[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.

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

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...

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...

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.

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.

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,

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.

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.

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.

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.

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.

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 ...

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.

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.

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...

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...

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...

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...

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.

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....

[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.

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.

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.

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...

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

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.

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

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

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...

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.

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....

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.

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...

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.

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.

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.

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

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.

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

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)

Science.gov (United States)

2012-01-01

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 (pwhiplash was more commonly reported than whiplash-injury a long time ago, and the association of interest weakly increased with time since whiplash

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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...

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.)

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.)

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.

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...

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

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.

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.

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.

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

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.

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

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

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

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

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…

[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.

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...

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.

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

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.

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.

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.

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.

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

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

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

The influence of psychosocial factors on recovery following acute whiplash trauma.

Science.gov (United States)

Carstensen, Tina Birgitte Wisbech

2012-12-01

Persistent pain and disability after whiplash trauma has become an increasingly significant problem in many industrialized countries entailing comprehensive individual as well as social costs. The dissertation includes two areas of research within whiplash trauma. The first part contains two empirical articles focusing on risk factors for poor recovery. The second part contains a systematic review and an empirical article and concerns the influence of coping strategies on recovery with a special emphasis on possible gender differences. All empirical articles in the dissertation are based on self-reported questionnaire data on a patient cohort of whiplash-exposed. Patients are consecutively included in the study within the first ten days of collision recruited from emergency departments and general practitioners in four counties in Denmark from April 2001 to June 2003. One of the empirical articles in the dissertation is supplemented with data from a social register of transfer benefits on the patient cohort as well as on a matched register control cohort in the general population. In this dissertation we wish to answer the following questions: 1) Do self-reported pre-collision health-related and socio-demographic factors affect self-reported work capability and neck pain one year after acute whiplash trauma? 2) Do transfer benefits before the accident predict negative change in future health-related provisional situation and future neck pain? 3) Do persons with acute whiplash trauma experience more negative change in future health-related provisional situation compared to a matched register control group? 4) Does research in the use of coping strategies after whiplash trauma show that these predict poor restitution and is there any research on gender differences in the use of coping strategies in whiplash-exposed? 5) Do gender and coping strategies interact in the prediction of future neck pain following acute whiplash trauma? Self-reported unspecified pain, female

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.

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...

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.

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.

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.

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

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.

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.

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...

Population-based estimates of whiplash injury using nass cds data - biomed 2009.

Science.gov (United States)

Storvik, Steven G; Stemper, Brian D; Yoganandan, Narayan; Pintar, Frank A

2009-01-01

Clinical investigations identified occupant-related factors that may predispose specific populations to increased whiplash injury susceptibility. However, clinical studies represent a specific patient population and are not representative of the population at large. The present objective was to analyze nationally-representative data to assess the association between gender and whiplash in motor vehicle rear-end impacts. A cohort of front-seat occupants in rear impacts (5-7 o'clock) from 1998-2007 were acquired using the National Automotive Sampling System (NASS) Crashworthiness Data System database. Outcome measure was "cervical spine strain" without fracture or dislocation, coded as 640278.1. Differences between injured population proportions were analyzed using Chi-Square test of independence. 1,973 rear impacts were selected, representing 936,439 weighted crashes from across the United States. Females accounted for 69% of the weighted whiplash injuries, and the proportion of females sustaining whiplash was 10% higher than males. Furthermore, gender was associated with acquiring whiplash in rear impacts (odds ratio for females: 2.16; 95% confidence interval: 1.5-3.1). Although NASS data is inherently weighted toward more severe impacts (i.e., tow-away collisions), this population-based study has demonstrated increased female susceptibility to whiplash injury. The importance of gender suggests that specific safety measures for female front-seat occupants should be addressed separately from males.

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.

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.

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.

Laypersons' expectations of recovery and beliefs about whiplash injury: a cross-cultural comparison between Australians and Singaporeans.

Science.gov (United States)

Ng, T S; Bostick, G; Pedler, A; Buchbinder, R; Vicenzino, B; Sterling, M

2013-09-01

Beliefs and expectations are thought to influence outcome following whiplash injury. Studies have proposed a link between rates of chronic whiplash and laypersons' expectations about outcome following a motor vehicle accident. The prevalence of chronic whiplash is relatively high in Australia and apparently low in Singapore. This study's objectives were to compare laypersons' beliefs and expectations of recovery of whiplash injury in Brisbane and Singapore and to assess the effect of demographic factors on whiplash beliefs. A cross-sectional study using online surveys was conducted on adult Internet users in Brisbane (Australia) and Singapore. The 14-item whiplash beliefs questionnaire (WBQ) was used to evaluate whiplash beliefs. Two additional items assessed expectations of recovery. Individual items of WBQ, WBQ score and expectations of recovery were analysed. Stratified analysis was performed to adjust for sampling bias due to quota sampling. A total of 402 participants from Singapore and 411 participants from Brisbane, Australia, completed the survey. While participants from Singapore demonstrated slightly more negative whiplash beliefs than participants from Brisbane [t(811)  = -5.72; p expectations of quick recovery and return to normal activities following whiplash injury. Only gender had a significant effect on whiplash beliefs [estimated marginal means of WBQ score for men = 21.5; standard error (SE) = 0.20; women = 22.5; SE = 0.20; F(1,810)  = 11.2; p = 0.001]. Laypersons' expectations of recovery and beliefs about whiplash injury in Brisbane and Singapore were generally similar and mostly positive. Our results demonstrate that cultural differences reflected by laypersons' beliefs may not reflect the differences in prevalence of chronic whiplash between countries. © 2012 European Federation of International Association for the Study of Pain Chapters.

Whiplash headache is transitory worsening of a pre-existing primary headache.

Science.gov (United States)

Stovner, L J; Obelieniene, D

2008-07-01

Acute and chronic whiplash headache are new diagnostic entities in the ICHD-2 (5.3, 5.4). In a prospective cohort study, 210 rear-end collision victims were identified consecutively from police records and asked about head and neck pain in questionnaires after 2 weeks, 3 months and 1 year. The results were compared with those of matched controls who were also followed for 1 year. Of 210 accident victims, 75 developed headache within 7 days. Of these, 37 had also neck pain and complied with the criteria for acute whiplash headache. These 37 had the same headache diagnoses, headache features, accompanying symptoms and long-term prognosis as the 38 without initial neck pain who therefore did not comply with the acute whiplash headache diagnosis. Previous headache was a major risk factor for headache both in the acute and chronic stage. Compared with the non-traumatized controls, headache in the whiplash group had the same prevalence, the same diagnoses and characteristic features, and the same prognosis. Both acute and chronic whiplash headache lack specificity compared with the headache in a control group, and have the same long-term prognosis, indicating that such headaches are primary headaches, probably elicited by the stress of the situation.

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.

An unusual presentation of whiplash injury: long thoracic and spinal accessory nerve injury

Science.gov (United States)

Omar, N.; Srinivasan, M. S.

2007-01-01

Whiplash injuries from motor vehicle accidents are very common. The usual presentation and course of this condition normally results in resolution of symptoms within a few weeks. Brachial plexus traction injuries without any bone or joint lesion of the cervical spine have been reported before. We report a case where a gentleman was involved in a rear end vehicle collision, sustained a whiplash injury and was later found to have a long thoracic nerve palsy and spinal accessory nerve palsy. Although isolated injuries of both nerves following a whiplash injury have been reported, combined injury of the two nerves following a whiplash injury is very uncommon and is being reported for the first time. PMID:17587067

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.

Whiplash evokes descending muscle recruitment and sympathetic responses characteristic of startle

Science.gov (United States)

Mang, Daniel WH; Siegmund, Gunter P; Blouin, Jean-Sébastien

2014-01-01

Whiplash injuries are the most common injuries following rear-end collisions. During a rear-end collision, the human muscle response consists of both a postural and a startle response that may exacerbate injury. However, most previous studies only assessed the presence of startle using data collected from the neck muscles and head/neck kinematics. The startle response also evokes a descending pattern of muscle recruitment and changes in autonomic activity. Here we examined the recruitment of axial and appendicular muscles along with autonomic responses to confirm whether these other features of a startle response were present during the first exposure to a whiplash perturbation. Ten subjects experienced a single whiplash perturbation while recording electromyography, electrocardiogram, and electrodermal responses. All subjects exhibited a descending pattern of muscle recruitment, and increasing heart rate and electrodermal responses following the collision. Our results provide further support that the startle response is a component of the response to whiplash collisions. PMID:24932015

Mechanisms underlying chronic whiplash: contributions from an incomplete spinal cord injury?

Science.gov (United States)

Elliott, James M; Dewald, Julius P A; Hornby, T George; Walton, David M; Parrish, Todd B

2014-11-01

To explore the association between findings on advanced, but available, magnetic resonance imaging (MRI) sequences of the cervical spinal cord and muscular system, in tandem with biomechanical measures of maximum volitional plantar flexion torques as a proxy for a mild incomplete spinal cord injury. Observational case series. University research laboratory. Three patients with chronic whiplash and one patient with history of whiplash injury but no current symptoms. We measured lower extremity muscle fat, morphological changes in descending spinal cord pathways with advanced MRI applications and maximal activation of the plantar flexors. Larger magnitudes of lower extremity muscle fat corresponded to altered spinal cord anatomy and reductions in the ability to maximally activate plantar flexor torques in the three subjects with chronic whiplash. Such findings were not present in the recovered participant. The potential value of MRI to quantify neuromuscular degeneration in chronic whiplash is recognized. Larger scaled prospective studies are warranted before stronger conclusions can be drawn. Wiley Periodicals, Inc.

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.

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

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

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.

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...

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.

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

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...

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.

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

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.

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...

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.

Disability in subacute whiplash patients: usefulness of the neck disability index.

Science.gov (United States)

Nieto, Rubén; Miró, Jordi; Huguet, Anna

2008-08-15

Cross-sectional study. To analyze the psychometric properties of the neck disability index (NDI), with a special emphasis in its factor structure, and its usefulness, in a sample of patients suffering from a subacute whiplash problem. A valid and reliable instrument to assess pain-related disability would be of great help to clinicians and researchers interested in whiplash associated disorders. First, to better understand the impact of whiplash on the patient's life, and his or her progress over time. Second, to formulate comprehensive treatment plans, and evaluate the results from therapeutic actions. Finally, to follow-up patients' changes and improvement. The NDI could be an appropriate instrument for these purposes. A convenience sample of 150 subacute whiplash patients participated. They were requested to complete the Catalan version of the NDI, and report about their pain intensity, pain interference and depression. RESULTS.: An exploratory factor analysis showed that the NDI can be viewed as a 2-factor instrument. The items and the instrument's total score were normally distributed. Internal consistency was also appropriate both for the total score (Cronbach's alpha: 0.87) and the 2 subscales (0.7 for the pain and interference with cognitive functioning scale, and 0.83 for the physical functioning scale). Total NDI and subscales scores significantly correlated with pain intensity, pain interference, and depression. The NDI showed excellent psychometric properties in a sample of subacute whiplash patients. Additional research is needed to replicate the NDIs factor structure.

Association between body mass index and recovery from whiplash injuries: a cohort study.

Science.gov (United States)

Yang, Xiaoqing; Côté, Pierre; Cassidy, J David; Carroll, Linda

2007-05-01

It is hypothesized that excess weight is a risk factor for delayed recovery from neck pain, such as from whiplash injuries. However, the association between obesity and recovery from whiplash injury has not been studied. The authors examined the association between body mass index and time to recovery from whiplash injuries in a population-based cohort study of traffic injuries in Saskatchewan, Canada. The cohort included 4,395 individuals who made an insurance claim to Saskatchewan Government Insurance and were treated for whiplash injury between July 1, 1994, and December 31, 1995. Of those, 87.7% had recovered by November 1, 1997. No association was found between baseline body mass index and time to recovery. Compared with individuals with normal weight, those who were underweight (hazard rate ratio = 0.88, 95% confidence interval: 0.73, 1.06), overweight (hazard rate ratio = 1.01, 95% confidence interval: 0.94, 1.09), and obese (hazard rate ratio = 0.99, 95% confidence interval: 0.90, 1.08) had similar rates of recovery, even after adjustment for other factors. The results do not support the hypothesis that individuals who are overweight or obese have a worse prognosis for whiplash.

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.

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.

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

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.

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....

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

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�

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

Science.gov (United States)

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

2013-01-01

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 may cause persistent pain and medically unexplained symptoms after a whiplash injury. The present study examines attachment insecurity and PTSD symptoms as possible vulnerability factors in relation to high levels of pain and somatisation after sub-acute whiplash injury. Data were collected from 327 patients (women = 204) referred consecutively to the emergency unit after acute whiplash injury. Within 1-month post injury, patients answered a questionnaire regarding attachment insecurity, pain, somatisation, and PTSD symptoms. Multiple mediation analyses were performed to assess whether the PTSD symptom clusters mediated the association between attachment insecurity, pain, and somatisation. A total of 15% fulfilled the DSM-IV symptom cluster criteria for a possible PTSD diagnosis and 11.6% fulfilled the criteria for somatisation. PTSD increased the likelihood of belonging to the moderate-severe pain group three-fold. In relation to somatisation the likelihood of belonging to the group was almost increased four-fold. The PTSD symptom clusters of avoidance and hyperarousal mediated the association between the attachment dimensions, pain, and somatisation. Acknowledging that PTSD is part of the aetiology involved in explaining persistent symptoms after whiplash, may help sufferers to gain early and more suited treatment, which in turn may prevent the condition from becoming chronic.

Factors related to non-recovery from whiplash. The Nord-Trøndelag Health Study (HUNT).

Science.gov (United States)

Myrtveit, Solbjørg Makalani; Skogen, Jens Christoffer; Petrie, Keith J; Wilhelmsen, Ingvard; Wenzel, Hanne Gro; Sivertsen, Børge

2014-06-01

Whiplash injuries show a variable prognosis which is difficult to predict. Most individuals experiencing whiplash injuries rapidly recover but a significant proportion develop chronic symptoms and ongoing disability. By employing longitudinal data, we investigated how psychological and physical symptoms, self-rated health, use of health services and medications, health behavior and demographic factors predict recovery from whiplash. Data from two waves of a large, Norwegian, population-based study (The Nord-Trøndelag Health Study: HUNT2 and HUNT3) were used. Individuals reporting whiplash in HUNT2 (baseline) were identified in HUNT3 11 years later. The characteristics of individuals still suffering from whiplash in HUNT3 were compared with the characteristics of individuals who had recovered using Pearson's chi-squared test, independent sample t-tests and logistic regression. At follow-up, 31.6 % of those reporting whiplash at baseline had not recovered. These individuals (n = 199) reported worse health at baseline than recovered individuals (n = 431); they reported poorer self-rated health (odds ratio [OR] = 3.12; 95 % confidence interval [CI], 2.20-4.43), more symptoms of anxiety (OR = 1.70; 95 % CI, 1.15-2.50), more diffuse somatic symptoms (OR = 2.38; 95 % CI, 1.61-3.51) and more musculoskeletal symptoms (OR = 1.21; 95 % CI, 1.13-1.29). Individuals still suffering from whiplash also visited more health practitioners at baseline (OR = 1.18; 95 % CI, 1.06-1.32) and used more medications (OR = 1.24; 95 % CI, 1.09-1.40). Poor self-rated health seems to be a strong risk factor for whiplash injuries becoming chronic. Diffuse somatic symptoms, musculoskeletal symptoms and symptoms of anxiety at baseline are important prognostic risk factors. Knowledge of these maintaining risk factors enables identification of individuals at risk of non-recovery, facilitating adequate treatment for this vulnerable group.

Acute headache attributed to whiplash in arcuate foramen and non-arcuate foramen subjects.

Science.gov (United States)

Ríos, Luis; Mata-Escolano, Federico; Blanco-Pérez, Esther; Llidó, Susanna; Bastir, Markus; Sanchis-Gimeno, Juan A

2017-04-01

To test the association between arcuate foramen (AF) in the first cervical vertebra with acute headache attributed to whiplash. Retrospective study of 128 patients that suffered a whiplash. The presence or absence of AF was recorded after a radiographic study, as well as the presence or absence of acute headache after the whiplash. The frequency of AF was 17.2%. Patients with bilateral AF presented a significant (p = 0.000, Fisher's test) increase in the frequency of acute headache (90.9%) in comparison with the non-AF group (5.7%). The ratio between the presence and absence of acute headache was 166.6 times higher (IC 95% 18.2-1526.22) in subjects with bilateral AF in comparison with non-AF subjects. The presence of bilateral AF is associated to an increased frequency of acute headache after suffering a whiplash, information of interest for the attention to these patients.

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,

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,

A narrative review on cervical interventions in adults with chronic whiplash-associated disorder

Science.gov (United States)

Yeung, Euson; Tong, Tiffany; Reed, Nick

2018-01-01

Introduction Whiplash injuries are common in society, but clinical interventions are inconclusive on the most effective treatment. Research and reviews have been completed with the goal of determining clinical interventions that are effective for whiplash injuries and disorders, but literature has not recently been summarised on best practices for cervical spine interventions for adults with chronic whiplash. Purpose The objective of this narrative review is to update and expand on previous works, to provide recommendations for clinical interventions and future research in the area of cervical spine rehabilitation for adults with chronic whiplash-associated disorder. Method The Arskey and O’Malley methodology was used for this narrative review. CINHAL, EMBASE, Medline, PsychInfo, Scopus, Web of Science, as well as grey literature, were searched from 2003 to April 2017. Two reviewers screened titles and abstracts for relevance to the review, and content analysis summarised the study findings. A total of 14 citations were included in the final review. Findings Exercise-based interventions targeted at the cervical spine appear most beneficial for adults with chronic whiplash-associated disorder (WAD). Invasive interventions still require more rigorous studies to deem their effectiveness for this population. Conclusion Further research is required to investigate and determine clinically relevant results for cervical spine intervention in patients with chronic WAD. PMID:29719724

Sick Leave within 5 Years of Whiplash Trauma Predicts Recovery: A Prospective Cohort and Register-Based Study.

Science.gov (United States)

Carstensen, Tina Birgitte Wisbech; Fink, Per; Oernboel, Eva; Kasch, Helge; Jensen, Troels Staehelin; Frostholm, Lisbeth

2015-01-01

10-22% of individuals sustaining whiplash trauma develop persistent symptoms resulting in reduced working ability and decreased quality of life, but it is poorly understood why some people do not recover. Various collision and post-collision risk factors have been studied, but little is known about pre-collision risk factors. In particular, the impact of sickness and socioeconomic factors before the collision on recovery is sparsely explored. The aim of this study was to examine if welfare payments received within five years pre-collision predict neck pain and negative change in provisional situation one year post-collision. 719 individuals with acute whiplash trauma consecutively recruited from emergency departments or primary care after car accidents in Denmark completed questionnaires on socio-demographic and health factors immediately after the collision. After 12 months, a visual analogue scale on neck pain intensity was completed. 3595 matched controls in the general population were sampled, and national public register data on social benefits and any other welfare payments were obtained for participants with acute whiplash trauma and controls from five years pre-collision to 15 months after. Participants with acute whiplash trauma who had received sickness benefit for more than 12 weeks pre-collision had increased odds for negative change in future provisional situation (Odds Ratio (OR) (95% Confidence Interval (CI) = 3.8 (2.1;7.1)) and future neck pain (OR (95%CI) = 3.3 (1.8;6.3)), controlling for other known risk factors. Participants with acute whiplash trauma had weaker attachment to labour market (more weeks of sick leave (χ2(2) = 36.7, p whiplash trauma raised the odds for future negative change in provisional situation (OR (95%CI) = 3.1 (2.3;4.4)) compared with controls. Sick leave before the collision strongly predicted prolonged recovery following whiplash trauma. Participants with acute whiplash trauma had weaker attachment to labour market pre

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

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

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.

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)

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)

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

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

Sick Leave within 5 Years of Whiplash Trauma Predicts Recovery: A Prospective Cohort and Register-Based Study

Science.gov (United States)

Carstensen, Tina Birgitte Wisbech; Fink, Per; Oernboel, Eva; Kasch, Helge; Jensen, Troels Staehelin; Frostholm, Lisbeth

2015-01-01

Background 10–22% of individuals sustaining whiplash trauma develop persistent symptoms resulting in reduced working ability and decreased quality of life, but it is poorly understood why some people do not recover. Various collision and post-collision risk factors have been studied, but little is known about pre-collision risk factors. In particular, the impact of sickness and socioeconomic factors before the collision on recovery is sparsely explored. The aim of this study was to examine if welfare payments received within five years pre-collision predict neck pain and negative change in provisional situation one year post-collision. Methods and Findings 719 individuals with acute whiplash trauma consecutively recruited from emergency departments or primary care after car accidents in Denmark completed questionnaires on socio-demographic and health factors immediately after the collision. After 12 months, a visual analogue scale on neck pain intensity was completed. 3595 matched controls in the general population were sampled, and national public register data on social benefits and any other welfare payments were obtained for participants with acute whiplash trauma and controls from five years pre-collision to 15 months after. Participants with acute whiplash trauma who had received sickness benefit for more than 12 weeks pre-collision had increased odds for negative change in future provisional situation (Odds Ratio (OR) (95% Confidence Interval (CI) = 3.8 (2.1;7.1)) and future neck pain (OR (95%CI) = 3.3 (1.8;6.3)), controlling for other known risk factors. Participants with acute whiplash trauma had weaker attachment to labour market (more weeks of sick leave (χ2(2) = 36.7, p whiplash trauma raised the odds for future negative change in provisional situation (OR (95%CI) = 3.1 (2.3;4.4)) compared with controls. Conclusions Sick leave before the collision strongly predicted prolonged recovery following whiplash trauma. Participants with acute whiplash trauma

Sick Leave within 5 Years of Whiplash Trauma Predicts Recovery: A Prospective Cohort and Register-Based Study.

Directory of Open Access Journals (Sweden)

Tina Birgitte Wisbech Carstensen

Full Text Available 10-22% of individuals sustaining whiplash trauma develop persistent symptoms resulting in reduced working ability and decreased quality of life, but it is poorly understood why some people do not recover. Various collision and post-collision risk factors have been studied, but little is known about pre-collision risk factors. In particular, the impact of sickness and socioeconomic factors before the collision on recovery is sparsely explored. The aim of this study was to examine if welfare payments received within five years pre-collision predict neck pain and negative change in provisional situation one year post-collision.719 individuals with acute whiplash trauma consecutively recruited from emergency departments or primary care after car accidents in Denmark completed questionnaires on socio-demographic and health factors immediately after the collision. After 12 months, a visual analogue scale on neck pain intensity was completed. 3595 matched controls in the general population were sampled, and national public register data on social benefits and any other welfare payments were obtained for participants with acute whiplash trauma and controls from five years pre-collision to 15 months after. Participants with acute whiplash trauma who had received sickness benefit for more than 12 weeks pre-collision had increased odds for negative change in future provisional situation (Odds Ratio (OR (95% Confidence Interval (CI = 3.8 (2.1;7.1 and future neck pain (OR (95%CI = 3.3 (1.8;6.3, controlling for other known risk factors. Participants with acute whiplash trauma had weaker attachment to labour market (more weeks of sick leave (χ2(2 = 36.7, p < 0.001 and unemployment (χ2(2 = 12.5, p = 0.002 pre-collision compared with controls. Experiencing a whiplash trauma raised the odds for future negative change in provisional situation (OR (95%CI = 3.1 (2.3;4.4 compared with controls.Sick leave before the collision strongly predicted prolonged recovery

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....

Patterns of acute whiplash-associated disorder in the Lithuanian population after road traffic accidents.

Science.gov (United States)

Pajediene, Evelina; Janusauskaite, Jolita; Samusyte, Gintaute; Stasaitis, Kestutis; Petrikonis, Kestutis; Bileviciute-Ljungar, Indre

2015-01-01

To investigate acute whiplash-associated disorder in the Lithuanian population who are unaware of the phenomenon. Controlled cohort study. Seventy-one patients were enrolled from the emergency departments of the Kaunas region of Lithuania following road traffic accidents, examined within 3-14 days after the accident, and compared with 53 matched controls. Clinical neurological examination, including range of motion and motion-evoked pain or stiffness in the neck; spontaneous pain and pain pressure threshold. Questionnaires: Quebec Task Force questionnaire (QTFQ); Disability Rating Index (DRI); Cognitive Failures Questionnaire (CFQ); Hospital Anxiety and Depression Scale (HADS) and health perception. Sixty-six of 71 (93%) patients developed acute symptoms. The most frequent symptoms found after road traffic accidents were neck or shoulder pain; reduced or painful neck movements, including decreased range of motion; multiple subjective symptoms according to QTFQ and significantly reduced pain threshold. Perceived health status was decreased and DRI was increased, while HADS showed a significantly higher risk of developing anxiety. Higher grade whiplash-associated disorder was linked with a greater reduction in range of motion and more prominent neck pain. Road traffic accidents induce whiplash-associated disorder in patients who seek help, but who are unaware of the condition whiplash-associated disorder. Whiplash-associated disorder should be considered and treated as an entity per se.

