionnaires: the Neck Disability Index, Medical Outcome Study Short-Form General Health Survey, Anamnestic Comparative Self-Assessment measure of overall well-being, Symptom Checklist-90, Dutch Personality Questionnaire, and the Social Support List. The recruitment method (either through the local emergency department or patient support group) accounted for the differences in insufficiency, somatization, disability, quality of life, self-satisfaction, and dominance (all p values recruitment methods generated chronic WAD patients comparable for psychoneurotism, social support, self-sufficiency, (social) inadequacy, rigidity, and resentment (p>.01). The recruitment of chronic WAD patients solely through patient support groups generates bias with respect to the various aspects of health status and personality, but not social support. In order to enhance the external validity of study findings, chronic WAD studies should combine a variety of recruitment procedures.

  2. Vestibular Rehabilitation in a Patient with Whiplash-associated Disorders

    Directory of Open Access Journals (Sweden)

    Kwo-Shieng Tuo

    2006-12-01

    Full Text Available Whiplash-associated disorders are characterized by multiple physical complaints after a flexion-extension trauma to the neck. They are difficult to treat, and they often result in great impact on the patient's quality of life. In this paper, the comprehensive treatment of a patient with whiplash-associated disorders is presented. The purpose is to highlight the importance of accurate diagnosis and appropriate treatment plans to improve patients' quality of life. This 23-year-old woman experienced a traffic accident which caused severely painful neck disability, numbness over bilateral upper limbs, dizziness, double vision and loss of balance. Among these symptoms, dizziness was the problem that bothered the patient most. She received a comprehensive rehabilitation program including physical modalities, trigger point injections for relief of pain, as well as a vestibular rehabilitation program, which included exercises challenging and improving her balance function, head-eye coordination exercise, visual-ocular control exercise and sensory substitution-promoting exercises. She resumed her previous full-time work after 3 weeks of treatment. This successfully treated case illustrates the importance of correct diagnosis and appropriate treatment for patients who suffer from whiplash-associated disorders.

  3. Somatic symptoms beyond those generally associated with a whiplash injury are increased in self-reported chronic whiplash. A population-based cross sectional study: the Hordaland Health Study (HUSK

    Directory of Open Access Journals (Sweden)

    Myrtveit Solbjørg

    2012-08-01

    Full Text Available Abstract Background Chronic whiplash leads to considerable patient suffering and substantial societal costs. There are two competing hypothesis on the etiology of chronic whiplash. The traditional organic hypothesis considers chronic whiplash and related symptoms a result of a specific injury. In opposition is the hypothesis that chronic whiplash is a functional somatic syndrome, and related symptoms a result of society-induced expectations and amplification of symptoms. According to both hypotheses, patients reporting chronic whiplash are expected to have more neck pain, headache and symptoms of anxiety and depression than the general population. Increased prevalence of somatic symptoms beyond those directly related to a whiplash neck injury is less investigated. The aim of this study was to test an implication derived from the functional hypothesis: Is the prevalence of somatic symptoms as seen in somatization disorder, beyond symptoms related to a whiplash neck injury, increased in individuals self-reporting chronic whiplash? We further aimed to explore recall bias by comparing the symptom profile displayed by individuals self-reporting chronic whiplash to that among those self-reporting a non-functional injury: fractures of the hand or wrist. We explored symptom load, etiologic origin could not be investigated in this study. Methods Data from the Norwegian population-based “Hordaland Health Study” (HUSK, 1997–99; N = 13,986 was employed. Chronic whiplash was self-reported by 403 individuals and fractures by 1,746. Somatization tendency was measured using a list of 17 somatic symptoms arising from different body parts and organ systems, derived from the research criteria for somatization disorder (ICD-10, F45. Results Chronic whiplash was associated with an increased level of all 17 somatic symptoms investigated (p Conclusions The increased prevalence of somatic symptoms beyond symptoms expected according to the organic injury model

  4. Structural and construct validity of the Whiplash Disability Questionnaire in adults with acute whiplash-associated disorders

    DEFF Research Database (Denmark)

    Stupar, Maja; Côté, Pierre; Beaton, Dorcas E

    2015-01-01

    BACKGROUND CONTEXT: Few instruments are available to measure disability associated with whiplash-associated disorders (WAD). The Whiplash Disability Questionnaire (WDQ) was developed to measure disability resulting from WAD, but its validity is unknown for acute WAD. PURPOSE: The aim...... included insurance claimants who were aged 18 years or older and diagnosed with acute WAD Grades I to III. All participants completed the WDQ, a 13-item questionnaire scored from 0 (no disability) to 130 (complete disability). We assessed the factor structure of the WDQ and tested its construct validity...... against self-perceived recovery, neck pain (Numerical Rating Scale [NRS]), neck disability (Neck Disability Index [NDI] and Neck Bournemouth Questionnaire), health-related quality of life (36-Item Short Form Health Survey [SF-36]), and depressive symptoms (Center for Epidemiologic Studies Depression Scale...

  5. Protocol for the combined immunosuppression & radiotherapy in thyroid eye disease (CIRTED trial: A multi-centre, double-masked, factorial randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Kingston Laura

    2008-01-01

    Full Text Available Abstract Background Medical management of thyroid eye disease remains controversial due to a paucity of high quality evidence on long-term treatment outcomes. Glucocorticoids are known to be effective initially but have significant side-effects with long-term use and recrudescence can occur on cessation. Current evidence is conflicting on the efficacy of radiotherapy and non-steroid systemic immunosuppression, and the majority of previous studies have been retrospective, uncontrolled, small or poorly designed. The Combined Immunosuppression and Radiotherapy in Thyroid Eye Disease (CIRTED trial was designed to investigate the efficacy of radiotherapy and azathioprine in combination with a standard course of oral prednisolone in patients with active thyroid eye disease. Methods/design Patients with active thyroid eye disease will be randomised to receive (i azathioprine or oral placebo and (ii radiotherapy or sham-radiotherapy in this multi-centre, factorial randomised control trial. The primary outcome is improvement in disease severity (assessed using a composite binary measure at 12 months and secondary end-points include quality of life scores and health economic measures. Discussion The CIRTED trial is the first study to evaluate the role of radiotherapy and azathioprine as part of a long-term, combination immunosuppressive treatment regime for Thyroid Eye Disease. It will provide evidence for the role of radiotherapy and prolonged immunosuppression in the management of this condition, as well as pilot data on their use in combination. We have paid particular attention in the trial design to establishing (a robust placebo controls and masking protocols which are effective and safe for both radiotherapy and the systemic administration of an antiproliferative drug; (b constructing effective inclusion and exclusion criteria to select for active disease; and (c selecting pragmatic outcome measures. Trial registration Current controlled trials

  6. Understanding influences on teachers' uptake and use of behaviour management strategies within the STARS trial: process evaluation protocol for a randomised controlled trial.

    Science.gov (United States)

    Hansford, Lorraine; Sharkey, Siobhan; Edwards, Vanessa; Ukoumunne, Obioha; Byford, Sarah; Norwich, Brahm; Logan, Stuart; Ford, Tamsin

    2015-02-10

    The 'Supporting Teachers And childRen in Schools' (STARS) study is a cluster randomised controlled trial evaluating the Incredible Years Teacher Classroom Management (TCM) programme as a public health intervention. TCM is a 6 day training course delivered to groups of 8-12 teachers. The STARS trial will investigate whether TCM can improve children's behaviour, attainment and wellbeing, reduce teachers' stress and improve their self-efficacy. This protocol describes the methodology of the process evaluation embedded within the main trial, which aims to examine the uptake and implementation of TCM strategies within the classroom plus the wider school environment and improve the understanding of outcomes. The STARS trial will work with eighty teachers of children aged 4-9 years from eighty schools. Teachers will be randomised to attend the TCM course (intervention arm) or to "teach as normal" (control arm) and attend the course a year later. The process evaluation will use quantitative and qualitative approaches to assess fidelity to model, as well as explore headteachers' and teachers' experiences of TCM and investigate school factors that influence the translation of skills learnt to practice. Four of the eight groups of teachers (n = 40) will be invited to participate in focus groups within one month of completing the TCM course, and again a year later, while 45 of the 80 headteachers will be invited to take part in telephone interviews. Standardised checklists will be completed by group leaders and each training session will be videotaped to assess fidelity to model. Teachers will also complete standardised session evaluations. This study will provide important information about whether the Teacher Classroom Management course influences child and teacher mental health and well-being in both the short and long term. The process evaluation will provide valuable insights into factors that may facilitate or impede any impact. The trial has been registered with ISCTRN

  7. Cluster randomized trial in the general practice research database: 2. Secondary prevention after first stroke (eCRT study: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Dregan Alex

    2012-10-01

    Full Text Available Abstract Background The purpose of this research is to develop and evaluate methods for conducting pragmatic cluster randomized trials in a primary care electronic database. The proposal describes one application, in a less frequent chronic condition of public health importance, secondary prevention of stroke. A related protocol in antibiotic prescribing was reported previously. Methods/Design The study aims to implement a cluster randomized trial (CRT using the electronic patient records of the General Practice Research Database (GPRD as a sampling frame and data source. The specific objective of the trial is to evaluate the effectiveness of a computer-delivered intervention at enhancing the delivery of stroke secondary prevention in primary care. GPRD family practices will be allocated to the intervention or usual care. The intervention promotes the use of electronic prompts to support adherence with the recommendations of the UK Intercollegiate Stroke Working Party and NICE guidelines for the secondary prevention of stroke in primary care. Primary outcome measure will be the difference in systolic blood pressure between intervention and control trial arms at 12-month follow-up. Secondary outcomes will be differences in serum cholesterol, prescribing of antihypertensive drugs, statins, and antiplatelet therapy. The intervention will continue for 12 months. Information on the utilization of the decision-support tools will also be analyzed. Discussion The CRT will investigate the effectiveness of using a computer-delivered intervention to reduce the risk of stroke recurrence following a first stroke event. The study will provide methodological guidance on the implementation of CRTs in electronic databases in primary care. Trial registration Current Controlled Trials ISRCTN35701810

  8. The transvaginal hybrid NOTES versus conventionally assisted laparoscopic sigmoid resection for diverticular disease (TRANSVERSAL) trial: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Senft, Jonas D; Warschkow, Rene; Diener, Markus K; Tarantino, Ignazio; Steinemann, Daniel C; Lamm, Sebastian; Simon, Thomas; Zerz, Andreas; Müller-Stich, Beat P; Linke, Georg R

    2014-11-20

    current surgical standard for sigmoid resection. The trial protocol was registered in the German Clinical Trials Register ( DRKS00005995) on March 27, 2014.

  9. Intensive group training protocol versus guideline physiotherapy for patients with chronic low back pain: a randomised controlled trial.

    Science.gov (United States)

    van der Roer, Nicole; van Tulder, Maurits; Barendse, Johanna; Knol, Dirk; van Mechelen, Willem; de Vet, Henrica

    2008-09-01

    Intensive group training using principles of graded activity has been proven to be effective in occupational care for workers with chronic low back pain. Objective of the study was to compare the effects of an intensive group training protocol aimed at returning to normal daily activities and guideline physiotherapy for primary care patients with non-specific chronic low back pain. The study was designed as pragmatic randomised controlled trial with a setup of 105 primary care physiotherapists in 49 practices and 114 patients with non-specific low back pain of more than 12 weeks duration participated in the study. In the intensive group training protocol exercise therapy, back school and operant-conditioning behavioural principles are combined. Patients were treated during 10 individual sessions along 20 group sessions. Usual care consisted of physiotherapy according to the Dutch guidelines for Low Back Pain. Main outcome measures were functional disability (Roland Morris disability questionnaire), pain intensity, perceived recovery and sick leave because of low back pain assessed at baseline and after 6, 13, 26 and 52 weeks. Both an intention-to-treat analysis and a per-protocol analysis were performed. Multilevel analysis did not show significant differences between both treatment groups on any outcome measures during the complete follow-up period, with one exception. After 26 weeks the protocol group showed more reduction in pain intensity than the guideline group, but this difference was absent after 52 weeks. We finally conclude that an intensive group training protocol was not more effective than usual physiotherapy for chronic low back pain.

  10. Use of protocol and evaluation of postoperative residual curarization incidence in the absence of intraoperative acceleromyography - Randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Filipe Nadir Caparica Santos

    Full Text Available Abstract Objective Evaluate the incidence of postoperative residual curarization (PORC in the post-anesthesia care unit (PACU after the use of protocol and absence of intraoperative acceleromyography (AMG. Methods Randomized clinical trial with 122 patients allocated into two groups (protocol and control. Protocol group received initial and additional doses of rocuronium (0.6 mg·kg-1 and 10 mg, respectively; the use of rocuronium was avoided in the final 45 min; blockade reversal with neostigmine (50 µg·kg-1; time ≥15 min between reversion and extubation. Control: initial and additional doses of rocuronium, blockade reversal, neostigmine dose, and extubation time, all at the discretion of the anesthesiologist. AMG was used in the PACU and PORC considered at T4/T1 ratio <1.0. Results The incidence of PORC was lower in protocol group than in control group (25% vs. 45.2%, p = 0.02. In control group, total dose of rocuronium was higher in patients with PORC than without PORC (0.43 vs. 0.35 mg·kg-1·h-1, p = 0.03 and the time interval between the last administration of rocuronium and neostigmine was lower (75.0 vs. 101.0 min, p < 0.01. In protocol group, there was no difference regarding the analyzed parameters (with PORC vs. without PORC. Considering the entire study population and the presence or absence of PORC, total dose of rocuronium was higher in patients with PORC (0.42 vs. 0.31 mg·kg-1·h-1, p = 0.01, while the time interval between the last administration of rocuronium and neostigmine was lower (72.5 vs. 99.0 min, p ≤ 0.01. Conclusion The proposed systematization reduced PORC incidence in PACU in the absence of intraoperative AMG.

  11. Measuring the impact and costs of a universal group based parenting programme: protocol and implementation of a trial

    Directory of Open Access Journals (Sweden)

    Winstanley Sarah

    2010-06-01

    new UK research governance procedures. Discussion Whilst there are strong theoretical arguments to support universal provision of parenting programmes, few universal programmes have been subjected to randomised controlled trials. In this paper we describe a RCT protocol with quantitative and qualitative outcome measures and an economic evaluation designed to provide clear evidence with regard to effectiveness and costs. We describe challenges implementing the protocol and how we are addressing these. Trial Registration Current Controlled Trials ISRCTN13919732

  12. Effectiveness of trigger point dry needling for plantar heel pain: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Landorf Karl B

    2011-01-01

    Full Text Available Abstract Background Plantar heel pain (plantar fasciitis is a common and disabling condition, which has a detrimental impact on health-related quality of life. Despite the high prevalence of plantar heel pain, the optimal treatment for this disorder remains unclear. Consequently, an alternative therapy such as dry needling is increasingly being used as an adjunctive treatment by health practitioners. Only two trials have investigated the effectiveness of dry needling for plantar heel pain, however both trials were of a low methodological quality. This manuscript describes the design of a randomised controlled trial to evaluate the effectiveness of dry needling for plantar heel pain. Methods Eighty community-dwelling men and woman aged over 18 years with plantar heel pain (who satisfy the inclusion and exclusion criteria will be recruited. Eligible participants with plantar heel pain will be randomised to receive either one of two interventions, (i real dry needling or (ii sham dry needling. The protocol (including needling details and treatment regimen was formulated by general consensus (using the Delphi research method using 30 experts worldwide that commonly use dry needling for plantar heel pain. Primary outcome measures will be the pain subscale of the Foot Health Status Questionnaire and "first step" pain as measured on a visual analogue scale. The secondary outcome measures will be health related quality of life (assessed using the Short Form-36 questionnaire - Version Two and depression, anxiety and stress (assessed using the Depression, Anxiety and Stress Scale - short version. Primary outcome measures will be performed at baseline, 2, 4, 6 and 12 weeks and secondary outcome measures will be performed at baseline, 6 and 12 weeks. Data will be analysed using the intention to treat principle. Conclusion This study is the first randomised controlled trial to evaluate the effectiveness of dry needling for plantar heel pain. The trial will

  13. Promoting physical activity in sedentary elderly Malays with type 2 diabetes: a protocol for randomised controlled trial

    Science.gov (United States)

    Sazlina, Shariff-Ghazali; Browning, Colette Joy; Yasin, Shajahan

    2012-01-01

    Introduction Like many countries Malaysia is facing an increase in the number of people with type 2 diabetes mellitus diabetes (T2DM) and modifiable lifestyle factors such as sedentary behaviour are important drivers of this increase. The level of physical activity is low among elderly Malay people. In Malaysia, strategies to promote physical activity in elderly Malay people with T2DM are not well documented in the research literature. This paper discusses an intervention to increase physical activity in elderly Malay people with T2DM. The aim of our study was to evaluate the effectiveness of personalised feedback alone and in combination with peer support in promoting and maintaining physical activity in comparison with usual care. Methods and analysis A three-arm randomised controlled trial will be conducted among sedentary Malay adults aged 60 years and above with T2DM attending an urban primary healthcare clinic in Malaysia. The participants will be randomised into three groups for a 12-week intervention with a follow-up at 24 and 36 weeks to assess adherence. The primary outcome of this study is pedometer-determined physical activity. Glycaemic and blood pressure control, body composition, cardiorespiratory fitness, balance, lipid profile, health-related quality of life, psychological well-being, social support and self-efficacy for exercise are the secondary measures. Linear mixed models will be used to determine the effect of the intervention over time and between groups. Ethical and dissemination The Monash University Human Research Ethics Committee and the Malaysian Ministry of Health's Medical Research Ethics Committee approved this protocol. The findings of this study will be presented at international conferences and published in peer-reviewed journals. Trial registration This study protocol has been registered with the Malaysian National Medical Research Registry and with the Current Controlled Trial Ltd (http://www.controlled-trials

  14. Study protocol: a randomized controlled trial investigating the effects of a psychosexual training program for adolescents with autism spectrum disorder.

    Science.gov (United States)

    Visser, Kirsten; Greaves-Lord, Kirstin; Tick, Nouchka T; Verhulst, Frank C; Maras, Athanasios; van der Vegt, Esther J M

    2015-08-28

    Previous research shows that adolescents with autism spectrum disorder (ASD) run several risks in their psychosexual development and that these adolescents can have limited access to reliable information on puberty and sexuality, emphasizing the need for specific guidance of adolescents with ASD in their psychosexual development. Few studies have investigated the effects of psychosexual training programs for adolescents with ASD and to date no randomized controlled trials are available to study the effects of psychosexual interventions for this target group. The randomized controlled trial (RCT) described in this study protocol aims to investigate the effects of the Tackling Teenage Training (TTT) program on the psychosexual development of adolescents with ASD. This parallel clinical trial, conducted in the South-West of the Netherlands, has a simple equal randomization design with an intervention and a waiting-list control condition. Two hundred adolescents and their parents participate in this study. We assess the participants in both conditions using self-report as well as parent-report questionnaires at three time points during 1 year: at baseline (T1), post-treatment (T2), and for follow-up (T3). To our knowledge, the current study is the first that uses a randomized controlled design to study the effects of a psychosexual training program for adolescents with ASD. It has a number of methodological strengths, namely a large sample size, a wide range of functionally relevant outcome measures, the use of multiple informants, and a standardized research and intervention protocol. Also some limitations of the described study are identified, for instance not making a comparison between two treatment conditions, and no use of blinded observational measures to investigate the ecological validity of the research results. Dutch Trial Register NTR2860. Registered on 20 April 2011.

  15. Nodule management protocol of the NELSON randomised lung cancer screening trial

    NARCIS (Netherlands)

    Xu, Dong Ming; Gietema, Hester; de Koning, Harry; Vernhout, Rene; Nackaerts, Kristiaan; Prokop, Mathias; Weenink, Carla; Lammers, Jan-Willem; Groen, Harry; Oudkerk, Matthijs; van Klaveren, Rob

    In December 2003, the Dutch-Belgian NELSON trial, a Dutch acronym for "Nederlands-Leuvens Longkanker Screenings ONderzoek", has been launched. Primary objective of the NELSON trial is to investigate whether screening for lung cancer by 16-detector multi-slice CT with 16 mm x 0.75 mm collimation and

  16. The relaxation exercise and social support trial-resst: study protocol for a randomized community based trial

    Directory of Open Access Journals (Sweden)

    Nakkash Rima

    2011-08-01

    Full Text Available Abstract Background Studies suggests a possible link between vaginal discharge and common mental distress, as well as highlight the implications of the subjective burden of disease and its link with mental health. Methods/Design This is a community-based intervention trial that aims to evaluate the impact of a psycho-social intervention on medically unexplained vaginal discharge (MUVD in a group of married, low-income Lebanese women, aged 18-49, and suffering from low to moderate levels of anxiety and/or depression. The intervention consisted of 12 sessions of structured social support, problem solving techniques, group discussions and trainer-supervised relaxation exercises (twice per week over six weeks. Women were recruited from Hey el Selloum, a southern disadvantaged suburb of Beirut, Lebanon, during an open recruitment campaign. The primary outcome was self-reported MUVD, upon ruling out reproductive tract infections (RTIs, through lab analysis. Anxiety and/or depression symptoms were the secondary outcomes for this trial. These were assessed using an Arabic validated version of the Hopkins Symptoms Checklist-25 (HSCL-25. Assessments were done at baseline and six months using face-to face interviews, pelvic examinations and laboratory tests. Women were randomized into either intervention or control group. Intent to treat analysis will be used. Discussion The results will indicate whether the proposed psychosocial intervention was effective in reducing MUVD (possibly mediated by common mental distress. Trial Registration The trial is registered at the Wellcome Trust Registry, ISRCTN assigned: ISRCTN: ISRCTN98441241

  17. Stopping randomized trials early for benefit: a protocol of the Study Of Trial Policy Of Interim Truncation-2 (STOPIT-2)

    Science.gov (United States)

    Briel, Matthias; Lane, Melanie; Montori, Victor M; Bassler, Dirk; Glasziou, Paul; Malaga, German; Akl, Elie A; Ferreira-Gonzalez, Ignacio; Alonso-Coello, Pablo; Urrutia, Gerard; Kunz, Regina; Culebro, Carolina Ruiz; da Silva, Suzana Alves; Flynn, David N; Elamin, Mohamed B; Strahm, Brigitte; Murad, M Hassan; Djulbegovic, Benjamin; Adhikari, Neill KJ; Mills, Edward J; Gwadry-Sridhar, Femida; Kirpalani, Haresh; Soares, Heloisa P; Elnour, Nisrin O Abu; You, John J; Karanicolas, Paul J; Bucher, Heiner C; Lampropulos, Julianna F; Nordmann, Alain J; Burns, Karen EA; Mulla, Sohail M; Raatz, Heike; Sood, Amit; Kaur, Jagdeep; Bankhead, Clare R; Mullan, Rebecca J; Nerenberg, Kara A; Vandvik, Per Olav; Coto-Yglesias, Fernando; Schünemann, Holger; Tuche, Fabio; Chrispim, Pedro Paulo M; Cook, Deborah J; Lutz, Kristina; Ribic, Christine M; Vale, Noah; Erwin, Patricia J; Perera, Rafael; Zhou, Qi; Heels-Ansdell, Diane; Ramsay, Tim; Walter, Stephen D; Guyatt, Gordon H

    2009-01-01

    Background Randomized clinical trials (RCTs) stopped early for benefit often receive great attention and affect clinical practice, but pose interpretational challenges for clinicians, researchers, and policy makers. Because the decision to stop the trial may arise from catching the treatment effect at a random high, truncated RCTs (tRCTs) may overestimate the true treatment effect. The Study Of Trial Policy Of Interim Truncation (STOPIT-1), which systematically reviewed the epidemiology and reporting quality of tRCTs, found that such trials are becoming more common, but that reporting of stopping rules and decisions were often deficient. Most importantly, treatment effects were often implausibly large and inversely related to the number of the events accrued. The aim of STOPIT-2 is to determine the magnitude and determinants of possible bias introduced by stopping RCTs early for benefit. Methods/Design We will use sensitive strategies to search for systematic reviews addressing the same clinical question as each of the tRCTs identified in STOPIT-1 and in a subsequent literature search. We will check all RCTs included in each systematic review to determine their similarity to the index tRCT in terms of participants, interventions, and outcome definition, and conduct new meta-analyses addressing the outcome that led to early termination of the tRCT. For each pair of tRCT and systematic review of corresponding non-tRCTs we will estimate the ratio of relative risks, and hence estimate the degree of bias. We will use hierarchical multivariable regression to determine the factors associated with the magnitude of this ratio. Factors explored will include the presence and quality of a stopping rule, the methodological quality of the trials, and the number of total events that had occurred at the time of truncation. Finally, we will evaluate whether Bayesian methods using conservative informative priors to "regress to the mean" overoptimistic tRCTs can correct observed

  18. Stopping randomized trials early for benefit: a protocol of the Study Of Trial Policy Of Interim Truncation-2 (STOPIT-2

    Directory of Open Access Journals (Sweden)

    Mullan Rebecca J

    2009-07-01

    Full Text Available Abstract Background Randomized clinical trials (RCTs stopped early for benefit often receive great attention and affect clinical practice, but pose interpretational challenges for clinicians, researchers, and policy makers. Because the decision to stop the trial may arise from catching the treatment effect at a random high, truncated RCTs (tRCTs may overestimate the true treatment effect. The Study Of Trial Policy Of Interim Truncation (STOPIT-1, which systematically reviewed the epidemiology and reporting quality of tRCTs, found that such trials are becoming more common, but that reporting of stopping rules and decisions were often deficient. Most importantly, treatment effects were often implausibly large and inversely related to the number of the events accrued. The aim of STOPIT-2 is to determine the magnitude and determinants of possible bias introduced by stopping RCTs early for benefit. Methods/Design We will use sensitive strategies to search for systematic reviews addressing the same clinical question as each of the tRCTs identified in STOPIT-1 and in a subsequent literature search. We will check all RCTs included in each systematic review to determine their similarity to the index tRCT in terms of participants, interventions, and outcome definition, and conduct new meta-analyses addressing the outcome that led to early termination of the tRCT. For each pair of tRCT and systematic review of corresponding non-tRCTs we will estimate the ratio of relative risks, and hence estimate the degree of bias. We will use hierarchical multivariable regression to determine the factors associated with the magnitude of this ratio. Factors explored will include the presence and quality of a stopping rule, the methodological quality of the trials, and the number of total events that had occurred at the time of truncation. Finally, we will evaluate whether Bayesian methods using conservative informative priors to "regress to the mean" overoptimistic t

  19. Chronic Neck Pain and Whiplash: A Case-Control Study of the Relationship between Acute Whiplash Injuries and Chronic Neck Pain

    OpenAIRE

    Freeman, Michael D; Croft, Arthur C; Rossignol, Annette M; Centeno, Christopher J; Elkins, Whitney L

    2006-01-01

    The authors undertook a case-control study of chronic neck pain and whiplash injuries in nine states in the United States to determine whether whiplash injuries contributed significantly to the population of individuals with chronic neck and other spine pain.Four hundred nineteen patients and 246 controls were randomly enrolled. Patients were defined as individuals with chronic neck pain, and controls as those with chronic back pain. The two groups were surveyed for cause of chronic pain as w...

  20. The OPERA trial: protocol for a randomised trial of an exercise intervention for older people in residential and nursing accommodation

    Directory of Open Access Journals (Sweden)

    Taylor Stephanie

    2011-02-01

    Full Text Available Abstract Background Depression is common in residents of Residential and Nursing homes (RNHs. It is usually undetected and often undertreated. Depression is associated with poor outcomes including increased morbidity and mortality. Exercise has potential to improve depression, and has been shown in existing trials to improve outcomes among younger and older people. Existing evidence comes from trials that are short, underpowered and not from RNH settings. The aim of the OPERA trial is to establish whether exercise is effective in reducing the prevalence of depression among older RNH residents. Method OPERA is a cluster randomised controlled trial. RNHs are randomised to one of two groups with interventions lasting 12 months Intervention group: a depression awareness and physical activity training session for care home staff, plus a whole home physical activation programme including twice weekly physiotherapist-led exercise groups. The intervention lasts for one year from randomisation, or Control group: a depression awareness training session for care home staff. Participants are people aged 65 or over who are free of severe cognitive impairment and willing to participate in the study. Our primary outcome is the prevalence of depressive symptoms, a GDS-15 score of five or more, in all participants at the end of the one year intervention period. Our secondary depression outcomes include remission of depressive symptoms and change in GDS-15 scores in those with depressive symptoms prior to randomisation. Other secondary outcomes include, fear of falling, mobility, fractures, pain, cognition, costs and health related quality of life. We aimed to randomise 77 RNHs. Discussion Home recruitment was completed in May 2010; 78 homes have been randomised. Follow up will finish in May 2011 and results will be available late 2011. Trial Registration [ISRCTN: ISRCTN43769277

  1. Pressure and pain In Systemic sclerosis/Scleroderma - an evaluation of a simple intervention (PISCES: randomised controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Alcacer-Pitarch Begonya

    2012-02-01

    Full Text Available Abstract Background Foot problems associated with Systemic Sclerosis (SSc/Scleroderma have been reported to be both common and disabling. There are only limited data describing specifically, the mechanical changes occurring in the foot in SSc. A pilot project conducted in preparation for this trial confirmed the previous reports of foot related impairment and reduced foot function in people with SSc and demonstrated a link to mechanical etiologies. To-date there have been no formal studies of interventions directed at the foot problems experienced by people with Systemic Sclerosis. The primary aim of this trial is to evaluate whether foot pain and foot-related health status in people with Systemic Sclerosis can be improved through the provision of a simple pressure-relieving insole. Methods The proposed trial is a pragmatic, multicenter, randomised controlled clinical trial following a completed pilot study. In four participating centres, 140 consenting patients with SSc and plantar foot pain will be randomised to receive either a commercially available pressure relieving and thermally insulating insole, or a sham insole with no cushioning or thermal properties. The primary end point is a reduction in pain measured using the Foot Function Index Pain subscale, 12 weeks after the start of intervention. Participants will complete the primary outcome measure (Foot Function Index pain sub-scale prior to randomisation and at 12 weeks post randomisation. Secondary outcomes include participant reported pain and disability as derived from the Manchester Foot Pain and Disability Questionnaire and plantar pressures with and without the insoles in situ. Discussion This trial protocol proposes a rigorous and potentially significant evaluation of a simple and readily provided therapeutic approach which, if effective, could be of a great benefit for this group of patients. Trial registration number ISRCTN: ISRCTN02824122

  2. Study protocol for a controlled trial of Strengths Model Case Management in mental health services in Hong Kong.

    Science.gov (United States)

    Tsoi, Wing-See Emily; Tse, Samson; Fukui, Sadaaki; Jones, Steven

    2015-10-06

    Although strengths-based models are popular within recovery-oriented approaches, there is still a lack of conclusive research to guide how they should be implemented. A recent meta-analysis confirmed the lack of clarity in how this perspective is operationalised and that fidelity monitoring during the implementation process is lacking. Hence, there is a clear need to evaluate the feasibility of delivering and evaluating a clearly operationalised strengths-based intervention that incorporates fidelity checks to inform more definitive research. This protocol therefore describes a controlled trial of Strengths Model Case Management (SMCM), a complex intervention, for people with severe mental illnesses in Hong Kong. This trial follows the guidelines of the Medical Research Council as a phase 2 trial. Hence, it is a pilot study that tests the feasibility and effectiveness of the model. This is a 9-month controlled trial that uses the Kansas Model. Participants and a matched control group are recruited on a voluntary basis, after screening for eligibility. Effectiveness of the SMCM will be measured through outcome measures taken at baseline, the mid-point and at the end of the trial. Outcomes for service users include personal recovery, hope, subjective well-being, psychiatric symptoms, perceived level of recovery features within the organisation, therapeutic alliance and achievement of recovery goals. Outcomes for care workers will include job burnout, organisational features of recovery and perceived supervisory support. With a 2×3 analysis of variance design and a moderate intervention effect (Cohen's d=0.50), a total of 86 participants will be needed for a statistical power of 0.80. Ethical approval has been obtained from the Human Research Ethics Committee for Non-Clinical Faculties at The University of Hong Kong (HRECNCF: EA140913). Australian New Zealand Clinical Trial Registry (ACTRN)12613001120763. Published by the BMJ Publishing Group Limited. For permission

  3. Study protocol for a pragmatic randomised controlled trial evaluating efficacy of a smoking cessation e-‘Tabac Info Service’: ee-TIS trial

    Science.gov (United States)

    Cambon, L; Bergman, P; Le Faou, Al; Vincent, I; Le Maitre, B; Pasquereau, A; Arwidson, P; Thomas, D; Alla, F

    2017-01-01

    Introduction A French national smoking cessation service, Tabac Info Service, has been developed to provide an adapted quitline and a web and mobile application involving personalised contacts (eg, questionnaires, advice, activities, messages) to support smoking cessation. This paper presents the study protocol of the evaluation of the application (e-intervention Tabac Info Service (e-TIS)). The primary objective is to assess the efficacy of e-TIS. The secondary objectives are to (1) describe efficacy variations with regard to users' characteristics, (2) analyse mechanisms and contextual conditions of e-TIS efficacy. Methods and analyses The study design is a two-arm pragmatic randomised controlled trial including a process evaluation with at least 3000 participants randomised to the intervention or to the control arm (current practices). Inclusion criteria are: aged 18 years or over, current smoker, having completed the online consent forms, possessing a mobile phone with android or apple systems and using mobile applications, wanting to stop smoking sooner or later. The primary outcome is the point prevalence abstinence of 7 days at 6 months later. Data will be analysed in intention to treat (primary) and per protocol analyses. A logistic regression will be carried out to estimate an OR (95% CI) for efficacy. A multivariate multilevel analysis will explore the influence on results of patients' characteristics (sex, age, education and socioprofessional levels, dependency, motivation, quit experiences) and contextual factors, conditions of use, behaviour change techniques. Ethics and dissemination The study protocol was reviewed by the ethical and deontological institutional review board of the French Institute for Public Health Surveillance on 18 April 2016. The findings of this study will allow us to characterise the efficacy of e-TIS and conditions of its efficacy. These findings will be disseminated through peer-reviewed articles. Trial registration

  4. Canadian Optically-guided approach for Oral Lesions Surgical (COOLS) trial: study protocol for a randomized controlled trial

    International Nuclear Information System (INIS)

    Poh, Catherine F; Durham, J Scott; Brasher, Penelope M; Anderson, Donald W; Berean, Kenneth W; MacAulay, Calum E; Lee, J Jack; Rosin, Miriam P

    2011-01-01

    Oral cancer is a major health problem worldwide. The 5-year survival rate ranges from 30-60%, and has remained unchanged in the past few decades. This is mainly due to late diagnosis and high recurrence of the disease. Of the patients who receive treatment, up to one third suffer from a recurrence or a second primary tumor. It is apparent that one major cause of disease recurrence is clinically unrecognized field changes which extend beyond the visible tumor boundary. We have previously developed an approach using fluorescence visualization (FV) technology to improve the recognition of the field at risk surrounding a visible oral cancer that needs to be removed and preliminary results have shown a significant reduction in recurrence rates. This paper describes the study design of a randomized, multi-centre, double blind, controlled surgical trial, the COOLS trial. Nine institutions across Canada will recruit a total of 400 patients with oral severe dysplasia or carcinoma in situ (N = 160) and invasive squamous cell carcinoma (N = 240). Patients will be stratified by participating institution and histology grade and randomized equally into FV-guided surgery (experimental arm) or white light-guided surgery (control arm). The primary endpoint is a composite of recurrence at or 1 cm within the previous surgery site with 1) the same or higher grade histology compared to the initial diagnosis (i.e., the diagnosis used for randomization); or 2) further treatment due to the presence of severe dysplasia or higher degree of change at follow-up. This is the first randomized, multi-centre trial to validate the effectiveness of the FV-guided surgery. In this paper we described the strategies, novelty, and challenges of this unique trial involving a surgical approach guided by the FV technology. The success of the trial requires training, coordination, and quality assurance across multiple sites within Canada. The COOLS trial, an example of translational research, may result in

  5. Ibuprofen versus mecillinam for uncomplicated cystitis - a randomized controlled trial study protocol

    DEFF Research Database (Denmark)

    Vik, Ingvild; Bollestad, Marianne; Grude, Nils

    2014-01-01

    , controlled, double blind trial following the principles of Good Clinical Practice. Women between the ages of 18 to 60 presenting with symptoms of uncomplicated cystitis are screened for eligibility. 500 women from four sites in Norway, Sweden and Denmark are allocated to treatment with 600 mg ibuprofen three.......DiscussionIf treatment of uncomplicated cystitis with ibuprofen is as effective as mecillinam for symptom relief, we can potentially reduce the use of antibiotics on a global scale.Trial registrationEudraCTnr: 2012-002776-14. ClinicalTrials.gov: NCT01849926....

  6. Protocol for a scoping review of post-trial extensions of randomised controlled trials using individually linked administrative and registry data.

    Science.gov (United States)

    Fitzpatrick, Tiffany; Perrier, Laure; Tricco, Andrea C; Straus, Sharon E; Jüni, Peter; Zwarenstein, Merrick; Lix, Lisa M; Smith, Mark; Rosella, Laura C; Henry, David A

    2017-02-17

    Well-conducted randomised controlled trials (RCTs) provide the least biased estimates of intervention effects. However, RCTs are costly and time-consuming to perform and long-term follow-up of participants may be hampered by lost contacts and financial constraints. Advances in computing and population-based registries have created new possibilities for increasing the value of RCTs by post-trial extension using linkage to routinely collected administrative/registry data in order to determine long-term interventional effects. There have been recent important examples, including 20+ years follow-up studies of trials of pravastatin and mammography. Despite the potential value of post-trial extension, there has been no systematic study of this literature. This scoping review aims to characterise published post-trial extension studies, assess their value, and identify any potential challenges associated with this approach. This review will use the recommended methods for scoping reviews. We will search MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials. A draft search strategy is included in this protocol. Review of titles and abstracts, full texts of potentially eligible studies and data/information extraction will be conducted independently by pairs of investigators. Eligible studies will be RCTs that investigated healthcare interventions that were extended by individual linkage to administrative/registry/electronic medical records data after the completion of the planned follow-up period. Information concerning the original trial, characteristics of the extension study, any clinical, policy or ethical implications and methodological or practical challenges will be collected using standardised forms. As this study uses secondary data, and does not include person-level data, ethics approval is not required. We aim to disseminate these findings through journals and conferences targeting triallists and researchers involved in health data linkage. We

  7. Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bouwense Stefan A

    2012-11-01

    Full Text Available Abstract Background After an initial attack of biliary pancreatitis, cholecystectomy minimizes the risk of recurrent biliary pancreatitis and other gallstone-related complications. Guidelines advocate performing cholecystectomy within 2 to 4 weeks after discharge for mild biliary pancreatitis. During this waiting period, the patient is at risk of recurrent biliary events. In current clinical practice, surgeons usually postpone cholecystectomy for 6 weeks due to a perceived risk of a more difficult dissection in the early days following pancreatitis and for logistical reasons. We hypothesize that early laparoscopic cholecystectomy minimizes the risk of recurrent biliary pancreatitis or other complications of gallstone disease in patients with mild biliary pancreatitis without increasing the difficulty of dissection and the surgical complication rate compared with interval laparoscopic cholecystectomy. Methods/Design PONCHO is a randomized controlled, parallel-group, assessor-blinded, superiority multicenter trial. Patients are randomly allocated to undergo early laparoscopic cholecystectomy, within 72 hours after randomization, or interval laparoscopic cholecystectomy, 25 to 30 days after randomization. During a 30-month period, 266 patients will be enrolled from 18 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite endpoint of mortality and acute re-admissions for biliary events (that is, recurrent biliary pancreatitis, acute cholecystitis, symptomatic/obstructive choledocholithiasis requiring endoscopic retrograde cholangiopancreaticography including cholangitis (with/without endoscopic sphincterotomy, and uncomplicated biliary colics occurring within 6 months following randomization. Secondary endpoints include the individual endpoints of the composite endpoint, surgical and other complications, technical difficulty of cholecystectomy and costs. Discussion The PONCHO trial is designed to show that early

  8. Perioperative antibiotic prophylaxis in the treatment of acute cholecystitis (PEANUTS II trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Loozen, Charlotte S; van Santvoort, Hjalmar C; van Geloven, Antoinette A W; Nieuwenhuijzen, Grard A P; de Reuver, Philip R; Besselink, Mark H G; Vlaminckx, Bart; Kelder, Johannes C; Knibbe, Catherijne A J; Boerma, Djamila

    2017-08-23

    The additional value of perioperative antibiotic prophylaxis in preventing infectious complications after emergency cholecystectomy for acute cholecystitis is a much-debated subject in the surgical community. Evidence-based guidelines are lacking, and consequently the use of antibiotic prophylaxis varies greatly among surgeons and hospitals. Recently, high-level evidence became available demonstrating that postoperative antibiotic prophylaxis in patients with acute cholecystitis does not reduce the risk of infectious complications. Preoperative antibiotic prophylaxis in relation to the risk of infectious complications, however, has never been studied. The PEANUTS II trial is a randomized, controlled, multicenter, open-label noninferiority trial whose aim is to determine the utility of preoperative antibiotic prophylaxis in patients undergoing emergency cholecystectomy for acute calculous cholecystitis. Patients with mild or moderate acute cholecystitis, as defined according the Tokyo Guidelines, will be randomly assigned to a single preoperative dose of antibiotic prophylaxis (2000 mg of first-generation cephalosporin delivered intravenously) or no antibiotic prophylaxis before emergency cholecystectomy. The primary endpoint is a composite endpoint consisting of all postoperative infectious complications occurring during the first 30 days after surgery. Secondary endpoints include all the individual components of the primary endpoint, all other complications, duration of hospital stay, and total costs. The hypothesis is that the absence of antibiotic prophylaxis is noninferior to the presence of antibiotic prophylaxis. A noninferiority margin of 10% is assumed. With a 1-sided risk of 2.5% and a power of 80%, a total of 454 subjects will have to be included. Analysis will be performed according to the intention-to-treat principle. The PEANUTS II trial will provide evidence-based advice concerning the utility of antibiotic prophylaxis in patients undergoing

  9. The Healthy Steps Study: A randomized controlled trial of a pedometer-based Green Prescription for older adults. Trial protocol

    Directory of Open Access Journals (Sweden)

    Schluter Philip J

    2009-11-01

    Full Text Available Abstract Background Graded health benefits of physical activity have been demonstrated for the reduction of coronary heart disease, some cancers, and type-2 diabetes, and for injury reduction and improvements in mental health. Older adults are particularly at risk of physical inactivity, and would greatly benefit from successful targeted physical activity interventions. Methods/Design The Healthy Steps study is a 12-month randomized controlled trial comparing the efficacy of a pedometer-based Green Prescription with the conventional time-based Green Prescription in increasing and maintaining physical activity levels in low-active adults over 65 years of age. The Green Prescription interventions involve a primary care physical activity prescription with 3 follow-up telephone counselling sessions delivered by trained physical activity counsellors over 3 months. Those in the pedometer group received a pedometer and counselling based around increasing steps that can be monitored on the pedometer, while those in the standard Green Prescription group received counselling using time-based goals. Baseline, 3 month (end of intervention, and 12 month measures were assessed in face-to-face home visits with outcomes measures being physical activity (Auckland Heart Study Physical Activity Questionnaire, quality of life (SF-36 and EQ-5D, depressive symptoms (Geriatric Depression Scale, blood pressure, weight status, functional status (gait speed, chair stands, and tandem balance test and falls and adverse events (self-report. Utilisation of health services was assessed for the economic evaluation carried out alongside this trial. As well, a process evaluation of the interventions and an examination of barriers and motives for physical activity in the sample were conducted. The perceptions of primary care physicians in relation to delivering physical activity counselling were also assessed. Discussion The findings from the Healthy Steps trial are due in late

  10. Danish method study on cervical screening in women offered HPV vaccination as girls (Trial23): a study protocol.

    Science.gov (United States)

    Thamsborg, Lise Holst; Andersen, Berit; Larsen, Lise Grupe; Christensen, Jette; Johansen, Tonje; Hariri, Jalil; Christiansen, Sanne; Rygaard, Carsten; Lynge, Elsebeth

    2018-05-26

    The first birth cohorts of women offered human papillomavirus (HPV) vaccination as girls are now entering cervical screening. However, there is no international consensus on how to screen HPV vaccinated women. These women are better protected against cervical cancer and could therefore be offered less intensive screening. Primary HPV testing is more sensitive than cytology, allowing for a longer screening interval. The aim of Trial23 is to investigate if primary HPV testing with cytology triage of HPV positive samples is a reasonable screening scheme for women offered HPV vaccination as girls. Trial23 is a method study embedded in the existing cervical screening programme in four out of five Danish regions. Without affecting the screening programme, women born in 1994 are randomised to present screening with liquid-based cytology every third year (present programme arm) or present screening plus an HPV test (HPV arm). The study started 1 February 2017 and will run over three screening rounds corresponding to 7-8 years. The primary endpoint is cervical intraepithelial neoplasia grade 3 or above. The trial is undertaken as a non-inferiority study including intention-to-treat and per-protocol analyses. The potential effect of primary HPV screening with a 6-year interval will be calculated from the observed data. The study protocol has been submitted to the ethical committee and deemed a method study. All women are screened according to routine guidelines. The study will contribute new evidence on the future screening of HPV vaccinated birth cohorts of women. All results will be published in open-access journal. NCT03049553; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  11. A randomized controlled trial of community health workers using patient stories to support hypertension management: Study protocol.

    Science.gov (United States)

    Hargraves, J Lee; Bonollo, Debra; Person, Sharina D; Ferguson, Warren J

    2018-04-12

    Uncontrolled hypertension is a significant public health problem in the U.S. with about one half of people able to keep blood pressure (BP) under control. Uncontrolled hypertension leads to increased risk of stroke, heart attack, and death. Furthermore, the social and economic costs of poor hypertension control are staggering. People living with hypertension can benefit from additional educational outreach and support. This randomized trial conducted at two Community Health Centers (CHCs) in Massachusetts assessed the effect of community health workers (CHWs) assisting patients with hypertension. In addition to the support provided by CHWs, the study uses video narratives from patients who have worked to control their BP through diet, exercise, and better medication adherence. Participants enrolled in the study were randomly assigned to immediate intervention (I) by CHWs or a delayed intervention (DI) (4 to 6 months later). Each participant was asked to meet with the CHW 5 times (twice in person and three times telephonically). Study outcomes include systolic and diastolic BP, diet, exercise, and body mass index. CHWs working directly with patients, using multiple approaches to support patient self-management, can be effective agents to support change in chronic illness management. Moreover, having culturally appropriate tools, such as narratives available through videos, can be an important, cost effective aid to CHWs. Recruitment and intervention delivery within a busy CHC environment required adaptation of the study design and protocols for staff supervision, data collection and intervention delivery and lessons learned are presented. Clinical Trials.gov registration submitted 8/17/16: Protocol ID# 5P60MD006912-02 and Clinical trials.gov ID# NCT02874547 Community Health Workers Using Patient Stories to Support Hypertension Management. Copyright © 2018. Published by Elsevier Inc.

  12. Meta Salud Diabetes study protocol: a cluster-randomised trial to reduce cardiovascular risk among a diabetic population of Mexico

    Science.gov (United States)

    Cornejo Vucovich, Elsa; Ingram, Maia; Valenica, Celina; Castro Vasquez, Maria del Carmen; Gonzalez-Fagoaga, Eduardo; Geurnsey de Zapien, Jill

    2018-01-01

    Introduction Northern Mexico has among the highest rates of cardiovascular disease (CVD) and diabetes in the world. This research addresses core gaps in implementation science to develop, test and scale-up CVD risk-reduction interventions in diabetics through a national primary care health system. Methods and analysis The Meta Salud Diabetes (MSD) research project is a parallel two-arm cluster-randomised clinical behavioural trial based in 22 (n=22) health centres in Sonora, Mexico. MSD aims to evaluate the effectiveness of the MSD intervention for the secondary prevention of CVD risk factors among a diabetic population (n=320) compared with the study control of usual care. The MSD intervention consists of 2-hour class sessions delivered over a 13-week period providing educational information to encourage sustainable behavioural change to prevent disease complications including the adoption of physical activity. MSD is delivered within the context of Mexico’s national primary care health centre system by health professionals, including nurses, physicians and community health workers via existing social support groups for individuals diagnosed with chronic disease. Mixed models are used to estimate the effect of MSD by comparing cardiovascular risk, as measured by the Framingham Risk Score, between the trial arms. Secondary outcomes include hypertension, behavioural risk factors and psychosocial factors. Ethics and dissemination This work is supported by the National Institutes of Health, National Heart Lung and Blood Institute (1R01HL125996-01) and approved by the University of Arizona Research Institutional Review Board (Protocol 1508040144) and the Research Bioethics Committee at the University of Sonora. The first Internal Review Board approval date was 31 August 2015 with five subsequent approved amendments. This article refers to protocol V.0.2, dated 30 January 2017. Results will be disseminated via peer-reviewed publication and presentation at

  13. Promoting physical activity in sedentary elderly Malays with type 2 diabetes: a protocol for randomised controlled trial.