A rare and lethal case of right common carotid pseudoaneurysm following whiplash trauma.

Science.gov (United States)

Pomara, Cristoforo; Bello, Stefania; Serinelli, Serenella; Fineschi, Vittorio

2015-03-01

Whiplash trauma from a car crash is one of the most common causes of neck injury, resulting in pain and dysfunction. We report on an unusual case of post-whiplash pseudoaneurysm of the right common carotid artery, which led to acute massive hemorrhage and death days after the initial trauma. A post-mortem computed tomography angiography showed rupture of the pseudoaneurysm of the right common carotid artery with the contrast agent leaking out into the mouth. The subsequent autopsy confirmed a large hemorrhagic clot extending to the right side of the neck and mediastinum. A rupture of the right wall of the oropharynx was identified with massive bronchial hemoaspiration. The case demonstrates a rare but lethal clinical entity, and is important in providing a better understanding of the potentially fatal consequences of minor trauma, such as whiplash injury, and its physiopathological mechanisms. Thus, changing symptoms after a whiplash injury should be carefully evaluated since they can be related to the underlying severe consequences of a rapid hyperextension-hyperflexion of the neck, as in the reported case.

Persistent pseudomyopia following a whiplash injury in a previously emmetropic woman

OpenAIRE

Hughes, Fintan E.; Treacy, Maxwell P.; Duignan, Emma S.; Mullaney, Paul B.

2017-01-01

Purpose: Accommodative spasm, which manifests as ciliary muscle spasm, convergent strabismus or miosis, is a recognised consequence of head trauma. In whiplash cases, cervical spine hyperextension poses a risk of contra-coup injury and brainstem trauma, and is known to affect the visual system. However, to date, no cases of accommodative spasm due to whiplash injury have been reported. Observations: We present the case of a 34-year-old female who developed sudden onset blurred distance vis...

Cervical muscle dysfunction in chronic whiplash-associated disorder grade 2: the relevance of the trauma.

Science.gov (United States)

Nederhand, Marc J; Hermens, Hermie J; IJzerman, Maarten J; Turk, Dennis C; Zilvold, Gerrit

2002-05-15

Surface electromyography measurements of the upper trapezius muscles were performed in patients with a chronic whiplash-associated disorder Grade 2 and those with nonspecific neck pain. To determine the etiologic relation between acceleration-deceleration trauma and the presence of cervical muscle dysfunction in the chronic stage of whiplash-associated disorder. From a biopsychosocial perspective, the acceleration-deceleration trauma in patients with whiplash-associated disorder is not regarded as a cause of chronicity of neck pain, but rather as a risk factor triggering response systems that contribute to the maintenance of neck pain. One of the contributing factors is dysfunction of the cervical muscles. Considering the limited etiologic significance of the trauma, it is hypothesized that in patients with neck pain, there are no differences in muscle activation patterns between those with and those without a history of an acceleration-deceleration trauma. Muscle activation patterns, expressed in normalized smooth rectified electromyography levels of the upper trapezius muscles, in patients with whiplash-associated disorder Grade 2 were compared with those of patients with nonspecific neck pain. The outcome parameters were the mean level of muscle activity before and after a physical exercise, the muscle reactivity in response to the exercise, and the time-dependent behavior of muscle activity after the exercise. There were no statistical significant differences in any of the outcome parameters between patients with whiplash-associated disorder Grade 2 and those with nonspecific neck pain. There was only a tendency of higher muscle reactivity in patients with whiplash-associated disorder Grade 2. It appears that the cervical muscle dysfunction in patients with chronic whiplash-associated disorder Grade 2 is not related to the specific trauma mechanism. Rather, cervical muscle dysfunction appears to be a general sign in diverse chronic neck pain syndromes.

Headache and musculoskeletal complaints among subjects with self reported whiplash injury. The HUNT-2 study

Directory of Open Access Journals (Sweden)

Nygaard Oystein

2011-06-01

Full Text Available Abstract Background To evaluate the life-time prevalence of self reported whiplash injury and the relationship to chronic musculoskeletal complaints (MSCs and headache in a large unselected adult population. Methods Between 1995 and 1997, all inhabitants 20 years and older in Nord-Trondelag county in Norway were invited to a comprehensive health survey. Out of 92,936 eligible for participation, a total of 59,104 individuals (63.6% answered the question about whiplash injury (whiplash. Among these, 46,895 (79.3% responded to the questions of musculoskeletal complaints and headache. Results The total life-time prevalence of self reported whiplash injury was 2.9%, for women 2.7% and for men 3.0%. There was a significant association between self reported whiplash injury and headache (OR = 2.1; 95% CI 1.8-2.4, and chronic MSCs (OR = 3.3; 95% CI 2.8-3.8, evident for all ten anatomical sites investigated. The association was most pronounced for those with a combination of headache and chronic MSC for both men (OR = 4.8; 95% CI 3.6-6.2 and women (OR = 5.2; 95% CI 3.7-7.1. Conclusions Subjects with self reported whiplash injury had significantly more headache and musculoskeletal complaints than those without, and may in part be due to selective reporting. The causal mechanism remains unclear and cannot be addressed in the present study design.

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.

A new stratified risk assessment tool for whiplash injuries developed from a prospective observational study

DEFF Research Database (Denmark)

Kasch, Helge; Kongsted, Alice; Qerama, Erisela

2013-01-01

OBJECTIVES: An initial stratification of acute whiplash patients into seven risk-strata in relation to 1-year work disability as primary outcome is presented. DESIGN: The design was an observational prospective study of risk factors embedded in a randomised controlled study. SETTING: Acute whiplash...... patients from units, general practitioners in four Danish counties were referred to two research centres. PARTICIPANTS: During a 2-year inclusion period, acute consecutive whiplash-injured (age 18-70 years, rear-end or frontal-end car accident and WAD (whiplash-associated disorders) grades I-III, symptoms...... and examined by a study nurse after 5 days; 605 were completed after 1 year. A risk score which included items of initial neck pain/headache intensity, a number of non-painful complaints and active neck mobility was applied. The primary outcome parameter was 1-year work disability. RESULTS: The risk score...

[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.

Investigation of the Effect of Neck Muscle Active Force on Whiplash Injury of the Cervical Spine

Directory of Open Access Journals (Sweden)

Yu Yan

2018-01-01

Full Text Available The objective of the present study is to investigate the influence of neck muscle activation on whiplash neck injury of the occupants of a passenger vehicle under different severities of frontal and rear-end impact collisions. The finite element (FE model has been used as a versatile tool to simulate and understand the whiplash injury mechanism for occupant injury prevention. However, whiplash injuries and injury mechanisms have rarely been investigated in connection with neck active muscle forces, which restricts the complete reappearance and understanding of the injury mechanism. In this manuscript, a mixed FE human model in a sitting posture with an active head-neck was developed. The response of the cervical spine under frontal and rear-end collision conditions was then studied using the FE model with and without neck muscle activation. The effect of the neck muscle activation on the whiplash injury was studied based on the results of the FE simulations. The results indicated that the neck active force influenced the head-neck dynamic response and whiplash injury during a collision, especially in a low-speed collision.

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....

Subacromial impingement in patients with whiplash injury to the cervical spine

Directory of Open Access Journals (Sweden)

Giddins Grey E

2008-06-01

Full Text Available Abstract Background Impingement syndrome and shoulder pain have been reported to occur in a proportion of patients following whiplash injuries to the neck. In this study we aim to examine these findings to establish the association between subacromial impingement and whiplash injuries to the cervical spine. Methods and results We examined 220 patients who had presented to the senior author for a medico-legal report following a whiplash injury to the neck. All patients were assessed for clinical evidence of subacromial impingement. 56/220 patients (26% had developed shoulder pain following the injury; of these, 11/220 (5% had clinical evidence of impingement syndrome. Only 3/11 patients (27% had the diagnosis made prior to evaluation for their medico-legal report. In the majority, other clinicians had overlooked the diagnosis. The seatbelt shoulder was involved in 83% of cases (p Conclusion After a neck injury a significant proportion of patients present with shoulder pain, some of whom have treatable shoulder pathology such as impingement syndrome. The diagnosis is, however, frequently overlooked and shoulder pain is attributed to pain radiating from the neck resulting in long delays before treatment. It is important that this is appreciated and patients are specifically examined for signs of subacromial impingement after whiplash injuries to the neck. Direct seatbelt trauma to the shoulder is one possible explanation for its aetiology.

The association between anxiety and chronic pain after whiplash injury: gender-specific effects.

Science.gov (United States)

Elklit, Ask; Jones, Allan

2006-06-01

There is increasing evidence to suggest that anxiety is related more strongly to chronic pain experience in men relative to women. The aim of the present study was to examine for the first time gender-specific associations between anxiety and chronic pain experience in men and women exposed to whiplash trauma. One thousand seven hundred and nine people with whiplash (1349 women, 360 men) belonging to the Danish Society for Polio, Traffic, and Accident Victims completed a battery of questionnaires measuring demographic, psychologic, and pain-related factors (including frequency of painful episodes, level of pain interference, number of anatomic regions in which pain was felt, and the level of general disability). Anxiety was found to be positively related to the level of general disability to a significantly stronger magnitude in men compared with women. A trend difference in correlation magnitude was also found between men and women when comparing anxiety with pain frequency, with the magnitude of correlation being higher in men. The stronger association between anxiety and symptoms of whiplash trauma in men compared with women may be due to gender differences in the attribution of anxiety-related autonomic arousal as symptoms of whiplash injury. Alternatively, anxiety may differentially affect the willingness of men and women to report pain and other health indices. Anxiety is an important factor in understanding gender differences in whiplash-related symptoms such as chronic pain and disability, and requires further investigation.

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

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

The return-to-work process of individuals sick-listed because of whiplash-associated disorder

DEFF Research Database (Denmark)

Biering-Sørensen, Sarah; Møller, Anne; Stoltenberg, C.

2014-01-01

BACKGROUND: The chronic course of whiplash-associated disorder (WAD) has implications for both the individual and society. It has been shown that up to 50% of patients have not yet returned to work six months after a whiplash injury. We wanted to study the return-to-work (RTW) process in individu...

Pain and Disability in the Jaw and Neck Region following Whiplash Trauma.

Science.gov (United States)

Häggman-Henrikson, B; Lampa, E; Marklund, S; Wänman, A

2016-09-01

The relationship between whiplash trauma and chronic orofacial pain is unclear, especially with regard to the time elapsed from trauma to development of orofacial pain. The aim was to analyze prevalence of jaw pain and disability, as well as the relationship between pain and disability in the jaw and neck regions in the early nonchronic stage after whiplash trauma. In this case-control study, 70 individuals (40 women, 30 men, mean age 35.5 y) who visited an emergency department with neck pain following a car accident were examined within 3 wk of trauma (group 1) and compared with 70 individuals (42 women, 28 men, mean age 33.8 y), who declined to attend a clinical examination but agreed to fill in questionnaires (group 2). The 2 case groups were compared with a matched control group of 70 individuals (42 women, 28 men, mean age 37.6 y) without a history of neck trauma. All participants completed questionnaires regarding jaw pain and dysfunction, rating pain intensity in jaw and neck regions on the Numerical Rating Scale, the Neck Disability Index, and Jaw Disability Checklist. Compared with controls, individuals with a recent whiplash trauma reported more jaw pain and dysfunction. Furthermore, there was a moderate positive correlation between jaw and neck pain ratings for group 1 (r = 0.61, P whiplash trauma report more jaw pain and disability compared with controls without a history of neck trauma. Furthermore, the correlation between jaw and neck pain intensity implies that intensity of neck pain in the acute stage after whiplash trauma might be a possible risk factor also for development of chronic orofacial pain. © International & American Associations for Dental Research 2016.

Differential Predictors of Pain and Disability in Patients with Whiplash Injuries

Directory of Open Access Journals (Sweden)

Michael JL Sullivan

2002-01-01

Full Text Available The psychological predictors of pain and disability were examined in a sample of people who sustained whiplash injuries during rear-end motor vehicle accidents. Sixty-five patients referred to a specialty pain clinic with a diagnosis of whiplash injury completed measures of depression, anxiety, catastrophizing, pain and perceived disability. Regression analysis revealed that psychological variables accounted for 18% of the variance in pain ratings. The magnification subscale of the Pain Catastrophizing Scale was the only variable that contributed significant, unique variance to the prediction of pain. Psychological variables accounted for 37% of the variance in perceived disability scores. In the latter analysis, however, none of the independent variables contributed significant, unique variance to the prediction of perceived disability. Psychological variables accounted for significant variance in disability ratings, even when controlling for pain intensity. Discussion focuses on the need to draw clearer distinctions between determinants of pain and disability, and directions for interventions aimed at minimizing disability following whiplash injury are suggested.

MR imaging evaluation of the temporomandibular joint following cervical extension-flexion injury (whiplash)

International Nuclear Information System (INIS)

Shellock, F.G.; Pressman, B.D.; Schames, J.; Schames, M.; Meeks, T.

1990-01-01

To determine abnormalities of the temporomandibular joint (TMJ) associated with cervical extension-flexion injury (whiplash) with use of MR imaging. Sixteen patients (32 joints) with TMJ syndrome-related symptoms after whiplash injuries from automobile accidents were evaluated by MR imaging. None of the patients had direct trauma to the jaw, mouth, or face. T1-weighted closed- and opened-mouth views were obtained in the sagittal plane, and closed-mouth views were obtained in the coronal plane. T2-weighted closed-mouth views obtained in the sagittal plane were also obtained to optimize identification of fluid/edema. Fourteen (87%) of 16 patients had one or more of the following TMJ abnormalities: 11 (34%) had anterior displacement of the disk with reduction and 2 (6%) had anterior displacement of the disk without reduction. On T2-weighted images, 17 TMJs (53%) had joint fluid and 5 (16%) had fluid localized to the capsule and/or pterygoid muscle. These data demonstrated a high incidence of TMJ abnormalities related to whiplash injury. The predominant finding was associated fluid/edema, suggesting that T2-weighted images are particularly useful for the evaluation of patients who present with whiplash injury

Evidence for cervical muscle morphometric changes on magnetic resonance images after whiplash: A systematic review and meta-analysis.

Science.gov (United States)

Owers, Daniel S; Perriman, Diana M; Smith, Paul N; Neeman, Teresa; Webb, Alexandra L

2018-02-01

Morphometric changes to cervical musculature in whiplash associated disorder have been reported in several studies with varying results. However, the evidence is not clear because only a limited number of cohorts have been studied and one cohort has been reported in multiple publications. The aim of this study was to assess the evidence for cervical muscle morphometric changes on magnetic resonance (MR) images after whiplash using a systematic review with meta-analysis. PubMed, MEDLINE and Cochrane Library were searched without language restriction using combinations of the MeSH terms "muscles", "whiplash injuries", and "magnetic resonance imaging". Studies of acute and chronic whiplash were included if they compared whiplash and control cervical spine muscle morphometry measurements from MR images. The search identified 380 studies. After screening, eight studies describing five cohorts (one acute, three chronic, one both acute and chronic) met the inclusion criteria. Participant characteristics and outcome measures were extracted using a standard extraction format. Quality of eligible studies was assessed using the Newcastle-Ottawa Scale. Muscle cross-sectional area (CSA) and fat infiltrate (MFI) for acute and chronic whiplash cohorts were compared using mean difference and 95% confidence intervals. Meta-analysis models were created when data from more than two eligible cohorts was available, using inverse-variance random-effects models (RevMan5 version 5.3.5). Quality assessment was uniformly good but only two studies blinded the assessor. Analysis of the acute cohorts revealed no consensus with respect to CSA. MFI was not measured in the acute cohorts. Analysis of the chronic cohorts revealed CSA is probably increased in some muscles after whiplash but there is insufficient evidence to confirm whether MFI is also increased. Because the available data were limited, meta-analyses of only multifidus were performed. In chronic whiplash multifidus CSA was

Modic changes of the cervical spine in patients with whiplash injury: a prospective 11-year follow-up study.

Science.gov (United States)

Matsumoto, Morio; Ichihara, Daisuke; Okada, Eijiro; Toyama, Yoshiaki; Fujiwara, Hirokazu; Momoshima, Suketaka; Nishiwaki, Yuji; Takahata, Takeshi

2013-06-01

There are few studies on Modic changes of the cervical spine in patients suffering from whiplash. This study compared Modic changes seen in whiplash patients 10 years after the injury with those observed in asymptomatic volunteers. This is a follow-up study of 133 patients who suffered whiplash injuries in 1994-1996 and underwent MRI with a superconductive imager (63 men, 70 women, mean age 49.6±15.3 years, mean follow-up 11.4 years). In addition, 223 healthy volunteers who underwent MRI during the same period were included as controls (123 men, 100 women, mean age 50.5±15.0 years, mean follow-up 11.6 years). All participants underwent follow-up MRI. We examined all participants for Modic changes, and investigated relationships between Modic changes and clinical symptoms or potentially related factors. Modic changes were observed in 4 patients (3%) and at 7 intervertebral levels in the initial study, and in 17 patients (12.8%) and at 30 intervertebral levels at the follow-up. Modic Type 2 changes were the most prevalent in the whiplash patients in both the initial and follow-up studies. There was no significant difference in the percentage of whiplash patients versus control subjects with positive Modic changes, either at the initial study or at follow-up. Modic changes were not related to clinical symptoms present at follow-up, but were associated with preexisting disc degeneration. There was no association between Modic changes and the details of the car accident that caused the injury. While Modic changes became more common in whiplash patients in the 10-year period after the accident, they occurred with a similar frequency in control subjects. We did not find any association between Modic changes and the nature of the car accident in which the whiplash occurred. Modic changes found in whiplash patients may be a result of the physiological ageing process rather than pathological findings relating to the whiplash injury. Copyright © 2012 Elsevier Ltd. All

[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.

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

The relationship between chronic whiplash-associated disorder and post-traumatic stress: attachment-anxiety may be a vulnerability factor

OpenAIRE

Andersen, Tonny Elmose; Elklit, Ask; Vase, Lene

2011-01-01

Background: In more than 90% of whiplash accidents a good explanation regarding the association between trauma mechanism, organic pathology, and persistent symptoms has failed to be provided. Objective: We predicted that the severity of chronic whiplash-associated disorder (WAD), measured as number of whiplash symptoms, pain duration, pain-related disability, and degree of somatisation would be associated with the number of post-traumatic stress disorder symptoms (PTSD). Secondly, we expected...

Vestibular and stabilometric findings in whiplash injury and minor head trauma.

Science.gov (United States)

Nacci, A; Ferrazzi, M; Berrettini, S; Panicucci, E; Matteucci, J; Bruschini, L; Ursino, F; Fattori, B

2011-12-01

Vertigo and postural instability following whiplash and/or minor head injuries is very frequent. According to some authors, post-whiplash vertigo cannot be caused by real injury to vestibular structures; other authors maintain that vestibular damage is possible even in the case of isolated whiplash, with vascular or post-traumatic involvement. Furthermore, many of the balance disorders reported after trauma can be justified by post-traumatic modification to the cervical proprioceptive input, with consequent damage to the vestibular spinal reflex. The aim of this study was to evaluate the vestibular condition and postural status in a group of patients (Group A, n = 90) affected with balance disorders following whiplash, and in a second group (Group B, n = 20) with balance disorders after minor head injury associated with whiplash. Both groups were submitted to videonystagmography (VNG) and stabilometric investigation (open eyes - O E, closed eyes - CE, closed eyes with head retroflexed - CER) within 15 days of their injuries and repeated within 10 days after conclusion of cervical physiotherapy treatment. The VNG tests revealed vestibulopathy in 19% of cases in Group A (11% peripheral, 5% central, 3% in an undefined site) and in 60% of subjects in Group B (50% peripheral, 10% central). At the follow-up examination, all cases of non-compensated labyrinth deficit showed signs of compensation, while there were two cases (2%) in Group A and one case (5%) in Group B of PPV. As far as the altered posturographic recordings are concerned, while there was no specific pattern in the two groups, they were clearly pathologic, especially during CER. Both in OE and in CE there was an increase in the surface values and in those pertaining to shifting of the gravity centre on the sagittal plane, which was even more evident during CER. In Group A, the pre-post-physiotherapy comparison of CER results showed that there was a statistically significant improvement in the majority of the

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...

Persistent pseudomyopia following a whiplash injury in a previously emmetropic woman.

Science.gov (United States)

Hughes, Fintan E; Treacy, Maxwell P; Duignan, Emma S; Mullaney, Paul B

2017-12-01

Accommodative spasm, which manifests as ciliary muscle spasm, convergent strabismus or miosis, is a recognised consequence of head trauma. In whiplash cases, cervical spine hyperextension poses a risk of contra-coup injury and brainstem trauma, and is known to affect the visual system. However, to date, no cases of accommodative spasm due to whiplash injury have been reported. We present the case of a 34-year-old female who developed sudden onset blurred distance vision after a rear impact car crash, having previously been emmetropic. Her unaided distance visual acuity was 20/70 in the right eye and 20/20 in the left. Best-corrected visual acuity in the right eye was 20/20 with a correction that progressed from -1.75 to -3.50 DS over the 12 months following the accident.This patient's sudden unilateral myopia, with unilaterally increased amplitude of accommodation suggests pseudomyopia due to accommodative spasm. Magnetic resonance imaging showed no evidence of injury to her brain stem, frontal lobes or oculomotor nerve. The patient is now well adjusted with a -3.50DS corrective lens for the right eye. The accommodation reflex is susceptible to injury at the occipital lobe, frontal eye fields, Edinger-Westphal nuclei and oculomotor nerves. As such it should be examined in patients who present with visual disturbances following whiplash injury.It is important that such cases are identified at presentation, as early intervention can improve outcomes in accommodative spasm and reduce the long term psychological effects often associated with whiplash injuries.

Recovery in whiplash-associated disorders: do you get what you expect?

Science.gov (United States)

Carroll, Linda J; Holm, Lena W; Ferrari, Robert; Ozegovic, Dejan; Cassidy, J David

2009-05-01

Positive expectations predict better outcome in a number of health conditions, but the role of expectations in predicting health recovery after injury is not well understood. We investigated whether early expectations of recovery in whiplash associated disorders (WAD) predict subsequent recovery, and studied the role of "expectations" to predict recovery as determined by pain cessation and resolution of pain-related limitations in daily activities. A cohort of 6,015 adults with traffic-related whiplash injuries was assessed, using multivariable Cox proportional hazards analysis, for association between these expectations and self-perceived recovery over a 1-year period following the injury. Recovery was assessed using 3 indices: self-perceived global recovery (primary outcome); resolution of neck pain severity; and resolution of pain-related limitations in daily activities. After adjusting for the effect of sociodemographic characteristics, post-crash symptoms and pain, prior health status and collision-related factors, those who expected to get better soon recovered over 3 times as quickly (hazard rate ratio = 3.62, 95% confidence interval 2.55-5.13) as those who expected that they would never get better. Findings were similar for resolution of pain-related limitations and resolution of neck pain intensity, although the effect sizes for the latter outcome were smaller. Patients' early expectations for recovery are an important prognostic factor in recovery after whiplash injury, and are potentially modifiable. Clinicians should assess these expectations in order to identify those patients at risk of chronic whiplash, and future studies should focus on the effect of changing these early expectations.

Information needs of patients with whiplash associated disorders: A Delphi study of patient beliefs.

Science.gov (United States)

Sterling, Joanna; Maujean, Annick; Sterling, Michele

2018-02-01

Whiplash associated disorders (WAD) result in significant personal and economic costs. Patient education and reassurance are recommended treatments for acute WAD but the information needs of patients have not been investigated. To determine what information whiplash-injured patients believe is important to help recovery in the acute stage of injury. A Delphi design survey series with three rounds. Thirty-three participants who had sustained a whiplash injury within the last three years were invited to participate. Participants were asked to provide five statements, in response to an open-ended question, regarding what they believed was the most important information to provide to patients following a whiplash injury. Nineteen patients responded and 85 statements were collected and reviewed independently by two of the authors to remove duplicates. The importance of the remaining items was rated by the participants in the second survey round. Items rated by >50% of participants as important were included in the third survey round. To be deemed key information, >80% of participants had to rate an item as important in this final round. Eighteen items met the criteria for key information. These points addressed four areas: assessment and treatment, recovery and symptoms, patient attitudes during treatment and relationships with health practitioners. The key information points endorsed by patients in this study may provide useful information to constitute a basis for reassurance and education provided to patients with WAD. The results also suggest that improved relationships between patients with whiplash and health practitioners is required. Copyright © 2017 Elsevier Ltd. All rights reserved.