    Science.gov (United States)

    Sazlina, Shariff-Ghazali; Browning, Colette Joy; Yasin, Shajahan

    2012-01-01

    Like many countries Malaysia is facing an increase in the number of people with type 2 diabetes mellitus diabetes (T2DM) and modifiable lifestyle factors such as sedentary behaviour are important drivers of this increase. The level of physical activity is low among elderly Malay people. In Malaysia, strategies to promote physical activity in elderly Malay people with T2DM are not well documented in the research literature. This paper discusses an intervention to increase physical activity in elderly Malay people with T2DM. The aim of our study was to evaluate the effectiveness of personalised feedback alone and in combination with peer support in promoting and maintaining physical activity in comparison with usual care. A three-arm randomised controlled trial will be conducted among sedentary Malay adults aged 60 years and above with T2DM attending an urban primary healthcare clinic in Malaysia. The participants will be randomised into three groups for a 12-week intervention with a follow-up at 24 and 36 weeks to assess adherence. The primary outcome of this study is pedometer-determined physical activity. Glycaemic and blood pressure control, body composition, cardiorespiratory fitness, balance, lipid profile, health-related quality of life, psychological well-being, social support and self-efficacy for exercise are the secondary measures. Linear mixed models will be used to determine the effect of the intervention over time and between groups. ETHICAL AND DISSEMINATION: The Monash University Human Research Ethics Committee and the Malaysian Ministry of Health's Medical Research Ethics Committee approved this protocol. The findings of this study will be presented at international conferences and published in peer-reviewed journals. This study protocol has been registered with the Malaysian National Medical Research Registry and with the Current Controlled Trial Ltd (http://www.controlled-trials.com/ISRCTN71447000/).

  14. Tongue pressure profile training for dysphagia post stroke (TPPT): study protocol for an exploratory randomized controlled trial.

    Science.gov (United States)

    Steele, Catriona M; Bayley, Mark A; Péladeau-Pigeon, Melanie; Stokely, Shauna L

    2013-05-07

    It is estimated that approximately 50% of stroke survivors will experience swallowing difficulty, or dysphagia. The associated sequelae of dysphagia include dehydration, malnutrition, and aspiration pneumonia, all of which have can have serious medical consequences. To improve swallowing safety and efficiency, alternative nutritional intake methods (for example, a feeding tube) or a modified diet texture (such as pureed foods or thickened liquids) may be recommended but these modifications may negatively affect quality of life. An alternative approach to treating dysphagia has emerged over the past few years, targeting stronger lingual muscles through maximal isometric pressure tasks. Although these studies have shown promising results, thin-liquid bolus control continues to be challenging for patients with dysphagia. Previous work investigating lingual pressures when healthy participants swallow has suggested that greater task specificity in lingual exercises may yield improved results with thin liquids. This is a small, exploratory randomized clinical trial being conducted with post-stroke patients 4 to 20 weeks after onset of dysphagia secondary to impaired lingual control. At enrollment, participants are randomly assigned to one of two treatment protocols, either tongue pressure profile training (TPPT) or the control treatment, tongue pressure strength-and-accuracy training (TPSAT). Each treatment protocol consists of 24 sessions of treatment over 8 to 12 weeks with monitoring of tongue pressure as well as a baseline and outcome videofluoroscopic swallowing study. Tongue pressure measures, videofluoroscopic measures, and functional outcome measures will be obtained following training of 60 participants (30 in each condition), to determine whether TPPT yields better outcomes. This study will continue to explore options beyond tube feeding and modified diets for people with neurogenic dysphagia following stroke. Should the novel protocol, TPPT, prove to be more

  15. Facilitating return to work through early specialist health-based interventions (FRESH): protocol for a feasibility randomised controlled trial.

    Science.gov (United States)

    Radford, Kathryn A; Phillips, Julie; Jones, Trevor; Gibson, Ali; Sutton, Chris; Watkins, Caroline; Sach, Tracey; Duley, Lelia; Walker, Marion; Drummond, Avril; Hoffman, Karen; O'Connor, Rory; Forshaw, Denise; Shakespeare, David

    2015-01-01

    Over one million people sustain traumatic brain injury each year in the UK and more than 10 % of these are moderate or severe injuries, resulting in cognitive and psychological problems that affect the ability to work. Returning to work is a primary rehabilitation goal but fewer than half of traumatic brain injury survivors achieve this. Work is a recognised health service outcome, yet UK service provision varies widely and there is little robust evidence to inform rehabilitation practice. A single-centre cohort comparison suggested better work outcomes may be achieved through early occupational therapy targeted at job retention. This study aims to determine whether this intervention can be delivered in three new trauma centres and to conduct a feasibility, randomised controlled trial to determine whether its effects and cost effectiveness can be measured to inform a definitive trial. Mixed methods study, including feasibility randomised controlled trial, embedded qualitative studies and feasibility economic evaluation will recruit 102 people with traumatic brain injury and their nominated carers from three English UK National Health Service (NHS) trauma centres. Participants will be randomised to receive either usual NHS rehabilitation or usual rehabilitation plus early specialist traumatic brain injury vocational rehabilitation delivered by an occupational therapist. The primary objective is to assess the feasibility of conducting a definitive trial; secondary objectives include measurement of protocol integrity (inclusion/exclusion criteria, intervention adherence, reasons for non-adherence) recruitment rate, the proportion of eligible patients recruited, reasons for non-recruitment, spectrum of TBI severity, proportion of and reasons for loss to follow-up, completeness of data collection, gains in face-to-face V s postal data collection and the most appropriate methods of measuring primary outcomes (return to work, retention) to determine the sample size for a

  16. Thromboelastometry versus standard coagulation tests versus restrictive protocol to guide blood transfusion prior to central venous catheterization in cirrhosis: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Rocha, Leonardo Lima; Pessoa, Camila Menezes Souza; Neto, Ary Serpa; do Prado, Rogerio Ruscitto; Silva, Eliezer; de Almeida, Marcio Dias; Correa, Thiago Domingos

    2017-02-27

    Liver failure patients have traditionally been empirically transfused prior to invasive procedures. Blood transfusion is associated with immunologic and nonimmunologic reactions, increased risk of adverse outcomes and high costs. Scientific evidence supporting empirical transfusion is lacking, and the best approach for blood transfusion prior to invasive procedures in cirrhotic patients has not been established so far. The aim of this study is to compare three transfusion strategies (routine coagulation test-guided - ordinary or restrictive, or thromboelastometry-guided) prior to central venous catheterization in critically ill patients with cirrhosis. Design and setting: a double-blinded, parallel-group, single-center, randomized controlled clinical trial in a tertiary private hospital in São Paulo, Brazil. adults (aged 18 years or older) admitted to the intensive care unit with cirrhosis and an indication for central venous line insertion. Patients will be randomly assigned to three groups for blood transfusion strategy prior to central venous catheterization: standard coagulation tests-based, thromboelastometry-based, or restrictive. The primary efficacy endpoint will be the proportion of patients transfused with any blood product prior to central venous catheterization. The primary safety endpoint will be the incidence of major bleeding. Secondary endpoints will be the proportion of transfusion of fresh frozen plasma, platelets and cryoprecipitate; infused volume of blood products; hemoglobin and hematocrit before and after the procedure; intensive care unit and hospital length of stay; 28-day and hospital mortality; incidence of minor bleeding; transfusion-related adverse reactions; and cost analysis. This study will evaluate three strategies to guide blood transfusion prior to central venous line placement in severely ill patients with cirrhosis. We hypothesized that thromboelastometry-based and/or restrictive protocols are safe and would significantly

  17. Immediate vs. delayed insertion of intrauterine contraception after second trimester abortion: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Soon Judith A

    2011-06-01

    Full Text Available Abstract Background We describe the rationale and protocol for a randomized controlled trial (RCT to assess whether intrauterine contraception placed immediately after a second trimester abortion will result in fewer pregnancies than current recommended practice of intended placement at 4 weeks post-abortion. Decision analysis suggests the novel strategy could substantially reduce subsequent unintended pregnancies and abortions. This paper highlights considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion. Methods/Design Consenting women choosing to use intrauterine contraception after abortion for a pregnancy of 12 to 24 weeks will be randomized to insertion timing groups either immediately (experimental intervention or four weeks (recommended care post abortion. Primary outcome measure is pregnancy rate at one year. Secondary outcomes include: cumulative pregnancy rates over five year follow-up period, comprehensive health economic analyses comparing immediate and delayed insertion groups, and device retention rates, complication rates (infection, expulsion and, contraceptive method satisfaction. Web-based Contraception Satisfaction Questionnaires, clinical records and British Columbia linked health databases will be used to assess primary and secondary outcomes. Enrolment at all clinics in the province performing second trimester abortions began in May 2010 and is expected to complete in late 2011. Data on one year outcomes will be available for analysis in 2014. Discussion The RCT design combined with access to clinical records at all provincial abortion clinics, and to information in provincial single-payer linked administrative health databases, birth registry and hospital records, offers a unique opportunity to evaluate such an approach by determining pregnancy rate at one

  18. EARLYDRAIN- outcome after early lumbar CSF-drainage in aneurysmal subarachnoid hemorrhage: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Bardutzky, Jürgen; Witsch, Jens; Jüttler, Eric; Schwab, Stefan; Vajkoczy, Peter; Wolf, Stefan

    2011-09-14

    Aneurysmal subarachnoid hemorrhage (SAH) may be complicated by delayed cerebral ischemia, which is a major cause of unfavorable clinical outcome and death in SAH-patients. Delayed cerebral ischemia is presumably related to the development of vasospasm triggered by the presence of blood in the basal cisterns. To date, oral application of the calcium antagonist nimodipine is the only prophylactic treatment for vasospasm recognized under international guidelines.In retrospective trials lumbar drainage of cerebrospinal fluid has been shown to be a safe and feasible measure to remove the blood from the basal cisterns and decrease the incidence of delayed cerebral ischemia and vasospasm in the respective study populations. However, the efficacy of lumbar drainage has not been evaluated prospectively in a randomized controlled trial yet. This is a protocol for a 2-arm randomized controlled trial to compare an intervention group receiving early continuous lumbar CSF-drainage and standard neurointensive care to a control group receiving standard neurointensive care only. Adults suffering from a first aneurysmal subarachnoid hemorrhage whose aneurysm has been secured by means of coiling or clipping are eligible for trial participation. The effect of early CSF drainage (starting measured in the following ways: the primary endpoint will be disability after 6 months, assessed by a blinded investigator during a personal visit or standardized telephone interview using the modified Rankin Scale. Secondary endpoints include mortality after 6 months, angiographic vasospasm, transcranial Doppler sonography (TCD) mean flow velocity in both middle cerebral arteries and rate of shunt insertion at 6 months after hospital discharge. Here, we present the study design of a multicenter prospective randomized controlled trial to investigate whether early application of a lumbar drainage improves clinical outcome after aneurysmal subarachnoid hemorrhage.

  19. Prevention of nosocomial infections in critically ill patients with lactoferrin (PREVAIL study): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Muscedere, John; Maslove, David; Boyd, John Gordon; O'Callaghan, Nicole; Lamontagne, Francois; Reynolds, Steven; Albert, Martin; Hall, Rick; McGolrick, Danielle; Jiang, Xuran; Day, Andrew G

    2016-09-29

    Nosocomial infections remain an important source of morbidity, mortality, and increased health care costs in hospitalized patients. This is particularly problematic in intensive care units (ICUs) because of increased patient vulnerability due to the underlying severity of illness and increased susceptibility from utilization of invasive therapeutic and monitoring devices. Lactoferrin (LF) and the products of its breakdown have multiple biological effects, which make its utilization of interest for the prevention of nosocomial infections in the critically ill. This is a phase II randomized, multicenter, double-blinded trial to determine the effect of LF on antibiotic-free days in mechanically ventilated, critically ill, adult patients in the ICU. Eligible, consenting patients will be randomized to receive either LF or placebo. The treating clinician will remain blinded to allocation during the study; blinding will be maintained by using opaque syringes and containers. The primary outcome will be antibiotic-free days, defined as the number of days alive and free of antibiotics 28 days after randomization. Secondary outcomes will include: antibiotic utilization, adjudicated diagnosis of nosocomial infection (longer than 72 h of admission to ICU), hospital and ICU length of stay, change in organ function after randomization, hospital and 90-day mortality, incidence of tracheal colonization, changes in gastrointestinal permeability, and immune function. Outcomes to inform the conduct of a larger definitive trial will also be evaluated, including feasibility as determined by recruitment rates and protocol adherence. The results from this study are expected to provide insight into a potential novel therapeutic use for LF in critically ill adult patients. Further, analysis of study outcomes will inform a future, large-scale phase III randomized controlled trial powered on clinically important outcomes related to the use of LF. The trial was registered at www.ClinicalTrials

  20. Improving Recovery and Outcomes Every Day after the ICU (IMPROVE): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Wang, Sophia; Hammes, Jessica; Khan, Sikandar; Gao, Sujuan; Harrawood, Amanda; Martinez, Stephanie; Moser, Lyndsi; Perkins, Anthony; Unverzagt, Frederick W; Clark, Daniel O; Boustani, Malaz; Khan, Babar

    2018-03-27

    Delirium affects nearly 70% of older adults hospitalized in the intensive care unit (ICU), and many of those will be left with persistent cognitive impairment or dementia. There are no effective and scalable recovery models to remediate ICU-acquired cognitive impairment and its attendant elevated risk for dementia or Alzheimer disease (AD). The Improving Recovery and Outcomes Every Day after the ICU (IMPROVE) trial is an ongoing clinical trial which evaluates the efficacy of a combined physical exercise and cognitive training on cognitive function among ICU survivors 50 years and older who experienced delirium during an ICU stay. This article describes the study protocol for IMPROVE. IMPROVE is a four-arm, randomized controlled trial. Subjects will be randomized to one of four arms: cognitive training and physical exercise; cognitive control and physical exercise; cognitive training and physical exercise control; and cognitive control and physical exercise control. Facilitators administer the physical exercise and exercise control interventions in individual and small group formats by using Internet-enabled videoconference. Cognitive training and control interventions are also facilitator led using Posit Science, Inc. online modules delivered in individual and small group format directly into the participants' homes. Subjects complete cognitive assessment, mood questionnaires, physical performance batteries, and quality of life scales at baseline, 3, and 6 months. Blood samples will also be taken at baseline and 3 months to measure pro-inflammatory cytokines and acute-phase reactants; neurotrophic factors; and markers of glial dysfunction and astrocyte activation. This study is the first clinical trial to examine the efficacy of combined physical and cognitive exercise on cognitive function in older ICU survivors with delirium. The results will provide information about potential synergistic effects of a combined intervention on a range of outcomes and mechanisms

  1. Wrist-ankle acupuncture (WAA) for primary dysmenorrhea (PD) of young females: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Chen, Yingfan; Tian, Sinan; Tian, Jing; Shu, Shi

    2017-08-22

    Primary dysmenorrhea (PD) is one of the most common health complaints all over the world, specifically among young females. Acupuncture has been employed to relieve the pain-based symptoms and to avoid the side effects of conventional medication, and wrist-ankle acupuncture (WAA) has confirmed analgesic efficacy for various types of pain. The aim of this study is to evaluate the immediate analgesia effect of WAA on PD of young females. This study will carry out a randomized parallel controlled single-blind trial to observe the immediate analgesia effect of WAA in PD of young females. Sixty participants who meet inclusion criteria will be recruited from September 2016 to September 2017 in Changhai hospital of China. They are randomly assigned to WAA therapy or sham acupuncture groups (30 patients for each group), and then receive real or sham acupuncture treatment, respectively. In this trial, the primary outcome measure is simple form of McGill pain questionnaire (SF-MPQ), while expectation and treatment credibility scale (ETCS), safety assessment, the COX menstrual symptom scale (CMSS), questionnaire about the feeling of being punctured are included in the secondary outcomes. This trial will be the first study protocol designed to evaluate the immediate analgesia effect of WAA in PD of young females. The strengths in methodology, including rigorous randomized, sham-controlled, participants-blinded and assessors-blinded, will guarantee the quality of this study. WAA doesn't require any needling sensation, so non-penetrating sham acupuncture can serve as an effective placebo intervention in this trial. Chinese Clinical Trial Registry (identifier: ChiCTR-IOR-16008546 ; registration date: 27 May 2016).

  2. A Review of Traumatic Axonal Injury following Whiplash Injury As Demonstrated by Diffusion Tensor Tractography

    Directory of Open Access Journals (Sweden)

    Sung Ho Jang

    2018-02-01

    Full Text Available Whiplash is a bony or soft tissue injury resulting from an acceleration–deceleration energy transfer in the neck. Although patients with whiplash injury often complain of cerebral symptoms, and previous studies have reported evidence indicating brain injury, such an association has not been clearly elucidated. Traumatic axonal injury (TAI is tearing of axons due to indirect shearing forces during acceleration, deceleration, and rotation of the brain or to direct head trauma. Diffusion tensor imaging (DTI has a unique advantage to detect TAI in patients whose conventional brain CT or magnetic resonance imaging (MRI results were negative following head trauma. Since the introduction of DTI, six studies using diffusion tensor tractography (DTT based on DTI data have reported TAI in patients with whiplash injury, even though conventional brain CT or MRI results were negative. A precise TAI diagnosis in whiplash patients is clinically important for proper management and prognosis. Among the methods employed to diagnose TAI in the six previous studies, the common diagnostic approach for neural tract TAI in individual patients with whiplash injury were (1 whiplash injury history due to car accident; (2 development of new clinical symptoms and signs after whiplash injury; (3 evidence of neural tract TAI in DTT results, mainly via configurational analysis; and (4 coincidence of newly developed clinical manifestations and the function of injured neural tracts. All six studies were individual patient case studies; therefore, further prospective studies involving larger number of subjects should be encouraged.

  3. How can animal models inform on the transition to chronic symptoms in whiplash?

    Science.gov (United States)

    Winkelstein, Beth A.

    2011-01-01

    Study Design A non-systematic review of the literature. Objective The objective was to present general schema for mechanisms of whiplash pain and review the role of animal models in understanding the development of chronic pain from whiplash injury. Summary of Background Data Extensive biomechanical and clinical studies of whiplash have been performed to understand the injury mechanisms and symptoms of whiplash injury. However, only recently have animal models of this painful disorder been developed based on other pain models in the literature. Methods A non-systematic review was performed and findings were integrated to formulate a generalized picture of mechanisms by chronic whiplash pain develops from mechanical tissue injuries. Results The development of chronic pain from tissue injuries in the neck due to whiplash involves complex interactions between the injured tissue and spinal neuroimmune circuits. A variety of animal models are beginning to define these mechanisms. Conclusion Continued work is needed in developing appropriate animal models to investigate chronic pain from whiplash injuries and care must be taken to determine whether such models aim to model the injury event or the pain symptom. PMID:22020616

  4. Factors predicting outcome in whiplash injury: a systematic meta-review of prognostic factors.

    Science.gov (United States)

    Sarrami, Pooria; Armstrong, Elizabeth; Naylor, Justine M; Harris, Ian A

    2017-03-01

    Whiplash injuries are among the leading injuries related to car crashes and it is important to determine the prognostic factors that predict the outcome of patients with these injuries. This meta-review aims to identify factors that are associated with outcome after acute whiplash injury. A systematic search for all systematic reviews on outcome prediction of acute whiplash injury was conducted across several electronic databases. The search was limited to publications in English, and there were no geographical or time of publication restrictions. Quality appraisal was conducted with A Measurement Tool to Assess Systematic Reviews. The initial search yielded 207 abstracts; of these, 195 were subsequently excluded by topic or method. Twelve systematic reviews with moderate quality were subsequently included in the analysis. Post-injury pain and disability, whiplash grades, cold hyperalgesia, post-injury anxiety, catastrophizing, compensation and legal factors, and early healthcare use were associated with continuation of pain and disability in patients with whiplash injury. Post-injury magnetic resonance imaging or radiographic findings, motor dysfunctions, or factors related to the collision were not associated with continuation of pain and disability in patients with whiplash injury. Evidence on demographic and three psychological factors and prior pain was conflicting, and there is a shortage of evidence related to the significance of genetic factors. This meta-review suggests an association between initial pain and anxiety and the outcome of acute whiplash injury, and less evidence for an association with physical factors. Level 1.

  5. Fluoxetine for Autistic Behaviors (FAB trial): study protocol for a randomized controlled trial in children and adolescents with autism.

    Science.gov (United States)

    Mouti, Anissa; Reddihough, Dinah; Marraffa, Catherine; Hazell, Philip; Wray, John; Lee, Katherine; Kohn, Michael

    2014-06-16

    Serotonin reuptake inhibitors (SSRIs) are commonly prescribed off-label for children with autism. To date, clinical trials examining the use of SSRIs in autism have been limited by small sample sizes and inconclusive results. The efficacy and safety of SSRIs for moderating autistic behaviors is yet to be adequately examined to provide evidence to support current clinical practice. The aim of the Fluoxetine for Autistic Behaviors (FAB) study is to determine the efficacy and safety of low dose fluoxetine compared with placebo, for reducing the frequency and severity of repetitive stereotypic behaviors in children and adolescents with an autism spectrum disorder (ASD). The relationship between the effectiveness of fluoxetine treatment and serotonin transporter genotype will also be explored. The FAB study is a multicenter, double-blinded, randomized controlled trial, funded by the Australian Government's National Health and Medical Research Council (NHMRC) grant. Participants will be aged between 7.5 and 17 years with a confirmed diagnosis of ASD. Eligible participants will be randomized to either placebo or fluoxetine for a 16-week period. Medication will be titrated over the first four weeks. Reponses to medication will be monitored fortnightly using the Clinical Global Impressions Scale (CGI). The primary outcome measure is the Children's Yale-Brown Obsessive Compulsive Scale-Modified for Pervasive Developmental Disorders (CYBOCS-PDD), administered at baseline and 16 weeks. Secondary outcome measures include the Aberrant Behaviour Scale (ABC), the Spence Children's Anxiety Scale Parent Report (SCAS-P), and the Repetitive Behaviors Scale (RBS-R), measured at baseline and 16 weeks. Participants will be invited to undergo genetic testing for SLC6A4 allele variants using a cheek swab. Continuous outcomes, including the primary outcome will be compared between the active and placebo groups using unadjusted linear regression. Binary outcomes will be compared using

  6. Systemic therapy for vulval Erosive Lichen Planus (the 'hELP' trial): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Simpson, Rosalind C; Murphy, Ruth; Bratton, Daniel J; Sydes, Matthew R; Wilkes, Sally; Nankervis, Helen; Dowey, Shelley; Thomas, Kim S

    2016-01-04

    Erosive lichen planus affecting the vulva (ELPV) is a relatively rare, chronic condition causing painful raw areas in the vulvovaginal region. Symptoms are pain and burning, which impact upon daily living. There is paucity of evidence regarding therapy. A 2012 Cochrane systematic review found no randomised controlled trials (RCTs) in this field. Topically administered corticosteroids are the accepted first-line therapy: however, there is uncertainty as to which second-line treatments to use. Several systemic agents have been clinically noted to show promise for ELPV refractory to topically administered corticosteroids but there is no RCT evidence to support these. The 'hELP' study is a RCT with an internal pilot phase designed to provide high-quality evidence. The objective is to test whether systemic therapy in addition to standard topical therapy is a beneficial second-line treatment for ELPV. Adjunctive systemic therapies used are hydroxychloroquine, methotrexate, mycophenolate mofetil and prednisolone. Topical therapy plus a short course of prednisolone given orally is considered the comparator intervention. The trial is a four-armed, open-label, pragmatic RCT which uses a blinded independent clinical assessor. To provide 80 % power for each comparison, 96 participants are required in total. The pilot phase aims to recruit 40 participants. The primary clinical outcome is the proportion of patients achieving treatment success at 6 months. 'Success' is defined by a composite measure of Patient Global Assessment score of 0 or 1 on a 4-point scale plus improvement from baseline on clinical photographs scored by a clinician blinded to treatment allocation. Secondary clinical outcomes include 6-month assessment of: (1) Reduction in pain/soreness; (2) Global assessment of disease; (3) Response at other affected mucosal sites; (4) Hospital Anxiety and Depression Scale scores; (5) Sexual function; (6) Health-related quality of life using 'Short Form 36' and 'Skindex

  7. Protocol for a pilot randomised controlled trial of an intervention to increase the use of traffic light food labelling in UK shoppers (the FLICC trial).

    Science.gov (United States)

    Scarborough, Peter; Hodgkins, Charo; Raats, Monique M; Harrington, Richard A; Cowburn, Gill; Dean, Moira; Doherty, Aiden; Foster, Charlie; Juszczak, Edmund; Matthews, Anne; Mizdrak, Anja; Mhurchu, Cliona Ni; Shepherd, Richard; Tiomotijevic, Lada; Winstone, Naomi; Rayner, Mike

    2015-01-01

    Traffic light labelling of foods-a system that incorporates a colour-coded assessment of the level of total fat, saturated fat, sugar and salt on the front of packaged foods-has been recommended by the UK Government and is currently in use or being phased in by many UK manufacturers and retailers. This paper describes a protocol for a pilot randomised controlled trial of an intervention designed to increase the use of traffic light labelling during real-life food purchase decisions. The objectives of this two-arm randomised controlled pilot trial are to assess recruitment, retention and data completion rates, to generate potential effect size estimates to inform sample size calculations for the main trial and to assess the feasibility of conducting such a trial. Participants will be recruited by email from a loyalty card database of a UK supermarket chain. Eligible participants will be over 18 and regular shoppers who frequently purchase ready meals or pizzas. The intervention is informed by a review of previous interventions encouraging the use of nutrition labelling and the broader behaviour change literature. It is designed to impact on mechanisms affecting belief and behavioural intention formation as well as those associated with planning and goal setting and the adoption and maintenance of the behaviour of interest, namely traffic light label use during purchases of ready meals and pizzas. Data will be collected using electronic sales data via supermarket loyalty cards and web-based questionnaires and will be used to estimate the effect of the intervention on the nutrition profile of purchased ready meals and pizzas and the behavioural mechanisms associated with label use. Data collection will take place over 48 weeks. A process evaluation including semi-structured interviews and web analytics will be conducted to assess feasibility of a full trial. The design of the pilot trial allows for efficient recruitment and data collection. The intervention could be

  8. mHealth Technology and Nurse Health Coaching to Improve Health in Diabetes: Protocol for a Randomized Controlled Trial.