Five years after the accident, whiplash casualties still have poorer quality of life in the physical domain than other mildly injured casualties: analysis of the ESPARR cohort.

Science.gov (United States)

Tournier, Charlène; Hours, Martine; Charnay, Pierrette; Chossegros, Laetitia; Tardy, Hélène

2016-01-05

This study aims to compare health status and quality of life five years after a road accident between casualties with whiplash versus other mild injuries, to compare evolution of quality of life at 1 and 5 years after the accident, and to explore the relation between initial injury (whiplash vs. other) and quality of life. The study used data from the ESPARR cohort (a representative cohort of road accident casualties) and included 167 casualties with "pure" whiplash and a population of 185 casualties with other mild injuries (MAIS-1). All subjects with lesions classified as cervical contusion (AIS code 310402) or neck sprain (AIS code 640278) were considered as whiplash casualties. Diagnosis was made by physicians, at the outset of hospital care, based on interview, clinical findings and X-ray. Whiplash injuries were then classified following the Quebec classification (grades 1 and 2). Quality of life was assessed on the WHOQoL-Bref questionnaire. Correlations between explanatory variables and quality of life were explored by Poisson regression and variance analysis. Between 1 and 5 years, global QoL improved for both whiplash and non-whiplash casualties; but, considering the two whiplash groups separately, improvement in grade 2 was much less than in grade 1. At 5 years, grade-2 whiplash casualties were more dissatisfied with their health (39.4%; p whiplash (24.3%) or grade-1 whiplash casualties (27.0%). Deteriorated quality of life in the mental, social and environmental domains was mainly related to psychological and socioeconomic factors for both whiplash and other mildly injured road-accident casualties. While PTSD was a major factor for the physical domain, whiplash remained a predictive factor after adjustment on PTSD; unsatisfactory health at 5 years, with deteriorated quality of life in the physical domain, was observed specifically in the whiplash group, pain playing a predominant intermediate role. Deteriorated quality of life in the physical domain

Post-traumatic stress symptom clusters in acute whiplash associated disorder and their prediction of chronic pain-related disability.

Science.gov (United States)

Maujean, Annick; Gullo, Matthew J; Andersen, Tonny Elmose; Ravn, Sophie Lykkegaard; Sterling, Michele

2017-11-01

The presence of post-traumatic stress disorder (PTSD) symptoms has been found to be associated with an increased risk of persisting neck pain and disability in motor vehicle crash (MVC) survivors with whiplash injuries. The findings are mixed as to which PTSD symptom(s) best predicts recovery in this population. The aims were (1) to explore the factor structure of the Post-traumatic Stress Diagnostic Scale (PDS) in a sample of acute whiplash-injured individuals following a MVC and (2) to identify the PTSD-symptom clusters that best predict long-term neck pain-related disability in this population as measured by the Neck Pain Disability Index (NDI). A sample (N = 146) of whiplash-injured individuals completed the NDI and the PDS at baseline (whiplash-injured individuals following a MVC.

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�

Disc pathology after whiplash injury. A prospective magnetic resonance imaging and clinical investigation.

Science.gov (United States)

Pettersson, K; Hildingsson, C; Toolanen, G; Fagerlund, M; Björnebrink, J

1997-02-01

This study was used to evaluate the relationship between magnetic resonance imaging findings and clinical findings after whiplash injury. To identify initial soft-tissue damage after whiplash injury, the development of disc pathology, and the relationship of disc pathology to clinical findings. Although a few studies have reported pathological magnetic resonance imaging findings after whiplash injuries, there is no prospective study published to our knowledge. Thirty-nine patients, 20 women and 19 men with a mean age of 32 years, were treated for whiplash injury. Magnetic resonance imaging and clinical examination were performed in a blinded manner at a mean of 11 days after trauma. The procedure was repeated at a 2-year follow-up visit. Two patients could not be examined with the second magnetic resonance imaging because of claustrophobia and pregnancy, respectively. The authors found 13 patients (33%) with disc herniations with medullary (six cases) or dura (seven cases) impingement over the 2-year follow-up period. At the follow-up examination all patients with medullary impingement had persistent or increased symptoms, and three of 27 patients (11%) with no or slight changes on magnetic resonance imaging had persistent symptoms. No ligament injuries were diagnosed. Although disc pathology seems to be one contributing factor in the development of chronic symptoms after whiplash injury, it may be unnecessary to examine these patients in the acute phase with magnetic resonance imaging; correlating initial symptoms and signs to magnetic resonance imaging findings is difficult because of the relatively high proportion of false-positive results. Magnetic resonance imaging is indicated later in the course of treatment in patients with persistent arm pain, neurologic deficits or clinical signs of nerve root compression to diagnose disc herniations requiring surgery.

Chronic neck pain and whiplash: a case-control study of the relationship between acute whiplash injuries and chronic neck pain.

Science.gov (United States)

Freeman, M 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 well as demographic information. The two groups were compared using an exposure-odds ratio. Forty-five per cent of the patients attributed their pain to a motor vehicle accident. An OR of 4.0 and 2.1 was calculated for men and women, respectively. Based on the results of the present study, it reasonable to infer that a significant proportion of individuals with chronic neck pain in the general population were originally injured in a motor vehicle accident.

Chronic neck pain and whiplash: A case-control study of the relationship between acute whiplash injuries and chronic neck pain

Science.gov (United States)

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 well as demographic information. The two groups were compared using an exposure-odds ratio. Forty-five per cent of the patients attributed their pain to a motor vehicle accident. An OR of 4.0 and 2.1 was calculated for men and women, respectively. Based on the results of the present study, it reasonable to infer that a significant proportion of individuals with chronic neck pain in the general population were originally injured in a motor vehicle accident. PMID:16770448

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.

The Catalan version of the Pain Catastrophizing Scale: a useful instrument to assess catastrophic thinking in whiplash patients.

Science.gov (United States)

Miró, Jordi; Nieto, Rubén; Huguet, Anna

2008-05-01

The main aims of this work were to test the psychometric properties of the Catalan version of the Pain Catastrophizing Scale (PCS) and to assess the usefulness of the scale when used with whiplash patients. This article reports results from 2 complementary studies. In the first one, the PCS was administered to 280 students and 146 chronic pain patients to examine the psychometric properties of a new Catalan version of the instrument. A confirmatory factor analysis supported a second-order structure, in which 3 second-order factors (ie, rumination, helplessness, and magnification) load in a higher-order factor (ie, catastrophizing). The reliability of the Catalan version was supported by an acceptable internal consistency and test-retest values. Validity was supported by the correlations found among the PCS and pain intensity, pain interference, and depression. The objective of the second study was to evaluate the PCS when used with whiplash patients. In this second study, 141 patients with whiplash disorders participated. In general, the psychometric properties of the PCS were found appropriate, with factor analysis supporting the structure described in patients with chronic pain. Our data suggest that the PCS is a good instrument to assess catastrophic thinking in whiplash patients. The usefulness of the PCS in whiplash disorders has been explored in this study. Results of our work show that the PCS can be a very useful tool to assess catastrophic thinking about pain in whiplash patients.

Investigation of whiplash injuries in the upper cervical spine using a detailed neck model.

Science.gov (United States)

Fice, Jason B; Cronin, Duane S

2012-04-05

Whiplash injuries continue to have significant societal cost; however, the mechanism and location of whiplash injury is still under investigation. Recently, the upper cervical spine ligaments, particularly the alar ligament, have been identified as a potential whiplash injury location. In this study, a detailed and validated explicit finite element model of a 50th percentile male cervical spine in a seated posture was used to investigate upper cervical spine response and the potential for whiplash injury resulting from vehicle crash scenarios. This model was previously validated at the segment and whole spine levels for both kinematics and soft tissue strains in frontal and rear impact scenarios. The model predicted increasing upper cervical spine ligament strain with increasing impact severity. Considering all upper cervical spine ligaments, the distractions in the apical and alar ligaments were the largest relative to their failure strains, in agreement with the clinical findings. The model predicted the potential for injury to the apical ligament for 15.2 g frontal or 11.7 g rear impacts, and to the alar ligament for a 20.7 g frontal or 14.4 g rear impact based on the ligament distractions. Future studies should consider the effect of initial occupant position on ligament distraction. Copyright © 2012 Elsevier Ltd. All rights reserved.

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.

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

Is temporomandibular pain in chronic whiplash-associated disorders part of a more widespread pain syndrome?

Science.gov (United States)

Visscher, Corine; Hofman, Nico; Mes, Carola; Lousberg, Richel; Naeije, Machiel

2005-01-01

The prevalence of temporomandibular disorders in patients with chronic whiplash-associated disorder is a controversial issue that may be influenced by the widespread pain character and psychologic distress frequently observed in patients with chronic pain. The aim of this study was to determine the prevalence of temporomandibular disorder pain, widespread pain, and psychologic distress in persons with chronic whiplash-associated disorder pain, using a controlled, single blind study design. The prevalence of temporomandibular disorder pain in the chronic whiplash-associated disorder pain group was compared with 2 control groups: a chronic neck pain group and a no neck pain group. From 65 persons, a standardized oral history was taken, a physical examination of the neck and the masticatory system was performed, widespread pain was investigated by tender point palpation, and psychologic distress was measured with a questionnaire (SCL-90). Because the recognition of temporomandibular disorder pain and neck pain remains a matter of debate, 3 well-defined classification systems were used: one based on the oral history, a second on a combination of oral history and pain on active movements and palpation, and a third one based on a combination of oral history and function tests. Irrespective of the classification system used, the chronic whiplash-associated disorder pain group more often suffered from temporomandibular disorder pain (0.001neck pain group. Moreover, patients with whiplash-associated disorder showed more psychologic distress (0.000disorder suggests that the higher prevalence of temporomandibular disorder pain in these patients is part of a more widespread chronic pain disorder.

One year after mild injury: comparison of health status and quality of life between casualties with whiplash versus other injuries

OpenAIRE

HOURS, Martine; KHATI, Inès; CHARNAY, Pierrette; CHOSSEGROS, Laetitia; TARDY, Hélène; TOURNIER, Charlène; PERRINE, Anne-Laure; LUAUTE, Jacques; LAUMON, Bernard

2014-01-01

Objectives: To compare health status, family and occupational impact and quality of life one year after an accident between casualties with whiplash versus other mild injuries, and to explore the relation between initial injury (whiplash vs. other) and quality of life. Design: Prospective cohort study. Subjects: The study used data from the ESPARR cohort (a representative cohort of road accident casualties) and included 173 casualties with 'pure' whiplash and a population of 207 casualties wi...

What information do patients need following a whiplash injury? The perspectives of patients and physiotherapists.

Science.gov (United States)

Maujean, Annick; Sterling, Joanna; Sterling, Michele

2018-05-01

The aims of the present study were to identify information that individuals with whiplash associated disorders (WAD) need to know in the early stages of recovery and to establish whether there is a difference between what physiotherapists and whiplash-injured patients perceive as important information. Forty-one participants were recruited (20 whiplash-injured patients, 21 physiotherapists). Participants were asked to provide five statements to one open-ended question about what they believe is the most important information individuals with WAD need to know in the early stages of recovery. Participants provided 182 statements which were reviewed independently and organised into themes by two of the authors. Six key themes emerged from the statements. These included general information about whiplash injury, treatment and recovery, reassurance, provision of poor information and patients' interaction with general practitioners, maintaining daily activities, and compensation claims and litigation. Both patients and physiotherapists agreed on the type of general whiplash information that should be provided however, major differences were found with regard to information pertaining to compensation claims and litigation and maintaining daily activities. The findings of this study provide some insight into the type of information that WAD individuals require in the early stages of recovery. Implications for Rehabilitation The provision of reassurance can be an effective communication tool to decrease patients concerns about their injury and help strengthen the patient-health practitioner relationship. Although clinical guidelines for the management of whiplash injuries recommend that individuals must remain physically active post-injury, statements from the patient group indicate that this information is not always provided and clearly explained to patients. Keeping in line with the patient centred care approach of being responsive to patient needs and values, it is

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...

Alar ligaments: radiological aspects in the diagnosis of patients with whiplash injuries

International Nuclear Information System (INIS)

Muhle, C.; Brossmann, J.; Biederer, J.; Jahnke, Th.; Grimm, J.; Heller, M.

2002-01-01

Post-traumatic changes of the alar ligaments have been proposed to be the cause of chronic pain in patients after whiplash injury of the cervical spine. In addition to an asymmetric dens position, widening of the atlantodental distance to more than 12 mm can be an indirect sign of an alar ligament rupture. CT is recommended for detection of a avulsion fracture of the occipital condyle. Isolated ruptures of the alar ligaments are best visualized on MRI. In patients with chronic impairments after whiplash injuries changes of the alar ligaments on MRI must be differentiated from normal variants in healthy individuals. (orig.) [de

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....

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.

Magnetic Resonance Imaging-Based Prediction of the Relationship between Whiplash Injury and Temporomandibular Disorders.

Science.gov (United States)

Lee, Yeon-Hee; Lee, Kyung Mi; Auh, Q-Schick; Hong, Jyung-Pyo

2017-01-01

Whiplash injury can cause internal derangement of the temporomandibular joint (TMJ) and lead to temporomandibular disorders (TMDs). Our aim was to evaluate whether the initial clinical findings in TMD patients with whiplash injury are correlated with their magnetic resonance imaging (MRI) characteristics. This case-control study involved 219 patients (135 women, 84 men; mean age: 37.84 years) who visited our orofacial pain clinic with TMD; TMD was diagnosed using the diagnostic criteria for TMD Axis I. Patients were categorized into three groups based on the presence and type of macrotrauma: in the "wTMD" group, patients had suffered whiplash injury; patients in the "pTMD" group had post-traumatic TMD; the "iTMD" group comprised patients who had presented with TMD symptoms and had sustained no macrotrauma. We investigated the presence of disk displacement, effusion, disk deformity, and condylar degeneration, and changes in the lateral pterygoid muscle (LPM). To evaluate the severity of TMD pain and objectively analyze symptoms, we used a visual analog scale (VAS), palpation index (PI), neck PI, dysfunction index, and craniomandibular index (CMI). The VAS scores, and the severity indexes of the TMD including PI, neck PI, and CMI were highest in the wTMD patients. Atrophy of the LPM was most commonly seen in the wTMD group, as was disk deformity. In wTMD patients only, VAS score was significantly correlated with stress; it was correlated with headache in wTMD and iTMD patients. The clinical symptoms of TMD were not correlated with MRI findings in the wTMD group. However, alterations in the LPM were strongly correlated with disk displacement. If clinicians recognize alterations in the LPM and disk displacement in the TMJ, they will better understand the clinical symptoms and pathophysiology of TMD with whiplash injury. Whiplash injury may lead to TMD via different mechanisms from other macrotraumas.

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...

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...

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...

One year after mild injury: comparison of health status and quality of life between patients with whiplash versus other injuries.

Science.gov (United States)

Hours, Martine; Khati, Inès; Charnay, Pierrette; Chossegros, Laetitia; Tardy, Hélène; Tournier, Charlène; Perrine, Anne-Laure; Luauté, Jacques; Laumon, Bernard

2014-03-01

To compare health status, effect on family, occupational consequences, and quality of life (QOL) 1 year after an accident between patients with whiplash versus other mild injuries, and to explore the relationship between initial injury (whiplash vs other) and QOL. This was a prospective cohort study. The study used data from the ESPARR cohort (a representative cohort of road accident victims) and included 173 individuals with "pure" whiplash and 207 with other mild injuries. QOL at 1-year followup was assessed on the World Health Organization Quality of Life questionnaire. Correlations between explanatory variables and QOL were explored by Poisson regression to provide adjusted relative risks, with ANOVA for the various QOL scores explored. One year post-accident, more patients who had whiplash than other casualties complained of nonrecovery of health status (56% vs 43%) and of the occupational effect of pain (31% vs 23%). QOL and posttraumatic stress disorder (PTSD) were similar in the 2 groups. Impaired QOL did not correlate with whiplash when models were adjusted on sociodemographic variables and history of psychological distress. Whatever the initial lesion, PTSD was a determining factor for poorer QOL. Sociodemographic factors, preaccident psychological history prior to the accident, and PTSD were the main factors influencing QOL, rather than whether the injury was whiplash. PTSD may also be related to pain.

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…

The craniocervical connection: a retrospective analysis of 300 whiplash patients with cervical and temporomandibular disorders.

Science.gov (United States)

Friedman, M H; Weisberg, J

2000-07-01

Because the concept of whiplash as a causative factor for temporomandibular disorders (TMD) is highly controversial, we decided to do a retrospective analysis of patients treated in our office who had sustained whiplash injuries and were treated for cervical and temporomandibular disorders. The records of 300 patients with TMD preceded by a motor vehicle accident were examined retrospectively. The most common presenting symptoms, in order, were: jaw pain, neck pain, post-traumatic headache, jaw fatigue, and severe temporomandibular joint (TMJ) clicking. The most common TMD diagnoses were: masseter trigger points, closing jaw muscle hyperactivity, TMJ synovitis, opening jaw muscle hyperactivity, and advanced TMJ disk derangement. Based primarily on the physical examination, we concluded that the TMJ and surrounding musculature should be examined similarly to other joints, with no preconceived notion that TMD pathology after whiplash is unlikely.

Pre- and post-operative gait analysis for evaluation of neck pain in chronic whiplash

Directory of Open Access Journals (Sweden)

Ginsburg Glen M

2009-07-01

Full Text Available Abstract Introduction Chronic neck pain after whiplash is notoriously refractory to conservative treatment, and positive radiological findings to explain the symptoms are scarce. The apparent disproportionality between subjective complaints and objective findings is significant for the planning of treatment, impairment ratings, and judicial questions on causation. However, failure to identify a symptom's focal origin with routine imaging studies does not invalidate the symptom per se. It is therefore of a general interest both to develop effective therapeutic strategies in chronic whiplash, and to establish techniques for objectively evaluation of treatment outcomes. Methods Twelve patients with chronic neck pain after whiplash underwent pre- and postoperative computerized 3D gait analysis. Results Significant improvement was found in all gait parameters, cervical range-of-motion, and self reported pain (VAS. Conclusion Chronic neck pain is associated with abnormal cervical spine motion and gait patterns. 3D gait analysis is a useful instrument to assess the outcome of treatment for neck pain.

Altered cerebral blood flow in chronic neck pain patients but not in whiplash patients: a 99mTc-HMPAO rCBF study.

Science.gov (United States)

Sundström, Torbjörn; Guez, Michel; Hildingsson, Christer; Toolanen, Göran; Nyberg, Lars; Riklund, Katrine

2006-08-01

A cross-sectional study to investigate regional cerebral blood flow (rCBF) in patients with chronic whiplash syndrome and chronic neck pain patients without previous history of trauma along with a healthy control group. Chronic neck pain is a common disorder and a history of cervical spine injury including whiplash trauma constitute a risk factor for persistent neck pain. The aetiology of the late whiplash syndrome is unknown with no specific diagnostic criteria based on imaging, physiological, or psychological examination. Earlier studies indicate a parieto-occipital hypoperfusion but it is unclear if the hypoperfusion represents a response to chronic pain. The rCBF was monitored in 45 patients with chronic neck pain: 27 cases with chronic whiplash syndrome and 18 age and gender matched cases with non-traumatic chronic neck pain. The rCBF was estimated with single-photon emission computed tomography (SPECT) using technetium-99m hexamethylpropylene amine oxime (HMPAO). The non-traumatic patients displayed rCBF changes in comparison with the whiplash group and the healthy control group. These changes included rCBF decreases in a right temporal region close to hippocampus, and increased rCBF in left insula. The whiplash group displayed no significant differences in rCBF in comparison with the healthy controls. The present study suggests different pain mechanisms in patients with chronic neck pain of non-traumatic origin compared to those with chronic neck pain due to a whiplash trauma.

Gender differences in care-seeking behavior and healthcare consumption immediately after whiplash trauma.

Directory of Open Access Journals (Sweden)

Artur Tenenbaum

Full Text Available The aim was to study gender differences in care-seeking behavior and treatment provided immediately after whiplash trauma.Participants were residents from a defined geographical area, Skaraborg County in the southwestern part of Sweden. A cohort of 3,368 persons exposed to whiplash trauma and attending a healthcare facility immediately after the trauma between 1999 and 2008 were identified in a database. Information about gender, age, time elapsed prior to seeking care, type of healthcare contact, initial treatment provided and eventual hospitalization time was retrieved.Women sought care later than men (p = 0.00074. Women consulted primary healthcare first more often than men, who more often first sought hospital care (p = 0.0060. There were no gender differences regarding the type of treatment after trauma. Women had longer hospital admission than men (p = 0.022, indicating their injuries were at least similar to or worse than men's.Women sought healthcare later than men after whiplash trauma. Although not directly investigated in this study, it raises the question if this may reduce their probability of getting financial compensation compared to men.

Laypersons' expectation of the sequelae of whiplash injury: a cross-cultural comparative study between Canada and Greece.

Science.gov (United States)

Ferrari, Robert; Constantoyannis, Constantine; Papadakis, Nikolas

2003-03-01

The objective of the present study is to compare the frequency and nature of expected 'whiplash' symptoms in Greece [a country where the chronic whiplash syndrome is rare or unknown] with that in Canada. A symptom checklist was administered to 2 subject groups selected from local companies in Patras Greece, and Edmonton, Canada, respectively. 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 the Greek and Edmontonian groups, the pattern of symptoms anticipated closely resembled the acute symptoms commonly reported by accident victims with acute neck sprain, but while up to 50% of Edmontonians also anticipated symptoms to last months or years, very few Greek subjects selected any symptoms as likely to persist. In Greece, 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. What current or previous aspects of society that underlie this remain uncertain. This lack of expectation of chronicity in Greece 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.

Laypersons' expectation of the sequelae of whiplash injury. A cross-cultural comparative study between Canada and Lithuania.

Science.gov (United States)

Ferrari, Robert; Obelieniene, Diana; Russell, Anthony; Darlington, Paul; Gervais, Roger; Green, Paul

2002-11-01

The objective of the present study is to compare the frequency and nature of expected 'whiplash' symptoms in Lithuania (a country where the late whiplash syndrome is rare or unknown) with that in Canada. A symptom checklist was administered to 2 subject groups selected from local companies in Kaunas, Lithuania, and Edmonton, Canada, respectively. Subjects were asked to imagine having suffered a neck sprain (whiplash injury) with no loss of consciousness in a motor vehicle accident, 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 the Lithuanian and Edmontonian groups, the pattern of symptoms anticipated closely resembled the acute symptoms commonly reported by accident victims with acute neck sprain, but while up to 50% of Edmontonians also anticipated symptoms to last months or years, very few Lithuanian subjects selected any symptoms as likely to persist. In Lithuania, despite the documented occurrence of neck sprain symptoms in some 50% of individuals following motor vehicle accidents, there is a very low rate of expectation of any sequelae from this injury. What current or previous aspects of society that underlie this remain uncertain. This lack of expectation of chronicity in Lithuania may, in part, determine the low prevalence of the late whiplash syndrome there. Further studies of symptom expectation as an etiologic factor in the late whiplash syndrome are needed.

Expectancies mediate the relationship between perceived injustice and return to work following whiplash injury: A 1-year prospective study.

Science.gov (United States)

Carriere, J S; Thibault, P; Adams, H; Milioto, M; Ditto, B; Sullivan, M J L

2017-08-01

Emerging evidence suggests that perceived injustice is a risk factor for work disability in individuals with whiplash injury. At present, however, little is known about the processes by which perceived injustice impacts on return to work. The purpose of this study was to examine whether expectancies mediated the relationship between perceived injustice and return to work in patients with whiplash injury. One hundred and fifty-two individuals (81 men, 71 women) with a primary diagnosis of whiplash injury completed self-report measures of pain intensity, perceived injustice and return-to-work expectancies following admission to a rehabilitation programme. Work status was assessed 1 year after discharge. Consistent with previous research, high scores on a measure of perceived injustice were associated with prolonged work disability. Results indicated that high perceptions of injustice were associated with low return-to-work expectancies. Causal mediation analyses revealed that expectancies fully mediated the relationship between perceived injustice and return to work. The findings suggest that intervention techniques designed to target expectancies could improve return-to-work outcomes in patients with whiplash injury. Discussion addresses the processes by which expectancies might impact on return-to-work outcomes and the manner in which negative return-to-work expectancies might be modified through intervention. The study confirms that expectancies are the mechanism through which perceived injustice impacts return to work following whiplash injury. The findings suggest that interventions designed to specifically target return-to-work expectancies might improve rehabilitation outcomes in patients with whiplash injury. © 2017 European Pain Federation - EFIC®.