    Science.gov (United States)

    Miyamoto, Sheridan; Dharmar, Madan; Fazio, Sarina; Tang-Feldman, Yajarayma; Young, Heather M

    2018-02-15

    Chronic diseases, including diabetes mellitus, are the leading cause of mortality and disability in the United States. Current solutions focus primarily on diagnosis and pharmacological treatment, yet there is increasing evidence that patient-centered models of care are more successful in improving and addressing chronic disease outcomes. The objective of this clinical trial is to evaluate the impact of a mobile health (mHealth) enabled nurse health coaching intervention on self-efficacy among adults with type-2 diabetes mellitus. A randomized controlled trial was conducted at an academic health system in Northern California. A total of 300 participants with type-2 diabetes were scheduled to be enrolled through three primary care clinics. Participants were randomized to either usual care or intervention. All participants received training on use of the health system patient portal. Participants in the intervention arm received six scheduled health-coaching telephone calls with a registered nurse and were provided with an activity tracker and mobile application that integrated data into the electronic health record (EHR) to track their daily activity and health behavior decisions. All participants completed a baseline survey and follow-up surveys at 3 and 9 months. Primary and secondary outcomes include diabetes self-efficacy, hemoglobin A 1c (HbA 1c ), and quality of life measures. Data collection for this trial, funded by the Patient-Centered Outcomes Research Institute, will be completed by December 2017. Results from the trial will be available mid-2018. This protocol details a patient-centered intervention using nurse health coaching, mHealth technologies, and integration of patient-generated data into the EHR. The aim of the intervention is to enhance self-efficacy and health outcomes by providing participants with a mechanism to track daily activity by offering coaching support to set reasonable and attainable health goals, and by creating a complete feedback

  9. Protocol for a randomised controlled trial of treatment of asymptomatic candidiasis for the prevention of preterm birth [ACTRN12610000607077

    Directory of Open Access Journals (Sweden)

    Rickard Kristen R

    2011-03-01

    Full Text Available Abstract Background Prevention of preterm birth remains one of the most important challenges in maternity care. We propose a randomised trial with: a simple Candida testing protocol that can be easily incorporated into usual antenatal care; a simple, well accepted, treatment intervention; and assessment of outcomes from validated, routinely-collected, computerised databases. Methods/Design Using a prospective, randomised, open-label, blinded-endpoint (PROBE study design, we aim to evaluate whether treating women with asymptomatic vaginal candidiasis early in pregnancy is effective in preventing spontaneous preterm birth. Pregnant women presenting for antenatal care The study protocol draws on the usual antenatal care schedule, has been pilot-tested and the intervention involves only a minor modification of current practice. Women who agree to participate will self-collect a vaginal swab and those who are culture positive for Candida will be randomised (central, telephone to open-label treatment or usual care (screening result is not revealed, no treatment, routine antenatal care. Outcomes will be obtained from population databases. A sample size of 3,208 women with Candida colonisation (1,604 per arm is required to detect a 40% reduction in the spontaneous preterm birth rate among women with asymptomatic candidiasis from 5.0% in the control group to 3.0% in women treated with clotrimazole (significance 0.05, power 0.8. Analyses will be by intention to treat. Discussion For our hypothesis, a placebo-controlled trial had major disadvantages: a placebo arm would not represent current clinical practice; knowledge of vaginal colonisation with Candida may change participants' behaviour; and a placebo with an alcohol preservative may have an independent affect on vaginal flora. These disadvantages can be overcome by the PROBE study design. This trial will provide definitive evidence on whether screening for and treating asymptomatic candidiasis in

  10. Effectiveness of the universal prevention program 'Healthy School and Drugs': Study protocol of a randomized clustered trial

    Directory of Open Access Journals (Sweden)

    Malmberg Monique

    2010-09-01

    Full Text Available Abstract Background Substance use is highly prevalent among Dutch adolescents. The Healthy School and Drugs program is a nationally implemented school-based prevention program aimed at reducing early and excessive substance use among adolescents. Although the program's effectiveness was tested in a quasi-experimental design before, many program changes were made afterwards. The present study, therefore, aims to test the effects of this widely used, renewed universal prevention program. Methods/Design A randomized clustered trial will be conducted among 3,784 adolescents of 23 secondary schools in The Netherlands. The trial has three conditions; two intervention conditions (i.e., e-learning and integral and a control condition. The e-learning condition consists of three digital learning modules (i.e., about alcohol, tobacco, and marijuana that are sequentially offered over the course of three school years (i.e., grade 1, grade 2, and grade 3. The integral condition consists of parental participation in a parental meeting on substance use, regulation of substance use, and monitoring and counseling of students' substance use at school, over and above the three digital modules. The control condition is characterized as business as usual. Participating schools were randomly assigned to either an intervention or control condition. Participants filled out a digital questionnaire at baseline and will fill out the same questionnaire three more times at follow-up measurements (8, 20, and 32 months after baseline. Outcome variables included in the questionnaire are the percentage of binge drinking (more than five drinks per occasion, the average weekly number of drinks, and the percentage of adolescents who ever drunk a glass of alcohol and the percentage of adolescents who ever smoked a cigarette or a joint respectively for tobacco and marijuana. Discussion This study protocol describes the design of a randomized clustered trial that evaluates the

  11. Blockchain protocols in clinical trials: Transparency and traceability of consent [version 3; referees: 1 approved, 2 approved with reservations, 1 not approved

    OpenAIRE

    Mehdi Benchoufi; Raphael Porcher; Philippe Ravaud

    2017-01-01

    Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing the collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we will built a consent workflow using a rising technology called Blockchain. This is a...

  12. A randomized controlled trial of culturally adapted motivational interviewing for Hispanic heavy drinkers: Theory of Adaptation and Study Protocol

    Science.gov (United States)

    Lee, Christina S.; Colby, Suzanne M.; Magill, Molly; Almeida, Joanna; Tavares, Tonya; Rohsenow, Damaris J.

    2016-01-01

    Background The NIH Strategic Plan prioritizes health disparities research for socially disadvantaged Hispanics, to reduce the disproportionate burden of alcohol-related negative consequences compared to other racial/ethnic groups. Cultural adaptation of evidence-based treatments, such as motivational interviewing (MI), can improve access and response to alcohol treatment. However, the lack of rigorous clinical trials designed to test the efficacy and theoretical underpinnings of cultural adaptation has made proof of concept difficult. Objective The CAMI2 (Culturally Adapted Motivational Interviewing) study design and its theoretical model, is described to illustrate how MI adapted to social and cultural factors (CAMI) can be discriminated against non-adapted MI. Methods and Design CAMI2, a large, 12 month randomized prospective trial, examines the efficacy of CAMI and MI among heavy drinking Hispanics recruited from the community (n=257). Outcomes are reductions in heavy drinking days (Time Line Follow-Back) and negative consequences of drinking among Hispanics (Drinkers Inventory of Consequences). A second aim examines perceived acculturation stress as a moderator of treatment outcomes in the CAMI condition. Summary The CAMI2 study design protocol is presented and the theory of adaptation is presented. Findings from the trial described may yield important recommendations on the science of cultural adaptation and improve MI dissemination to Hispanics with alcohol risk. PMID:27565832

  13. PAAPPAS community trial protocol: a randomized study of obesity prevention for adolescents combining school with household intervention

    Directory of Open Access Journals (Sweden)

    Michele R. Sgambato

    2016-08-01

    Full Text Available Abstract Background The prevalence of childhood obesity is increasing at a high rate in Brazil, making prevention a health priority. Schools are the central focus of interventions aiming the prevention and treatment of childhood obesity, however, randomized trials and cohort studies have not yet provided clear evidence of strategies to reduce prevalence of obesity. The aim of this study is to present a protocol to evaluate the efficacy of combining school and household level interventions to reduce excessive weight gain among students. Methods The intervention target fifth and sixth graders from 18 public schools (9 interventions and 9 controls in the municipality of Duque de Caxias, metropolitan area of Rio de Janeiro, Brazil. A sample size of 2500 students will be evaluated at school for their weight status and those from the intervention group who are overweight or obese will be followed monthly at home by community health agents. Demographic, socioeconomic, anthropometric, eating behavior and food consumption data will be collected at school using a standardized questionnaire programmed in personal digital assistant. At school, all students from the intervention group will be encouraged to change eating habits and food consumption and to increase physical activity and reducing sedentary behavior. Discussion This study will provide evidence whether integration of school with primary health care can prevent excessive weight gain among adolescents. Positive results will inform a sustainable strategy to be disseminated in the health care system in Brazil. Trial registration ClinicalTrials.gov, NCT02711488 . Date of registration: March 11, 2016.

  14. Magnetic resonance imaging for cerebral lesions during minimal invasive mitral valve surgery: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Barbero, Cristina; Ricci, Davide; Cura Stura, Erik; Pellegrini, Augusto; Marchetto, Giovanni; ElQarra, Suad; Boffini, Massimo; Passera, Roberto; Valentini, Maria Consuelo; Rinaldi, Mauro

    2017-02-21

    Recent data have highlighted a higher rate of neurological injuries in minimal invasive mitral valve surgery (MIMVS) compared with the standard sternotomy approach; therefore, the role of specific clamping techniques and perfusion strategies on the occurrence of this complication is a matter of discussion in the medical literature. The purpose of this trial is to prospectively evaluate major, minor and silent neurological events in patients undergoing right mini-thoracotomy mitral valve surgery using retrograde perfusion and an endoaortic clamp or a transthoracic clamp. A prospective, blinded, randomized controlled study on the rate of neurological embolizations during MIMVS started at the University of Turin in June 2014. Major, minor and silent neurological events are being investigated through standard neurological evaluation and magnetic resonance imaging assessment. The magnetic resonance imaging protocol includes conventional sequences for the morphological and quantitative assessment and nonconventional sequences for the white matter microstructural evaluation. Imaging studies are performed before surgery as baseline assessment and on the third postoperative day and, in patients who develop postoperative ischemic lesions, after 6 months. Despite recent concerns raised about the endoaortic setting with retrograde perfusion, we expect to show equivalence in terms of neurological events of this technique compared with the transthoracic clamp in a selected cohort of patients. With the first results expected in December 2016 the findings would be of help in confirming the efficacy and safety of MIMVS. ClinicalTrials.gov, Identifier: NCT02818166 . Registered on 8 February 2016 - trial retrospectively registered.

  15. Efficacy and Safety of Electroacupuncture on Treating Depression Related Sleep Disorders: Study Protocol of a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Xuan Yin

    2016-01-01

    Full Text Available Background. Depression is frequently accompanied by sleep disturbances including insomnia. Insomnia may persist even after mood symptoms have been adequately treated. Acupuncture is considered to be beneficial to adjust the state of body and mind and restore the normal sleep-awake cycle. This trial is aimed at evaluating the efficacy and safety of electroacupuncture on treating insomnia in patients with depression. Methods. We describe a protocol for a randomized, single-blinded, sham controlled trial. Ninety eligible patients will be randomly assigned to one of 3 treatment groups: treatment group (acupuncture, control A group (superficial acupuncture at sham points, and control B group (sham acupuncture. All treatment will be given 3 times per week for 8 weeks. The primary outcome is the Pittsburgh Sleep Quality Index (PSQI. The secondary outcomes are sleep parameters recorded in the Actigraphy, Hamilton Rating Scale for Depression (HAMD, and Self-Rating Depression Scale (SDS. All adverse effects will be accessed by the Treatment Emergent Symptom Scale (TESS. Outcomes will be evaluated at baseline, 4 weeks after treatment, 8 weeks after treatment, and 4 weeks of follow-up. Ethics. This trial has been approved by the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine (2015SHL-KY-21 and is registered with ChiCTR-IIR-16008058.

  16. Study Protocol: Screening and Treatment of Alcohol-Related Trauma (START – a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Jayaraj Rama

    2012-10-01

    Full Text Available Abstract Background The incidence of mandibular fractures in the Northern Territory of Australia is very high, especially among Indigenous people. Alcohol intoxication is implicated in the majority of facial injuries, and substance use is therefore an important target for secondary prevention. The current study tests the efficacy of a brief therapy, Motivational Care Planning, in improving wellbeing and substance misuse in youth and adults hospitalised with alcohol-related facial trauma. Methods and design The study is a randomised controlled trial with 6 months of follow-up, to examine the effectiveness of a brief and culturally adapted intervention in improving outcomes for trauma patients with at-risk drinking admitted to the Royal Darwin Hospital maxillofacial surgery unit. Potential participants are identified using AUDIT-C questionnaire. Eligible participants are randomised to either Motivational Care Planning (MCP or Treatment as Usual (TAU. The outcome measures will include quantity and frequency of alcohol and other substance use by Timeline Followback. The recruitment target is 154 participants, which with 20% dropout, is hoped to provide 124 people receiving treatment and follow-up. Discussion This project introduces screening and brief interventions for high-risk drinkers admitted to the hospital with facial trauma. It introduces a practical approach to integrating brief interventions in the hospital setting, and has potential to demonstrate significant benefits for at-risk drinkers with facial trauma. Trial Registration The trial has been registered in Australian New Zealand Clinical Trials Registry (ANZCTR and Trial Registration: ACTRN12611000135910.

  17. Laparoscopic versus open peritoneal dialysis catheter insertion, the LOCI-trial: a study protocol

    Directory of Open Access Journals (Sweden)

    Hagen Sander M

    2011-12-01

    Full Text Available Abstract Background Peritoneal dialysis (PD is an effective treatment for end-stage renal disease. It allows patients more freedom to perform daily activities compared to haemodialysis. Key to successful PD is the presence of a well-functioning dialysis catheter. Several complications, such as in- and outflow obstruction, peritonitis, exit-site infections, leakage and migration, can lead to catheter removal and loss of peritoneal access. Currently, different surgical techniques are in practice for PD-catheter placement. The type of insertion technique used may greatly influence the occurrence of complications. In the literature, up to 35% catheter failure has been described when using the open technique and only 13% for the laparoscopic technique. However, a well-designed randomized controlled trial is lacking. Methods/Design The LOCI-trial is a multi-center randomized controlled, single-blind trial (pilot. The study compares the laparoscopic with the open technique for PD catheter insertion. The primary objective is to determine the optimum placement technique in order to minimize the incidence of catheter malfunction at 6 weeks postoperatively. Secondary objectives are to determine the best approach to optimize catheter function and to study the quality of life at 6 months postoperatively comparing the two operative techniques. Discussion This study will generate evidence on any benefits of laparoscopic versus open PD catheter insertion. Trial registration Dutch Trial Register NTR2878

  18. Efficacy of electroacupuncture for symptoms of menopausal transition: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Liu, Zhishun; Wang, Yang; Xu, Huanfang; Wu, Jiani; He, Liyun; Jiang, John Yi; Yan, Shiyan; Du, Ruosang; Liu, Baoyan

    2014-06-21

    Previous studies have shown that acupuncture can alleviate postmenopausal symptoms, such as hot flashes, but few studies have assessed symptoms during the menopausal transition (MT) period. Thus, the effect of acupuncture upon MT symptoms is unclear. We designed a large-scale trial aimed at evaluating the efficacy of electroacupuncture for MT symptoms compared with sham electroacupuncture and at observing the safety of electroacupuncture. In this multicenter randomized controlled trial, 360 women will be randomized to either an electroacupuncture group or a sham electroacupuncture group. During the 8-week-long treatment, a menopause rating scale, average 24-hour hot flash score, Menopause-Specific Quality of Life Questionnaire score, and level of female hormones will be observed. Follow-ups at the 20th and 32nd week will be made. Though there is no completely inert placebo acupuncture and blinding is difficult in acupuncture trials, the placebo effect of EA can still be partially excluded in this study. For the placebo control, we use non-points and a tailor-made sham needle. This needle is different from a retractable needle, which is usually used for sham acupuncture. The needle in this trial is more simply constructed and more acceptable to Chinese people. We expect to evaluate the efficacy of electroacupuncture for MT symptoms and clarify its effect on these symptoms. ClinicalTrials.gov Identifier: NCT01849172 (Date of registration: 05/05/2013).

  19. Weight-loss intervention using implementation intentions and mental imagery: a randomised control trial study protocol

    OpenAIRE

    Hattar, Anne; Hagger, Martin S; Pal, Sebely

    2015-01-01

    Background Overweight and obesity are major health problems worldwide. This protocol describes the HEALTHI (Healthy Eating and Active LifesTyle Health Intervention) Program, a 12-week randomised-controlled weight-loss intervention that adopts two theory-based intervention techniques, mental imagery and implementation intentions, a behaviour-change technique based on planning that have been shown to be effective in promoting health-behaviour change in previous research. The effectiveness of go...

  20. Effects of two exercise protocols on postural balance of elderly women: a randomized controlled trial

    OpenAIRE

    Mesquita, Laiana Sep?lveda de Andrade; de Carvalho, Fabiana Texeira; Freire, Lara Sep?lveda de Andrade; Neto, Osmar Pinto; Z?ngaro, Renato Amaro

    2015-01-01

    Background The aging process reduces both sensory capabilities and the capabilities of the motor systems responsible for postural control, resulting in a high number of falls among the elderly. Some therapeutic interventions can directly interrupt this process, including physical exercise. This study compares and examines the effects of two exercise protocols on the balance of elderly women. Methods Elderly women who participated in a local church project (n?=?63) were randomly divided into t...

  1. Local administration of enriched mononuclear cells, platelets and zoledronic acid for preventing collapse of the femoral head in the early stage of osteonecrosis: study protocol for a prospective randomized parallel-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Ning Ma

    2016-01-01

    Trial registration: ClinicalTrial.gov identifier: NCT02721940. Written approval for this protocol was obtained from the ethics committee of the Chinese PLA General Hospital in China (approval No. S2015-082-01.

  2. Study protocol: effect of playful training on functional abilities of older adults - a randomized controlled trial

    DEFF Research Database (Denmark)

    Jessen, Jari Due; Lund, Henrik Hautop

    2017-01-01

    of community dwelling elderly as a result of short-term playing with an exergame system in the form of interactive modular tiles. Such playful training may be motivational to perform and viewed by the subjects to offer life-fulfilling quality, while providing improvement in physical abilities, e.g. related...... to prevent fall accidents. The RCT will test for a variety of health parameters of community-dwelling elderly playing on interactive modular tiles.Methods: The study will be a single blinded, randomized controlled trial with 60 community-dwelling adults 70+ years. The trial will consist an intervention group...... paired t-test, otherwise using Wilcoxon signed-rank test. "Intention to treat" analysis will be done.Discussion: The trial tests for increased mobility, agility, balancing and general fitness of community-dwelling elderly as a result of playing, in this case on modular interactive tiles. A positive...

  3. Calculation and analysis of whiplash effect in multi-DOF system

    Science.gov (United States)

    Chen, Gong; Qi, Qunfu; Yang, Hongmei; Li, Ling

    2017-04-01

    The response of structural vibration depends on the degree of freedomss, mass, stiffness, external effect of the structure. Natural frequency of structure is its inherent property, also it is related to its own factors, but not related to the external factors. Firstly the nature and characteristics of resonance effect and whiplash effect are analyzed. Secondly whiplash effect of multi-degree freedomss system is analyzed, then orthogonality in main models is used to verify the results of calculation. Then the improvements of whiplash effect are proposed, also the improved models are analyzed. Finally the conclusions are made.

  4. MR diagnosis and clinical management of whiplash injury syndrome of spinal cord

    International Nuclear Information System (INIS)

    Lin Shixu; Lin Daiying; Wu Xianheng; Zeng Xianting

    2003-01-01

    Objective: To study the MR manifestations of whiplash injury syndrome of spinal cord. Methods: MR images of 21 cases diagnosed as whiplash injury syndrome were retrospectively studied. Those images included transverse and sagittal views and coronal scan had been performed in some cases. Results: MRI inspection safely and objectively reveals the extent of the spinal injury, and helps the anticipation of the prognosis. Conclusion: MRI is the first choice of the imaging modalities assessing the whiplash injury syndrome of the spinal cord. An early diagnosis is valuable to clinical management and rehabilitation

  5. What characterizes individuals developing chronic whiplash?: The Nord-Trøndelag Health Study (HUNT).

    Science.gov (United States)

    Myrtveit, Solbjørg Makalani; Wilhelmsen, Ingvard; Petrie, Keith J; Skogen, Jens Christoffer; Sivertsen, Børge

    2013-05-01

    Most individuals experiencing whiplash accidents recover rapidly. A considerable proportion, however, develop chronic symptoms. Psychological factors may slow recovery, possibly by increasing the likelihood of other symptoms being misattributed to, and amplified by the whiplash injury. We aimed to investigate how pre-injury mental and somatic symptoms, self-rated health, use of health-services and medications, health-behavior and socio-demographics predict the development of chronic whiplash. Data from two waves of a large, population based study (HUNT2 (baseline) and HUNT3) were used. Individuals reporting no whiplash at baseline were identified in HUNT3. Characteristics reported at baseline were compared between those who had developed chronic whiplash in HUNT3 (n=199) and those who had not (n=20,600), using Pearson's chi-squared tests, independent sample t-tests and logistic regression analyses. Individuals developing chronic whiplash reported worse baseline health than those reporting no chronic whiplash. Poor self-rated health was a strong risk factor for subsequent chronic whiplash (OR=2.26, 95%CI: 1.68-3.04). Musculoskeletal pain also increased the risk (OR=1.21, 95%CI: 1.15-1.26), as did diffuse somatic symptoms (OR=2.09, 95%CI: 1.47-2.96), use of different health services (OR=1.31, 95%CI: 1.19-1.45), high use of medications (OR=1.28, 95%CI: 1.14-1.43) and symptoms of anxiety (OR=1.93, 95%CI: 1.39-2.68). Physical activity was protective (OR=0.67, 95%CI: 0.49-0.91). Most socio-demographic variables were not significantly associated with chronic whiplash. Poor somatic and mental pre-injury health increased the risk of subsequent chronic whiplash. This suggests that chronic whiplash is not merely an organic disorder, and highlights the importance of individual expectations, symptom reattribution and amplification in development of chronic whiplash. Copyright © 2013 Elsevier Inc. All rights reserved.

  6. Clinical Trials

    Medline Plus

    Full Text Available ... to-kol). This plan explains how the trial will work. The trial is led by a principal ... for the clinical trial. The protocol outlines what will be done during the clinical trial and why. ...

  7. Effectiveness of electroacupuncture for polycystic ovary syndrome: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Chen, Jiao; Feng, Shuwei; Zeng, Jiuzhi; Wu, Xi; Yang, Mingxiao; Tang, Hongzhi; Fan, Huaying; Yang, Jie; Liang, Fanrong

    2016-05-21

    Whether electroacupuncture is effective for patients with polycystic ovary syndrome is still inconclusive. Therefore, this study aims to evaluate the add-on effects of electroacupuncture to conventional drugs for the treatment of polycystic ovary syndrome. This study is a two-center, open-labeled, randomized, controlled trial. A total of 116 eligible patients with polycystic ovary syndrome will be randomly allocated in a 1:1 ratio to the electroacupuncture plus clomiphene citrate group or to the clomiphene citrate group. Participants in the electroacupuncture plus clomiphene citrate group will receive electroacupuncture treatment in addition to clomiphene citrate capsules, whereas participants in the clomiphene citrate group will be prescribed clomiphene citrate capsules only. Electroacupuncture treatment will be performed from the fifth day of menstruation or withdrawal bleeding until the next menstruation, in three sessions per week for three menstrual cycles. The primary outcome is the ovulation rate. The secondary outcomes include the dominant follicle rate, mean number of dominant follicles, endometrial thickness, time point of ovulation, follicular size before ovulation, luteinizing hormone, estradiol level, and pregnancy rate. The measuring points for outcomes will be baseline and the completion of treatment. Any adverse events occurring during the trial process will be recorded. In addition, a quality-monitoring group independent from the research team will be set up to control the quality of the trial. The design and methodological rigor of this trial will allow for the collection of valuable data to evaluate the effectiveness of electroacupuncture for treating polycystic ovary syndrome. Therefore, this trial will contribute reliable evidence for use in clinical decision-making in acupuncture therapy of polycystic ovary syndrome as well as to future research in acupuncture for polycystic ovary syndrome. Chinese Clinical Trial Registry, ChiCTR-IOR-15007358

  8. Intervention on whole grain with healthy balanced diet to manage childhood obesity (GReat-Child™trial): study protocol for a quasi-experimental trial.