Determination of fibromyalgia syndrome after whiplash injuries: methodologic issues.

Science.gov (United States)

Robinson, James P; Theodore, Brian R; Wilson, Hilary D; Waldo, Peter G; Turk, Dennis C

2011-06-01

Problems in diagnosing fibromyalgia syndrome (FM) among motor vehicle collision (MVC) patients with whiplash (WL) include the following: the predominance of tender points (TPs) in the neck/shoulder girdle region; the 3-month duration of widespread pain criterion; and, the stability of diagnosis. The present study examined the prevalence of FM in a cohort (N = 326) patients with persistent neck pain 3 months after WL injury who were enrolled in a treatment program. Physical examinations were performed at baseline and at the end of treatment. Results indicated that WL patients had a greater proportion of neck/shoulder girdle TPs, relative to distal TPs. Compared with a matched cohort of treatment-seeking FM patients, WL patients indicated less distal TPs (mean = 7.3 TPs vs. mean = 5.6 TPs, P whiplash patients because of persistent localized tenderness after motor vehicle collisions. Copyright © 2011 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

Persistent pseudomyopia following a whiplash injury in a previously emmetropic woman

Directory of Open Access Journals (Sweden)

Fintan E. Hughes

2017-12-01

It is important that such cases are identified at presentation, as early intervention can improve outcomes in accommodative spasm and reduce the long term psychological effects often associated with whiplash injuries.

Do X-ray-occult fractures play a role in chronic pain following a whiplash injury?

DEFF Research Database (Denmark)

Hertzum-Larsen, Rasmus; Petersen, Henrik; Kasch, Helge

2014-01-01

symptoms following an MVA was invited to have a cervical SPECT shortly post injury and again 6 months later. Associations between occult fractures and pain levels at baseline, 6 and 12 months of follow-up were analyzed. Eighty-eight patients had baseline SPECT performed at median 15 days (range 3-28) post......Whiplash trauma in motor vehicle accidents (MVA) may involve various painful soft tissue damages, but weeks/months later a minority of victims still suffers from various long-lasting and disabling symptoms, whiplash-associated disorders (WAD). The etiology is currently unknown, but X......-ray-occult fractures may be one cause in some cases. The purpose of this prospective study was to examine the association between occult fractures, as seen on bone single photon emission computed tomography (SPECT), with neck-, head- and arm pain. An inception cohort of 107 patients presenting with acute whiplash...

Five years post whiplash injury: Symptoms and psychological factors in recovered versus non-recovered

Directory of Open Access Journals (Sweden)

Stålnacke Britt-Marie

2010-07-01

Full Text Available Abstract Background Few studies have focused on the differences between persons who are recovered after whiplash injury and those who suffer from persistent disability. The primary aim of this study was therefore to examine differences in symptoms, psychological factors and life satisfaction between subjects classified as recovered and those with persistent disability five years after whiplash injury based on the Neck Disability Index (NDI. Methods A set of questionnaires was answered by 158 persons (75 men, 83 women to assess disability (NDI, pain intensity (VAS, whiplash-related symptoms (Rivermead Post-Concussion Symptoms Questionnaire, RPQ, post-traumatic stress (Impact of Event Scale, IES, depression (Beck's depression inventory, BDI and life satisfaction (LiSat-11. The participants were divided into three groups based on the results of the NDI: recovered (34.8%, mild disability (37.3% and moderate/severe disability (27.3%. Results The moderate/severe group reported significantly higher VAS, BDI and IES scores and lower level of physical health and psychological health compared to the mild and the recovered groups. Less significant differences were reported between the mild and the recovered groups. Conclusions The group with the highest disability score reported most health problems with pain, symptoms, depression, post-traumatic stress and decreased life satisfaction. These findings indicate that classifying these subjects into subgroups based on disability levels makes it possible to optimize the management and treatment after whiplash injury.

The relationship of whiplash injury and temporomandibular disorders: a narrative literature review☆

Science.gov (United States)

Fernandez, Charles E.; Amiri, Abid; Jaime, Joseph; Delaney, Paul

2009-01-01

Objective The purpose of this article is to offer a narrative review and discuss the possible relationship between temporomandibular disorders (TMDs) and whiplash injuries. Methods Databases from 1966 to present were searched including PubMed; Manual, Alternative, and Natural Therapy Index System; and Cumulative Index for Nursing and Allied Health Literature. Search terms used included whiplash injury, temporomandibular disorders and craniomandibular disorders. Inclusion criteria consisted of studies on orofacial pain of a musculoskeletal origin addressing the following topics: posttraumatic temporomandibular disorder (pTMD) incidence and prevalence, mechanism of injury, clinical findings and characteristics, prognosis (including psychologic factors). Excluded were studies of orofacial pain from nontraumatic origin, as well as nonmusculoskeletal causes including neurologic, vascular, neoplastic, or infectious disease. Results Thirty-two studies describing the effects of whiplash on TMD were reviewed based on inclusion/exclusion criteria. The best evidence from prospective studies indicates a low to moderate incidence and prevalence. Only 3 studies addressed mechanism of injury theories. Most studies focusing on clinical findings and characteristics suggest significant differences when comparing pTMD to idiopathic/nontraumatic patients. Regarding prognosis, most studies suggest a significant difference when comparing pTMD to idiopathic/nontraumatic TMD patients, with pTMD having a poorer prognosis. Conclusions There is conflicting evidence regarding the effects of whiplash on the development of TMD. Furthermore, because of lack of homogeneity in the study populations and lack of standardization of data collection procedures and outcomes measured, this review cannot conclusively resolve the controversies that exist concerning this relationship. This review of the literature is provided to clarify the issues and to provide useful clinical information for health care

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

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 ...

MRI assessment of the alar ligaments in the late stage of whiplash injury - a study of structural abnormalities and observer agreement

Energy Technology Data Exchange (ETDEWEB)

Krakenes, J.; Moen, G.; Nordli, H. [Section of Neuroradiology, Department of Radiology, Haukeland University Hospital, University of Bergen Medical School (Norway); Kaale, B.R. [Firda Medical Centre, Sandane (Norway); Gilhus, N.E. [Department of Neurology, Haukeland University Hospital, University of Bergen Medical School (Norway); Rorvik, J. [Department of Radiology, Haukeland University Hospital, University of Bergen Medical School (Norway)

2002-07-01

Our aim was to characterise and classify structural changes in the alar ligaments in the late stage of whiplash injuries by use of a new MRI protocol, and to evaluate the reliability and the validity of this classification. We studied 92 whiplash-injured and 30 uninjured individuals who underwent proton density-weighted MRI of the craniovertebral junction in three orthogonal planes. Changes in the alar ligaments (grades 0-3) based on the ratio between the high signal area and the total cross-sectional area were rated twice at a 4-month interval, independently by three radiologists. Inter- and intraobserver statistics were calculated by ordinary and weighted kappa. Cases classified differently were reviewed to identify potential causes for disagreement. The alar ligaments were satisfactorily demonstrated in all cases (244 ligaments in 122 individuals). The lesions, 2-9 years after the injury, varied from small high-signal spots to high signal throughout the cross-sectional area. Signal was highest near the condylar insertion in 82 of 94 ligaments, indicating a lesion near that insertion, and near the dental insertion in eight, indicating a medial lesion. No grade 2 or 3 lesion was found in the control group. At least two observers assigned the same grade to 214 ligaments (87.7%) on the second occasion. In 30 ligaments (12.3%) this agreement was not obtained. Pair-wise interobserver agreement (weighted kappa) was fair to moderate (0.31-0.54) in the first grading, improving to moderate (0.49-0.57) in the second. Intraobserver agreement (weighted kappa) was moderate to good (0.43-0.70). Whiplash trauma can cause permanent damage to the alar ligaments, which can be shown by high-resolution proton density-weighted MRI. Reliability of classification of alar ligament lesions needs to be improved. (orig.)

MRI assessment of the alar ligaments in the late stage of whiplash injury - a study of structural abnormalities and observer agreement

International Nuclear Information System (INIS)

Krakenes, J.; Moen, G.; Nordli, H.; Kaale, B.R.; Gilhus, N.E.; Rorvik, J.

2002-01-01

Our aim was to characterise and classify structural changes in the alar ligaments in the late stage of whiplash injuries by use of a new MRI protocol, and to evaluate the reliability and the validity of this classification. We studied 92 whiplash-injured and 30 uninjured individuals who underwent proton density-weighted MRI of the craniovertebral junction in three orthogonal planes. Changes in the alar ligaments (grades 0-3) based on the ratio between the high signal area and the total cross-sectional area were rated twice at a 4-month interval, independently by three radiologists. Inter- and intraobserver statistics were calculated by ordinary and weighted kappa. Cases classified differently were reviewed to identify potential causes for disagreement. The alar ligaments were satisfactorily demonstrated in all cases (244 ligaments in 122 individuals). The lesions, 2-9 years after the injury, varied from small high-signal spots to high signal throughout the cross-sectional area. Signal was highest near the condylar insertion in 82 of 94 ligaments, indicating a lesion near that insertion, and near the dental insertion in eight, indicating a medial lesion. No grade 2 or 3 lesion was found in the control group. At least two observers assigned the same grade to 214 ligaments (87.7%) on the second occasion. In 30 ligaments (12.3%) this agreement was not obtained. Pair-wise interobserver agreement (weighted kappa) was fair to moderate (0.31-0.54) in the first grading, improving to moderate (0.49-0.57) in the second. Intraobserver agreement (weighted kappa) was moderate to good (0.43-0.70). Whiplash trauma can cause permanent damage to the alar ligaments, which can be shown by high-resolution proton density-weighted MRI. Reliability of classification of alar ligament lesions needs to be improved. (orig.)

Magnetic Resonance Imaging-Based Prediction of the Relationship between Whiplash Injury and Temporomandibular Disorders

Directory of Open Access Journals (Sweden)

Yeon-Hee Lee

2018-01-01

Full Text Available PurposeWhiplash injury can cause internal derangement of the temporomandibular joint (TMJ and lead to temporomandibular disorders (TMDs. Our aim was to evaluate whether the initial clinical findings in TMD patients with whiplash injury are correlated with their magnetic resonance imaging (MRI characteristics.Materials and methodsThis case–control study involved 219 patients (135 women, 84 men; mean age: 37.84 years who visited our orofacial pain clinic with TMD; TMD was diagnosed using the diagnostic criteria for TMD Axis I. Patients were categorized into three groups based on the presence and type of macrotrauma: in the “wTMD” group, patients had suffered whiplash injury; patients in the “pTMD” group had post-traumatic TMD; the “iTMD” group comprised patients who had presented with TMD symptoms and had sustained no macrotrauma. We investigated the presence of disk displacement, effusion, disk deformity, and condylar degeneration, and changes in the lateral pterygoid muscle (LPM. To evaluate the severity of TMD pain and objectively analyze symptoms, we used a visual analog scale (VAS, palpation index (PI, neck PI, dysfunction index, and craniomandibular index (CMI.ResultsThe VAS scores, and the severity indexes of the TMD including PI, neck PI, and CMI were highest in the wTMD patients. Atrophy of the LPM was most commonly seen in the wTMD group, as was disk deformity. In wTMD patients only, VAS score was significantly correlated with stress; it was correlated with headache in wTMD and iTMD patients. The clinical symptoms of TMD were not correlated with MRI findings in the wTMD group. However, alterations in the LPM were strongly correlated with disk displacement.ConclusionIf clinicians recognize alterations in the LPM and disk displacement in the TMJ, they will better understand the clinical symptoms and pathophysiology of TMD with whiplash injury. Whiplash injury may lead to TMD via different mechanisms from other macrotraumas.

Altered cerebral blood flow in chronic neck pain patients but not in whiplash patients: a 99mTc-HMPAO rCBF study

OpenAIRE

Sundström, Torbjörn; Guez, Michel; Hildingsson, Christer; Toolanen, Göran; Nyberg, Lars; Riklund, Katrine

2006-01-01

A cross-sectional study to investigate regional cerebral blood flow (rCBF) in patients with chronic whiplash syndrome and chronic neck pain patients without previous history of trauma along with a healthy control group. Chronic neck pain is a common disorder and a history of cervical spine injury including whiplash trauma constitute a risk factor for persistent neck pain. The aetiology of the late whiplash syndrome is unknown with no specific diagnostic criteria based on imaging, physiologica...

Factors associated with work ability in patients with chronic whiplash-associated disorder grade II-III: A cross-sectional analysis.

Science.gov (United States)

Agnew, Louise; Johnston, Venerina; Landén Ludvigsson, Maria; Peterson, Gunnel; Overmeer, Thomas; Johansson, Gun; Peolsson, Anneli

2015-06-01

To investigate the factors related to self-perceived work ability in patients with chronic whiplash-associated disorder grades II-III. Cross-sectional analysis. A total of 166 working age patients with chronic whiplash-associated disorder. A comprehensive survey collected data on work ability (using the Work Ability Index); demographic, psychosocial, personal, work- and condition-related factors. Forward, stepwise regression modelling was used to assess the factors related to work ability. The proportion of patients in each work ability category were as follows: poor (12.7%); moderate (39.8%); good (38.5%); excellent (9%). Seven factors explained 65% (adjusted R2 = 0.65, p whiplash-associated disorder.

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

Elevated [11C]-D-Deprenyl Uptake in Chronic Whiplash Associated Disorder Suggests Persistent Musculoskeletal Inflammation

Science.gov (United States)

Linnman, Clas; Appel, Lieuwe; Fredrikson, Mats; Gordh, Torsten; Söderlund, Anne; Långström, Bengt; Engler, Henry

2011-01-01

There are few diagnostic tools for chronic musculoskeletal pain as structural imaging methods seldom reveal pathological alterations. This is especially true for Whiplash Associated Disorder, for which physical signs of persistent injuries to the neck have yet to be established. Here, we sought to visualize inflammatory processes in the neck region by means Positron Emission Tomography using the tracer 11C-D-deprenyl, a potential marker for inflammation. Twenty-two patients with enduring pain after a rear impact car accident (Whiplash Associated Disorder grade II) and 14 healthy controls were investigated. Patients displayed significantly elevated tracer uptake in the neck, particularly in regions around the spineous process of the second cervical vertebra. This suggests that whiplash patients have signs of local persistent peripheral tissue inflammation, which may potentially serve as a diagnostic biomarker. The present investigation demonstrates that painful processes in the periphery can be objectively visualized and quantified with PET and that 11C-D-deprenyl is a promising tracer for these purposes. PMID:21541010

Novel insights into the interplay between ventral neck muscles in individuals with whiplash-associated disorders

Science.gov (United States)

Peterson, Gunnel; Nilsson, David; Trygg, Johan; Falla, Deborah; Dedering, Åsa; Wallman, Thorne; Peolsson, Anneli

2015-01-01

Chronic whiplash-associated disorder (WAD) is common after whiplash injury, with considerable personal, social, and economic burden. Despite decades of research, factors responsible for continuing pain and disability are largely unknown, and diagnostic tools are lacking. Here, we report a novel model of mechanical ventral neck muscle function recorded from non-invasive, real-time, ultrasound measurements. We calculated the deformation area and deformation rate in 23 individuals with persistent WAD and compared them to 23 sex- and age-matched controls. Multivariate statistics were used to analyse interactions between ventral neck muscles, revealing different interplay between muscles in individuals with WAD and healthy controls. Although the cause and effect relation cannot be established from this data, for the first time, we reveal a novel method capable of detecting different neck muscle interplay in people with WAD. This non-invasive method stands to make a major breakthrough in the assessment and diagnosis of people following a whiplash trauma. PMID:26472599

Elevated [11C]-D-deprenyl uptake in chronic Whiplash Associated Disorder suggests persistent musculoskeletal inflammation.

Directory of Open Access Journals (Sweden)

Clas Linnman

Full Text Available There are few diagnostic tools for chronic musculoskeletal pain as structural imaging methods seldom reveal pathological alterations. This is especially true for Whiplash Associated Disorder, for which physical signs of persistent injuries to the neck have yet to be established. Here, we sought to visualize inflammatory processes in the neck region by means Positron Emission Tomography using the tracer (11C-D-deprenyl, a potential marker for inflammation. Twenty-two patients with enduring pain after a rear impact car accident (Whiplash Associated Disorder grade II and 14 healthy controls were investigated. Patients displayed significantly elevated tracer uptake in the neck, particularly in regions around the spineous process of the second cervical vertebra. This suggests that whiplash patients have signs of local persistent peripheral tissue inflammation, which may potentially serve as a diagnostic biomarker. The present investigation demonstrates that painful processes in the periphery can be objectively visualized and quantified with PET and that (11C-D-deprenyl is a promising tracer for these purposes.

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

Acute stress response and recovery after whiplash injuries. A one-year prospective study.

Science.gov (United States)

Kongsted, Alice; Bendix, Tom; Qerama, Erisela; Kasch, Helge; Bach, Flemming W; Korsholm, Lars; Jensen, Troels S

2008-05-01

Chronic whiplash-associated disorder (WAD) represents a major medical and psycho-social problem. The typical symptomatology presented in WAD is to some extent similar to symptoms of post traumatic stress disorder. In this study we examined if the acute stress reaction following a whiplash injury predicted long-term sequelae. Participants with acute whiplash-associated symptoms after a motor vehicle accident were recruited from emergency units and general practitioners. The predictor variable was the sum score of the impact of event scale (IES) completed within 10 days after the accident. The main outcome-measures were neck pain and headache, neck disability, general health, and working ability one year after the accident. A total of 737 participants were included and completed the IES, and 668 (91%) participated in the 1-year follow-up. A baseline IES-score denoting a moderate to severe stress response was obtained by 13% of the participants. This was associated with increased risk of considerable persistent pain (OR=3.3; 1.8-5.9), neck disability (OR=3.2; 1.7-6.0), reduced working ability (OR=2.8; 1.6-4.9), and lowered self-reported general health one year after the accident. These associations were modified by baseline neck pain intensity. It was not possible to distinguish between participants who recovered and those who did not by means of the IES (AUC=0.6). In conclusion, the association between the acute stress reaction and persistent WAD suggests that post traumatic stress reaction may be important to consider in the early management of whiplash injury. However, the emotional response did not predict chronicity in individuals.

Gender differences in care-seeking behavior and healthcare consumption immediately after whiplash trauma

Science.gov (United States)

Tenenbaum, Artur; Nordeman, Lena; Sunnerhagen, Katharina S.; Gunnarsson, Ronny

2017-01-01

Objective The aim was to study gender differences in care-seeking behavior and treatment provided immediately after whiplash trauma. Methods Participants were residents from a defined geographical area, Skaraborg County in the southwestern part of Sweden. A cohort of 3,368 persons exposed to whiplash trauma and attending a healthcare facility immediately after the trauma between 1999 and 2008 were identified in a database. Information about gender, age, time elapsed prior to seeking care, type of healthcare contact, initial treatment provided and eventual hospitalization time was retrieved. Results Women sought care later than men (p = 0.00074). Women consulted primary healthcare first more often than men, who more often first sought hospital care (p = 0.0060). There were no gender differences regarding the type of treatment after trauma. Women had longer hospital admission than men (p = 0.022), indicating their injuries were at least similar to or worse than men’s. Conclusion Women sought healthcare later than men after whiplash trauma. Although not directly investigated in this study, it raises the question if this may reduce their probability of getting financial compensation compared to men. PMID:28441465

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

Pain, perceived injustice and the persistence of post-traumatic stress symptoms during the course of rehabilitation for whiplash injuries.

Science.gov (United States)

Sullivan, Michael J L; Thibault, Pascal; Simmonds, Maureen J; Milioto, Maria; Cantin, André-Philippe; Velly, Ana M

2009-10-01

The present study assessed the role of pain and pain-related psychological variables in the persistence of post-traumatic stress symptoms following whiplash injury. Individuals (N=112) with whiplash injuries who had been admitted to a standardized multidisciplinary rehabilitation program were asked to complete measures of pain, post-traumatic stress symptoms, physical function and pain-related psychological variables at three different points during their treatment program. The findings are consistent with previous research showing that indicators of injury severity such as pain, reduced function and disability, and scores on pain-related psychological were associated with more severe post-traumatic stress symptoms in individuals with whiplash injuries. Contrary to expectations, indicators of pain severity did not contribute to the persistence of post-traumatic stress symptoms. Univariate analyses revealed that self-reported disability, pain catastrophizing and perceived injustice were significant determinants of the persistence of post-traumatic stress symptoms. In multivariate analyses, only perceived injustice emerged as a unique predictor of the persistence of post-traumatic stress symptoms. The results suggest that early adequate management of pain symptoms and disability consequent to whiplash injury might reduce the severity of post-traumatic stress symptoms. The development of effective intervention techniques for targeting perceptions of injustice might be important for promoting recovery of post-traumatic stress symptoms consequent to whiplash injury.

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.

Rear impact whiplash neck injury reduction technology; Jidosha komen shototsu ni okeru muchiuchisho teigen gijutsu

Energy Technology Data Exchange (ETDEWEB)

Watanabe, Y.; Ichikawa, H.; Kayama, O. [Nissan Motor Co. Ltd., Tokyo (Japan)

1999-11-01

Even though whiplash neck injuries suffered in low-speed rear impacts are one of the major concern in traffic accidents, the mechanism of the injuries is not fully understood at present. Hence, the countermeasures have not been clear, yet. The bio-mechanical research was done to understand the injuries and three different modes of occupant's motion related to the mechanism were found. Based on this research, Nissan Active Head Restraint has been developed to reduce whiplash neck injuries in low-speed rear impacts. (author)

Maintaining a balance: a focus group study on living and coping with chronic whiplash-associated disorder

Directory of Open Access Journals (Sweden)

Ihlebæk Camilla

2010-07-01

Full Text Available Abstract Background There is little qualitative insight into how persons with chronic Whiplash-Associated Disorder cope on a day to day basis. This study seeks to identify the symptoms persons with Whiplash-Associated Disorder describe as dominating and explore their self-initiated coping strategies. Methods Qualitative study using focus groups interviews. Fourteen Norwegian men and women with Whiplash-Associated Disorder (I or II were recruited to participate in two focus groups. Data were analyzed according to a phenomenological approach, and discussed within the model of Cognitive Activation Theory of Stress (CATS. Results Participants reported neck and head pain, sensory hypersensitivity, and cognitive dysfunction following their whiplash injury. Based on the intensity of symptoms, participants divided everyday life into good and bad periods. In good periods the symptoms were perceived as manageable. In bad periods the symptoms intensified and took control of the individual. Participants expressed a constant notion of trying to balance their three main coping strategies; rest, exercise, and social withdrawal. In good periods participants experienced coping by expecting good results from the strategies they used. In bad periods they experienced no or negative relationships between their behavioral strategies and their complaints. Conclusions Neck and head pain, sensory hypersensitivity, and cognitive dysfunction were reported as participants' main complaints. A constant notion of balancing between their three main coping strategies; rest, exercise, and social withdrawal, was described.

Sex Differences in Patients with Chronic Pain Following Whiplash Injury: The Role of Depression, Fear, Somatization, Social Support, and Personality Traits.

Science.gov (United States)

Malfliet, Anneleen; De Kooning, Margot; Inghelbrecht, Els; Hachimi-Idrissi, Said; Willems, Bert; Bernheim, Jan; Nijs, Jo

2015-11-01

Chronic whiplash-associated disorders (chronic WAD) cover a large variety of clinical manifestations that can occur after a whiplash injury. Women have an increased risk of developing chronic WAD, and it is suggested that psychosocial factors are related to long-term pain and functioning following whiplash injury and persistence of chronic pain. This leads to the question whether there are sex differences in psychosocial factors in chronic WAD. This study included 117 subjects who had experienced a whiplash injury at least 3 months before the start of the study (mean duration of pain: 67.29 ± 63.86 months, range: 297 months). They were selected as chronically symptomatic, by excluding those who had recovered from their whiplash injury. Psychosocial aspects (including depression, fear, somatization, social support, and personality traits) were assessed by validated questionnaires, and sex differences were tested using a univariate analysis of variance (ANCOVA), with age and time from whiplash injury as covariates. No differences in depression, fear, somatization, discrepancy in social support personality trait, Neck Disability Index scores, physical functioning, bodily pain, or general health were present between women and men with chronic WAD. Women with chronic WAD reported higher levels of emotional support in problem situations and social companionship. Except for emotional support in problem situations and social companionship, psychosocial factors do not differ between men and women with chronic WAD. These findings imply little to no risk for sex bias in studies investigating psychosocial issues in patients with chronic WAD. © 2014 World Institute of Pain.

A Research Synthesis of Therapeutic Interventions for Whiplash-Associated Disorder (WAD: Part 4 – Noninvasive Interventions for Chronic WAD

Directory of Open Access Journals (Sweden)

Robert W Teasell

2010-01-01

Full Text Available Whiplash-associated disorder (WAD represents a significant public health problem, resulting in substantial social and economic costs throughout the industrialized world. While many treatments have been advocated for patients with WAD, scientific evidence supporting their effectiveness is often lacking. A systematic review was conducted to evaluate the strength of evidence for 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 fourth in a five-part series, evaluates the evidence for noninvasive interventions initiated during the chronic phase of WAD. Twenty-two studies that met the inclusion criteria were identified, 12 of which were randomized controlled trials with ‘good’ overall methodological quality (median Physiotherapy Evidence Database score of 6. For the treatment of chronic WAD, there is evidence to suggest that exercise programs are effective in relieving whiplash-related pain, at least over the short term. While the majority of a subset of nine studies supported the effectiveness of interdisciplinary interventions, the two randomized controlled trials provided conflicting results. Finally, there was limited evidence, consisting of one supportive case series each, that both manual joint manipulation and myofeedback training may provide some benefit. Based on the available research, exercise programs were the most effective noninvasive treatment for patients with chronic WAD, although many questions remain regarding the relative effectiveness of various exercise regimens.

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.

Eye movements in patients with Whiplash Associated Disorders: A systematic review

NARCIS (Netherlands)

B.K. Ischebeck (B.); J. de Vries (Jurryt); J.N. van der Geest (Jos); M. Janssen (Malou); J.-P. van Wingerden (Jan-Paul); G.J. Kleinrensink (Gert Jan); M.A. Frens (Maarten)

2016-01-01

textabstractBackground: Many people with Whiplash Associated Disorders (WAD) report problems with vision, some of which may be due to impaired eye movements. Better understanding of such impaired eye movements could improve diagnostics and treatment strategies. This systematic review surveys the

[Whiplash injury as a function of the accident mechanism. Neuro-otological differential diagnostic findings].

Science.gov (United States)

Geiger, G; Aliyev, R M

2012-07-01

Depending on the type of collision, car occupants who are involved in traffic accidents are often exposed to the unexpected effects on the cervical spine of traumatic stimuli from different directions. In a rear-end collision or a frontal collision of the car it is most likely that there is an effect of linear acceleration and a lateral or side impact acceleration of axial rotation on the cervical spine. The neuro-otological manifestations of whiplash injuries that can occur in response to various trauma mechanisms have not yet been sufficiently investigated. Data from 64 patients who suffered a whiplash injury were selected for analysis. In 32 patients the trauma mechanism was a sudden action on the cervical spine from a linear impulse caused by a head-on collision of cars or rear-end collision. In the other 32 patients the trauma mechanism was a sudden action of an axial neck rotation at a side impact collision or a cross collision. The study compared the results of neuro-otological findings between the two patient groups. A comparison of the neuro-otological examination data of 64 patients revealed that there were 32 patients who had a sudden injury mechanism of cervical axial rotation, the prevalence of central vestibular and sensory impairments, such as pathological central nystagmus disinhibition, pathological changes in the auditory brainstem evoked potentials (ABEP), the auditory evoked cortical potentials (ALEP) and visual evoked potentials (VEP). In the second group of patients where the injury mechanism consisted of an unexpected linear momentum, peripheral vestibular and sensory disorders were predominant. The observed differences in neuro-otological manifestations of whiplash trauma, which occur depending on the trauma mechanism, can be used for differential diagnostic purposes. The whiplash injuries of the cervical spine induced by an axial rotation acceleration showed a prevalence of central vestibular and sensory disturbances, while the whiplash

Therapy Recommendation “Act as Usual” in Patients with Whiplash Injuries QTF I°

Science.gov (United States)

Dehner, Christoph; Kraus, Michael; Schöll, Hendrik; Schneider, Florian; Richter, Peter; Kramer, Michael

2012-01-01

Up to now no therapy study has used the classification system of the Quebec Task Force (QTF) to differentiate between patients with (QTF II°) and without functional disorders (QTF I°). This differentiation seems meaningful, as this difference may be relevant for the correct treatment planning. In this context the effect of the therapy recommendation “act as usual” has been evaluated in a homogeneous patient collective with whiplash injuries QTF I°. 470 patients with acute whiplash injuries had been catched in this study and classified according to the QTF. 359 patients (76.4%) with QTF I° injuries could be identified. Out of that 162 patients were enrolled to the study and received the therapy recommendation “act as usual” and the adapted pain treatment with non-steroidal anti-inflammatory drugs (NSAID). After six months the outcome was evaluated by phone. After injury the median pain score assessed by a visual analogue scale (VAS) was 5.4 (min = 3.3; max = 8.5). After six months 5 of the 162 patients complained intermittent pain symptoms (VAS values whiplash injuries QTF I° do not need physical therapy. An escalation of therapy measures should be reserved to patients with complicated healing processes. PMID:23121740

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

Science.gov (United States)

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

2003-07-01

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, there is some inconsistency in the literature and there have been no systematic attempts to analyze the level of evidence for prognostic factors in whiplash recovery. Studies were selected for inclusion following a comprehensive search of MEDLINE, EMBASE, CINAHL, the database of the Dutch Institute of Allied Health Professions up until April 2002 and hand searches of the reference lists of retrieved articles. Studies were selected if the objective was to assess prognostic factors associated with recovery; the design was a prospective cohort study; the study population included at least an identifiable subgroup of patients suffering from a whiplash injury; and the paper was a full report published in English, German, French or Dutch. The methodological quality was independently assessed by two reviewers. A study was considered to be of 'high quality' if it satisfied at least 50% of the maximum available quality score. Two independent reviewers extracted data and the association between prognostic factors and functional recovery was calculated in terms of risk estimates. Fifty papers reporting on twenty-nine cohorts were included in the review. Twelve cohorts were considered to be of 'high quality'. Because of the heterogeneity of patient selection, type of prognostic factors and outcome measures, no statistical pooling was able to be performed. Strong evidence was found for high initial pain intensity being an adverse prognostic factor. There was strong evidence that for older age, female gender, high acute psychological response, angular deformity of the neck, rear-end collision, and compensation not being associated with an adverse prognosis. Several physical (e

A new stratified risk assessment tool for whiplash injuries developed from a prospective observational study

Science.gov (United States)

Kasch, Helge; Kongsted, Alice; Qerama, Erisela; Bach, Flemming W; Bendix, Tom; Jensen, Troels Staehelin

2013-01-01

Objectives An initial stratification of acute whiplash patients into seven risk-strata in relation to 1-year work disability as primary outcome is presented. Design The design was an observational prospective study of risk factors embedded in a randomised controlled study. Setting Acute whiplash patients from units, general practitioners in four Danish counties were referred to two research centres. Participants During a 2-year inclusion period, acute consecutive whiplash-injured (age 18–70 years, rear-end or frontal-end car accident and WAD (whiplash-associated disorders) grades I–III, symptoms within 72 h, examination prior to 10 days postinjury, capable of written/spoken Danish, without other injuries/fractures, pre-existing significant somatic/psychiatric disorder, drug/alcohol abuse and previous significant pain/headache). 688 (438 women and 250 men) participants were interviewed and examined by a study nurse after 5 days; 605 were completed after 1 year. A risk score which included items of initial neck pain/headache intensity, a number of non-painful complaints and active neck mobility was applied. The primary outcome parameter was 1-year work disability. Results The risk score and number of sick-listing days were related (Kruskal-Wallis, pwhiplash. Neck-mobility was a strong predictor in this study; however, it was a more inconsistent predictor in other studies. Conclusions Application of the risk assessment score and use of the risk strata system may be beneficial in future studies and may be considered as a valuable tool to assess return-to-work following injuries; however, further studies are needed. PMID:23370009

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

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

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...

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...

A new stratified risk assessment tool for whiplash injuries developed from a prospective observational study

DEFF Research Database (Denmark)

Kasch, Helge; Kongsted, Alice; Qerama, Erisela

2013-01-01

within 72 h, examination prior to 10 days postinjury, capable of written/spoken Danish, without other injuries/fractures, pre-existing significant somatic/psychiatric disorder, drug/alcohol abuse and previous significant pain/headache). 688 (438 women and 250 men) participants were interviewed......OBJECTIVES: An initial stratification of acute whiplash patients into seven risk-strata in relation to 1-year work disability as primary outcome is presented. DESIGN: The design was an observational prospective study of risk factors embedded in a randomised controlled study. SETTING: Acute whiplash...... and number of sick-listing days were related (Kruskal-Wallis, p

Tratamiento osteopático en una lesión por Whiplash. Caso clínico

OpenAIRE

Ruiz Morcillo, Irene

2008-01-01

Introducción: El caso que presentamos a continuación se trata de un hombre de 25 años. Acude a consulta a los diez días de sufrir un accidente de tráfico y con un diagnóstico médico de whiplash o latigazo cervical. El paciente refiere dolor y disminución de la movilidad en la región cervical, dorsal alta, lumbosacra y mareos leves desde el accidente. Objetivos: Explicar el mecanismo de la lesión por Whiplash; valoración de los resultados obtenidos tras el tratamiento osteopátic...

Expectancies Mediate the Relations Among Pain Catastrophizing, Fear of Movement, and Return to Work Outcomes After Whiplash Injury.

Science.gov (United States)

Carriere, Junie S; Thibault, Pascal; Milioto, Maria; Sullivan, Michael J L

2015-12-01

Pain catastrophizing and fear of movement have been identified as key predictors of prolonged work disability after whiplash injury. However, little is known about the processes by which pain catastrophizing and fear of movement affect return to work. This study investigated the mediating role of expectancies on the relations between pain catastrophizing and return to work, and between fear of movement and return to work after whiplash injury. The study sample consisted of 154 individuals with whiplash injury who were enrolled in a multidisciplinary pain rehabilitation program. Participants completed measures of pain catastrophizing, fear of movement, and return-to-work expectancies after admission to a rehabilitation program. A follow-up telephone interview was used to assess work status 1 year after discharge. Consistent with previous research, analyses revealed that expectancies, pain catastrophizing, and fear of movement were significant predictors of return to work at 1-year follow-up. Regression analyses (bootstrapping) revealed that expectancies partially mediated the relation between catastrophizing and return to work. Expectancies completely mediated the relation between fear of movement and return to work. The significant predictive and mediating role of expectancies on return to work argues for the inclusion of expectancies as a specific target of intervention for individuals with whiplash injury. The findings suggest that expectancies might be part of the pathways by which pain catastrophizing and fear of movement affect return-to-work outcomes after whiplash injury. The findings argue for greater attention to return-to-work expectancies as a risk factor for problematic recovery outcomes as well as a target of intervention. Copyright © 2015 American Pain Society. Published by Elsevier Inc. All rights reserved.

The relationship between chronic whiplash-associated disorder and post-traumatic stress: attachment-anxiety may be a vulnerability factor.

Science.gov (United States)

Andersen, Tonny Elmose; Elklit, Ask; Vase, Lene

2011-01-01

In more than 90% of whiplash accidents a good explanation regarding the association between trauma mechanism, organic pathology, and persistent symptoms has failed to be provided. We predicted that the severity of chronic whiplash-associated disorder (WAD), measured as number of whiplash symptoms, pain duration, pain-related disability, and degree of somatisation would be associated with the number of post-traumatic stress disorder symptoms (PTSD). Secondly, we expected attachment-anxiety to be a vulnerability factor in relation to both PTSD and WAD. Data were collected from 1,349 women and 360 men suffering from WAD from the Danish Society for Polio, Traffic, and Accident Victims. The PTSD symptoms were measured by the Harvard Trauma Questionnaire. All three core PTSD clusters were included: re-experiencing, avoidance, and hyperarousal. Attachment security was measured along the two dimensions, attachment-anxiety and attachment-avoidance, by the Revised Adult Attachment Scale. PTSD symptoms were significantly related to the severity of WAD. In particular, the PTSD clusters of avoidance and hyperarousal were associated with the number of whiplash symptoms, disability, and somatisation. Attachment-anxiety was significantly related to PTSD symptoms and somatisation but not to pain and disability. A co-morbidity of 38.8% was found between the PTSD diagnosis and WAD, and about 20% of the sample could be characterised as securely attached. The PTSD clusters of avoidance and hyperarousal were significantly associated with severity of WAD. The study emphasises the importance of assessing PTSD symptomatology after whiplash injury. Furthermore, it highlights that attachment theory may facilitate the understanding of why some people are more prone to develop PTSD and WAD than others.

Can kinesiophobia predict the duration of neck symptoms in acute whiplash?

NARCIS (Netherlands)

Buitenhuis, J; Jaspers, JPC; Fidler, [No Value

2006-01-01

Objectives: In low back pain, clinical studies suggest that kinesiophobia (fear of movement/(re)injury) is important in the etiology of chronic symptoms. In this prospective cohort study, the predictive role of kinesiophobia in the development of late whiplash syndrome was examined. Methods: Victims

Deep muscle pain, tender points and recovery in acute whiplash patients: a 1-year follow-up study.

Science.gov (United States)

Kasch, Helge; Qerama, Erisela; Kongsted, Alice; Bach, Flemming W; Bendix, Tom; Jensen, Troels S

2008-11-15

Local sensitization to noxious stimuli has been previously described in acute whiplash injury and has been suggested to be a risk factor for chronic sequelae following acute whiplash injury. In this study, we prospectively examined the development of tender points and mechano-sensitivity in 157 acute whiplash injured patients, who fulfilled criteria for WAD grade 2 (n=153) or grade 3 (n=4) seen about 5 days after injury (4.8+/-2.3) and who subsequently had or had not recovered 1 year after a cervical sprain. Tender point scores and stimulus-response function for mechanical pressure were determined in injured and non-injured body regions at specific time-points after injury. Thirty-six of 157 WAD grade 2 patients (22.9%) had not recovered, defined as reduced work capacity after 1 year. Non-recovered patients had higher total tender point scores after 12 (pwhiplash injury and the development of further sensitization in patients with long-term disability.

Validity of the neck disability index, Northwick Park neck pain questionnaire, and problem elicitation technique for measuring disability associated with whiplash-associated disorders

NARCIS (Netherlands)

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

2003-01-01

The Neck Disability Index (NDI) and Northwick Park Neck Pain Questionnaire (NPQ) were developed to measure self-perceived disability from neck pain, including that which may arise from whiplash injury. However, there is little data specifically concerning their validity for whiplash-associated

Physiotherapists' Beliefs About Whiplash-associated Disorder: A Comparison Between Singapore and Queensland, Australia.

Science.gov (United States)

Ng, Tze Siong; Pedler, Ashley; Vicenzino, Bill; Sterling, Michele

2015-06-01

Healthcare providers' beliefs may play a role in the outcome of whiplash-associated disorders (WAD), a condition which is proposed to be culturally dependent. Clinical practice guidelines recommend an active approach for the management of WAD, which is often delivered by physiotherapists. However, there is no data on physiotherapists' whiplash beliefs. Our primary objective was to determine physiotherapists' beliefs from Queensland (Australia) and Singapore, two cultures with differing prevalence of chronic musculoskeletal pain and chronic WAD. A pen and paper survey of musculoskeletal physiotherapists practicing in Queensland and Singapore was conducted. Participants completed questionnaires consisting of patient vignettes and statements inquiring knowledge and attitudes towards WAD. Chi-square tests of significance were used to compare the responses of physiotherapists from both samples. Ninety-one (response rate 45%) Queensland-based and 94 (response rate 98%) Singapore-based physiotherapists participated in the study. The beliefs in the management strategies for the patient vignettes were generally consistent with practice guidelines. A higher proportion of Queensland-based physiotherapists expected permanent disabilities for the patient vignette depicting chronic WAD (Queensland: 55% Singapore: 28% Pearson chi-sq 18.76, p Queensland and Singapore were similar but there were specific differences. Physiotherapists' whiplash beliefs in Queensland and Singapore did not clearly reflect the difference in prevalence of chronic musculoskeletal pain or chronic WAD in Queensland and Singapore. Copyright © 2014 John Wiley & Sons, Ltd.

Post-traumatic stress symptom clusters in acute whiplash associated disorder and their prediction of chronic pain-related disability

OpenAIRE

Annick Maujean; Matthew J. Gullo; Tonny Elmose Andersen; Sophie Lykkegaard Ravn; Michele Sterling

2017-01-01

Abstract. Introduction:. The presence of post-traumatic stress disorder (PTSD) symptoms has been found to be associated with an increased risk of persisting neck pain and disability in motor vehicle crash (MVC) survivors with whiplash injuries. The findings are mixed as to which PTSD symptom(s) best predicts recovery in this population. Objectives:. The aims were (1) to explore the factor structure of the Post-traumatic Stress Diagnostic Scale (PDS) in a sample of acute whiplash-injured in...

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.

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

The relationship between chronic whiplash-associated disorder and post-traumatic stress: attachment-anxiety may be a vulnerability factor

Directory of Open Access Journals (Sweden)

Tonny Elmose Andersen

2011-01-01

Full Text Available Background: In more than 90% of whiplash accidents a good explanation regarding the association between trauma mechanism, organic pathology, and persistent symptoms has failed to be provided. Objective: We predicted that the severity of chronic whiplash-associated disorder (WAD, measured as number of whiplash symptoms, pain duration, pain-related disability, and degree of somatisation would be associated with the number of post-traumatic stress disorder symptoms (PTSD. Secondly, we expected attachment-anxiety to be a vulnerability factor in relation to both PTSD and WAD. Design: Data were collected from 1,349 women and 360 men suffering from WAD from the Danish Society for Polio, Traffic, and Accident Victims. The PTSD symptoms were measured by the Harvard Trauma Questionnaire. All three core PTSD clusters were included: re-experiencing, avoidance, and hyperarousal. Attachment security was measured along the two dimensions, attachment-anxiety and attachment-avoidance, by the Revised Adult Attachment Scale. Results: PTSD symptoms were significantly related to the severity of WAD. In particular, the PTSD clusters of avoidance and hyperarousal were associated with the number of whiplash symptoms, disability, and somatisation. Attachment-anxiety was significantly related to PTSD symptoms and somatisation but not to pain and disability. A co-morbidity of 38.8% was found between the PTSD diagnosis and WAD, and about 20% of the sample could be characterised as securely attached. Conclusions: The PTSD clusters of avoidance and hyperarousal were significantly associated with severity of WAD. The study emphasises the importance of assessing PTSD symptomatology after whiplash injury. Furthermore, it highlights that attachment theory may facilitate the understanding of why some people are more prone to develop PTSD and WAD than others.For abstract or full text in other languages, please see Supplementary files under Reading Tools online

Morphological changes in the cervical muscles of women with chronic whiplash can be modified with exercise-A pilot study.

Science.gov (United States)

O'leary, Shaun; Jull, Gwendolen; Van Wyk, Luke; Pedler, Ashley; Elliott, James

2015-11-01

In this preliminary study we determined whether MRI markers of cervical muscle degeneration [elevated muscle fatty infiltration (MFI), cross-sectional area (CSA), and reduced relative muscle CSA (rmCSA)] could be modified with exercise in patients with chronic whiplash. Five women with chronic whiplash undertook 10 weeks of neck exercise. MRI measures of the cervical multifidus (posterior) and longus capitus/colli (anterior) muscles, neck muscle strength, and self-reported neck disability were recorded at baseline and at completion of the exercise program. Overall significant increases in CSA and rmCSA were observed for both muscles, but significant reductions in MFI were only evident in the cervical multifidus muscle. These changes coincided with increased muscle strength and reduced neck disability. MRI markers of muscle morphology in individuals with chronic whiplash appear to be modifiable with exercise. © 2015 Wiley Periodicals, Inc.

Noise-intolerance and state-dependent factors in patients with whiplash associated disorder

NARCIS (Netherlands)

Blokhorst, M.G.B.G.; Meeldijk, S.J.; Luijtelaar, E.L.J.M. van; Toor, T. van; Lousberg, R.; Ganzevles, P.

2005-01-01

An experiment was carried out in which the level of noise-intolerance in patients with a Whiplash Associated Disorder (WAD) was compared to healthy matched control subjects. In addition, the relationship between state-dependent factors (as headache, neck pain, fatigue and tension) and

Increasing climate whiplash in 21st century California

Science.gov (United States)

Swain, D. L.; Langenbrunner, B.; Neelin, J. D.; Hall, A. D.

2017-12-01

Temperate "Mediterranean" climate regimes across the globe are particularly susceptible to wide swings between drought and flood—of which California's rapid transition from record multi-year dryness between 2012-2016 to extreme wetness during 2016-2017 provides a dramatic example. The wide-ranging human and environmental impacts of this recent "climate whiplash" event in a highly-populated, economically critical, and biodiverse region highlight the importance of understanding weather and climate extremes at both ends of the hydroclimatic spectrum. Previous studies have examined the potential contribution of anthropogenic warming to recent California extremes, but findings to date have been mixed and primarily drought-focused. Here, we use specific historical California flood and drought events as thresholds for quantifying long-term changes in precipitation extremes using a large ensemble of multi-decadal climate model simulations (CESM-LENS). We find that greenhouse gas emissions are already responsible for a detectable increase in both wet and dry extremes across portions of California, and that increasing 21st century "climate whiplash" will likely yield large increases in the frequency of both rapid "dry-to-wet" transitions and severe flood events over a wide range of timescales. This projected intensification of California's hydrological cycle would seriously challenge the region's existing water storage, conveyance, and flood control infrastructure—even absent large changes in mean precipitation.

Therapy recommendation "act as usual" in patients with whiplash injuries QTF I°.

Science.gov (United States)

Dehner, Christoph; Kraus, Michael; Schöll, Hendrik; Schneider, Florian; Richter, Peter; Kramer, Michael

2012-08-20

Up to now no therapy study has used the classification system of the Quebec Task Force (QTF) to differentiate between patients with (QTF II°) and without functional disorders (QTF I°). This differentiation seems meaningful, as this difference may be relevant for the correct treatment planning. In this context the effect of the therapy recommendation "act as usual" has been evaluated in a homogeneous patient collective with whiplash injuries QTF I°. 470 patients with acute whiplash injuries had been catched in this study and classified according to the QTF. 359 patients (76.4%) with QTF I° injuries could be identified. Out of that 162 patients were enrolled to the study and received the therapy recommendation "act as usual" and the adapted pain treatment with non-steroidal anti-inflammatory drugs (NSAID). After six months the outcome was evaluated by phone. After injury the median pain score assessed by a visual analogue scale (VAS) was 5.4 (min = 3.3; max = 8.5). After six months 5 of the 162 patients complained intermittent pain symptoms (VAS values < 2). This is consistent with a chronification rate of 3.1%. After injury, the median pain disability index (PDI) was 3.9 (min = 1.9; max = 7.7). After six months 3 of the 162 patients stated persisting disability during sporting and physical activities (VAS values < 1). The therapy recommendation "act as usual" in combination with an adapted pain treatment is sufficient. Usually patients with whiplash injuries QTF I° do not need physical therapy. An escalation of therapy measures should be reserved to patients with complicated healing processes.

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

Advancements in Imaging Technology: Do They (or Will They) Equate to Advancements in Our Knowledge of Recovery in Whiplash?

Science.gov (United States)

Elliott, James M; Dayanidhi, Sudarshan; Hazle, Charles; Hoggarth, Mark A; McPherson, Jacob; Sparks, Cheryl L; Weber, Kenneth A

2016-10-01

Synopsis It is generally accepted that up to 50% of those with a whiplash injury following a motor vehicle collision will fail to fully recover. Twenty-five percent of these patients will demonstrate a markedly complex clinical picture that includes severe pain-related disability, sensory and motor disturbances, and psychological distress. A number of psychosocial factors have shown prognostic value for recovery following whiplash from a motor vehicle collision. To date, no management approach (eg, physical therapies, education, psychological interventions, or interdisciplinary strategies) for acute whiplash has positively influenced recovery rates. For many of the probable pathoanatomical lesions (eg, fracture, ligamentous rupture, disc injury), there remains a lack of available clinical tests for identifying their presence. Fractures, particularly at the craniovertebral and cervicothoracic junctions, may be radiographically occult. While high-resolution computed tomography scans can detect fractures, there remains a lack of prevalence data for fractures in this population. Conventional magnetic resonance imaging has not consistently revealed lesions in patients with acute or chronic whiplash, a "failure" that may be due to limitations in the resolution of available devices and the use of standard sequences. The technological evolution of imaging techniques and sequences eventually might provide greater resolution to reveal currently elusive anatomical lesions (or, perhaps more importantly, temporal changes in physiological responses to assumed lesions) in those patients at risk of poor recovery. Preliminary findings from 2 prospective cohort studies in 2 different countries suggest that this is so, as evidenced by changes to the structure of skeletal muscles in those who do not fully recover. In this clinical commentary, we will briefly introduce the available imaging decision rules and the current knowledge underlying the pathomechanics and pathophysiology of

Assessing the existence of dissociative PTSD in sub-acute patients of whiplash

DEFF Research Database (Denmark)

Hansen, Maj; Hyland, Philip; Armour, Cherie

2018-01-01

-acute patients of whiplash and associated risk factors. The results of LCA showed a three-class solution primarily distributed according to PTSD symptom severity and thus no indication of D-PTSD. Dissociative symptoms, psychological distress (i.e. anxiety/depression), and pain severity significantly predicted...