    Science.gov (United States)

    Koo, H C; Poh, B K; Ruzita, Abd Talib

    2016-01-01

    The rapid increase in childhood obesity is a serious public health problem, and has led to the development of many interventions. However, no intervention has emphasized whole grains as a strategy to manage childhood obesity. Therefore, this article describes the protocol of a 12-week multi-component, family-based intervention on whole grain, using a healthy balanced diet for managing childhood obesity. The GReat-Child trial utilize a quasi-experimental method in which two schools in Kuala Lumpur are assigned to intervention and control groups. The eligibility criteria are overweight/obese children, aged 9 through 11 years, who has no serious co-morbidities. The children who report consuming whole-grain foods in their 3-day diet-recall during the screening will be excluded. The study sample is characterized by anthropometric measurements (weight, height, percentage of body fat and waist circumference), whole grain and nutrient intakes (3-day 24-h diet recalls), and their knowledge, attitudes and practices towards whole grain. The 12-week intervention is comprised of three components addressing behaviour, personal and environmental factors, based on social cognitive theory: (1) individual diet counselling for the parents; (2) six 30-min nutrition education classes and (3) school delivery of whole-grain foods; The control school does not receive any interventions, however, for ethical purposes, a health talk is conducted after the entire GReat-Child Trial is completed. The GReat-Child trial represents a novel approach to examining the effectiveness of the intervention of whole grain in a healthy balanced diet on managing childhood obesity. We anticipate that this trial will reveal not only whether whole grain intervention will be effective in managing childhood obesity, but also provide greater insights into the acceptance of whole grain among Malaysian children.

  9. Effect of joint mobilization techniques for primary total knee arthroplasty: Study protocol for a randomized controlled trial.

    Science.gov (United States)

    Xu, Jiao; Zhang, Juan; Wang, Xue-Qiang; Wang, Xuan-Lin; Wu, Ya; Chen, Chan-Cheng; Zhang, Han-Yu; Zhang, Zhi-Wan; Fan, Kai-Yi; Zhu, Qiang; Deng, Zhi-Wei

    2017-12-01

    Total knee arthroplasty (TKA) has become the most preferred procedure by patients for the relief of pain caused by knee osteoarthritis. TKA patients aim a speedy recovery after the surgery. Joint mobilization techniques for rehabilitation have been widely used to relieve pain and improve joint mobility. However, relevant randomized controlled trials showing the curative effect of these techniques remain lacking to date. Accordingly, this study aims to investigate whether joint mobilization techniques are valid for primary TKA. We will manage a single-blind, prospective, randomized, controlled trial of 120 patients with unilateral TKA. Patients will be randomized into an intervention group, a physical modality therapy group, and a usual care group. The intervention group will undergo joint mobilization manipulation treatment once a day and regular training twice a day for a month. The physical modality therapy group will undergo physical therapy once a day and regular training twice a day for a month. The usual care group will perform regular training twice a day for a month. Primary outcome measures will be based on the visual analog scale, the knee joint Hospital for Special Surgery score, range of motion, surrounded degree, and adverse effect. Secondary indicators will include manual muscle testing, 36-Item Short Form Health Survey, Berg Balance Scale function evaluation, Pittsburgh Sleep Quality Index, proprioception, and muscle morphology. We will direct intention-to-treat analysis if a subject withdraws from the trial. The important features of this trial for joint mobilization techniques in primary TKA are randomization procedures, single-blind, large sample size, and standardized protocol. This study aims to investigate whether joint mobilization techniques are effective for early TKA patients. The result of this study may serve as a guide for TKA patients, medical personnel, and healthcare decision makers. It has been registered at http

  10. Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Brown, Sarah; Smith, Isabelle L; Brown, Julia M; Hulme, Claire; McGinnis, Elizabeth; Stubbs, Nikki; Nelson, E Andrea; Muir, Delia; Rutherford, Claudia; Walker, Kay; Henderson, Valerie; Wilson, Lyn; Gilberts, Rachael; Collier, Howard; Fernandez, Catherine; Hartley, Suzanne; Bhogal, Moninder; Coleman, Susanne; Nixon, Jane E

    2016-12-20

    demonstrating either superiority, inferiority of mattresses or futility of the trial. The trial optimises the potential for producing robust clinical evidence on the effectiveness of two commonly used mattresses in clinical practice earlier than in a conventional design. ISRCTN01151335 . Registered on 14 May 2013. Protocol version: 5.0, dated 25 September 2015 Trial sponsor: Clare Skinner, Faculty Head of Research Support, University of Leeds, Leeds, LS2 9JT; 0113 343 4897; C.E.Skinner@leeds.ac.uk.

  11. The Quality Initiative in Rectal Cancer (QIRC trial: study protocol of a cluster randomized controlled trial in surgery

    Directory of Open Access Journals (Sweden)

    Thabane Lehana

    2008-02-01

    Full Text Available Abstract Background Two unfortunate outcomes for patients treated surgically for rectal cancer are placement of a permanent colostomy and local tumor recurrence. Total mesorectal excision is a new technique for rectal cancer surgery that can lead to improved patient outcomes. We describe a cluster randomized controlled trial that is testing if the above patient outcomes can be improved through a knowledge translation strategy called the Quality Initiative in Rectal Cancer (QIRC strategy. The strategy is designed to optimize the use of total mesorectal excision techniques. Methods and Design Hospitals were randomized to the QIRC strategy (experimental group versus normal practice environment (control group. Participating hospitals, and the respective surgeon group operating in them, are from Ontario, Canada and have an annual procedure volume for major rectal cancer resections of 15 or greater. Patients were eligible if they underwent major rectal surgery for a diagnosis of primary rectal cancer. The surgeon-directed QIRC interventions included a workshop, use of opinion leaders, operative demonstrations, a post-operative questionnaire, and, audit and feedback. For an operative demonstration participating surgeons invited a study team surgeon to assist them with a case of rectal cancer surgery. The intent was to demonstrate total mesorectal excision techniques. Control arm surgeons received no intervention. Sample size calculations were two-sided, considered the clustering of data at the hospital level, and were driven by requirements for the outcome local recurrence. To detect an improvement in local recurrence from 20% to 8% with confidence we required 16 hospitals and 672 patients – 8 hospitals and 336 patients in each arm. Outcomes data are collected via chart review for at least 30 months after surgery. Analyses will use an intention-to-treat principle and will consider the clustering of data. Data collection will be complete by the end of

  12. Effects of Adding an Internet-Based Pain Coping Skills Training Protocol to a Standardized Education and Exercise Program for People With Persistent Hip Pain (HOPE Trial): Randomized Controlled Trial Protocol.

    Science.gov (United States)

    Bennell, Kim L; Rini, Christine; Keefe, Francis; French, Simon; Nelligan, Rachel; Kasza, Jessica; Forbes, Andrew; Dobson, Fiona; Abbott, J Haxby; Dalwood, Andrew; Vicenzino, Bill; Harris, Anthony; Hinman, Rana S

    2015-10-01

    Persistent hip pain in older people is usually due to hip osteoarthritis (OA), a major cause of pain, disability, and psychological dysfunction. The purpose of this study is to evaluate whether adding an Internet-based pain coping skills training (PCST) protocol to a standardized intervention of education followed by physical therapist-instructed home exercise leads to greater reductions in pain and improvements in function. An assessor-, therapist-, and participant-blinded randomized controlled trial will be conducted. The study will be conducted in a community setting. The participants will be 142 people over 50 years of age with self-reported hip pain consistent with hip OA. Participants will be randomly allocated to: (1) a control group receiving a 24-week standardized intervention comprising an 8-week Internet-based education package followed by 5 individual physical therapy exercise sessions plus home exercises (3 times weekly) or (2) a PCST group receiving an 8-week Internet-based PCST protocol in addition to the control intervention. Outcomes will be measured at baseline and 8, 24, and 52 weeks, with the primary time point at 24 weeks. Primary outcomes are hip pain on walking and self-reported physical function. Secondary outcomes include health-related quality-of-life, participant-perceived treatment response, self-efficacy for pain management and function, pain coping attempts, pain catastrophizing, and physical activity. Measurements of adherence, adverse events, use of health services, and process measures will be collected at 24 and 52 weeks. Cost-effectiveness will be assessed at 52 weeks. A self-reported diagnosis of persistent hip pain will be used. The findings will help determine whether adding an Internet-based PCST protocol to standardized education and physical therapist-instructed home exercise is more effective than education and exercise alone for persistent hip pain. This study has the potential to guide clinical practice toward innovative

  13. Protocol for the atWork trial: a randomised controlled trial of a workplace intervention targeting subjective health complaints

    Directory of Open Access Journals (Sweden)

    Tone Langjordet Johnsen

    2016-08-01

    Full Text Available Abstract Background Subjective health complaints, such as musculoskeletal and mental health complaints, have a high prevalence in the general population, and account for a large proportion of sick leave in Norway. It may be difficult to prevent the occurrence of subjective health complaints, but it may be possible to influence employees’ perception and management of these complaints, which in turn may have impact on sick leave and return to work after sick leave. Long term sick leave has many negative health and social consequences, and it is important to gain knowledge about effective interventions to prevent and reduce long term sick leave. Methods/Design This study is a cluster randomised controlled trial to evaluate the effect of the modified atWork intervention, targeting non-specific musculoskeletal complaints and mental health complaints. This intervention will be compared to the original atWork intervention targeting only non-specific musculoskeletal complaints. Kindergartens in Norway are invited to participate in the study and will be randomly assigned to one of the two interventions. Estimated sample size is 100 kindergartens, with a total of approximately 1100 employees. Primary outcome is sick leave at unit level, measured using register data from the Norwegian Labour and Welfare Administration. One kindergarten equals one unit, regardless of number of employees. Secondary outcomes will be measured at the individual level and include coping, health, job satisfaction, social support, and workplace inclusion, collected through questionnaires distributed at baseline and at 12 months follow up. All employees in the included kindergartens are eligible for participating in the survey. Discussion The effect evaluation of the modified atWork intervention is a large and comprehensive project, providing evidence-based information on prevention of long-term sick leave, which may be of considerable benefit both from a societal

  14. Protocol for the SEED-trial: Supported Employment and preventing Early Disability

    Directory of Open Access Journals (Sweden)

    Vigdis Sveinsdottir

    2016-07-01

    Full Text Available Abstract Background Early withdrawal or exclusion from the labor market leads to significant personal and societal costs. In Norway, the increasing numbers of young adults receiving disability pension is a growing problem. While a large body of research demonstrates positive effects of Supported Employment (SE in patients with severe mental illness, no studies have yet investigated the effectiveness of SE in young adults with a range of social and health conditions who are receiving benefits. Methods/design The SEED-trial is a randomized controlled trial (RCT comparing traditional vocational rehabilitation (TVR to SE in 124 unemployed individuals between the ages of 18-29 who are receiving benefits due to various social- or health-related problems. The primary outcome is labor market participation during the first year after enrollment. Secondary outcomes include physical and mental health, health behaviors, and well-being, collected at baseline, 6, and 12 months. A cost-benefit analysis will also be conducted. Discussion The SEED-trial is the first RCT to compare SE to TVR in this important and vulnerable group, at risk of being excluded from working life at an early age. Trial registration Clinicaltrials.gov, registration number NCT02375074 . Registered on December 3rd 2014

  15. Study Protocol- An exploratory trial on health promoting schools at Dutch secondary schools

    NARCIS (Netherlands)

    Busch, Vincent; Leeuw, Rob J. de; Schrijvers, A.J.P.

    2012-01-01

    Background: Recent studies show adolescent health-related behaviours to co-occur synergistically. This paper describes the study design for an exploratory trial on the effects of a comprehensive, whole-school health promoting school intervention. This intervention tackles seven different behavioural

  16. Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial.

    Science.gov (United States)

    de Rooij, Thijs; van Hilst, Jony; Vogel, Jantien A; van Santvoort, Hjalmar C; de Boer, Marieke T; Boerma, Djamila; van den Boezem, Peter B; Bonsing, Bert A; Bosscha, Koop; Coene, Peter-Paul; Daams, Freek; van Dam, Ronald M; Dijkgraaf, Marcel G; van Eijck, Casper H; Festen, Sebastiaan; Gerhards, Michael F; Groot Koerkamp, Bas; Hagendoorn, Jeroen; van der Harst, Erwin; de Hingh, Ignace H; Dejong, Cees H; Kazemier, Geert; Klaase, Joost; de Kleine, Ruben H; van Laarhoven, Cornelis J; Lips, Daan J; Luyer, Misha D; Molenaar, I Quintus; Nieuwenhuijs, Vincent B; Patijn, Gijs A; Roos, Daphne; Scheepers, Joris J; van der Schelling, George P; Steenvoorde, Pascal; Swijnenburg, Rutger-Jan; Wijsman, Jan H; Abu Hilal, Moh'd; Busch, Olivier R; Besselink, Marc G

    2017-04-08

    Observational cohort studies have suggested that minimally invasive distal pancreatectomy (MIDP) is associated with better short-term outcomes compared with open distal pancreatectomy (ODP), such as less intraoperative blood loss, lower morbidity, shorter length of hospital stay, and reduced total costs. Confounding by indication has probably influenced these findings, given that case-matched studies failed to confirm the superiority of MIDP. This accentuates the need for multicenter randomized controlled trials, which are currently lacking. We hypothesize that time to functional recovery is shorter after MIDP compared with ODP even in an enhanced recovery setting. LEOPARD is a randomized controlled, parallel-group, patient-blinded, multicenter, superiority trial in all 17 centers of the Dutch Pancreatic Cancer Group. A total of 102 patients with symptomatic benign, premalignant or malignant disease will be randomly allocated to undergo MIDP or ODP in an enhanced recovery setting. The primary outcome is time (days) to functional recovery, defined as all of the following: independently mobile at the preoperative level, sufficient pain control with oral medication alone, ability to maintain sufficient (i.e. >50%) daily required caloric intake, no intravenous fluid administration and no signs of infection. Secondary outcomes are operative and postoperative outcomes, including clinically relevant complications, mortality, quality of life and costs. The LEOPARD trial is designed to investigate whether MIDP reduces the time to functional recovery compared with ODP in an enhanced recovery setting. Dutch Trial Register, NTR5188 . Registered on 9 April 2015.

  17. Consensus recommendations for a standardized Brain Tumor Imaging Protocol in clinical trials

    NARCIS (Netherlands)

    B.M. Ellingson (Benjamin M.); M. Bendszus (Martin); J. Boxerman (Jerrold); D. Barboriak (Daniel); B.J. Erickson (Bradley J.); M. Smits (Marion); S.J. Nelson (Sarah J.); E. Gerstner (Elizabeth); B. Alexander (Brian); G. Goldmacher (Gregory); W. Wick (Wolfgang); M.A. Vogelbaum (Michael); M. Weller (Michael); E. Galanis (Evanthia); J. Kalpathy-Cramer (Jayashree); L. Shankar; P. Jacobs (Paula); W.B. Pope (Whitney B.); D. Yang (Dewen); C. Chung (Caroline); R.H. Knopp; S. Cha (Soonme); M.J. van den Bent (Martin); S.M. Chang (Susan); W.K. Al Yung; T.F. Cloughesy (Timothy F.); P.Y. Wen (Patrick Y.); M.R. Gilbert (Mark R.); A. Whitney (Andrew); D. Sandak (David); A. Musella (Al); C. Haynes (Chas); M. Wallace (Max); D.F. Arons (David F.); A. Kingston (Ann)

    2015-01-01

    textabstractA recent joint meeting was held on January 30, 2014, with the US Food and Drug Administration (FDA), National Cancer Institute (NCI), clinical scientists, imaging experts, pharmaceutical and biotech companies, clinical trials cooperative groups, and patient advocate groups to discuss

  18. Organisation and management of the first clinical trial of BNCT in Europe (EORTC Protocol 11961)

    International Nuclear Information System (INIS)

    Sauerwein, W.; Rassow, J.; Hideghety, K.; Sack, H.; Moss, R.; Stecher-Rasmussen, F.; Wolbers, J.G.

    1999-01-01

    Boron Neutron Capture Therapy is based on the ability of the isotope 10 B to capture thermal neutrons and to disintegrate instantaneously producing high LET particles. The only neutron beam available in Europe for such a treatment is based at the European High Flux Reactor HFR at Petten (The Netherlands). The European Commission, owners of the reactor, decided that the potential benefit of the facility should be opened to all European citizens and therefore insisted on a multinational approach to perform the first clinical trial in Europe on BNCT. This precondition had to be respected as well as the national laws and regulations. Together with the Dutch authorities actions were undertaken to overcome the obvious legal problems. Furthermore, the clinical trial at Petten takes place in a nuclear research reactor, which apart from being conducted in a non-hospital environment, is per se known to be dangerous. It was therefore of the utmost importance that special attention is given to safety, beyond normal rules, and to the training of staff. In itself, the trial is an unusual Phase I study, introducing a new drug with a new irradiation modality, with really an unknown dose-effect relationship. This trial must follow optimal procedures, which underscore the quality and qualified manner of performance. (orig.)

  19. Trial protocol: a parallel group, individually randomized clinical trial to evaluate the effect of a mobile phone application to improve sexual health among youth in Stockholm County.

    Science.gov (United States)

    Nielsen, Anna; De Costa, Ayesha; Bågenholm, Aspasia; Danielsson, Kristina Gemzell; Marrone, Gaetano; Boman, Jens; Salazar, Mariano; Diwan, Vinod

    2018-02-05

    Genital Chlamydia trachomatis infection is a major public health problem worldwide affecting mostly youth. Sweden introduced an opportunistic screening approach in 1982 accompanied by treatment, partner notification and case reporting. After an initial decline in infection rate till the mid-90s, the number of reported cases has increased over the last two decades and has now stabilized at a high level of 37,000 reported cases in Sweden per year (85% of cases in youth). Sexual risk-taking among youth is also reported to have significantly increased over the last 20 years. Mobile health (mHealth) interventions could be particularly suitable for youth and sexual health promotion as the intervention is delivered in a familiar and discrete way to a tech savvy at-risk population. This paper presents a protocol for a randomized trial to study the effect of an interactive mHealth application (app) on condom use among the youth of Stockholm. 446 youth resident in Stockholm, will be recruited in this two arm parallel group individually randomized trial. Recruitment will be from Youth Health Clinics or via the trial website. Participants will be randomized to receive either the intervention (which comprises an interactive app on safe sexual health that will be installed on their smart phones) or a control group (standard of care). Youth will be followed up for 6 months, with questionnaire responses submitted periodically via the app. Self-reported condom use over 6 months will be the primary outcome. Secondary outcomes will include presence of an infection, Chlamydia tests during the study period and proxy markers of safe sex. Analysis is by intention to treat. This trial exploits the high mobile phone usage among youth to provide a phone app intervention in the area of sexual health. If successful, the results will have implications for health service delivery and health promotion among the youth. From a methodological perspective, this trial is expected to provide

  20. The synchronized trial on expectant mothers with depressive symptoms by omega-3 PUFAs (SYNCHRO): Study protocol for a randomized controlled trial.

    Science.gov (United States)

    Nishi, Daisuke; Su, Kuan-Pin; Usuda, Kentaro; Chiang, Yi-Ju Jill; Guu, Tai-Wei; Hamazaki, Kei; Nakaya, Naoki; Sone, Toshimasa; Sano, Yo; Tachibana, Yoshiyuki; Ito, Hiroe; Isaka, Keiich; Hashimoto, Kenji; Hamazaki, Tomohito; Matsuoka, Yutaka J

    2016-09-15

    Maternal depression can be harmful to both mothers and their children. Omega-3 polyunsaturated fatty acid (PUFA) supplementation has been investigated as an alternative intervention for pregnant women with depressive symptoms because of the supporting evidence from clinical trials in major depression, the safety advantage, and its anti-inflammatory and neuroplasticity effects. This study examines the efficacy of omega-3 PUFA supplementation for pregnant women with depressive symptoms in Taiwan and Japan, to provide evidence available for Asia. The rationale and protocol of this trial are reported here. The Synchronized Trial on Expectant Mothers with Depressive Symptoms by Omega-3 PUFAs (SYNCHRO) is a multicenter, double-blind, parallel group, randomized controlled trial. Participants will be randomized to either the omega-3 PUFAs arm (1,200 mg eicosapentaenoic acid and 600 mg docosahexaenoic acid daily) or placebo arm. Primary outcome is total score on the Hamilton Rating Scale for Depression (HAMD) at 12 weeks after the start of the intervention. We will randomize 56 participants to have 90 % power to detect a 4.7-point difference in mean HAMD scores with omega-3 PUFAs compared with placebo. Because seafood consumption varies across countries and this may have a major effect on the efficacy of omega-3 PUFA supplementation, 56 participants will be recruited at each site in Taiwan and Japan, for a total number of 112 participants. Secondary outcomes include depressive symptoms at 1 month after childbirth, diagnosis of major depressive disorder, changes in omega-3 PUFAs concentrations and levels of biomarkers at baseline and at 12 weeks' follow-up, and standard obstetric outcomes. Data analyses will be by intention to treat. The trial was started in June 2014 and is scheduled to end in February 2018. The trial is expected to provide evidence that can contribute to promoting mental health among mothers and children in Asian populations. Clinicaltrials.gov: NCT

  1. Home medicines reviews following acute coronary syndrome: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bernal Daniel DL

    2012-04-01

    Full Text Available Abstract Background Despite continual improvements in the management of acute coronary syndromes, adherence to guideline-based medications remains suboptimal. We aim to improve adherence with guideline-based therapy following acute coronary syndrome using an existing service that is provided by specifically trained pharmacists, called a Home Medicines Review. We have made two minor adjustments to target the focus of the existing service including an acute coronary syndrome specific referral letter and a training package for the pharmacists providing the service. Methods/Design We will be conducting a randomized controlled trial to compare the directed home medicines review service to usual care following acute coronary syndromes. All patients aged 18 to 80 years and with a working diagnosis of acute coronary syndrome, who are admitted to two public, acute care hospitals, will be screened for enrolment into the trial. Exclusion criteria will include: not being discharged home, documented cognitive decline, non-Medicare eligibility, and presence of a terminal malignancy. Randomization concealment and sequence generation will occur through a centrally-monitored computer program. Patients randomized to the control group will receive usual post-discharge care. Patients randomized to receive the intervention will be offered usual post-discharge care and a directed home medicines review at two months post-discharge. The study endpoints will be six and twelve months post-discharge. The primary outcome will be the proportion of patients who are adherent to a complete, guideline-based medication regimen. Secondary outcomes will include hospital readmission rates, length of hospital stays, changes in quality of life, smoking cessation rates, cardiac rehabilitation completion rates, and mortality. Discussion As the trial is closely based on an existing service, any improvements observed should be highly translatable into regular practice. Possible

  2. Expectations for Recovery Important in the Prognosis of Whiplash Injuries

    OpenAIRE

    Holm, Lena W; Carroll, Linda J; Cassidy, J. David; Skillgate, Eva; Ahlbom, Anders

    2008-01-01

    Editors' Summary Background The disability associated with injury is a major source of distress for patients, and can be costly to the health care system and employers when persons fail to recover quickly and are unable to return to work. Finding ways to help people recover quickly and get back to optimal health is important. Some of the most common injuries causing disability and time off work result from whiplash?the sudden hyperextension or ?whipping? of the neck, which can occur from a mo...

  3. Whiplash-associated disorders: who gets depressed? Who stays depressed?

    OpenAIRE

    Phillips, Leah A.; Carroll, Linda J.; Cassidy, J. David; Côté, Pierre

    2010-01-01

    Depression is common in whiplash-associated disorders (WAD). Our objectives were to identify factors associated with depressive symptomatology occurring in the initial stages of WAD, and to identify factors predicting the course of depressive symptoms. A population-based cohort of adults sustaining traffic-related WAD was followed at 6 weeks, 3, 6, 9, and 12 months. Baseline measures (assessed a median of 11 days post-crash) included demographic and collision-related factors, prior health, an...

  4. Whiplash Injuries Can be Visible by Functional Magnetic Resonance Imaging

    Directory of Open Access Journals (Sweden)

    Bengt H Johansson

    2006-01-01

    Full Text Available Whiplash trauma can result in injuries that are difficult to diagnose. Diagnosis is particularly difficult in injuries to the upper segments of the cervical spine (craniocervical joint [CCJ] complex. Studies indicate that injuries in that region may be responsible for the cervicoencephalic syndrome, as evidenced by headache, balance problems, vertigo, dizziness, eye problems, tinnitus, poor concentration, sensitivity to light and pronounced fatigue. Consequently, diagnosis of lesions in the CCJ region is important. Functional magnetic resonance imaging is a radiological technique that can visualize injuries of the ligaments and the joint capsules, and accompanying pathological movement patterns.