Development of an active behavioural physiotherapy intervention (ABPI) for acute whiplash-associated disorder (WAD) II management: a modified Delphi study.

Science.gov (United States)

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

2016-09-14

To develop an active behavioural physiotherapy intervention (ABPI) for managing acute whiplash-associated disorder (WAD) II using a modified Delphi method to develop consensus for the basic features of the ABPI. Modified Delphi study. Our systematic review and meta-analysis evaluating conservative management for acute WADII found that a combined ABPI may be a useful intervention to prevent patients progressing to chronicity. No previous research has considered a combined behavioural approach and active physiotherapy in the management of acute WADII patients. The ABPI was therefore developed using a rigorous consensus method using international research and local clinical whiplash experts. Descriptive statistics were used to assess consensus in each round. Online international survey. A purposive sample of 97 potential participants (aiming to recruit n=30) consisting of international research whiplash experts, UK private physiotherapists and UK postgraduate musculoskeletal physiotherapy students were invited to participate via electronic mail with an attached participant information sheet and consent form. 36 individuals signed and returned the consent form. In round 1, 32/36 participants (response rate=89%, mean age±SD=36.03±13.22 years) across 8 countries (Australia, Finland, Greece, India, Netherlands, Norway, Sweden and UK) contributed to round 1 questionnaire. Response rates were 78% and 75% for rounds 2 and 3, respectively. Following round 3, 12 underlying principles (eg, return to normal function as soon as possible, pain management, encouragement of self-management, reduce fear avoidance and anxiety) achieved consensus. The treatment components reaching consensus included behavioural (eg, education, reassurance, self-management) and physiotherapy components (eg, exercises for stability and mobility). No passive intervention achieved consensus. Experts suggested and agreed the underlying principles and treatment components of the ABPI for the management

Treatment of Whiplash-Associated Disorders - Part I: Non-Invasive Interventions

Directory of Open Access Journals (Sweden)

Anne Conlin

2005-01-01

Full Text Available BACKGROUND: A whiplash-associated disorder (WAD is an injury due to an acceleration-deceleration mechanism at the neck. WAD represents a very common and costly condition, both economically and socially. In 1995, the Quebec Task Force published a report that contained evidence-based recommendations regarding the treatment of WAD based on studies completed before 1993 and consensus-based recommendations.

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

Clinical assessment of prognostic factors for long-term pain and handicap after whiplash injury: a 1-year prospective study

DEFF Research Database (Denmark)

Kasch, H; Qerama, E; Kongsted, Alice

2008-01-01

BACKGROUND AND PURPOSE: Physical mechanisms are the possible factors involved in the development and maintenance of long-term handicaps after acute whiplash injury. This study prospectively examined the role of active neck mobility, cervical and extra-cervical pains, as well as non-painful...... of non-painful complaints and active neck mobility [active cervical range of motion (CROM)]. All 458 high-risk patients and 230 low-risk patients received mailed questionnaires after 3, 6 and 12 months. Two examiners examined all high-risk patients (n = 458) and 41 consecutive low-risk patients at median...... complaints after a whiplash injury as predictors for subsequent handicap. METHODS: Consecutive acute whiplash patients (n = 688) were interviewed and examined by a study nurse after the median of 5 days after injury, and divided into a high- or a low-risk group by an algorithm based on pain intensity, number...

Treatment of Whiplash-Associated Disorders - Part II: Medical and Surgical Interventions

Directory of Open Access Journals (Sweden)

Anne Conlin

2005-01-01

Full Text Available BACKGROUND: Whiplash-associated disorder (WAD is a term used to describe injury due to an acceleration-deceleration mechanism at the neck. In 1995, the Quebec Task Force published a report that contained evidence-based recommendations regarding the treatment of WAD based on studies completed before 1993 and consensus-based recommendations.

MR Analysis of the Transverse Ligament in the Late Stage of Whiplash Injury

Energy Technology Data Exchange (ETDEWEB)

Krakenes, J.; Nordli, H.; Moen, G. [Haukeland Univ. Hospital, Bergen (Norway). Section of Neuroradiology; Kaale, B.R. [Firda Medical Center, Sandane (Norway); Rorvik, J. [Haukeland Univ. Hospital, Bergen (Norway). Dept. of Radiology; Gilhus, N.E. [Haukeland Univ. Hospital, Bergen (Norway). Dept. of Neurology

2003-11-01

Purpose: To analyse and classify structural changes in the transverse ligament in the late stage of whiplash injury by use of high-resolution MRI, and to evaluate the reliability of our classification. Material and Methods: Ninety-two whiplash-injured (2-9 years previously, mean 6 years) and 30 non-injured individuals underwent proton-weighted MR imaging of the craniovertebral junction in three orthogonal planes. Structural changes in the transverse ligaments were graded twice (grades 1-3) based on increased signal, independently by 3 radiologists with a 4-month interval. Inter- and intraobserver statistics were calculated by ordinary and weighted kappa (K). Results: Image quality was excellent in 109 cases and slightly reduced in 13. Twenty-two out of 30 ligaments in the control group were classified as normal (73%) compared with only 32 out of 92 in the injured group (36%). Two or all 3 observers agreed in their grading in 101 out of 122 ligaments (83%). Intraobserver agreement (weighted K) was fair to good (0.33-0.73). Pair-wise interobserver agreement was fair (0.24-0.39). Reasons for divergent grading were insufficient knowledge of normal variations, low signal intensity in the peridental soft tissue obscuring the ligament and interpretation flaw. Conclusion: Whiplash trauma can damage the transverse ligament. By use of high-resolution proton-weighted MR images such lesions can be detected and classified. The reliability of this classification still needs improvement.

MR Analysis of the Transverse Ligament in the Late Stage of Whiplash Injury

International Nuclear Information System (INIS)

Krakenes, J.; Nordli, H.; Moen, G.; Rorvik, J.; Gilhus, N.E.

2003-01-01

Purpose: To analyse and classify structural changes in the transverse ligament in the late stage of whiplash injury by use of high-resolution MRI, and to evaluate the reliability of our classification. Material and Methods: Ninety-two whiplash-injured (2-9 years previously, mean 6 years) and 30 non-injured individuals underwent proton-weighted MR imaging of the craniovertebral junction in three orthogonal planes. Structural changes in the transverse ligaments were graded twice (grades 1-3) based on increased signal, independently by 3 radiologists with a 4-month interval. Inter- and intraobserver statistics were calculated by ordinary and weighted kappa (K). Results: Image quality was excellent in 109 cases and slightly reduced in 13. Twenty-two out of 30 ligaments in the control group were classified as normal (73%) compared with only 32 out of 92 in the injured group (36%). Two or all 3 observers agreed in their grading in 101 out of 122 ligaments (83%). Intraobserver agreement (weighted K) was fair to good (0.33-0.73). Pair-wise interobserver agreement was fair (0.24-0.39). Reasons for divergent grading were insufficient knowledge of normal variations, low signal intensity in the peridental soft tissue obscuring the ligament and interpretation flaw. Conclusion: Whiplash trauma can damage the transverse ligament. By use of high-resolution proton-weighted MR images such lesions can be detected and classified. The reliability of this classification still needs improvement

The cervical facet capsule and its role in whiplash injury: a biomechanical investigation.

Science.gov (United States)

Winkelstein, B A; Nightingale, R W; Richardson, W J; Myers, B S

2000-05-15

Cervical facet capsular strains were determined during bending and at failure in the human cadaver. To determine the effect of an axial pretorque on facet capsular strains and estimate the risk for subcatastrophic capsular injury during normal bending motions. Epidemiologic and clinical studies have identified the facet capsule as a potential site of injury and prerotation as a risk factor for whiplash injury. Unfortunately, biomechanical data on the cervical facet capsule and its role in whiplash injury are not available. Cervical spine motion segments were tested in a pure-moment test frame and the full-field strains determined throughout the facet capsule. Motion segments were tested with and without a pretorque in pure bending. The isolated facet was then elongated to failure. Maximum principal strains during bending were compared with failure strains, by paired t test. Statistically significant increases in principal capsular strains during flexion-extension loading were observed when a pretorque was applied. All measured strains during bending were significantly less than strains at catastrophic joint failure. The same was true for subcatastrophic ligament failure strains, except in the presence of a pretorque. Pretorque of the head and neck increases facet capsular strains, supporting its role in the whiplash mechanism. Although the facet capsule does not appear to be at risk for gross injury during normal bending motions, a small portion of the population may be at risk for subcatastrophic injury.

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

Return to work helps maintain treatment gains in the rehabilitation of whiplash injury.

Science.gov (United States)

Sullivan, Michael; Adams, Heather; Thibault, Pascal; Moore, Emily; Carriere, Junie S; Larivière, Christian

2017-05-01

This study examined the relation between return to work and the maintenance of treatment gains made over the course of a rehabilitation intervention. The study sample consisted of 110 individuals who had sustained whiplash injuries in rear collision motor vehicle accidents and were work-disabled at the time of enrolment in the study. Participants completed pre- and post-treatment measures of pain severity, disability, cervical range of motion, depression, posttraumatic stress symptoms, and catastrophizing. Pain severity was assessed again at 1-year follow-up. At 1-year follow-up, 73 participants had returned to work and 37 remained work-disabled. Analyses revealed that participants who returned to work were more likely to maintain treatment gains (77.5%) than participants who remained work-disabled (48%), χ = 6.3, P whiplash injury are maintained. Clinical implications of the findings are also addressed.

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

Isolated amnesia following a bilateral paramedian thalamic infarct. Possible etiologic role of a whiplash injury.

Science.gov (United States)

Barontini, F; Maurri, S

1992-04-01

A previously healthy 45 years old carpenter suffered a whiplash injury in a road accident on July, 18th, 1990. He continued to work in spite of occipital headache, episodic sweatening and slight hypersomnia. On August, 8th, 1990 while parking his car into the deck of a ferry-boat he was found slightly confuse and markedly amnestic. A post-traumatic subdural haematoma was suspected. As a CT-scan of the brain was normal, a toxic encephalopathy or an hysterical amnesia were proposed. However, a MRI performed on August, 22th, 1990, apart from a small infarct in the white matter of the left occipital lobe, showed two small bilateral paramedian thalamic infarcts. The last lesions usually follow a thrombotic or embolic occlusion of the "basilar communicating artery" (BCA) belonging to the vertebro-basilar system. The possible etiologic relationship between this syndrome and the previous whiplash injury has been considered. Six months later, while a control MRI showed a reduction of the brain lesions, a neuropsychological examination revealed a slight improvement of memory dysfunction evident also at a distance of further 6 months. This case is interesting because it tests the high sensitivity of MRI in amnestic syndromes and because of the possible role of a whiplash injury in the etiology of BPTI.

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.

The relationship between insurance claim closure and recovery after traffic injuries for individuals with whiplash associated disorders

DEFF Research Database (Denmark)

Boyle, Eleanor; Cassidy, J David; Côté, Pierre

2017-01-01

PURPOSE: The purpose of this study was to determine if time to claim closure was similar to time to self-reported recovery in a no fault motor vehicle collision insurance system. METHOD: A prospective cohort of traffic injured adults with a whiplash-associated disorder (WAD) was assembled. We...... Time to claim closure as an outcome measure for whiplash-associated disorders has been criticized in the literature because it is thought that closure is not reflective of the health status of the individual. We found that claim closure was associated with lower levels of disability, but the time...

Cervical Muscle Dysfunction in the Chronic Whiplash Associated Disorder Grade II (WAD-II)

NARCIS (Netherlands)

Nederhand, Marcus Johannes; IJzerman, Maarten Joost; Hermens, Hermanus J.; Baten, Christian T.M.; Zilvold, Gerrit

2000-01-01

Study Design: In a cross-sectional study, surface electromyography measurements of the upper trapezius muscles were obtained during different functional tasks in patients with a chronic whiplash associated disorder Grade II and healthy control subjects. - Objectives: To investigate whether muscle

Functional health status in subjects after a motor vehicle accident, with emphasis on whiplash associated disorders: design of a descriptive, prospective inception cohort study

Directory of Open Access Journals (Sweden)

Helders Paul JM

2008-12-01

Full Text Available Abstract Background The clinical consequences of whiplash injuries resulting from a motor vehicle accident (MVA are poorly understood. Thereby, there is general lack of research on the development of disability in patients with acute and chronic Whiplash Associated Disorders. Methods/Design The objective is to describe the design of an inception cohort study with a 1-year follow-up to determine risk factors for the development of symptoms after a low-impact motor vehicle accident, the prognosis of chronic disability, and costs. Victims of a low-impact motor vehicle accident will be eligible for participation. Participants with a Neck Disability Index (NDI score of 7 or more will be classified as experiencing post-traumatic neck pain and will enter the experimental group. Participants without complaints (a NDI score less than 7 will enter the reference group. The cohort will be followed up by means of postal questionnaires and physical examinations at baseline, 3 months, 6 months, and 12 months. Recovery from whiplash-associated disorders will be measured in terms of perceived functional health, and employment status (return to work. Life tables will be generated to determine the 1-year prognosis of whiplash-associated disorders, and risk factors and prognostic factors will be assessed using multiple logistic regression analysis. Discussion Little is known about the development of symptoms and chronic disability after a whiplash injury. In the clinical setting, it is important to identify those people who are at risk of developing chronic symptoms. This inception prospective cohort study will provide insight in the influence of risk factors, of the development of functional health problems, and costs in people with whiplash-associated disorders.

Functional health status in subjects after a motor vehicle accident, with emphasis on whiplash associated disorders: design of a descriptive, prospective inception cohort study

Science.gov (United States)

Schmitt, Maarten A; van Meeteren, Nico LU; de Wijer, Anton; Helders, Paul JM; Graaf, Yolanda van der

2008-01-01

Background The clinical consequences of whiplash injuries resulting from a motor vehicle accident (MVA) are poorly understood. Thereby, there is general lack of research on the development of disability in patients with acute and chronic Whiplash Associated Disorders. Methods/Design The objective is to describe the design of an inception cohort study with a 1-year follow-up to determine risk factors for the development of symptoms after a low-impact motor vehicle accident, the prognosis of chronic disability, and costs. Victims of a low-impact motor vehicle accident will be eligible for participation. Participants with a Neck Disability Index (NDI) score of 7 or more will be classified as experiencing post-traumatic neck pain and will enter the experimental group. Participants without complaints (a NDI score less than 7) will enter the reference group. The cohort will be followed up by means of postal questionnaires and physical examinations at baseline, 3 months, 6 months, and 12 months. Recovery from whiplash-associated disorders will be measured in terms of perceived functional health, and employment status (return to work). Life tables will be generated to determine the 1-year prognosis of whiplash-associated disorders, and risk factors and prognostic factors will be assessed using multiple logistic regression analysis. Discussion Little is known about the development of symptoms and chronic disability after a whiplash injury. In the clinical setting, it is important to identify those people who are at risk of developing chronic symptoms. This inception prospective cohort study will provide insight in the influence of risk factors, of the development of functional health problems, and costs in people with whiplash-associated disorders. PMID:19099574

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

Science.gov (United States)

Stupar, Maja; Côté, Pierre; Beaton, Dorcas E; Boyle, Eleanor; Cassidy, J David

2015-01-01

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). We performed a test-retest reliability study. We included insurance claimants from Ontario who were at least 18 years of age, within 21 days of their motor vehicle collision and diagnosed as having acute WAD grades I to III. The WDQ, a 13-item questionnaire scored from 0 (no disability) to 130 (complete disability), was administered to all participants at baseline and by telephone 3 days later. We computed the intraclass correlation coefficient (model 2,1) and the MDC with 95% confidence intervals (CIs; MDC95). The mean (SD) age of the 66 participants was 41.6 (12.7) years and 71.2% were female. Twenty-nine percent had WAD I and 71.2% had WAD II. Time since injury ranged from 0 to 19 days. The mean (SD) baseline WDQ score was 49.3 (28.8) and 46.5 (29.8) 3 days later. The intraclass correlation coefficient for the WDQ total score was 0.89 (95% CI, 0.85-0.92) in the entire sample and 0.83 (95% CI, 0.69-0.93) for the 15 participants reporting no change in neck pain. The MDC95 of the WDQ was 21.4 (SD = 14.9) for participants reporting no change. The WDQ was reliable in individuals with acute WAD. There is 95% confidence that a change of approximately one-sixth of the total score is beyond the daily variation of a stable condition. This level of measurement error must be taken into consideration when interpreting change in WDQ scores. Copyright © 2015 National University of Health Sciences. Published by Elsevier Inc. All rights reserved.

An Integrated Model of Chronic Whiplash-Associated Disorder.

Science.gov (United States)

Walton, David M; Elliott, James M

2017-07-01

Synopsis The development of persistent symptoms following whiplash injury from a motor vehicle collision is common and contributes substantially to societal and personal costs. The popular Quebec Task Force classification system of whiplash-associated disorders (WADs) was meant to function as a prognostic and intervention decision aid, but its usefulness has been questioned. Emerging evidence highlights the heterogeneity of WAD by demonstrating physical and psychological impairments that are unique to those who develop persistent symptoms. These impairments are not recognized in the Quebec Task Force classification system. The purpose of this clinical commentary is to describe an integrated model that focuses on how psychological and neurobiological factors interact with, and are influenced by, existing personal and environmental factors to contribute to the development of chronic WAD. The model has been developed through more than 20 years of work in the field, consultation with experts, in-depth synthesis of existing evidence, and new evidence from the authors' own research programs. A subtheme is that a point of convergence currently exists between the psychological, physiological, and social determinants of health literature that can further explain the complex presentation of WAD. The new model is proposed to orient future research toward more interdisciplinary efforts across nontraditional fields, including data scientists and consumers, to clarify the WAD condition. J Orthop Sports Phys Ther 2017;47(7):462-471. Epub 16 Jun 2017. doi:10.2519/jospt.2017.7455.

Acute stress response and recovery after whiplash injuries. A one-year prospective study

DEFF Research Database (Denmark)

Kongsted, Alice; Bendix, Tom; Montvilas, Erisela Qerama

2008-01-01

Chronic whiplash-associated disorder (WAD) represents a major medical and psycho-social problem. The typical symptomatology presented in WAD is to some extent similar to symptoms of post traumatic stress disorder. In this study we examined if the acute stress reaction following a whiplash injury...... were modified by baseline neck pain intensity. It was not possible to distinguish between participants who recovered and those who did not by means of the IES (AUC=0.6). In conclusion, the association between the acute stress reaction and persistent WAD suggests that post traumatic stress reaction may...... outcome-measures were neck pain and headache, neck disability, general health, and working ability one year after the accident. A total of 737 participants were included and completed the IES, and 668 (91%) participated in the 1-year follow-up. A baseline IES-score denoting a moderate to severe stress...

Are there gender differences in coping with neck pain following acute whiplash trauma?

DEFF Research Database (Denmark)

Carstensen, T B W; Frostholm, Lisbeth; Oernboel, E

2012-01-01

BACKGROUND: Little is known about gender differences in coping after whiplash, and to date possible interaction of gender and coping on recovery has not been investigated. AIMS: To examine if gender differences in coping are associated with long-lasting neck pain after acute whiplash. METHODS...... they completed the Coping Strategies Questionnaire, and after 12months a VAS scale on neck pain intensity. RESULTS: The odds for long-lasting neck pain were more than twice as high for women than for men (OR=2.17 (95% CI: 1.40; 3.37). However, no gender difference in coping and no interaction between gender.......10 (95% CI: 1.05; 1.13) for each point on these scales. CONCLUSIONS: No interaction between coping and gender on neck pain was found, thus different coping strategies 3months post-collision did not explain the different prognosis observed in men and women. Clinically relevant influence...

Acute stress response and recovery after whiplash injuries. A one-year prospective study

DEFF Research Database (Denmark)

Kongsted, Alice; Bendix, Tom; Montvilas, Erisela Qerama

2008-01-01

outcome-measures were neck pain and headache, neck disability, general health, and working ability one year after the accident. A total of 737 participants were included and completed the IES, and 668 (91%) participated in the 1-year follow-up. A baseline IES-score denoting a moderate to severe stress...... were modified by baseline neck pain intensity. It was not possible to distinguish between participants who recovered and those who did not by means of the IES (AUC=0.6). In conclusion, the association between the acute stress reaction and persistent WAD suggests that post traumatic stress reaction may......Chronic whiplash-associated disorder (WAD) represents a major medical and psycho-social problem. The typical symptomatology presented in WAD is to some extent similar to symptoms of post traumatic stress disorder. In this study we examined if the acute stress reaction following a whiplash injury...

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...

Pain-catastrophizing and fear-avoidance beliefs as mediators between post-traumatic stress symptoms and pain following whiplash injury - A prospective cohort study.

Science.gov (United States)

Andersen, T E; Karstoft, K-I; Brink, O; Elklit, A

2016-09-01

Knowledge about the course of recovery after whiplash injury is important. Most valuable is identification of prognostic factors that may be reversed by intervention. The mutual maintenance model outlines how post-traumatic stress symptoms (PTSS) and pain may be mutually maintained by attention bias, fear, negative affect and avoidance behaviours. In a similar vein, the fear-avoidance model describes how pain-catastrophizing (PCS), fear-avoidance beliefs (FA) and depression may result in persistent pain. These mechanisms still need to be investigated longitudinally in a whiplash cohort. A longitudinal cohort design was used to assess patients for pain intensity and psychological distress after whiplash injury. Consecutive patients were all contacted within 3 weeks after their whiplash injury (n = 198). Follow-up questionnaires were sent 3 and 6 months post-injury. Latent Growth Mixture Modelling was used to identify distinct trajectories of recovery from pain. Five distinct trajectories were identified. Six months post-injury, 64.6% could be classified as recovered and 35.4% as non-recovered. The non-recovered (the medium stable, high stable and very high stable trajectories) displayed significantly higher levels of PTSS, PCS, FA and depression at all time points compared to the recovered trajectories. Importantly, PCS and FA mediated the effect of PTSS on pain intensity. The present study adds important knowledge about the development of psychological distress and pain after whiplash injury. The finding, that PCS and FA mediated the effect of PTSS on pain intensity is a novel finding with important implications for prevention and management of whiplash-associated disorders. WHAT DOES THIS STUDY ADD?: The study confirms the mechanisms as outlined in the fear-avoidance model and the mutual maintenance model. The study adds important knowledge of pain-catastrophizing and fear-avoidance beliefs as mediating mechanisms in the effect of post-traumatic stress on pain

HYPERTRANSLATION OF THE HEAD BACKWARDS - PART OF THE MECHANISM OF CERVICAL WHIPLASH INJURY

NARCIS (Netherlands)

PENNING, L

Based upon a review of the literature, a theory is developed that in whiplash injury the primary mechanism of the trauma is not hyperretroflexion but hypertranslation of the head backwards. Thus a hyperanteflexion (not hyperretroflexion) of the upper cervical spine, probably especially of the

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 ...

[Relevant factors in medico-legal prognosis of whiplash injury].

Science.gov (United States)

Pujol, Amadeo; Puig, Luisa; Mansilla, Joaquina; Idiaquez, Itziar

2003-07-12

Whiplash injury (WI) is commonly evaluated in medico-legal practice. With the aim of knowing the determining factors of WI's medico-legal prognosis, a prospective and observational study was carried out. One hundred and twenty consecutive patients who were clinically observed and evaluated in the Medico-Legal Clinic of Barcelona were studied. Socio-demographic, clinical, radiographic and evolutive factors were analyzed. We included 120 patients with a mean age of 35.6 (14) years (range, 4-74), with a homogeneous male/female distribution. An earlier cervical pathology was detected in 10% of patients; none of them had previous psychiatric pathology. 95% corresponded to road-traffic accident cases and there were 5 aggression cases. Over 50% of cases involved a rear-end collision. All patients had neck pain, almost 25% had headache and 13% had paresthesia. According to the Whiplash Association Disorders clinical classification, distribution in grades (G) was: G I 51%, G II 32% and G III 17%. Patients reported recovery within a mean time of 71.6 (46) days (range, 4-244), with 51,2 (45) no working days (range, 0-180 days). The 52% of the patients rest with complains. According to the recovery time, the following medico-legal prognostic factors were identified: age (p legal prognostic factors were age, being females, severity of initial clinical symptoms, previous cervical pathology and abnormal cervical MRI/CT.

A 10-year incidence of acute whiplash injuries after road traffic crashes in a defined population in northern Sweden.

Science.gov (United States)

Styrke, Johan; Stålnacke, Britt-Marie; Bylund, Per-Olof; Sojka, Peter; Björnstig, Ulf

2012-10-01

To examine the annual incidence of acute whiplash injuries after road traffic crashes in a geographic catchment area in Northern Sweden during the period 2000-2009. Descriptive epidemiology determined by prospectively collected data from a defined population. The study was conducted at a public hospital in Sweden. The population of the hospital's catchment area (136,600 inhabitants in 1999 and 144,500 in 2009). At the emergency department, all injured persons (approximately 11,000 per year) were asked to answer a questionnaire about the injury incident. Data from the medical records also were analyzed. From 2000-2009, 15,506 persons were injured in vehicle crashes. Persons who were subject to an acute neck injury within whiplash-associated disorder grades 1-3 were included. The overall and annual incidences were calculated as incidence. Age, gender, type of injury event, and direction of impact were described. The incidences were compared with national statistics on insurance claims from 2003, 2007, and 2008 to detect changes in the proportions of claims. The annual incidence of acute whiplash injuries. Secondary outcome measures were types of injury events, age and gender distribution, changes in the proportion of rear-end crashes during 2000-2009, and changes in the proportion of insurance claims during 2003-2008. During 2000-2009, 3297 cases of acute whiplash injury were encountered. The overall incidence was 235/100,000/year. The average yearly increase in incidence was 1.0%. Women comprised 51.9% and men 48.1% of the injured. Car occupants (86.4%) and bicycle riders (6.1%) were most frequently injured. The proportion of rear-end crashes decreased from 55% to 45% from 2000-2009. The proportion of insurance claims significantly decreased between 2003 and 2008 (P whiplash injuries after road traffic crashes have been relatively stable during the past decade in our area, except in 2007 and 2008, when a peak occurred. Copyright © 2012 American Academy of Physical

'A closer look upon whiplash, postconcussion syndrome and posttraumatic headache. Differences and similarities'

DEFF Research Database (Denmark)

Kasch, Helge

2017-01-01

Summary Post-whiplash, -concussion and -traumatic headache are all well-known entities described after accidents. Over the years they gave rise to discussion about the cause, treatment and consequences. Over the years the frequency of each of these diagnoses has varied. But are they really three...

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

Effect of head restraint backset on head-neck kinematics in whiplash.

Science.gov (United States)

Stemper, Brian D; Yoganandan, Narayan; Pintar, Frank A

2006-03-01

Although head restraints were introduced in the 1960s as a countermeasure for whiplash, their limited effectiveness has been attributed to incorrect positioning. The effect of backset on cervical segmental angulations, which were previously correlated with spinal injury, has not been delineated. Therefore, the practical restraint position to minimize injury remains unclear. A parametric study of increasing head restraint backset between 0 and 140mm was conducted using a comprehensively validated computational model. Head retraction values increased with increasing backset, reaching a maximum value of 53.5mm for backsets greater than 60mm. Segmental angulation magnitudes, greatest at levels C5-C6 and C6-C7, reached maximum values during the retraction phase and increased with increasing backset. Results were compared to a previously published head restraint rating system, wherein lower cervical extension magnitudes from this study exceeded mean physiologic limits for restraint positions rated good, acceptable, marginal, and poor. As head restraint contact was the limiting factor in head retraction and segmental angulations, the present study indicates that minimizing whiplash injury may be accomplished by limiting head restraint backset to less than 60mm either passively or actively after impact.

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

Directory of Open Access Journals (Sweden)

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.

The reliability of measuring pain distribution and location using body pain diagrams in patients with acute whiplash-associated disorders.

Science.gov (United States)

Southerst, Danielle; Stupar, Maja; Côté, Pierre; Mior, Silvano; Stern, Paula

2013-09-01

The objective of this study was to measure the interexaminer reliability of scoring pain distribution using paper and electronic body pain diagrams in patients with acute whiplash-associated disorder and to assess the intermethod reliability of measuring pain distribution and location using paper and electronic diagrams. We conducted an interexaminer reliability study on 80 participants recruited from a randomized controlled trial on the conservative management of acute grade I/II whiplash-associated disorder. Participants were assessed for inclusion/exclusion criteria by an experienced clinician. As part of the baseline assessment, participants independently completed paper and electronic pain diagrams. Diagrams were scored independently by 2 examiners using the body region method. Interexaminer and intermethod reliability was computed using intraclass correlation coefficients (ICCs) for pain distribution and κ coefficient for pain location. We used Bland-Altman plots to compute limits of agreement. The interexaminer reliability was ICC = 0.925 for paper and ICC = 0.997 for the electronic body pain diagram. The intermethod reliability for measuring pain distribution ranged from ICC = 0.63 to ICC = 0.93. For pain location, the intermethod reliability varied from κ = 0.23 (posterior neck) to κ = 0.90 (right side of the face). We found good to excellent interexaminer reliability for scoring 2 versions of the body pain diagram. Pain distribution and pain location were reliably and consistently measured on body pain diagrams using paper and electronic methods; therefore, clinicians and researchers may choose either medium when using body pain diagrams. Copyright © 2013 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

Confirmatory Factor Analysis and Multiple Linear Regression of the Neck Disability Index: Assessment If Subscales Are Equally Relevant in Whiplash and Nonspecific Neck Pain.

Science.gov (United States)

Croft, Arthur C; Milam, Bryce; Meylor, Jade; Manning, Richard

2016-06-01

Because of previously published recommendations to modify the Neck Disability Index (NDI), we evaluated the responsiveness and dimensionality of the NDI within a population of adult whiplash-injured subjects. The purpose of the present study was to evaluate the responsiveness and dimensionality of the NDI within a population of adult whiplash-injured subjects. Subjects who had sustained whiplash injuries of grade 2 or higher completed an NDI questionnaire. There were 123 subjects (55% female, of which 36% had recovered and 64% had chronic symptoms. NDI subscales were analyzed using confirmatory factor analysis, considering only the subscales and, secondly, using sex as an 11th variable. The subscales were also tested with multiple linear regression modeling using the total score as a target variable. When considering only the 10 NDI subscales, only a single factor emerged, with an eigenvalue of 5.4, explaining 53.7% of the total variance. Strong correlation (> .55) (P factor model of the NDI is not justified based on our results, and in this population of whiplash subjects, the NDI was unidimensional, demonstrating high internal consistency and supporting the original validation study of Vernon and Mior.

A Clinical Study on the Effects of Sweet Bee Venom Herbal Acupuncture for Patients with Whiplash Injury

Directory of Open Access Journals (Sweden)

Beom-Yong Song

2007-12-01

Full Text Available Objectives : The aim of this study is to investigate the effect of Sweet Bee Venom herbal acupuncture for patients with acute whiplash injury by Traffic Accident. Methods : This clinical study was carried out 25 cases of acute whiplash injury patients which had been treatment in Woosuk oriental hospital from March, 2007 to September, 2007. Sweet bee venom herbal acupuncture(N=15 and normal saline(N=10 injected on the acupoints that were cervical area. I checked the VAS for the pain and ROM(range of motion of the cervical. these were checked 3 times. one was before treatments, another was after 3 times treatments with sweet bee venom herbal acupuncture and normal saline injection, and the other was after 5 times treatments with sweet bee venom herbal acupuncture and normal saline injection. Results : VAS score was significantly improved after 5 times treatments with the sweet bee venom herbal acupuncture compared to normal saline I.M. on the acupoints that was cervical area. There were significant changes in the sweet bee venom herbal acupuncture group with VAS and ROM check. Conclusions : This study suggests that sweet bee venom herbal acupuncture can improve symptoms in patients with acute whiplash injury by traffic accident.

Comparative study of potential whiplash injuries for different occupant seated positions during rear end accidents.

Science.gov (United States)

Omerović, Senad; Tomasch, Ernst; Gutsche, Andreas J; Prebil, Ivan

2016-01-01

Whiplash injuries to the cervical spine represent a considerable economic burden on society with medical conditions, in some cases persisting for more than a year. Numerous studies of whiplash injuries have been made for occupant normal seated position, leaving the analysis of neck injuries for out-of-normal positions not well documented. For that purpose, a detailed human cervical spine finite element model was developed. The analysis was made for four most common occupant seated positions, such as: Normal Position with the torso against the seat back and the head looking straight ahead, Torso Lean forward position with the torso away from the seat back for approximately 10°, Head Flexed position with the head flexed forward approximately 20° from the normal position and Head-Flexed with Torso Lean forward position with the head flexed forward approximately 20° and torso 10° from the normal position. The comparative study included the analysis of capsular ligament deformation and the level of S-curvature of the cervical spine. The model developed predicted that Head Flexed seated position and Head-Flexed with Torso Lean forward seated position are most threatening for upper and lower cervical spine capsular ligament, respectively. As for the level of S-curvature, the model predicted that Head-Flexed with Torso Lean forward seated position would be most prone to neck injuries associated with it. This study demonstrated that the occupant seated position has a significant influence on potential whiplash injuries.

Cervical radiofrequency neurotomy reduces central hyperexcitability and improves neck movement in individuals with chronic whiplash.

Science.gov (United States)

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

2014-01-01

This study aims to determine if cervical medial branch radiofrequency neurotomy reduces psychophysical indicators of augmented central pain processing and improves motor function in individuals with chronic whiplash symptoms. Prospective observational study of consecutive patients with healthy control comparison. Tertiary spinal intervention centre in Calgary, Alberta, Canada. Fifty-three individuals with chronic whiplash associated disorder symptoms (Grade 2); 30 healthy controls. Measures were made at four time points: two prior to radiofrequency neurotomy, and 1- and 3-months post-radiofrequency neurotomy. Measures included: comprehensive quantitative sensory testing (including brachial plexus provocation test), nociceptive flexion reflex, and motor function (cervical range of movement, superficial neck flexor activity during the craniocervical flexion test). Self-report pain and disability measures were also collected. One-way repeated measures analysis of variance and Friedman's tests were performed to investigate the effect of time on the earlier measures. Differences between the whiplash and healthy control groups were investigated with two-tailed independent samples t-test or Mann-Whitney tests. Following cervical radiofrequency neurotomy, there were significant early (within 1 month) and sustained (3 months) improvements in pain, disability, local and widespread hyperalgesia to pressure and thermal stimuli, nociceptive flexor reflex threshold, and brachial plexus provocation test responses as well as increased neck range of motion (all P  0.13) was measured. Attenuation of psychophysical measures of augmented central pain processing and improved cervical movement imply that these processes are maintained by peripheral nociceptive input. Wiley Periodicals, Inc.

Loud preimpact tones reduce the cervical multifidus muscle response during rear-end collisions: a potential method for reducing whiplash injuries.

Science.gov (United States)

Mang, Daniel W H; Siegmund, Gunter P; Brown, Harrison J; Goonetilleke, Samanthi C; Blouin, Jean-Sébastien

2015-01-01

Neck muscle responses after unexpected rear-end collisions consist of a stereotypical combination of postural and startle responses. Prior work using surface electromyography (EMG) has shown that the superficial neck muscle responses can be attenuated when a loud tone (105 dB) is presented 250 milliseconds before impact, but the accompanying response of the deeper multifidus muscles remains unknown. Quantifying this response in multifidus is important because this muscle attaches directly to the cervical facet capsule and can potentially increase the strain in the capsule during an impact and contribute to whiplash injury. To investigate if a loud preimpact tone decreases the cervical multifidus muscle response during rear-end perturbations. After approval by the University Clinical Ethics Review Board, human volunteers experienced a series of three whiplash-like perturbations. Twelve subjects with no history of neurologic disorders or whiplash injury were recruited to participate in this experiment. Bilateral indwelling EMG of multifidus at the C4 and C6 levels, surface EMG of sternocleidomastoid (SCM) and C4 paraspinals (PARAs), and kinematics of the head/neck were measured. Subjects experienced three whiplash-like perturbations (peak acceleration of 19.5 m/s(2)) preceded by either no tone or a loud tone (105 dB) presented 250 milliseconds before sled acceleration onset. The loud tone decreased the muscle activity of C6 multifidus (42%) and C4 PARAs (30%), but did not affect the C4 multifidus or SCM activity. Peak head kinematic responses (extension angle: 6%, retraction: 9%, linear forward acceleration: 9%, and angular acceleration in extension: 13%) were also decreased by the loud preimpact tone. The attenuation of peak C6 multifidus activity and head kinematic responses suggests that a loud preimpact tone may reduce the strain in the cervical facet capsule, which may reduce the risk of whiplash injury during rear-end collisions. Copyright © 2015 Elsevier Inc

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

Directory of Open Access Journals (Sweden)

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.

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).

Smertetilstand og psykologisk distress før uheldet praedikterer gener efter whiplash-traume--sekundaerpublikation

DEFF Research Database (Denmark)

Carstensen, Tina Birgitte Wisbech; Frostholm, Lisbeth; Ørnbøl, Eva

2009-01-01

Patients with acute whiplash trauma were followed to examine if pre-collision pain and psychological distress were associated with reduced work capability and neck pain at 12 month follow-up. Pre-collision unspecified pain was associated with reduced work capability, and neck pain and pre-collisi...

Cervical Muscle Dysfunction in Chronic Whiplash-Associated Disorder Grade 2: The Relevance of the Trauma

NARCIS (Netherlands)

Nederhand, Marcus Johannes; Hermens, Hermanus J.; IJzerman, Maarten Joost; Turk, Dennis C.; Zilvold, Gerrit

2002-01-01

Study Design. Surface electromyography measurements of the upper trapezius muscles were performed in patients with a chronic whiplash-associated disorder Grade 2 and those with nonspecific neck pain. Objective. To determine the etiologic relation between acceleration–deceleration trauma and the

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.

Minor crashes and 'whiplash' in the United States.

Science.gov (United States)

Bartsch, Adam J; Gilbertson, Lars G; Prakash, Vikas; Morr, Douglas R; Wiechel, John F

2008-10-01

In the United States there is currently a paucity of available real world minor rear crash data with struck vehicle delta-V, or speed change, less than or equal to 15 kilometers per hour. These data are essential as researchers attempt to define 'whiplash' injury risk potential in these minor crashes. This study analyzed a new set of 105 U.S. minor rear aligned crashes between passenger vehicles. Mean struck vehicle delta-V and acceleration were 6.3 km/h (s.d. = 2.1 km/h) and 1.4 g (s.d. = 0.5 g), respectively. A total of 113 struck vehicle occupants were diagnosed within five weeks post-crash with 761 ICD-9-CM complaints and 427 AIS injuries (99.5% AIS1) attributed to the crashes. No striking vehicle occupants reported complaints. The main ICD-9-CM diagnoses were 40.6% cervical, 22.5% lumbar/sacral and 10.2% thoracic and the main AIS1 diagnoses were 29.7% cervical, 23.2% lumbar/sacral and 14.3% thoracic. The diagnosis disparity was mainly due to coding for pre-existing degenerative diagnosis in ICD-9-CM. Degenerative spine conditions were not significant for increased AIS1 injury risk. Surprisingly, many non-'whiplash' diagnoses were found. The AIS injury diagnosis distribution and frequency in these minor delta-V crashes did not correspond with previous minor rear crash studies. A prospectively collected and unbiased minor rear crash databank in the model of CIREN or NASS is highly desirable to verify or refute these results for the U.S. population since the current study cohort may have been influenced by litigation.

Eye movements in patients with Whiplash Associated Disorders: A systematic review

OpenAIRE

Ischebeck, B.; Vries, Jurryt; Geest, Jos; Janssen, Malou; Wingerden, Jan-Paul; Kleinrensink, Gert Jan; Frens, Maarten

2016-01-01

textabstractBackground: Many people with Whiplash Associated Disorders (WAD) report problems with vision, some of which may be due to impaired eye movements. Better understanding of such impaired eye movements could improve diagnostics and treatment strategies. This systematic review surveys the current evidence on changes in eye movements of patients with WAD and explains how the oculomotor system is tested. Methods: Nine electronic data bases were searched for relevant articles from incepti...

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.

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

Does expecting mean achieving? The association between expecting to return to work and recovery in whiplash associated disorders: a population-based prospective cohort study

OpenAIRE

Ozegovic, Dejan; Carroll, Linda J.; David Cassidy, J.

2009-01-01

To determine the association between expectations to return to work and self-assessed recovery. Positive expectations predict better outcomes in many health conditions, but to date the relationship between expecting to return to work after traffic-related whiplash-associated disorders and actual recovery has not been reported. We assessed early expectations for return to work in a cohort of 2,335 individuals with traffic-related whiplash injury to the neck. Using multivariable Cox proportiona...

Analysis of right anterolateral impacts: the effect of head rotation on the cervical muscle whiplash response

Directory of Open Access Journals (Sweden)

Narayan Yogesh

2005-05-01

Full Text Available Abstract Background The cervical muscles are considered a potential site of whiplash injury, and there are many impact scenarios for whiplash injury. There is a need to understand the cervical muscle response under non-conventional whiplash impact scenarios, including variable head position and impact direction. Methods Twenty healthy volunteers underwent right anterolateral impacts of 4.0, 7.6, 10.7, and 13.0 m/s2 peak acceleration, each with the head rotated to the left, then the head rotated to the right in a random order of impact severities. Bilateral electromyograms of the sternocleidomastoids, trapezii, and splenii capitis following impact were measured. Results At a peak acceleration of 13.0 m/s2, with the head rotated to the right, the right trapezius generated 61% of its maximal voluntary contraction electromyogram (MVC EMG, while all other muscles generated 31% or less of this variable (31% for the left trapezius, 13% for the right spleinus. capitis, and 16% for the left splenius capitis. The sternocleidomastoids muscles also tended to show an asymmetric EMG response, with the left sternocleidomastoid (the one responsible for head rotation to the right generating a higher percentage (26% of its MVC EMG than the left sternocleidomastoid (4% (p Conclusion The EMG response to a right anterolateral impact is highly dependent on the head position. The sternocleidomastoid responsible for the direction of head rotation and the trapezius ipsilateral to the direction of head rotation generate the most EMG activity.

Risk factors for persistent problems following whiplash injury: results of a systematic review and meta-analysis.

Science.gov (United States)

Walton, David M; Pretty, Jason; MacDermid, Joy C; Teasell, Robert W

2009-05-01

Systematic review and meta-analysis. Whiplash-associated disorder (WAD) is the most common reported injury following motor vehicle accident. Evidence for prognosis and intervention are difficult to interpret due to differences in inception times, outcomes used, and sample heterogeneity. An extensive literature search was conducted to identify published studies of prognosis following whiplash. Rigorous inclusion criteria were applied to allow for meaningful results to be drawn. Data were extracted, transformed where necessary, and pooled to allow estimation of the odds ratio for any factor with at least 3 data points in the literature. From 11 cohorts (n = 3193), 25 factors were identified with at least 3 data points in the existing literature. Of these, 9 were found to be significant predictors based on the odds ratio and confidence limits: no postsecondary education, female gender, history of previous neck pain,baseline neck pain intensity greater than 55/100, presence of neck pain at baseline, presence of headache at baseline, catastrophizing, WAD grade 2 or 3, and no seat belt in use at time of collision. Neck pain intensity, WAD grade, headache, and no postsecondary education were robust to publication bias. Using a rigorous process for the identification and extraction of data from a homogenous subset of the prognostic WAD literature, we were able to identify several factors for which information is easy to collect clinically and could provide clinicians with a good sense of prognosis following whiplash injury.

[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.

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

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.

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

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.

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...

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...

Postmortem MSCT diagnosis of whiplash injuries in a traffic accident: a case report and review of the literature.

Science.gov (United States)

Chen, Min; Huang, Ping; Wan, Lei; Zhang, Jian-Hua; Liu, Ning-Guo; Zou, Dong-Hua; Li, Zheng-Dong; Shao, Yu; Qin, Zhi-Qiang; Chen, Yi-Jiu

2014-04-01

A 45-year-old male car driver died in a traffic accident of four cars rear-end collision on the highway. He was found to have died after a respiratory and cardiac arrest at the scene. No sign of skin injuries was observed from the external inspection. The autopsy was not permitted by the family members because of the local culture. Multislice computed tomography (MSCT) was applied to the current case, showing dislocation of C3-4 cervical vertebrae with II degree, C4 vertebral plate fractures, and spinal stenosis. Post-mortem MSCT confirmed the diagnosis as whiplash injuries. MSCT was verified to be effective in showing the severity of whiplash injuries, thus providing certain objective evidence for medicolegal expertise.

Initial healthcare and coping preferences are associated with outcome 1 year after whiplash trauma: a multicentre 1-year follow-up study.

Science.gov (United States)

Myrtveit, Solbjørg Makalani; Carstensen, Tina; Kasch, Helge; Ørnbøl, Eva; Frostholm, Lisbeth

2015-03-20

Individuals exposed to whiplash collisions have to cope with the stressful event as well as early physical symptoms. As in other chronic pain conditions, coping has been associated with outcome after whiplash. In this study, our aim was to examine whether initial coping preferences were associated with the development of chronic whiplash. Prospective study. Primary care. 740 acute whiplash patients were recruited from emergency units and general practitioners after car collisions in Denmark. Within 10 days postinjury, participants were asked what they believed could help them get better. At 12-month follow-up, the level of neck pain and capability to work was obtained. Whether coping preferences (baseline) were associated with outcome was investigated using multiple regression analyses. Persistent neck pain was most strongly associated with preferring medications (mean difference=1.24 (95% CI 0.67 to 1.82)) and sickness absence (mean difference=1.18 (95% CI 0.53 to 1.82)). Reduced work capability was most strongly associated with preferring medications (OR=3.53 (95% CI 2.13 to 5.86)), sickness absence (OR=3.05 (95% CI 1.80 to 5.17)) and being referred to a physiotherapist/chiropractor (OR=3.03 (95% CI 1.33 to 6.91)). Active coping was associated with better outcomes: Participants preferring to change their lifestyle were protected against reduced work capability (OR=0.11 (95% CI 0.01 to 0.78)). Individuals who wanted to keep living as usual only (no other preference reported) were protected against neck pain (mean difference -1.62 (95% CI -2.39 to -0.84)) and reduced work capability (OR=0.09 (95% CI 0.01 to 0.64)). A simple nine-item measure of coping preferences is associated with the development of chronic neck pain and reduced capability to work following whiplash trauma and may be used to identify individuals at risk of poor recovery. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to

Longitudinal magnetic resonance imaging study on whiplash injury patients. Minimum 10-year follow-up

International Nuclear Information System (INIS)

Ichihara, Daisuke; Okada, Eijiro; Chiba, Kazuhiro

2009-01-01

We conducted a prospective long-term follow-up study to assess associations between magnetic resonance imaging (MRI) findings and changes in clinical symptoms, as well as factors relating to the prognosis of symptoms. A total of 133 patients with acute whiplash injury between 1993 and 1996 participated in this follow-up study. They underwent neurological examinations by spine surgeons and second MRI scans of the cervical spine were obtained. They also filled out a questionnaire regarding cervical symptoms and the accident details. The items evaluated by MRI were a decrease in the signal intensity of the intervertebral disc; anterior compression of the dura and the spinal cord; posterior disc protrusion; disc space narrowing; and foraminal stenosis. Relations between the presence/absence of degenerative changes on MRI, accident details, and patients' symptoms were assessed by calculating the adjusted odds ratio (OR). Progression of some degenerative changes was recognized on MRI in 98.5% of the 133 whiplash injury patients, and clinical symptoms diminished in more than a half of the 133 patients. There were no statistically significant associations between MRI findings and changes in clinical symptoms. The prognosis for neck pain tended to be poor after accidents with double collisions (rear-end collision followed by front-end collision) [adjusted OR 5.83, 95% confidence interval (CI) 1.15-29.71] and accidents with serious car damage (2.87, 1.03-7.99). The prognosis for stiff shoulders tended to be poor in women (2.83, 1.23-6.51); and the prognosis for numbness in the upper extremities tended to be poor after accidents with serious car damage (3.39, 1.14-10.06). This study demonstrated that progression of degenerative changes of the cervical spine on MRI was not associated with clinical symptoms during the 10-year period after whiplash injury. (author)

A prospective study of perceived injustice in whiplash victims and its relationship to recovery.