  5. A prospective study of 39 patients with whiplash injury

    DEFF Research Database (Denmark)

    Karlsborg, M; Smed, A; Jespersen, H

    1997-01-01

    of whiplash injury were examined clinically three times; within 14 days, after 1 month and finally 7 months postinjury. In addition, MRI of the brain and the cervical spine, neuropsychological tests and motor evoked potentials (MEP) were done one month postinjury and repeated after 6 months, if abnormalities...... were found. RESULTS: The total recovery rate (asymptomatic patients) was 29% after 7 months. MRI was repeated in 6 patients. The correlation between MRI and the clinical findings was poor. Cognitive dysfunction as a symptom of brain injury was not found. Stress at the same time predicted more symptoms...

  6. Effectiveness of group reminiscence for improving wellbeing of institutionalized elderly adults: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Gaggioli, Andrea; Scaratti, Chiara; Morganti, Luca; Stramba-Badiale, Marco; Agostoni, Monica; Spatola, Chiara A M; Molinari, Enrico; Cipresso, Pietro; Riva, Giuseppe

    2014-10-25

    Group reminiscence therapy is a brief and structured intervention in which participants share personal past events with peers. This approach has been shown to be promising for improving wellbeing and reducing depressive symptoms among institutionalized older adults. However, despite the considerable interest in reminiscence group therapy, controlled studies to determine its specific benefits as compared to generic social interactions with peers (group conversations about everyday subjects) are still lacking. We have designed a randomized controlled trial aimed at comparing the effects of group reminiscence therapy with those of group recreational activity on the psychological wellbeing of an institutionalized sample of older adults. The study includes two groups of 20 hospitalized elderly participants: the experimental group and the control group. Participants included in the experimental group will receive six sessions of group reminiscence therapy, while the control group will participate in a recreational group discussion. A repeated-measures design will be used post-intervention and three months post-intervention to evaluate changes in self-reported outcome measures of depressive symptoms, self-esteem, life satisfaction, and quality of life from baseline. The protocol of a study aimed at examining the specific effects of group reminiscence therapy on psychological wellbeing, depression, and quality of life among institutionalized elderly people is described. It is expected that the outcomes of this trial will contribute to our knowledge about the process of group reminiscence, evaluate its effectiveness in improving psychological wellbeing of institutionalized individuals, and identify the best conditions for optimizing this approach. This trial was registered with ClinicalTrials.gov (registration number: NCT02077153) on 31 January 2014.

  7. Evaluating the effectiveness of a smartphone app to reduce excessive alcohol consumption: protocol for a factorial randomised control trial

    Directory of Open Access Journals (Sweden)

    Claire Garnett

    2016-07-01

    Full Text Available Abstract Background Excessive alcohol consumption is a leading cause of death and morbidity worldwide and interventions to help people reduce their consumption are needed. Interventions delivered by smartphone apps have the potential to help harmful and hazardous drinkers reduce their consumption of alcohol. However, there has been little evaluation of the effectiveness of existing smartphone interventions. A systematic review, amongst other methodologies, identified promising modular content that could be delivered by an app: self-monitoring and feedback; action planning; normative feedback; cognitive bias re-training; and identity change. This protocol reports a factorial randomised controlled trial to assess the comparative potential of these five intervention modules to reduce excessive alcohol consumption. Methods A between-subject factorial randomised controlled trial. Hazardous and harmful drinkers aged 18 or over who are making a serious attempt to reduce their drinking will be randomised to one of 32 (25 experimental conditions after downloading the ‘Drink Less’ app. Participants complete baseline measures on downloading the app and are contacted after 1-month with a follow-up questionnaire. The primary outcome measure is change in past week consumption of alcohol. Secondary outcome measures are change in AUDIT score, app usage data and usability ratings for the app. A factorial between-subjects ANOVA will be conducted to assess main and interactive effects of the five intervention modules for the primary and secondary outcome measures. Discussion This study will establish the extent to which the five intervention modules offered in this app can help reduce hazardous and harmful drinking. This is the first step in optimising and understanding what component parts of an app could help to reduce excessive alcohol consumption. The findings from this study will be used to inform the content of a future integrated treatment app and

  8. The mPED randomized controlled clinical trial: applying mobile persuasive technologies to increase physical activity in sedentary women protocol

    Directory of Open Access Journals (Sweden)

    Fukuoka Yoshimi

    2011-12-01

    Full Text Available Abstract Background Despite the significant health benefits of regular physical activity, approximately half of American adults, particularly women and minorities, do not meet the current physical activity recommendations. Mobile phone technologies are readily available, easily accessible and may provide a potentially powerful tool for delivering physical activity interventions. However, we need to understand how to effectively apply these mobile technologies to increase and maintain physical activity in physically inactive women. The purpose of this paper is to describe the study design and protocol of the mPED (mobile phone based physical activity education randomized controlled clinical trial that examines the efficacy of a 3-month mobile phone and pedometer based physical activity intervention and compares two different 6-month maintenance interventions. Methods A randomized controlled trial (RCT with three arms; 1 PLUS (3-month mobile phone and pedometer based physical activity intervention and 6-month mobile phone diary maintenance intervention, 2 REGULAR (3-month mobile phone and pedometer based physical activity intervention and 6-month pedometer maintenance intervention, and 3 CONTROL (pedometer only, but no intervention will be conducted. A total of 192 physically inactive women who meet all inclusion criteria and successfully complete a 3-week run-in will be randomized into one of the three groups. The mobile phone serves as a means of delivering the physical activity intervention, setting individualized weekly physical activity goals, and providing self-monitoring (activity diary, immediate feedback and social support. The mobile phone also functions as a tool for communication and real-time data capture. The primary outcome is objectively measured physical activity. Discussion If efficacy of the intervention with a mobile phone is demonstrated, the results of this RCT will be able to provide new insights for current behavioral

  9. Intrathecal Morphine for Laparoscopic Segmental Colonic Resection as Part of an Enhanced Recovery Protocol: A Randomized Controlled Trial.

    Science.gov (United States)

    Koning, Mark V; Teunissen, Aart Jan W; van der Harst, Erwin; Ruijgrok, Elisabeth J; Stolker, Robert Jan

    2018-02-01

    Management of postoperative pain after laparoscopic segmental colonic resections remains controversial. We compared 2 methods of analgesia within an Enhanced Recovery After Surgery (ERAS) program. The goal of the study was to investigate whether administration of intrathecal bupivacaine/morphine would lead to an enhanced recovery. A single-center, randomized, double-blind controlled trial was performed (NL43488.101.13). Patients scheduled for laparoscopic segmental intestinal resections were considered. Exclusion criteria were patients in whom contraindications to spinal anesthesia were present, conversion to open surgery, and gastric and rectal surgery. The intervention group received single-shot intrathecal bupivacaine/morphine (12.5 mg/300 μg), with an altered dose for older patients. The control group received a sham procedure and a bolus of piritramide (0.1 mg/kg). Both groups received standardized general anesthesia and a patient-controlled intravenous analgesia pump as postoperative analgesia. All patients were treated according to an ERAS protocol. A decrease in days to "fit for discharge" was the primary outcome. Fifty-six patients were enrolled. Intervention group patients were fit for discharge earlier (median of 3 vs 4 days, P = 0.044). Furthermore, there was a significant decrease in opioid use and lower pain scores on the first postoperative day in the intervention group. There were no differences in adverse events (except for more pruritus), time to mobilization, fluid administration, or patient satisfaction. This randomized controlled trial shows that intrathecal morphine is a more effective method of postoperative analgesia in laparoscopic surgery than intravenous opioids within an ERAS program. Recovery is faster and less painful with intrathecal morphine. Other studies have confirmed these results, although data on faster recovery are new and require confirmation in future trials. This study was registered at ClinicalTrials.gov, identifier NCT

  10. Protocol for extended antibiotic therapy after laparoscopic cholecystectomy for acute calculous cholecystitis (Cholecystectomy Antibiotic Randomised Trial, CHART).

    Science.gov (United States)

    Pellegrini, Pablo; Campana, Juan Pablo; Dietrich, Agustín; Goransky, Jeremías; Glinka, Juan; Giunta, Diego; Barcan, Laura; Alvarez, Fernando; Mazza, Oscar; Sánchez Claria, Rodrigo; Palavecino, Martin; Arbues, Guillermo; Ardiles, Victoria; de Santibañes, Eduardo; Pekolj, Juan; de Santibañes, Martin

    2015-11-18

    Acute calculous cholecystitis represents one of the most common complications of cholelithiasis. While laparoscopic cholecystectomy is the standard treatment in mild and moderate forms, the need for antibiotic therapy after surgery remains undefined. The aim of the randomised controlled Cholecystectomy Antibiotic Randomised Trial (CHART) is therefore to assess if there are benefits in the use of postoperative antibiotics in patients with mild or moderate acute cholecystitis in whom a laparoscopic cholecystectomy is performed. A single-centre, double-blind, randomised trial. After screening for eligibility and informed consent, 300 patients admitted for acute calculus cholecystitis will be randomised into two groups of treatment, either receiving amoxicillin/clavulanic acid or placebo for 5 consecutive days. Postoperative evaluation will take place during the first 30 days. Postoperative infectious complications are the primary end point. Secondary end points are length of hospital stay, readmissions, need of reintervention (percutaneous or surgical reinterventions) and overall mortality. The results of this trial will provide strong evidence to either support or abandon the use of antibiotics after surgery, impacting directly in the incidence of adverse events associated with the use of antibiotics, the emergence of bacterial resistance and treatment costs. This study and informed consent sheets have been approved by the Research Projects Evaluating Committee (CEPI) of Hospital Italiano de Buenos Aires (protocol N° 2111). The results of the trial will be reported in a peer-reviewed publication. NCT02057679. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  11. The FLASSH study: protocol for a randomised controlled trial evaluating falls prevention after stroke and two sub-studies

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    Mackintosh Shylie F

    2009-03-01

    Full Text Available Abstract Background Falls are common in stroke survivors returning home after rehabilitation, however there is currently a lack of evidence about preventing falls in this population. This paper describes the study protocol for the FLASSH (FaLls prevention After Stroke Survivors return Home project. Methods and design This randomised controlled trial aims to evaluate the effectiveness of a multi-factorial falls prevention program for stroke survivors who are at high risk of falling when they return home after rehabilitation. Intervention will consist of a home exercise program as well as individualised falls prevention and injury minimisation strategies based on identified risk factors for falls. Additionally, two sub-studies will be implemented in order to explore other key areas related to falls in this population. The first of these is a longitudinal study evaluating the relationship between fear of falling, falls and function over twelve months, and the second evaluates residual impairment in gait stability and obstacle crossing twelve months after discharge from rehabilitation. Discussion The results of the FLASSH project will inform falls prevention practice for stroke survivors. If the falls prevention program is shown to be effective, low cost strategies to prevent falls can be implemented for those at risk around the time of discharge from rehabilitation, thus improving safety and quality of life for stroke survivors. The two sub-studies will contribute to the overall understanding and management of falls risk in stroke survivors. Trial registration This trial is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN012607000398404.

  12. The effect of Baduanjin exercise for physical and psychological wellbeing of college students: study protocol for a randomized controlled trial.

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    Zheng, Guohua; Li, Moyi; Lan, Xiulu; Yan, Xinghui; Lin, Qiu; Chen, Lidian; Tao, Jing; Zheng, Xin; Li, Junzhe; Chen, Bai; Fang, Qianying

    2013-12-05

    The physical and mental health of college students tends to continuously decline around the world. Since they are in a significant transition period which presents opportunities and challenges in health promotion, it is important to improve their health in this period. As a traditional Chinese exercise form which combines movements with breath and mind, Baduanjin may be one of the selectable effective exercises. However, evidence of Baduanjin exercise for college students has not been completely established. The primary aim of this trial is to evaluate the effectiveness and safety of Baduanjin exercise for physical and mental health of college students through a rigorous randomization, parallel-controlled design. We will conduct a randomized, single-blind, parallel-controlled trial. A total of 222 college students from Fujian University of Traditional Chinese Medicine who meet the eligibility criteria will be recruited and randomly allocated into Baduanjin training or usual exercise control group. Baduanjin training will last 12 weeks (1 h per day, 5 days per week). The physical and psychological outcomes, including lumbar muscle strength, lumbar proprioception function, physical fitness, as well as self-reported symptom intensity, stress, self-esteem, mood, quality of life, quality of sleep, and adverse events, will be evaluated by blinded outcome assessors at baseline, 13 weeks (at the end of intervention), and 25 weeks (after the 12-week follow-up period). This protocol presents an objective design of a randomized, single-blind trial that aims to evaluate the effectiveness and safety of Baduanjin exercise for physical and mental health of college students. If the outcome is positive, the results will provide higher-quality evidence to better inform the college students regarding their selection about whether to receive such exercise. Chinese Clinical Trial Registry: ChiCTR-TRC-13003329. Registration date: 18 July, 2013.

  13. Music in mind, a randomized controlled trial of music therapy for young people with behavioural and emotional problems: study protocol.

    Science.gov (United States)

    Porter, Sam; Holmes, Valerie; McLaughlin, Katrina; Lynn, Fiona; Cardwell, Chris; Braiden, Hannah-Jane; Doran, Jackie; Rogan, Sheelagh

    2012-10-01

    This article is a report of a trial protocol to determine if improvizational music therapy leads to clinically significant improvement in communication and interaction skills for young people experiencing social, emotional or behavioural problems. Music therapy is often considered an effective intervention for young people experiencing social, emotional or behavioural difficulties. However, this assumption lacks empirical evidence. Music in mind is a multi-centred single-blind randomized controlled trial involving 200 young people (aged 8-16 years) and their parents. Eligible participants will have a working diagnosis within the ambit of international classification of disease 10 mental and behavioural disorders and will be recruited over 15 months from six centres within the Child and Adolescent Mental Health Services of a large health and social care trust in Northern Ireland. Participants will be randomly allocated in a 1:1 ratio to receive standard care alone or standard care plus 12 weekly music therapy sessions delivered by the Northern Ireland Music Therapy Trust. Baseline data will be collected from young people and their parents using standardized outcome measures for communicative and interaction skills (primary endpoint), self-esteem, social functioning, depression and family functioning. Follow-up data will be collected 1 and 13 weeks after the final music therapy session. A cost-effectiveness analysis will also be carried out. This study will be the largest trial to date examining the effect of music therapy on young people experiencing social, emotional or behavioural difficulties and will provide empirical evidence for the use of music therapy among this population. Trial registration. This study is registered in the ISRCTN Register, ISRCTN96352204. Ethical approval was gained in October 2010. © 2012 Blackwell Publishing Ltd.

  14. Behavioral counseling to prevent childhood obesity – study protocol of a pragmatic trial in maternity and child health care

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    Mustila Taina

    2012-07-01

    Full Text Available Abstract Background Prevention is considered effective in combating the obesity epidemic. Prenatal environment may increase offspring's risk for obesity. A child starts to adopt food preferences and other behavioral habits affecting weight gain during preschool years. We report the study protocol of a pragmatic lifestyle intervention aiming at primary prevention of childhood obesity. Methods/Design A non-randomized controlled pragmatic trial in maternity and child health care clinics. The control group was recruited among families who visited the same clinics one year earlier. Eligibility criteria was mother at risk for gestational diabetes: body mass index ≥ 25 kg/m2, macrosomic newborn in any previous pregnancy, immediate family history of diabetes and/or age ≥ 40 years. All maternity clinics in town involved in recruitment. The gestational intervention consisted of individual counseling on diet and physical activity by a public health nurse, and of two group counseling sessions. Intervention continues until offspring’s age of five years. An option to participate a group counseling at child’s age 1 to 2 years was offered. The intervention includes advice on healthy diet, physical activity, sedentary behavior and sleeping pattern. The main outcome measure is offspring BMI z-score and its changes by the age of six years. Discussion Early childhood is a critical time period for prevention of obesity. Pragmatic trials targeting this period are necessary in order to find effective obesity prevention programs feasible in normal health care practice. Trial registration Clinical Trials gov NCT00970710

  15. Electroacupuncture for postoperative pain and gastrointestinal motility after laparoscopic appendectomy (AcuLap): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Kim, Gangmi

    2015-10-14

    Acupuncture is a widely serviced complementary medicine. Although acupuncture is suggested for managing postoperative ileus and pain, supporting evidence is weak. The AcuLap trial is designed to provide high-level evidence regarding whether or not electroacupuncture is effective in promoting gastrointestinal motility and controlling pain after laparoscopic surgery. This study is a prospective randomized controlled trial with a three-arm, parallel-group structure evaluating the efficacy of electroacupuncture for gastrointestinal motility and postoperative pain after laparoscopic appendectomy. Patients with appendicitis undergoing laparoscopic surgery are included and randomized into three groups: 1) electroacupuncture group, 2) sham acupuncture group, and 3) control group. Patients receive 1) acupuncture with electrostimulation or 2) fake electroacupuncture with sham device twice a day or 3) no acupuncture after laparoscopic appendectomy. The primary outcome is time to first passing flatus after operation. Secondary outcomes include postoperative pain, analgesics, nausea/vomiting, bowel motility, time to tolerable diet, complications, hospital stay, readmission rates, time to recovery, quality of life, medical costs, and protocol failure rate. Patients and hospital staff (physicians and nurses) are blinded to which group the patient is assigned, electroacupuncture or sham acupuncture. Data analysis personnel are blinded to group assignment among all three groups. Estimated sample size to detect a minimum difference of time to first flatus with 80 % power, 5 % significance, and 10 % drop rate is 29 × 3 groups = 87 patients. Analysis will be performed according to the intention-to-treat principle. The AcuLap trial will provide evidence on the merits and/or demerits of electroacupuncture for bowel motility recovery and pain relief after laparoscopic appendectomy. The trial was registered in Clinical Research Information Service (CRiS), Republic of Korea ( KCT0001486

  16. Study protocol: a randomised controlled trial of a theory-based online intervention to improve sun safety among Australian adults

    International Nuclear Information System (INIS)

    Cleary, Cathy M; White, Katherine M; Young, Ross McD; Hawkes, Anna L; Leske, Stuart; Starfelt, Louise C; Wihardjo, Kylie

    2014-01-01

    The effects of exposure to ultraviolet radiation are a significant concern in Australia which has one of the highest incidences of skin cancer in the world. Despite most skin cancers being preventable by encouraging consistent adoption of sun-protective behaviours, incidence rates are not decreasing. There is a dearth of research examining the factors involved in engaging in sun-protective behaviours. Further, online multi-behavioural theory-based interventions have yet to be explored fully as a medium for improving sun-protective behaviour in adults. This paper presents the study protocol of a randomised controlled trial of an online intervention based on the Theory of Planned Behaviour (TPB) that aims to improve sun safety among Australian adults. Approximately 420 adults aged 18 and over and predominantly from Queensland, Australia, will be recruited and randomised to the intervention (n = 200), information only (n = 200) or the control group (n = 20). The intervention focuses on encouraging supportive attitudes and beliefs toward sun-protective behaviour, fostering perceptions of normative support for sun protection, and increasing perceptions of control/self-efficacy over sun protection. The intervention will be delivered online over a single session. Data will be collected immediately prior to the intervention (Time 1), immediately following the intervention (Time 1b), and one week (Time 2) and one month (Time 3) post-intervention. Primary outcomes are intentions to sun protect and sun-protective behaviour. Secondary outcomes are the participants’ attitudes toward sun protection, perceptions of normative support for sun protection (i.e. subjective norms, group norms, personal norms and image norms) and perceptions of control/self-efficacy toward sun protection. The study will contribute to an understanding of the effectiveness of a TPB-based online intervention to improve Australian adults’ sun-protective behaviour. Australian and New Zealand Trials

  17. Improving the quality of depression and pain care in multiple sclerosis using collaborative care: The MS-care trial protocol.

    Science.gov (United States)

    Ehde, Dawn M; Alschuler, Kevin N; Sullivan, Mark D; Molton, Ivan P; Ciol, Marcia A; Bombardier, Charles H; Curran, Mary C; Gertz, Kevin J; Wundes, Annette; Fann, Jesse R

    2018-01-01

    Evidence-based pharmacological and behavioral interventions are often underutilized or inaccessible to persons with multiple sclerosis (MS) who have chronic pain and/or depression. Collaborative care is an evidence-based patient-centered, integrated, system-level approach to improving the quality and outcomes of depression care. We describe the development of and randomized controlled trial testing a novel intervention, MS Care, which uses a collaborative care model to improve the care of depression and chronic pain in a MS specialty care setting. We describe a 16-week randomized controlled trial comparing the MS Care collaborative care intervention to usual care in an outpatient MS specialty center. Eligible participants with chronic pain of at least moderate intensity (≥3/10) and/or major depressive disorder are randomly assigned to MS Care or usual care. MS Care utilizes a care manager to implement and coordinate guideline-based medical and behavioral treatments with the patient, clinic providers, and pain/depression treatment experts. We will compare outcomes at post-treatment and 6-month follow up. We hypothesize that participants randomly assigned to MS Care will demonstrate significantly greater control of both pain and depression at post-treatment (primary endpoint) relative to those assigned to usual care. Secondary analyses will examine quality of care, patient satisfaction, adherence to MS care, and quality of life. Study findings will aid patients, clinicians, healthcare system leaders, and policy makers in making decisions about effective care for pain and depression in MS healthcare systems. (PCORI- IH-1304-6379; clinicaltrials.gov: NCT02137044). This trial is registered at ClinicalTrials.gov, protocol NCT02137044. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. Trial protocol OPPTIMUM– Does progesterone prophylaxis for the prevention of preterm labour improve outcome?

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    Norman Jane E

    2012-08-01

    Full Text Available Abstract Background Preterm birth is a global problem, with a prevalence of 8 to 12% depending on location. Several large trials and systematic reviews have shown progestogens to be effective in preventing or delaying preterm birth in selected high risk women with a singleton pregnancy (including those with a short cervix or previous preterm birth. Although an improvement in short term neonatal outcomes has been shown in some trials these have not consistently been confirmed in meta-analyses. Additionally data on longer term outcomes is limited to a single trial where no difference in outcomes was demonstrated at four years of age of the child, despite those in the “progesterone” group having a lower incidence of preterm birth. Methods/Design The OPPTIMUM study is a double blind randomized placebo controlled trial to determine whether progesterone prophylaxis to prevent preterm birth has long term neonatal or infant benefit. Specifically it will study whether, in women with singleton pregnancy and at high risk of preterm labour, prophylactic vaginal natural progesterone, 200 mg daily from 22 – 34 weeks gestation, compared to placebo, improves obstetric outcome by lengthening pregnancy thus reducing the incidence of preterm delivery (before 34 weeks, improves neonatal outcome by reducing a composite of death and major morbidity, and leads to improved childhood cognitive and neurosensory outcomes at two years of age. Recruitment began in 2009 and is scheduled to close in Spring 2013. As of May 2012, over 800 women had been randomized in 60 sites. Discussion OPPTIMUM will provide further evidence on the effectiveness of vaginal progesterone for prevention of preterm birth and improvement of neonatal outcomes in selected groups of women with singleton pregnancy at high risk of preterm birth. Additionally it will determine whether any reduction in the incidence of preterm birth is accompanied by improved childhood outcome. Trial

  19. Parent-focused treatment for adolescent anorexia nervosa: a study protocol of a randomised controlled trial.

    Science.gov (United States)

    Hughes, Elizabeth K; Le Grange, Daniel; Court, Andrew; Yeo, Michele S M; Campbell, Stephanie; Allan, Erica; Crosby, Ross D; Loeb, Katharine L; Sawyer, Susan M

    2014-04-08

    Family-based treatment is an efficacious outpatient intervention for medically stable adolescents with anorexia nervosa. Previous research suggests family-based treatment may be more effective for some families when parents and adolescents attend separate therapy sessions compared to conjoint sessions. Our service developed a novel separated model of family-based treatment, parent-focused treatment, and is undertaking a randomised controlled trial to compare parent-focused treatment to conjoint family-based treatment. This randomised controlled trial will recruit 100 adolescents aged 12-18 years with DSM-IV anorexia nervosa or eating disorder not otherwise specified (anorexia nervosa type). The trial commenced in 2010 and is expected to be completed in 2015. Participants are recruited from the Royal Children's Hospital Eating Disorders Program, Melbourne, Australia. Following a multidisciplinary intake assessment, eligible families who provide written informed consent are randomly allocated to either parent-focused treatment or conjoint family-based treatment. In parent-focused treatment, the adolescent sees a clinical nurse consultant and the parents see a trained mental health clinician. In conjoint family-based treatment, the whole family attends sessions with the mental health clinician. Both groups receive 18 treatment sessions over 6 months and regular medical monitoring by a paediatrician. The primary outcome is remission at end of treatment and 6 and 12 month follow up, with remission defined as being ≥ 95% expected body weight and having an eating disorder symptom score within one standard deviation of community norms. The secondary outcomes include partial remission and changes in eating pathology, depressive symptoms and self-esteem. Moderating and mediating factors will also be explored. This will be first randomised controlled trial of a parent-focused model of family-based treatment of adolescent anorexia nervosa. If found to be efficacious, parent

  20. Physiotherapy Rehabilitation for Osteoporotic Vertebral Fracture (PROVE): study protocol for a randomised controlled trial

    Science.gov (United States)

    2014-01-01

    Background Osteoporosis and vertebral fracture can have a considerable impact on an individual’s quality of life. There is increasing evidence that physiotherapy including manual techniques and exercise interventions may have an important treatment role. This pragmatic randomised controlled trial will investigate the clinical and cost-effectiveness of two different physiotherapy approaches for people with osteoporosis and vertebral fracture, in comparison to usual care. Methods/Design Six hundred people with osteoporosis and a clinically diagnosed vertebral fracture will be recruited and randomly allocated to one of three management strategies, usual care (control - A), an exercise-based physiotherapy intervention (B) or a manual therapy-based physiotherapy intervention (C). Those in the usual care arm will receive a single session of education and advice, those in the active treatment arms (B + C) will be offered seven individual physiotherapy sessions over 12 weeks. The trial is designed as a prospective, adaptive single-blinded randomised controlled trial. An interim analysis will be completed and if one intervention is clearly superior the trial will be adapted at this point to continue with just one intervention and the control. The primary outcomes are quality of life measured by the disease specific QUALLEFO 41 and the Timed Loaded Standing test measured at 1 year. Discussion There are a variety of different physiotherapy packages used to treat patients with osteoporotic vertebral fracture. At present, the indication for each different therapy is not well defined, and the effectiveness of different modalities is unknown. Trial registration Reference number ISRCTN49117867. PMID:24422876

  1. A protocol for a trial of homeopathic treatment for irritable bowel syndrome

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    Peckham Emily J

    2012-11-01

    Full Text Available Abstract Background Irritable bowel syndrome is a chronic condition with no known cure. Many sufferers seek complementary and alternative medicine including homeopathic treatment. However there is much controversy as to the effectiveness of homeopathic treatment. This three-armed study seeks to explore the effectiveness of individualised homeopathic treatment plus usual care compared to both an attention control plus usual care and usual care alone, for patients with irritable bowel syndrome. Methods/design This is a three-armed pragmatic randomised controlled trial using the cohort multiple randomised trial methodology. Patients are recruited to an irritable bowel syndrome cohort from primary and secondary care using GP databases and consultants lists respectively. From this cohort patients are randomly selected to be offered, 5 sessions of homeopathic treatment plus usual care, 5 sessions of supportive listening plus usual care or usual care alone. The primary clinical outcome is the Irritable Bowel Syndrome Symptom Severity at 26 weeks. From a power calculation, it is estimated that 33 people will be needed for the homeopathic treatment arm and 132 for the usual care arm, to detect a minimal clinical difference at 80 percent power and 5 percent significance allowing for loss to follow up. An unequal group size has been used for reasons of cost. Analysis will be by intention to treat and will compare homeopathic treatment with usual care at 26 weeks as the primary analysis, and homeopathic treatment with supportive listening as an additional analysis. Discussion This trial has received NHS approval and results are expected in 2013. Trial registration Current Controlled Trials ISRCTN90651143

  2. Cognitive behavioral therapy for insomnia in euthymic bipolar disorder: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Steinan, Mette Kvisten; Krane-Gartiser, Karoline; Langsrud, Knut; Sand, Trond; Kallestad, Håvard; Morken, Gunnar

    2014-01-16

    Patients with bipolar disorder experience sleep disturbance, even in euthymic phases. Changes in sleep pattern are frequent signs of a new episode of (hypo)mania or depression. Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for primary insomnia, but there are no published results on the effects of CBT-I in patients with bipolar disorder. In this randomized controlled trial, we wish to compare CBT-I and treatment as usual with treatment as usual alone to determine its effect in improving quality of sleep, stabilizing minor mood variations and preventing new mood episodes in euthymic patients with bipolar disorder and comorbid insomnia. Patients with euthymic bipolar I or II disorder and insomnia, as verified by the Structured Clinical Interview for DSM Disorders (SCID-1) assessment, will be included. The patients enter a three-week run-in phase in which they complete a sleep diary and a mood diary, are monitored for seven consecutive days with an actigraph and on two of these nights with polysomnography in addition before randomization to an eight-week treatment trial. Treatment as usual consists of pharmacological and supportive psychosocial treatment. In this trial, CBT-I will consist of sleep restriction, psychoeducation about sleep, stabilization of the circadian rhythm, and challenging and correcting sleep state misperception, in three to eight sessions. This trial could document a new treatment for insomnia in bipolar disorder with possible effects on sleep and on stability of mood. In addition, more precise information can be obtained about the character of sleep disturbance in bipolar disorder. ClinicalTrials.gov: NCT01704352.

  3. Internet treatment for social anxiety disorder in Romania: study protocol for a randomized controlled trial

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    Tulbure Bogdan Tudor

    2012-10-01

    Full Text Available Abstract Background Social anxiety disorder (SAD is one of the most common anxiety disorders and is associated with marked impairments. However, a small proportion of individuals with SAD seek and receive treatment. Internet-administrated cognitive behavior therapy (iCBT has been found to be an effective treatment for SAD. This trial will be the first Internet-delivered guided self-help intervention for SAD in Romania. Methods Participants with social anxiety disorder (N = 96 will be recruited via newspapers, online banners and Facebook. Participants will be randomized to either: a an active treatment, or b a waiting list control group. The treatment will have a guided iCBT format and will last for nine weeks. Self-report questionnaires on social phobia, anxiety, depression, treatment credibility and irrational thinking will be used. All assessments will be collected pre, post and at follow-up (six months after intervention. Liebowitz Social Anxiety Scale – Self-Report version (LSAS-SR will be the primary outcome measure and will be administrated on a weekly basis in both conditions. Discussion The present randomized controlled trial investigates the efficacy of an Internet-administered intervention in reducing social anxiety symptoms in a culture where this form of treatment has not been tested. This trial will add to the body of knowledge on the efficacy of iCBT, and the results might lead to an increase of the accessibility of evidence-based psychological treatment in Romania. Trial registration ClinicalTrials.gov: NCT01557894

  4. The CRASH trial protocol (Corticosteroid randomisation after significant head injury [ISRCTN74459797

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    2001-06-01

    Full Text Available Abstract Background Worldwide, millions of people are treated each year for significant head injury. A substantial proportion die, and many more are disabled. If short term corticosteroid infusion could be reliably shown to reduce these risks by just a few percent then this might affect the treatment of a few hundred thousand patients a year, protecting thousands from death or long term disability. Study design CRASH is a large simple, placebo-controlled trial of the effects of a 48-hour infusion of corticosteroids on death and on neurological disability, among adults with head injury and some impairment of consciousness. Head injured patients with impaired consciousness who are judged to be 16 years or older are eligible if the responsible doctor is, for any reason, substantially uncertain whether or not to use corticosteroids. Organisation The CRASH trial will determine reliably the effects on death and disability of a short corticosteroid infusion following significant head injury. To detect or refute improvements of only a few percent in outcome, many thousands of acute head injury patients must be randomised between control and steroid infusions. Such large numbers will be possible only if hundreds of doctors and nurses can collaborate in the participating emergency departments. Since they are busy, and working in emergency situations, the trial involves them in almost no extra work: no special investigations or changes to usual management are required, and data collection is absolutely minimal. The trial is on-going and new collaborators are welcome. Further information about the trial is available at http://www.crash.lshtm.ac.uk

  5. Effects of acupuncture treatment on depression insomnia: a study protocol of a multicenter randomized controlled trial

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    Chen Yuan-Fang

    2013-01-01

    Full Text Available Abstract Background More than 70% of patients with depression who see their doctors experience insomnia. Insomnia treatment is a very important link for depression treatment. Furthermore, antidepression treatment is also important for depression insomnia. In acupuncture, LU-7 (Lie Que and KID-6 (Zhao Hai, which are two of the eight confluence points in meridian theory, are used as main points. An embedded needle technique is used, alternately, at two groups of points to consolidate the treatment effect. These two groups of points are BL-15 (Xin Shu with BL-23 (Shen Shu and BL-19 (Dan Shu with N-HN-54 (An Mian. The effectiveness of these optimized acupuncture formulas is well proven in the practice by our senior acupuncturists in Guangdong Provincial Hospital of TCM. This study has been designed to examine whether this set of optimized clinical formulas is able to increase the clinical efficacy of depression insomnia treatment. Methods/design In this randomized controlled multicenter trial, all the eligible participants are diagnosed with depression insomnia. All participants are randomly assigned to one of two groups in a ratio of 1:1 and receive either conventional acupuncture treatment or optimized acupuncture treatment. Patients are evaluated using the Pittsburgh Sleep Quality Index(PSQIand the Hamilton rating scale(HAMD for depression. The use of antidepression and hypnotics drugs is also considered. Results are obtained at the start of treatment, 1 and 2 months after treatment has begun, and at the end of treatment. The entire duration of the study will be approximately 36 months. Discussion A high quality of trial methodologies is utilized in the study, and the results may provide better evidence for the effectiveness of acupuncture as a treatment for depression insomnia. The optimized acupuncture formula has potential benefits in increasing the efficacy of treating depression insomnia. Trial registration The trial was registered in

  6. Effectiveness of proactive telephone counselling for smoking cessation in parents: Study protocol of a randomized controlled trial

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    Bricker Jonathan B

    2011-09-01

    Full Text Available Abstract Background Smoking is the world's fourth most common risk factor for disease, the leading preventable cause of death, and it is associated with tremendous social costs. In the Netherlands, the smoking prevalence rate is high. A total of 27.7% of the population over age 15 years smokes. In addition to the direct advantages of smoking cessation for the smoker, parents who quit smoking may also decrease their children's risk of smoking initiation. Methods/Design A randomized controlled trial will be conducted to evaluate the effectiveness of proactive telephone counselling to increase smoking cessation rates among smoking parents. A total of 512 smoking parents will be proactively recruited through their children's primary schools and randomly assigned to either proactive telephone counselling or a control condition. Proactive telephone counselling will consist of up to seven counsellor-initiated telephone calls (based on cognitive-behavioural skill building and Motivational Interviewing, distributed over a period of three months. Three supplementary brochures will also be provided. In the control condition, parents will receive a standard brochure to aid smoking cessation. Assessments will take place at baseline, three months after start of the intervention (post-measurement, and twelve months after start of the intervention (follow-up measurement. Primary outcome measures will include sustained abstinence between post-measurement and follow-up measurement and 7-day point prevalence abstinence and 24-hours point prevalence abstinence at both post- and follow-up measurement. Several secondary outcome measures will also be included (e.g., smoking intensity, smoking policies at home. In addition, we will evaluate smoking-related cognitions (e.g., attitudes towards smoking, social norms, self-efficacy, intention to smoke in 9-12 year old children of smoking parents. Discussion This study protocol describes the design of a randomized

  7. A mindfulness-based stress prevention training for medical students (MediMind): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Kuhlmann, Sophie Merle; Bürger, Arne; Esser, Günter; Hammerle, Florian

    2015-02-08

    Medical training is very demanding and associated with a high prevalence of psychological distress. Compared to the general population, medical students are at a greater risk of developing a psychological disorder. Various attempts of stress management training in medical school have achieved positive results on minimizing psychological distress; however, there are often limitations. Therefore, the use of a rigorous scientific method is needed. The present study protocol describes a randomized controlled trial to examine the effectiveness of a specifically developed mindfulness-based stress prevention training for medical students that includes selected elements of cognitive behavioral strategies (MediMind). This study protocol presents a prospective randomized controlled trial, involving four assessment time points: baseline, post-intervention, one-year follow-up and five-year follow-up. The aims include evaluating the effect on stress, coping, psychological morbidity and personality traits with validated measures. Participants are allocated randomly to one of three conditions: MediMind, Autogenic Training or control group. Eligible participants are medical or dental students in the second or eighth semester of a German university. They form a population of approximately 420 students in each academic term. A final total sample size of 126 (at five-year follow-up) is targeted. The trainings (MediMind and Autogenic Training) comprise five weekly sessions lasting 90 minutes each. MediMind will be offered to participants of the control group once the five-year follow-up is completed. The allotment is randomized with a stratified allocation ratio by course of studies, semester, and gender. After descriptive statistics have been evaluated, inferential statistical analysis will be carried out with a repeated measures ANOVA-design with interactions between time and group. Effect sizes will be calculated using partial η-square values. Potential limitations of this study

  8. A randomized controlled clinical trial evaluating quality of life when using a simple acupressure protocol in women with primary dysmenorrhea.

    Science.gov (United States)

    Bazarganipour, Fatemeh; Taghavi, Seyed-Abdolvahab; Allan, Helen; Hosseini, Nazafarin; Khosravi, Ahmad; Asadi, Rahimeh; Salari, Shohreh; Dehghani, Raziyeh; Jamshidi, Zahra; Rezaei, Marziyeh; Saberian, Mansoreh; Javedan, Fatemeh; Salari, Zahra; Miri, Fahimeh

    2017-10-01

    To evaluate a simple acupressure protocol in LIV3 and LI4 acupoints in women with primary dysmenorrhea. This paper reports a randomized, single blinded clinical trial. 90 young women with dysmenorrhea were recruited to three groups to receive 20min acupressure every day in either LIV3 or LI4, or placebo points. Acupressure was timed five days before menstruation for three successive menstrual cycles. On menstruation, each participant completed the Wong Baker faces pain scale, and the quality of life short form -12 (QOL SF-12). Intensity and duration of pain between the three groups in the second and third cycles during the intervention (pdysmenorrhea, and improve the QOL. Registration ID in IRCT: IRCT2016052428038N1. Copyright © 2017. Published by Elsevier Ltd.

  9. A clinical trial protocol for second line treatment of malignant brain tumors with BNCT at University of Tsukuba

    Energy Technology Data Exchange (ETDEWEB)

    Aiyama, H. [Department of Neurosurgery, Graduate School of Comprehensive Human Science, University of Tsukuba, 1-1-1 Tennodai, Tsukuba (Japan); Nakai, K., E-mail: knakai@Neurosurg-tsukuba.com [Department of Neurosurgery, Graduate School of Comprehensive Human Science, University of Tsukuba, 1-1-1 Tennodai, Tsukuba (Japan); Yamamoto, T. [Department of Neurosurgery, Graduate School of Comprehensive Human Science, University of Tsukuba, 1-1-1 Tennodai, Tsukuba (Japan)] [Department of Radiation Oncology, Graduate School of Comprehensive Human Science, University of Tsukuba, 1-1-1 Tennodai, Tsukuba (Japan); Nariai, T. [Department of Neurosurgery, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyouku (Japan); Kumada, H. [Department of Radiation Oncology, Graduate School of Comprehensive Human Science, University of Tsukuba, 1-1-1 Tennodai, Tsukuba (Japan); Ishikawa, E. [Department of Neurosurgery, Graduate School of Comprehensive Human Science, University of Tsukuba, 1-1-1 Tennodai, Tsukuba (Japan); Isobe, T. [Department of Radiation Oncology, Graduate School of Comprehensive Human Science, University of Tsukuba, 1-1-1 Tennodai, Tsukuba (Japan); Endo, K.; Takada, T.; Yoshida, F.; Shibata, Y.; Matsumura, A. [Department of Neurosurgery, Graduate School of Comprehensive Human Science, University of Tsukuba, 1-1-1 Tennodai, Tsukuba (Japan)

    2011-12-15

    We have evaluated the efficacy and safety of boron neutron capture therapy (BNCT) for recurrent glioma and malignant brain tumor using a new protocol. One of the two patients enrolled in this trial is a man with recurrent glioblastoma and the other is a woman with anaplastic meningioma. Both are still alive and no severe adverse events have been observed. Our findings suggest that NCT will be safe as a palliative therapy for malignant brain tumors. - Highlights: Black-Right-Pointing-Pointer Boron neutron capture therapy (BNCT) for recurrent glioma and malignant brain tumor. Black-Right-Pointing-Pointer Two cases with recurrent glioblastoma and anaplastic meningioma. Black-Right-Pointing-Pointer No severe adverse events have been observed using BNCT. Black-Right-Pointing-Pointer BNCT has a possibility of a safe palliative therapy for malignant brain tumors.

  10. A clinical trial protocol for second line treatment of malignant brain tumors with BNCT at University of Tsukuba

    International Nuclear Information System (INIS)

    Aiyama, H.; Nakai, K.; Yamamoto, T.; Nariai, T.; Kumada, H.; Ishikawa, E.; Isobe, T.; Endo, K.; Takada, T.; Yoshida, F.; Shibata, Y.; Matsumura, A.

    2011-01-01

    We have evaluated the efficacy and safety of boron neutron capture therapy (BNCT) for recurrent glioma and malignant brain tumor using a new protocol. One of the two patients enrolled in this trial is a man with recurrent glioblastoma and the other is a woman with anaplastic meningioma. Both are still alive and no severe adverse events have been observed. Our findings suggest that NCT will be safe as a palliative therapy for malignant brain tumors. - Highlights: ► Boron neutron capture therapy (BNCT) for recurrent glioma and malignant brain tumor. ► Two cases with recurrent glioblastoma and anaplastic meningioma. ► No severe adverse events have been observed using BNCT. ► BNCT has a possibility of a safe palliative therapy for malignant brain tumors.

  11. Efficacy of Mobile Serious Games in Increasing HIV Risk Perception in Swaziland: A Randomized Control Trial (SGprev Trial) Research Protocol

    Science.gov (United States)

    Musumari, Patou; El-Saaidi, Christina; Techasrivichien, Teeranee; Suguimoto, S. Pilar; Ono Kihara, Masako; Kihara, Masahiro

    2016-01-01

    Background The human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) continue to be a major public health problem in Sub-Saharan Africa (SSA), particularly in Swaziland, which has the highest HIV prevalence in this region. A wide range of strategies and interventions have been used to promote behavior change, though almost all such interventions have involved mass media. Therefore, innovative behavior change strategies beyond mass media communication are urgently needed. Serious games have demonstrated effectiveness in advancing health in the developed world; however, no rigorous serious games interventions have been implemented in HIV prevention in SSA. Objective We plan to test whether a serious game intervention delivered on mobile phones to increase HIV risk perception, increase intention to reduce sexual partnerships, and increase intention to know own and partners HIV status will be more effective compared with current prevention efforts. Methods This is a two-arm randomized intervention trial. We will recruit 380 participants who meet the following eligibility criteria: 18-29 years of age, own a smartphone running an Android-based operating system, have the WhatsApp messaging app, live in Swaziland, and can adequately grant informed consent. Participants will be allocated into a smartphone interactive, educational story game, and a wait-list control group in a 1:1 allocation ratio. Subsequently, a self-administered Web-based questionnaire will be issued at baseline and after 4 weeks of exposure to the game. We hypothesize that the change in HIV risk perception between pre- and post-intervention assessment is greater in the intervention group compared with the change in the control group. Our primary hypothesis is based on the assumption that increased perceived risk of HIV provides cues to engage in protective behavior. Our primary outcome measure is HIV risk perceived mean change between pre- and post-intervention compared with

  12. Effectiveness of a Nintendo Wii balance board exercise programme on standing balance of children with cerebral palsy: A randomised clinical trial protocol

    OpenAIRE

    Valeska Gatica-Rojas; Ricardo Cartes-Velásquez; Eduardo Guzmán-Muñoz; Guillermo Méndez-Rebolledo; Alex Soto-Poblete; Ana Carolina Pacheco-Espinoza; Carlos Amigo-Mendoza; M. Eliana Albornoz-Verdugo; Edith Elgueta-Cancino

    2017-01-01

    Background: Patients with cerebral palsy (CP) typically receive limited physical therapy services. However, the Nintendo Wii system offers a simple and affordable mode of virtual reality therapy. There are no clinical trials assessing the Nintendo Wii balance board for improving standing balance in CP. Methods: This randomised clinical trial will evaluate the effectiveness of an 18-session/six-week protocol using Wii therapy (W-t) compared with conventional therapy (C-t) in Chilean CP pati...

  13. Can integrating the Memory Support Intervention into cognitive therapy improve depression outcome? Study protocol for a randomized controlled trial.

    Science.gov (United States)

    Harvey, Allison G; Dong, Lu; Lee, Jason Y; Gumport, Nicole B; Hollon, Steven D; Rabe-Hesketh, Sophia; Hein, Kerrie; Haman, Kirsten; McNamara, Mary E; Weaver, Claire; Martinez, Armando; Notsu, Haruka; Zieve, Garret; Armstrong, Courtney C

    2017-11-14

    The Memory Support Intervention was developed in response to evidence showing that: (1) patient memory for treatment is poor, (2) poor memory for treatment is associated with poorer adherence and poorer outcome, (3) the impact of memory impairment can be minimized by the use of memory support strategies and (4) improved memory for treatment improves outcome. The aim of this study protocol is to conduct a confirmatory efficacy trial to test whether the Memory Support Intervention improves illness course and functional outcomes. As a "platform" for the next step in investigating this approach, we focus on major depressive disorder (MDD) and cognitive therapy (CT). Adults with MDD (n = 178, including 20% for potential attrition) will be randomly allocated to CT + Memory Support or CT-as-usual and will be assessed at baseline, post treatment and at 6 and 12 months' follow-up (6FU and 12FU). We will compare the effects of CT + Memory Support vs. CT-as-usual to determine if the new intervention improves the course of illness and reduces functional impairment (aim 1). We will determine if patient memory for treatment mediates the relationship between treatment condition and outcome (aim 2). We will evaluate if previously reported poor treatment response subgroups moderate target engagement (aim 3). The Memory Support Intervention has been developed to be "transdiagnostic" (relevant to a broad range of mental disorders) and "pantreatment" (relevant to a broad range of types of treatment). This study protocol describes a "next step" in the treatment development process by testing the Memory Support Intervention for major depressive disorder (MDD) and cognitive therapy (CT). If the results are promising, future directions will test the applicability to other kinds of interventions and disorders and in other settings. ClinicalTrials.gov, ID: NCT01790919 . Registered on 6 October 2016.

  14. Podoconiosis treatment in northern Ethiopia (GoLBet): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Negussie, Henok; Kassahun, Meseret Molla; Fegan, Greg; Njuguna, Patricia; Enquselassie, Fikre; McKay, Andy; Newport, Melanie; Lang, Trudie; Davey, Gail

    2015-07-16

    Podoconiosis is one of the forgotten types of leg swelling (elephantiasis) in the tropics. Unlike the other, better-known types of leg swelling, podoconiosis is not caused by any parasite, virus or bacterium, but by an abnormal reaction to minerals found in the clay soils of some tropical highland areas. Non-governmental Organizations (NGOs) have been responsible for the development of simple treatment methods without systematic evaluation of its effectiveness. It is essential that a large scale, fully controlled, pragmatic trial of the intervention is conducted. We aim to test the hypothesis that community-based treatment of podoconiosis lymphoedema reduces the frequency of acute dermatolymphangioadenitis episodes ('acute attacks') and improves other clinical, social and economic outcomes. This is a pragmatic, individually randomised controlled trial. We plan to randomly allocate 680 podoconiosis patients from the East Gojjam Zone in northern Ethiopia to one of two groups: 'Standard Treatment' or 'Delayed Treatment'. Those randomised to standard treatment will receive the hygiene and foot-care intervention from May 2015 for one year, whereas those in the control arm will be followed through 2015 and be offered the intervention in 2016. The trial will be preceded by an economic context survey and a Rapid Ethical Assessment to identify optimal methods of conveying information about the trial and the approaches to obtaining informed consent preferred by the community. The primary outcome will be measured by recording patient recall and using a simple, patient-held diary that will be developed to record episodes of acute attacks. Adherence to treatment, clinical stage of disease, quality of life, disability and stigma will be considered secondary outcome measures. Other outcomes will include adverse events and economic productivity. Assessments will be made at baseline and at 3, 6, 9 and 12 months thereafter. The evidence is highly likely to inform implementation of

  15. The Anticoagulation of Calf Thrombosis (ACT project: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Horner Daniel

    2012-04-01

    Full Text Available Abstract Background Half of all lower limb deep vein thrombi (DVT in symptomatic ambulatory patients are located in the distal (calf veins. While proximal disease warrants therapeutic anticoagulation to reduce the associated risks, distal DVT often goes untreated. However, a proportion of untreated distal disease will undoubtedly propagate or embolize. Concern also exists that untreated disease could lead to long-term post thrombotic changes. Currently, it is not possible to predict which distal thrombi will develop such complications. Whether these potential risks outweigh those associated with unrestricted anticoagulation remains unclear. The Anticoagulation of Calf Thrombosis (ACT trial aims to compare therapeutic anticoagulation against conservative management for patients with acute symptomatic distal deep vein thrombosis. Methods ACT is a pragmatic, open-label, randomized controlled trial. Adult patients diagnosed with acute distal DVT will be allocated to either therapeutic anticoagulation or conservative management. All patients will undergo 3 months of clinical and assessor blinded sonographic follow-up, followed by 2-year final review. The project will commence initially as an external pilot study, recruiting over a 16-month period at a single center to assess feasibility measures and clinical event rates. Primary outcome measures will assess feasibility endpoints. Secondary clinical outcomes will be collected to gather accurate data for the design of a definitive clinical trial and will include: (1 a composite endpoint combining thrombus propagation to the popliteal vein or above, development of symptomatic pulmonary embolism or sudden death attributable to venous thromboembolic disease; (2 the incidence of major and minor bleeding episodes; (3 the incidence of post-thrombotic leg syndrome at 2 years using a validated screening tool; and (4 the incidence of venous thromboembolism (VTE recurrence at 2 years. Discussion The ACT trial

  16. GENetic and clinical Predictors Of treatment response in Depression: the GenPod randomised trial protocol

    Directory of Open Access Journals (Sweden)

    O'Donovan Michael

    2008-05-01

    Full Text Available Abstract Background The most effective pharmacological treatments for depression inhibit the transporters that reuptake serotonin (Selective Serotonin Reuptake Inhibitors – SSRIs and noradrenaline (Noradrenaline Reuptake Inhibitors – NaRIs into the presynaptic terminal. There is evidence to suggest that noradrenaline and serotonin enhancing drugs work through separate mechanisms to produce their clinical antidepressant action. Although most of the current evidence suggests there is little difference in overall efficacy between SSRIs and NaRIs, there are patients who respond to one class of compounds and not another. This suggests that treatment response could be predicted by genetic and/or clinical characteristics. Firstly, this study aims to investigate the influence of a polymorphism (SLC6A4 in the 5HT transporter in altering response to SSRI medication. Secondly, the study will investigate whether those with more severe depression have a better response to NaRIs than SSRIs. Methods/design The GenPod trial is a multi-centre randomised controlled trial. GPs referred patients aged between 18–74 years presenting with a new episode of depression, who did not have any medical contraindications to antidepressant medication and who had no history of psychosis or alcohol/substance abuse. Patients were interviewed to ascertain their suitability for the study. Eligible participants (with a primary diagnosis of depression according to ICD10 criteria and a Beck Depression Inventory (BDI score > 14 were randomised to receive one of two antidepressant treatments, either the SSRI Citalopram or the NaRI Reboxetine, stratified according to severity. The final number randomised to the trial was 601. Follow-up assessments took place at 2, 6 and 12 weeks following randomisation. Primary outcome was measured at 6 weeks by the BDI. Outcomes will be analysed on an intention-to-treat basis and will use multiple regression models to compare treatments

  17. 'PhysioDirect' telephone assessment and advice services for physiotherapy: protocol for a pragmatic randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Hopper Cherida

    2009-08-01

    Full Text Available Abstract Background Providing timely access to physiotherapy has long been a problem for the National Health Service in the United Kingdom. In an attempt to improve access some physiotherapy services have introduced a new treatment pathway known as PhysioDirect. Physiotherapists offer initial assessment and advice by telephone, supported by computerised algorithms, and patients are sent written self-management and exercise advice by post. They are invited for face-to-face treatment only when necessary. Although several such services have been developed, there is no robust evidence regarding clinical and cost-effectiveness, nor the acceptability of PhysioDirect. Methods/Design This protocol describes a multi-centre pragmatic individually randomised trial, with nested qualitative research. The aim is to determine the effectiveness, cost-effectiveness, and acceptability of PhysioDirect compared with usual models of physiotherapy based on patients going onto a waiting list and receiving face-to-face care. PhysioDirect services will be established in four areas in England. Adult patients in these areas with musculoskeletal problems who refer themselves or are referred by a primary care practitioner for physiotherapy will be invited to participate in the trial. About 1875 consenting patients will be randomised in a 2:1 ratio to PhysioDirect or usual care. Data about outcome measures will be collected at baseline and 6 weeks and 6 months after randomisation. The primary outcome is clinical improvement at 6 months; secondary outcomes include cost, waiting times, time lost from work and usual activities, patient satisfaction and preference. The impact of PhysioDirect on patients in different age-groups and with different conditions will also be examined. Incremental cost-effectiveness will be assessed in terms of quality adjusted life years in relation to cost. Qualitative methods will be used to explore factors associated with the success or failure of

  18. Health-social partnership intervention programme for community-dwelling older adults: a research protocol for a randomized controlled trial.

    Science.gov (United States)

    Wong, Kwan Ching; Wong, Frances Kam Yuet; Chang, Katherine Ka Pik

    2015-11-01

    This paper aims to describe the research protocol that will be used to determine the effectiveness of a health-social partnership intervention programme among community-dwelling older adults. Ageing in place is a preferred option for overcoming challenges of the increasing prevalence of chronic diseases and the risk for hospitalization associated with the ageing population. Nevertheless, our knowledge of how to implement this concept is limited. The integrated efforts of health and social services may help to enable older adults to live with a sense of control over their daily life and to be independent to the fullest extent possible in the community. This is a randomized, controlled trial. Participants are community-dwelling older adults referred from a community centre. Sample size calculation was based on power analysis. The intervention group will receive the programme with the standard protocols guided by a comprehensive assessment-intervention-evaluation framework. Home visits and telephones follow-up will be employed as means of conducting the interventions and monitoring their progress. The customary care group will receive placebo social calls. The duration of the interventions will be 3 months. The study was funded by the School of Nursing in Hong Kong. Research Ethics Committee approval was obtained in September 2014. The results of this research are expected to enable older adults to stay in the community with optimal health and well-being. Health and social sciences are integrated into the practice in this research protocol. The scarce literature on this topic means that this study can also provide an opportunity to bridge the caring gap among older adults. © 2015 John Wiley & Sons Ltd.

  19. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials.

    Science.gov (United States)

    Charrier, Nathanael; Zarca, Kevin; Durand-Zaleski, Isabelle; Calinaud, Christine

    2016-02-08

    With the development of information and communication technologies, telemedicine has been proposed as a way to improve patient management by facilitating access to appropriate diagnosis and treatment. The Paris Ile de France Regional Health Agency is currently funding a comprehensive program of telemedicine experiments. This article describes the protocols for the evaluation of the implementation of telemedicine in the Paris region. Over 2,500 patients have been included in eight studies addressing the use of telemedicine in the context of specific diseases or settings. Two projects are randomized controlled trials, while the six other projects are based on before-after designs (differences in differences studies). Based on the MAST model and the French national framework, we identified endpoints to assess the impact of telemedicine on five dimensions: clinical effectiveness, cost-effectiveness, security of the application, patient satisfaction and quality of life and perception of professionals. Telemedicine encompasses a wide range of services and stakeholders, and thus study protocols must be tailored to the specific constraints and interests of the users. NCT02110433 (03/07/2014), NCT02157740 (05/27/2014), NCT02374697 (02/05/2015), NCT02157727 (05/27/2014), NCT02229279 (08/28/2014), NCT02368769 (02/05/2015), NCT02164747 (NCT02164747), NCT02309905 (11/27/2014).

  20. An oral health intervention for people with serious mental illness (Three Shires Early Intervention Dental Trial): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Jones, Hannah F; Adams, Clive E; Clifton, Andrew; Simpson, Jayne; Tosh, Graeme; Liddle, Peter F; Callaghan, Patrick; Yang, Min; Guo, Boliang; Furtado, Vivek

    2013-05-29

    Oral health is an important part of general physical health and is essential for self-esteem, self-confidence and overall quality of life. There is a well-established link between mental illness and poor oral health. Oral health problems are not generally well recognized by mental health professionals and many patients experience barriers to treatment. This is the protocol for a pragmatic cluster randomised trial that has been designed to fit within standard care. Dental awareness training for care co-ordinators plus a dental checklist for service users in addition to standard care will be compared with standard care alone for people with mental illness. The checklist consists of questions about service users' current oral health routine and condition. Ten Early Intervention in Psychosis (EIP) teams in Nottinghamshire, Derbyshire and Lincolnshire will be cluster randomised (five to intervention and five to standard care) in blocks accounting for location and size of caseload. The oral health of the service users will be monitored for one year after randomisation. Current Controlled Trials ISRCTN63382258.

  1. Design and protocol of the weight loss lottery- a cluster randomized trial.

    Science.gov (United States)

    van der Swaluw, Koen; Lambooij, Mattijs S; Mathijssen, Jolanda J P; Schipper, Maarten; Zeelenberg, Marcel; Polder, Johan J; Prast, Henriëtte M

    2016-07-01

    People often intend to exercise but find it difficult to attend their gyms on a regular basis. At times, people seek and accept deadlines with consequences to realize their own goals (i.e. commitment devices). The aim of our cluster randomized controlled trial is to test whether a lottery-based commitment device can promote regular gym attendance. The winners of the lottery always get feedback on the outcome but can only claim their prize if they attended their gyms on a regular basis. In this paper we present the design and baseline characteristics of a three-arm trial which is performed with 163 overweight participants in six in-company fitness centers in the Netherlands. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. Herbal medicine for idiopathic central precocious puberty: A protocol for a systematic review of controlled trials.

    Science.gov (United States)

    Lee, Hye Lim; Lee, Yoo Been; Choi, Jun-Yong; Lee, Ju Ah

    2018-03-01

    Herbal medicine is widely used in East Asia to treat idiopathic central precocious puberty (ICPP). Most of the available clinical trials that investigated herbal medicine for ICPP have been included in this review. This systematic review will assess the efficacy and safety of herbal medicine for ICPP. Eleven databases, including Asian databases, will be searched for studies conducted through 2018. We will include randomized controlled trials assessing herbal medicine for ICPP. The risk of bias will be evaluated using the Cochrane risk of bias assessment tool, and confidence in the cumulative evidence will be evaluated using the Grading of Recommendations Assessment, Development, and Evaluation instrument. This systematic review will be published in a peer-reviewed journal and disseminated both electronically and in print. The review will be updated to inform and guide health care practices. PROSPER 2018 CRD42018087988.

  3. Future long-term trials of postmenopausal hormone replacement therapy - what is possible and what is the optimal protocol and regimen?

    Science.gov (United States)

    Purbrick, B; Stranks, K; Sum, C; MacLennan, A H

    2012-06-01

    The ideal long-term, randomized, placebo-controlled trial of hormone replacement therapy (HRT) from near menopause for up to 30 years to assess major morbidity and mortality is impractical because of high cost, participant retention, therapy compliance, and continuity of research staff and funding. Also the trial regimen may become outdated. It is nihilistic to demand such a long-term trial before endorsing HRT. However, medium-term trials using surrogate measures for long-term morbidity and mortality are possible and two are near completion. If these studies have been able to maintain reasonable participant retention, therapy compliance and minimal breach of protocol, they will set standards for trials of new HRT regimens. This paper discusses lessons learnt from past attempts at long-term trials and suggests the currently optimal protocol and cost of assessing new HRT regimens to optimize potential benefits and minimize adverse effects. A 5-7-year randomized, placebo-controlled trial of a flexible transdermal estrogen regimen ± either a selective estrogen receptor modulator, e.g. bazedoxifene, or micronized progesterone is discussed. Mild to moderately symptomatic women, 1-4 years post menopause, can be recruited via general practice and group meetings. Future trials should be funded by independent agencies and are high priority in women's health.

  4. Erythropoietin in traumatic brain injury: study protocol for a randomised controlled trial.

    LENUS (Irish Health Repository)

    Nichol, Alistair

    2015-02-08

    Traumatic brain injury is a leading cause of death and disability worldwide. Laboratory and clinical studies demonstrate a possible beneficial effect of erythropoietin in improving outcomes in the traumatic brain injury cohort. However, there are concerns regarding the association of erythropoietin and thrombosis in the critically ill. A large-scale, multi-centre, blinded, parallel-group, placebo-controlled, randomised trial is currently underway to address this hypothesis.

  5. Effect of acupuncture on insomnia following stroke: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Cao, Yan; Yin, Xuan; Soto-Aguilar, Francisca; Liu, Yiping; Yin, Ping; Wu, Junyi; Zhu, Bochang; Li, Wentao; Lao, Lixing; Xu, Shifen

    2016-11-16

    The incidence, mortality, and prevalence of stroke are high in China. Stroke is commonly associated with insomnia; both insomnia and stroke have been effectively treated with acupuncture for a long time. The aim of this proposed trial is to assess the therapeutic effect of acupuncture on insomnia following stroke. This proposed study is a single-center, single-blinded (patient-assessor-blinded), parallel-group randomized controlled trial. We will randomly assign 60 participants with insomnia following stroke into two groups in a 1:1 ratio. The intervention group will undergo traditional acupuncture that achieves the De-qi sensation, and the control group will receive sham acupuncture without needle insertion. The same acupoints (DU20, DU24, EX-HN3, EX-HN22, HT7, and SP6) will be used in both groups. Treatments will be given to all participants three times a week for the subsequent 4 weeks. The primary outcome will be the Pittsburgh Sleep Quality Index. The secondary outcomes will be: the Insomnia Severity Index; sleep efficacy, sleep awakenings, and total sleep time recorded via actigraphy; the National Institutes of Health Stroke Scale; the Stroke-Specific Quality of Life score; the Hospital Anxiety and Depression Scale. The use of estazolam will be permitted and regulated under certain conditions. Outcomes will be assessed at baseline, 2 weeks after treatment commencement, 4 weeks after treatment commencement, and at the 8-week follow-up. This proposed study will contribute to expanding knowledge about acupuncture treatment for insomnia following stroke. This will be a high-quality randomized controlled trial with strict methodology and few design deficits. It will investigate the effectiveness of acupuncture as an alternative treatment for insomnia following stroke. Chinese Clinical Trial Registry identifier: ChiCTR-IIC-16008382 . Registered on 28 April 2016.

  6. Electroacupuncture for insomnia disorder: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Kim, Sung-Phil; Kim, Joo-Hee; Kim, Bo-Kyung; Kim, Hyeong-Jun; Jung, In Chul; Cho, Jung Hyo; Kim, Jung-Eun; Kim, Mi-Kyung; Kwon, O-Jin; Kim, Ae-Ran; Park, Hyo-Ju; Seo, Bok-Nam

    2017-04-13

    Insomnia is a common sleep disorder that affects many adults either transiently or chronically. The societal cost of insomnia is on the rise, while long-term use of current drug treatments can involve adverse effects. Recently, electroacupuncture (EA) has been used to treat various conditions including insomnia. The objective of this study is to provide scientific evidence for the effect and safety of using EA to treat insomnia. In this multicentre, assessor-blind, three-arm, parallel-design, randomised controlled trial, 150 participants will be assigned to the EA group, the sham EA (SEA) group, or the usual care group. The EA and SEA groups will receive the specific treatments 2-3 times a week for 4 weeks, for a total of 10 sessions, whereas the usual care group will not receive EA and will continue with usual care during the same time period. The primary outcome measure will be changes in the Insomnia Severity Index 5 weeks after randomisation. The secondary outcomes will include the Pittsburgh Sleep Quality Index, the Hospital Anxiety and Depression Scale, a sleep diary, the EuroQoL-5 dimension questionnaire, the levels of melatonin and cortisol, and the Patient Global Impression of Change. Safety will be assessed at each visit. The results of this multicentre randomised controlled trial will contribute to provide rigorous clinical evidence for the effects and safety of EA for insomnia disorder. Korean Clinical Trial Registry, CRIS, KCT0001685 . Registered on 2 November 2015 (retrospectively registered). Date of enrolment of the first participant to the trial 13 October 2015.

  7. A smartphone application for treating depressive symptoms: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Deady, M; Johnston, D A; Glozier, N; Milne, D; Choi, I; Mackinnon, A; Mykletun, A; Calvo, R A; Gayed, A; Bryant, R; Christensen, H; Harvey, S B

    2018-06-01

    Depression is a commonly occurring disorder linked to diminished role functioning and quality of life. The development of treatments that overcome barriers to accessing treatment remains an important area of clinical research as most people delay or do not receive treatment at an appropriate time. The workplace is an ideal setting to roll-out an intervention, particularly given the substantial psychological benefits associated with remaining in the workforce. Mobile health (mhealth) interventions utilising smartphone applications (apps) offer novel solutions to disseminating evidence based programs, however few apps have undergone rigorous testing. The present study aims to evaluate the effectiveness of a smartphone app designed to treat depressive symptoms in workers. The present study is a multicentre randomised controlled trial (RCT), comparing the effectiveness of the intervention to that of an attention control. The primary outcome measured will be reduced depressive symptoms at 3 months. Secondary outcomes such as wellbeing and work performance will also be measured. Employees from a range of industries will be recruited via a mixture of targeted social media advertising and Industry partners. Participants will be included if they present with likely current depression at baseline. Following baseline assessment (administered within the app), participants will be randomised to receive one of two versions of the Headgear application: 1) Intervention (a 30-day mental health intervention focusing on behavioural activation and mindfulness), or 2) attention control app (mood monitoring for 30 days). Participants will be blinded to their allocation. Analyses will be conducted within an intention to treat framework using mixed modelling. The results of this trial will provide valuable information about the effectiveness of mhealth interventions in the treatment of depressive symptoms in a workplace context. The current trial is registered with the Australian and

  8. Effects of acupuncture on patients with fibromyalgia: study protocol of a multicentre randomized controlled trial

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    Santos-Rey Koldo

    2011-02-01

    Full Text Available Abstract Background Fibromyalgia is a multidimensional disorder for which treatment as yet remains unsatisfactory. Studies of an acupuncture-based approach, despite its broad acceptance among patients and healthcare staff, have not produced sufficient evidence of its effectiveness in treating this syndrome. The present study aims to evaluate the effectiveness of individualized acupuncture for patients with fibromyalgia, with respect to reducing their pain and level of incapacity, and improving their quality of life. Methods/design Randomized controlled multicentre study, with 156 outpatients, aged over 17 years, diagnosed with fibromyalgia according to American College of Rheumatology criteria, either alone or associated with severe depression, according to the criteria of the Diagnostic and Statistical Manual for Mental Disorders. The participants will be randomly assigned to receive either "True acupuncture" or "Sham acupuncture". They will be evaluated using a specific measurement system, constituted of the Fibromyalgia Impact Questionnaire and the Hamilton rating scale for depression. Also taken into consideration will be the clinical and subjective pain intensity, the patient's family structure and relationships, psychological aspects, quality of life, the duration of previous temporary disability, the consumption of antidepressant, analgesic and anti-inflammatory medication, and the potential effect of factors considered to be predictors of a poor prognosis. All these aspects will be examined by questionnaires and other suitably-validated instruments. The results obtained will be analysed at 10 weeks, and 6 and 12 months from the start of treatment. Discussion This trial will utilize high quality trial methodologies in accordance with CONSORT guidelines. It may provide evidence for the effectiveness of acupuncture as a treatment for fibromyalgia either alone or associated with severe depression. Trial registration ISRCTN trial number

  9. Physical activity and nutrition program for seniors (PANS: protocol of a randomized controlled trial

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    Lee Andy

    2010-12-01

    Full Text Available Abstract Background Along with reduced levels of physical activity, older Australian's mean energy consumption has increased. Now over 60% of older Australians are considered overweight or obese. This study aims to confirm if a low-cost, accessible physical activity and nutrition program can improve levels of physical activity and diet of insufficiently active 60-70 year-olds. Methods/Design This 12-month home-based randomised controlled trial (RCT will consist of a nutrition and physical activity intervention for insufficiently active people aged 60 to 70 years from low to medium socio-economic areas. Six-hundred participants will be recruited from the Australian Federal Electoral Role and randomly assigned to the intervention (n = 300 and control (n = 300 groups. The study is based on the Social Cognitive Theory and Precede-Proceed Model, incorporating voluntary cooperation and self-efficacy. The intervention includes a specially designed booklet that provides participants with information and encourages dietary and physical activity goal setting. The booklet will be supported by an exercise chart, calendar, bi-monthly newsletters, resistance bands and pedometers, along with phone and email contact. Data will be collected over three time points: pre-intervention, immediately post-intervention and 6-months post-study. Discussion This trial will provide valuable information for community-based strategies to improve older adults' physical activity and dietary intake. The project will provide guidelines for appropriate sample recruitment, and the development, implementation and evaluation of a minimal intervention program, as well as information on minimising barriers to participation in similar programs. Trial Registration Australian and New Zealand Clinical Trials Registry ACTRN12609000735257

  10. Study protocol: home-based telehealth stroke care: a randomized trial for veterans

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    McGee-Hernandez Nancy

    2010-06-01

    Full Text Available Abstract Background Stroke is one of the most disabling and costly impairments of adulthood in the United States. Stroke patients clearly benefit from intensive inpatient care, but due to the high cost, there is considerable interest in implementing interventions to reduce hospital lengths of stay. Early discharge rehabilitation programs require coordinated, well-organized home-based rehabilitation, yet lack of sufficient information about the home setting impedes successful rehabilitation. This trial examines a multifaceted telerehabilitation (TR intervention that uses telehealth technology to simultaneously evaluate the home environment, assess the patient's mobility skills, initiate rehabilitative treatment, prescribe exercises tailored for stroke patients and provide periodic goal oriented reassessment, feedback and encouragement. Methods We describe an ongoing Phase II, 2-arm, 3-site randomized controlled trial (RCT that determines primarily the effect of TR on physical function and secondarily the effect on disability, falls-related self-efficacy, and patient satisfaction. Fifty participants with a diagnosis of ischemic or hemorrhagic stroke will be randomly assigned to one of two groups: (a TR; or (b Usual Care. The TR intervention uses a combination of three videotaped visits and five telephone calls, an in-home messaging device, and additional telephonic contact as needed over a 3-month study period, to provide a progressive rehabilitative intervention with a treatment goal of safe functional mobility of the individual within an accessible home environment. Dependent variables will be measured at baseline, 3-, and 6-months and analyzed with a linear mixed-effects model across all time points. Discussion For patients recovering from stroke, the use of TR to provide home assessments and follow-up training in prescribed equipment has the potential to effectively supplement existing home health services, assist transition to home and

  11. Study protocol: ICONS: Identifying continence options after stroke: A randomised trial

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    Leathley Michael J

    2011-05-01

    Full Text Available Abstract Background Urinary incontinence following acute stroke is common, affecting between 40%-60% of people in hospital after a stroke. Despite the availability of clinical guidelines for urinary incontinence and urinary incontinence after stroke, national audit data suggest incontinence is often poorly managed. Conservative interventions (e.g. bladder training, pelvic floor muscle training and prompted voiding have been shown to have some effect with participants in Cochrane systematic reviews, but have not had their effectiveness demonstrated with stroke patients. Methods/Design A cluster randomised controlled pilot trial designed to assess the feasibility of a full-scale cluster randomised trial and to provide preliminary evidence of the effectiveness and cost-effectiveness of a systematic voiding programme for the management of continence after stroke. Stroke services will be randomised to receive the systematic voiding programme, the systematic voiding programme plus supported implementation, or usual care. The trial aims to recruit at least 780 participants in 12 stroke services (4 per arm. The primary outcome is presence/absence of incontinence at six weeks post-stroke. Secondary outcomes include frequency and severity of incontinence, quality of life and cost-utility. Outcomes will be measured at six weeks, three months and (for participants recruited in the first three months twelve months after stroke. Process data will include rates of recruitment and retention and fidelity of intervention delivery. An integrated qualitative evaluation will be conducted in order to describe implementation and assist in explaining the potential mediators and modifiers of the process. Trial Registration ISRCTN: ISRCTN08609907

  12. The effect of continuous ultrasound on chronic low back pain: protocol of a randomized controlled trial

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    Naghdi Soofia

    2011-03-01

    Full Text Available Abstract Background Chronic non-specific low-back pain (LBP is one of the most common and expensive musculoskeletal disorders in industrialized countries. Similar to other countries in the world, LBP is a common health and socioeconomic problem in Iran. One of the most widely used modalities in the field of physiotherapy for treating LBP is therapeutic ultrasound. Despite its common use, there is still inconclusive evidence to support its effectiveness in this group of patients. This randomised trial will evaluate the effectiveness of continuous ultrasound in addition to exercise therapy in patients with chronic LBP. Methods and design A total of 46 patients, between the ages 18 and 65 years old who have had LBP for more than three months will be recruited from university hospitals. Participants will be randomized to receive continuous ultrasound plus exercise therapy or placebo ultrasound plus exercise therapy. These groups will be treated for 10 sessions during a period of 4 weeks. Primary outcome measures will be functional disability and pain intensity. Lumbar flexion and extension range of motion, as well as changes in electromyography muscle fatigue indices, will be measured as secondary outcomes. All outcome measures will be measured at baseline, after completion of the treatment sessions, and after one month. Discussion The results of this trial will help to provide some evidence regarding the use of continuous ultrasound in chronic LBP patients. This should lead to a more evidence-based approach to clinical decision making regarding the use of ultrasound for LBP. Trial registration Netherlands Trial Register (NTR: NTR2251

  13. Inhaled nitric oxide for the adjunctive therapy of severe malaria: Protocol for a randomized controlled trial

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