Science.gov (United States)

Ferrari, Robert

2015-05-01

The objectives of this paper are to to measure levels of perceived injustice in whiplash victims and determine the relationship to recovery at 6-month post-injury. Consecutive acute whiplash patients completed the Injustice Experience Questionnaire, at presentation, and also 3- and 6-month post-injury. At each of these two follow-up points, participants were examined for recovery. Of an initial 134 participants, 130 participants were followed up at 3 months and 124 at 6 months. At the 3-month follow-up, 62 % (80/130) of participants reported recovery from their injuries. At 6 months, 80 % (99/124) reported recovery. The initial Injustice Experience Questionnaire score was low, with a mean score of 6.0 ± 1.0 (range 5-10) out of a maximum of 48. The mean score at 3-month follow-up had increased in the cohort to 7.4 ± 1.6 (range 5-11). At 6-month post-injury, the mean of the Injustice Experience Questionnaire score for the cohort who still reported lack of recovery (25/124 participants) was 15.0 ± 6.0 (range 5-31), while that for the recovered group remained low at 8.2 ± 3.9 (range 5-11). In the primary care setting, a significant proportion of whiplash patients who have not recovered by 3-month post-injury subsequently develop higher levels of perceived injustice by 6-month post-injury. The development of high levels of perceived injustice at 6-month post-injury appears to follow the development of chronic pain and a lack of recovery at 3 months and, at that point, becomes a risk factor for lack of recovery thereafter.

Predicting nonrecovery among whiplash patients in the emergency room and in an insurance company setting.

Science.gov (United States)

Rydman, Eric; Ponzer, Sari; Ottosson, Carin; Järnbert-Pettersson, Hans

2017-04-01

To construct and validate a prediction instrument for early identification of patients with a high risk of delayed recovery after whiplash injuries (PPS-WAD) in an insurance company setting. Prospective cohort study. On the basis of a historic cohort (n = 130) of patients with a whiplash injury identified in an emergency room (ER, model-building set), we used logistic regression to construct an instrument consisting of two demographic variables (i.e. questions of educational level and work status) and the patient-rated physical and mental status during the acute phase to predict self-reported nonrecovery after 6 months. We evaluated the instrument's ability to predict nonrecovery in a new cohort (n = 204) of patients originating from an insurance company setting (IC, validation set). The prediction instrument had low reproducibility when the setting was changed from the ER cohort to the IC cohort. The overall percentage of correct predictions of nonrecovery in the ER cohort was 78 % compared with 62 % in the IC cohort. The sensitivity and specificity in relation to nonrecovery were both 78 % in the ER cohort. The sensitivity and specificity in the insurance company setting was lower, 67 and 50 %. Clinical decision rules need validation before they are used in a new setting. An instrument consisting of four questions with an excellent possibility of identifying patients with a high risk of nonrecovery after a whiplash injury in the emergency room was not as useful in an insurance company setting. The importance and type of the risk factors for not recovering probably differ between the settings, as well as the individuals.

Activity-related summation of pain and functional disability in patients with whiplash injuries.

Science.gov (United States)

Sullivan, Michael J L; Larivière, Christian; Simmonds, Maureen

2010-11-01

This study investigated the relation between repetition-induced summation of activity-related pain (RISP) and indicators of functional disability in a sample of 62 individuals who had sustained whiplash injuries. Participants completed measures of pain severity, pain catastrophizing, fear of movement and depression prior to lifting a series of 36 weighted canisters. An index of RISP was computed as the increase in pain reported by participants over successive lifts of the weighted canisters. Measures of functional disability included physical lifting tolerance, self-reported disability and perceived work demands. Regression analyses revealed that the index of RISP accounted for significant variance in measures of lifting tolerance and perceived work demands, even when controlling for age, sex and pain severity. The index of RISP was also significantly correlated with pain catastrophizing and pain duration. The discussion addresses the mechanisms by which physiological and psychological factors might contribute to increases in pain during repeated physical activity. Discussion also addresses whether RISP might represent a risk factor for problematic recovery outcomes following whiplash injury. Copyright © 2010 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

Clinical management of cranio-vertebral instability after whiplash, when guidelines should be adapted: a case report.

Science.gov (United States)

Rebbeck, Trudy; Liebert, Ann

2014-12-01

Cranio-vertebral instability (CVI) due to loss of bony or ligamentous integrity is one of the sequelae that may result after a whiplash mechanism injury. Due to the lack of specificity of diagnostic tests, this condition is often missed and the default classification of whiplash associated disorder (WAD) is assigned. This case report describes a 14-year-old boy who was initially classified with WAD II after a rugby injury. He was initially advised to return to usual activity, a treatment recommended in clinical guidelines for WAD. Due to an adverse response to this course of action, his primary carer, a musculoskeletal physiotherapist, continued with facilitating secondary referrals that ultimately led to a specialist physiotherapist. The patient was subsequently found to have CVI arising from a loss of bony integrity due to spina bifida atlanto, a congenital defect in the atlas. Treatment thus was immobilization and stabilization, a treatment usually recommended against in WAD guidelines. The patient recovered and within 8 weeks had returned to school and non-contact sports. This case study, therefore, presents a scenario where current clinical guidelines for whiplash could not be followed, and where pursuing clinical reasoning led to accurate diagnosis as well as safe and tailored management. The case also highlights the integrated roles that primary and specialist health professionals should play in the clinical pathway of care after WAD. As a result, an expanded diagnostic algorithm and pathway of care for WAD are proposed. Copyright © 2014 Elsevier Ltd. All rights reserved.

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

Directory of Open Access Journals (Sweden)

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.

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

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

The Nature of Whiplash in a Compensable Environment: Injury, Disability, Rehabilitation, and Compensation Systems.

Science.gov (United States)

Connelly, Luke B

2017-07-01

Synopsis Whiplash is a compensable injury in many jurisdictions, but there is considerable heterogeneity in the compensation arrangements that apply across jurisdictions, even within some countries. These compensation schemes have, however, been subject to a common set of interrelated concerns, chiefly concerning the incentives, behaviors, and outcomes that may arise when financial compensation for injuries is available to injured parties. This article provides a nontechnical overview of some of those concerns through the lens of economics: principally, insurance economics and health economics, including related subsets such as information economics and agency theory, as well as economics and the law. It notes that because it is generally infeasible to randomize the treatment (ie, compensation) via trials, analyses of observational data are necessary to discover more about the relationship between compensation and health outcomes. This poses the analytical challenge of discovering causal connections between phenomena from nonrandomized data sets. The present article calls for further research that would enable convincing causal interpretations of such relationships via the careful analysis of rich observational data sets using modern econometric methods. J Orthop Sports Phys Ther 2017;47(7):503-508. Epub 16 Jun 2017. doi:10.2519/jospt.2017.7533.

General Exercise Does Not Improve Long-Term Pain and Disability in Individuals With Whiplash-Associated Disorders: A Systematic Review.

Science.gov (United States)

Griffin, Alexandra; Leaver, Andrew; Moloney, Niamh

2017-07-01

Study Design Systematic review of randomized controlled trials. Background General exercise, defined as purposeful physical activity involving repetitive exercises and incorporating multiple muscle groups, is frequently used in the management of whiplash-associated disorders (WADs). Evidence supporting its efficacy is not well established. Objectives To determine whether general exercise is effective in reducing pain and disability in people with WAD. Methods Studies published in English in peer-reviewed journals between January 1990 and May 2015 were eligible if they evaluated a general exercise intervention compared with a different intervention or control. Studies were required to evaluate pain and disability at medium-term (6-14 weeks) and long-term (52 weeks) follow-ups. The mean ± SD and sample size were recorded for follow-up scores and for change scores from baseline to follow-up. Results Of the 3 high-quality studies that were eligible for inclusion, none investigated general exercise alone. There were no clinically meaningful differences between comprehensive exercise programs, which included general exercise, and minimal intervention controls in the medium and long term. No studies directly compared general exercise with a no-treatment control. All included studies used different control interventions, preventing meta-analysis. Conclusion A lack of significant long-term improvements from general exercise interventions in individuals with WAD was identified. This finding differs from the positive benefits of general exercise for other musculoskeletal conditions. This may, in part, relate to the complexity of whiplash conditions. This may also reflect the challenge of exercise prescription in this population, where the need for sufficient intensity is balanced against the impact that exercise has on pain. Level of Evidence Therapy, level 1a. J Orthop Sports Phys Ther 2017;47(7):472-480. Epub 16 Jun 2017. doi:10.2519/jospt.2017.7081.

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

Science.gov (United States)

Stupar, Maja; Côté, Pierre; Beaton, Dorcas E; Boyle, Eleanor; Cassidy, J David

2015-11-01

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. The aim was to determine the structural and construct validity of the WDQ in individuals with acute WAD. This was a cohort study. Ontario adults with WAD were enrolled within 3 weeks of their motor vehicle collision. The outcome measure was the WDQ. We 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 [CES-D]). The mean age of the 130 participants was 42.1 years (standard deviation [SD]=13.2), and 70% were women. Twenty-six percent had WAD I, 73.1% had WAD II, and 0.8% had WAD III. Mean time since injury was 6.5 days (SD=4.9). The mean WDQ score was 49.8 (SD=29.1). Our analysis suggested that the WDQ includes two factors: daily activities and emotional status. This factor structure remained stable in sensitivity analyses (eg, zeros imputed for missing values, and the item with the most missing values or resulting in complex loading excluded). Strong correlations were found between the total WDQ score and the NDI, the Bournemouth questionnaire, the SF-36 physical function, and the NRS (for the neck, shoulder, mid and low back pain) satisfying a priori hypotheses. We found a priori hypothesized moderate correlations between the WDQ, and the CES-D and SF-36 mental function

Applying the Quebec Task Force criteria as a frame of reference for studies of whiplash injuries

NARCIS (Netherlands)

Versteegen, GJ; van Es, FD; Kingma, J; Meijler, WJ; ten Duis, HJ

Research prior to 1995 showed a diversity of either inclusion or exclusion criteria (or both) for diagnosing whiplash injury. As a consequence, the Quebec Task Force (QTF) developed expert-based criteria, which may be considered as a the 'new' gold standard. Here, we examined the inclusion criteria

Study Protocol: Phase III single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease

Directory of Open Access Journals (Sweden)

Brafman-Kennedy Barbara

2011-05-01

Full Text Available Abstract Background Breathlessness in advanced disease causes significant distress to patients and carers and presents management challenges to health care professionals. The Breathlessness Intervention Service (BIS seeks to improve the care of breathless patients with advanced disease (regardless of cause through the use of evidence-based practice and working with other healthcare providers. BIS delivers a complex intervention (of non-pharmacological and pharmacological treatments via a multi-professional team. BIS is being continuously developed and its impact evaluated using the MRC's framework for complex interventions (PreClinical, Phase I and Phase II completed. This paper presents the protocol for Phase III. Methods/Design Phase III comprises a pragmatic, fast-track, single-blind randomised controlled trial of BIS versus standard care. Due to differing disease trajectories, the service uses two broad service models: one for patients with malignant disease (intervention delivered over two weeks and one for patients with non-malignant disease (intervention delivered over four weeks. The Phase III trial therefore consists of two sub-protocols: one for patients with malignant conditions (four week protocol and one for patients with non-malignant conditions (eight week protocol. Mixed method interviews are conducted with patients and their lay carers at three to five measurement points depending on randomisation and sub-protocol. Qualitative interviews are conducted with referring and non-referring health care professionals (malignant disease protocol only. The primary outcome measure is 'patient distress due to breathlessness' measured on a numerical rating scale (0-10. The trial includes economic evaluation. Analysis will be on an intention to treat basis. Discussion This is the first evaluation of a breathlessness intervention for advanced disease to have followed the MRC framework and one of the first palliative care trials to use fast

PET Imaging of Mild Traumatic Brain Injury and Whiplash Associated Disorder

OpenAIRE

Vállez García, David

2015-01-01

Traumatic brain injury is the leading cause of brain injury in our society with 235 per 100,000 inhabitants per year in the European Union and about 500 per 100,000 inhabitants per year in the United States. About 80% of all these events are accounted for as mild cases. At the same time, whiplash-associated disorder is one of the most frequent consequences of motor vehicle related accidents affecting about 300 per 100,000 inhabitants per year in the United States and Western European countrie...

Effect of Early Intensive Care on Recovery from Whiplash-Associated Disorders

DEFF Research Database (Denmark)

Skillgate, Eva; Côté, Pierre; Cassidy, J. David

2016-01-01

Objective To determine whether the results from previous research suggesting that early intensive health care delays recovery from whiplash-associated disorders (WADs) were confounded by expectations of recovery and whether the association between early health care intensity and time to recovery......; 95% CI,.68-.90) had significantly slower recovery. Conclusions Our study adds to the existing evidence that early intensive care is associated with slower recovery from WAD, independent of expectation of recovery. The results have policy implications and suggest that the optimal management of WADs...

Risk factors for persistent problems following acute whiplash injury: update of a systematic review and meta-analysis.

Science.gov (United States)

Walton, David M; Macdermid, Joy C; Giorgianni, Anthony A; Mascarenhas, Joanna C; West, Stephen C; Zammit, Caroline A

2013-02-01

Systematic review and meta-analysis. To update a previous review and meta-analysis on risk factors for persistent problems following whiplash secondary to a motor vehicle accident. Prognosis in whiplash-associated disorder (WAD) has become an active area of research, perhaps owing to the difficulty of treating chronic problems. A previously published review and meta-analysis of prognostic factors included primary sources up to May 2007. Since that time, more research has become available, and an update to that original review is warranted. A systematic search of international databases was conducted, with rigorous inclusion criteria focusing on studies published between May 2007 and May 2012. Articles were scored, and data were extracted and pooled to estimate the odds ratio for any factor that had at least 3 independent data points in the literature. Four new cohorts (n = 1121) were identified. In combination with findings of a previous review, 12 variables were found to be significant predictors of poor outcome following whiplash, 9 of which were new (n = 2) or revised (n = 7) as a result of additional data. The significant variables included high baseline pain intensity (greater than 5.5/10), report of headache at inception, less than postsecondary education, no seatbelt in use during the accident, report of low back pain at inception, high Neck Disability Index score (greater than 14.5/50), preinjury neck pain, report of neck pain at inception (regardless of intensity), high catastrophizing, female sex, WAD grade 2 or 3, and WAD grade 3 alone. Those variables robust to publication bias included high pain intensity, female sex, report of headache at inception, less than postsecondary education, high Neck Disability Index score, and WAD grade 2 or 3. Three existing variables (preaccident history of headache, rear-end collision, older age) and 1 additional novel variable (collision severity) were refined or added in this updated review but showed no significant

Head and neck control varies with perturbation acceleration but not jerk: implications for whiplash injuries.

Science.gov (United States)

Siegmund, Gunter P; Blouin, Jean-Sébastien

2009-04-15

Recent studies have proposed that a high rate of acceleration onset, i.e. high jerk, during a low-speed vehicle collision increases the risk of whiplash injury by triggering inappropriate muscle responses and/or increasing peak head acceleration. Our goal was to test these proposed mechanisms at realistic jerk levels and then to determine how collision jerk affects the potential for whiplash injuries. Twenty-three seated volunteers (8 F, 15 M) were exposed to multiple experiments involving perturbations simulating the onset of a vehicle collision in eyes open and eyes closed conditions. In the first experiment, subjects experienced five forward and five rearward perturbations to look for the inappropriate muscle responses and 'floppy' head kinematics previously attributed to high jerk perturbations. In the second experiment, we independently varied the jerk ( approximately 125 to 3 000 m s(-3)) and acceleration ( approximately 0.65 to 2.6 g) of the perturbation to assess their effect on the electromyographic (EMG) responses of the sternocleidomastoid (SCM), scalene (SCAL) and cervical paraspinal (PARA) muscles and the kinematic responses of the head and neck. In the first experiment, we found neither inappropriate muscle responses nor floppy head kinematics when subjects had their eyes open, but observed two subjects with floppy head kinematics with eyes closed. In the second experiment, we found that about 70% of the variations in the SCM and SCAL responses and about 95% of the variations in head/neck kinematics were explained by changes in perturbation acceleration in both the eyes open and eyes closed conditions. Less than 2% of the variation in the muscle and kinematic responses was explained by changes in perturbation jerk and, where significant, response amplitudes diminished with increasing jerk. Based on these findings, collision jerk appears to have little or no role in the genesis of whiplash injuries in low-speed vehicle crashes.

A systematic literature review of physical prognostic factors for the development of Late Whiplash Syndrome.

Science.gov (United States)

Williams, Mark; Williamson, Esther; Gates, Simon; Lamb, Sarah; Cooke, Matthew

2007-12-01

Systematic Review. To summarize evidence concerning physical prognostic factors for development of Late Whiplash Syndrome (LWS). There have been 3 previous systematic reviews of prognosis of whiplash with conflicting findings. The Quebec Task Force concluded that high priority should be given to determining prognostic factors. Subsequently their review was updated by Cote et al (Spine 2001;26:E445-58) and most recently by Scholten-Peeters et al (Pain 2003;104:303-22). We searched electronic databases from their inception to August 2006 using a prespecified search strategy. We included prospective cohort and case control studies that studied physical prognostic factors at baseline. Two independent reviewers selected articles, extracted data, and assessed quality. Meta-analysis was not performed due to the heterogeneity between studies. Instead, levels of evidence were generated by grouping similar findings from cohorts. Thirty-eight articles from 26 cohorts were reviewed. The majority of articles (25 of 38) were rated as low quality. No studies were rated as high quality. Only a minority of studies used validated prognostic measures and/or outcome measures. High initial neck pain intensity, neck pain related disability, and cold hyperalgesia all had moderate evidence for an association with the development of LWS. No factor was rated as having strong evidence. Pain has a central role to play as a prognostic factor for the development of LWS. Other physical factors commonly used in the clinical setting showed inconclusive evidence for their influence on prognosis. There is a need for improved quality of studies with consistent use of validated measures of all categories of prognostic factors and outcome. This may then provide a clearer understanding of prognosis of Whiplash Associated Disorders and therefore facilitate effective management of this costly problem.

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.

Cold hyperalgesia as a prognostic factor in whiplash associated disorders: a systematic review.

Science.gov (United States)

Goldsmith, Robert; Wright, Chris; Bell, Sarah F; Rushton, Alison

2012-10-01

To review and critically evaluate the existing literature for the prognostic value of cold hyperalgesia in Whiplash Associated Disorders (WAD). Embase, PsycINFO, and Medline databases were systematically searched (from inception to 20th September 2011) for prospective studies investigating a prognostic ability for cold hyperalgesia in WAD. Reference lists and lead authors were cross-referenced. Two independent reviewers selected studies, and consensus was achieved via a third reviewer. The risk of bias in identified studies was systematically evaluated by two reviewers using previously published guidance. The influences of seven potential covariates of cold hyperalgesia were considered. Quantitative synthesis was planned and homogeneity assessed. A modified Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) approach was used to qualitatively assess trials. The review screened 445 abstracts, from these 20 full text studies were retrieved and assessed for eligibility. Six prospective studies on four cohorts were identified and reviewed. Findings from all four cohorts supported cold hyperalgesia as a prognostic factor in WAD. There is moderate evidence supporting cold hyperalgesia as a prognostic factor for long-term pain and disability outcome in WAD. Further validation of the strength of this relationship and the influence of covariates are required. The mechanism for this relationship is unknown. Copyright © 2012 Elsevier Ltd. All rights reserved.

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.

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

Post-traumatic stress symptom clusters in acute whiplash associated disorder and their prediction of chronic pain-related disability

Directory of Open Access Journals (Sweden)

Annick Maujean

2017-12-01

Conclusion:. Given that only the hyperarousal/numbing symptom cluster predicted long-term neck pain-related disability, this finding may have implications in terms of diagnosis, assessment, and management of the psychological impact of whiplash-injured individuals following a MVC.

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.

Dynamic 3D FE modelling of the human temporomandibular joint during whiplash.

Science.gov (United States)

Pérez del Palomar, A; Doblaré, M

2008-07-01

Rear-end impacts account for more than one-third of vehicle accidents, and nearly 40% of these accidents produce whiplash injuries. Whiplash injury to the neck has often been considered a significant risk factor for the development of temporomandibular disorders (TMD). The objective of this study was to simulate the dynamic response of the temporomandibular joint during two types of impacts: a rear end and a frontal impact. To understand the dynamic forces acting on the joint, we extended a previous human temporomandibular joint model and analyzed the stress distributions in the soft elements of the joint. In the rear-end impact, it could be appreciated that the inertia of the mandible caused it to move posteriorly slower than the head, and this resulted in downward and forward displacements of the disc-condyle complex relative to the cranial base. Consequently, a rapid and big mouth opening occurs. In contrast, during the frontal impact, the mouth hardly opened, because the superior maxilla pushed the mandible to move together. There was not differential movement between bony components of the joint and therefore the soft tissues of the joint were not subjected to high loads. From these results, and despite the limitations of the simulations performed, we could conclude that neither a rear-end impact at low-velocity nor a frontal impact would produce damage to the soft tissues of the joint.

Differential diagnosis and treatment of bilateral facial pain after whiplash: a case report.

Science.gov (United States)

Peterson, Seth

2015-01-01

Clinical case report. Symptoms in the face and jaw are common after whiplash. Few studies have reported cervicogenic headache in a trigeminal nerve distribution, and no published studies could be found describing such symptoms experienced bilaterally after whiplash. The objective of the current case report was to detail the clinical reasoning and management of an uncommon patient presentation. The 41-year-old female patient of the current case complained of shooting pain in the jaw, cheek and forehead beginning 7 days after her accident. No imaging was performed, and examination ruled out serious pathology. The patient was treated primarily with deep neck flexor (DNF) and proprioceptive training for 10 visits over an 8-week period. The Numeric Pain Rating Scale improved from 2/10 to 0/10, the Neck Disability Index improved from 17/50 to 1/50, and the Neck Flexor Muscle Endurance Test improved from 13 to 30 s. The patient remained symptom-free at 4-month follow-up. The current case report describes a patient presentation unique to the literature. Significant changes were seen by week 3 with DNF and proprioceptive training. Additional research is required to determine the effectiveness of this intervention in similar presentations.

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.

Correlation of accident statistics to whiplash performance parameters using the RID 3D and BioRID dummy

NARCIS (Netherlands)

Cappon, H.J.; Hell, W.; Hoschopf, H.; Muser, M.; Song, E.; Wismans, J.S.H.M.

2005-01-01

Injury criteria are crucial in whiplash protection evaluations. Therefore, the real-life rear impact performance of eight car seats was compared with various injury criteria using linear correlation techniques. Two dummies, BioRID and RID 3D, and two types of pulses were used: generic and car

Blockchain protocols in clinical trials: Transparency and traceability of consent [version 5; referees: 1 approved, 2 approved with reservations, 2 not approved

Directory of Open Access Journals (Sweden)

Mehdi Benchoufi

2018-02-01

Full Text Available 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

Blockchain protocols in clinical trials: Transparency and traceability of consent [version 4; referees: 1 approved, 2 approved with reservations, 2 not approved

Directory of Open Access Journals (Sweden)

Mehdi Benchoufi

2017-12-01

Full Text Available 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

Complexities in understanding the role of compensation-related factors on recovery from whiplash-associated disorders : discussion paper 2

NARCIS (Netherlands)

Carroll, Linda J.; Connelly, Luke B.; Spearing, Natalie M.; Cote, Pierre; Buitenhuis, Jan; Kenardy, Justin

2011-01-01

Study Design. Focused discussion. Objective. To present some of the complexities in conducting research on the role of compensation and compensation-related factors in recovery from whiplash-associated disorders (WAD) and to suggest directions for future research. Summary of Background Data. There

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.

MRI of the tectorial and posterior atlanto-occipital membranes in the late stage of whiplash injury

Energy Technology Data Exchange (ETDEWEB)

Krakenes, J.; Moen, G.; Nordli, H.; Rorvik, J. [Department of Radiology, University of Bergen and Haukeland University Hospital, 5021, Bergen (Norway); Kaale, B.R. [Firda Medical Centre, 6823, Sandane (Norway); Gilhus, N.E. [Department of Neurology, University of Bergen and Haukeland University Hospital, 5021, Bergen (Norway)

2003-09-01

Our aim was to characterise and classify permanent structural changes in the tectorial and posterior atlanto-occipital membranes several years after a whiplash injury, and to evaluate the reliability of our classification. We obtained sagittal proton density-weighted images of the craniovertebral junction of 92 whiplash-injured and 30 uninjured individuals. Structural abnormalities in the two membranes were classified as grades 1-3 independently by three radiologists blinded for clinical information. Grading criteria were based on reduced tectorial membrane thickness, and elongation or rupture of the posterior atlanto-occipital membrane/dura mater complex. The same images were reassessed 4 months later. Image quality was graded good in 104 cases, slightly reduced in 13 and unsatisfactory in five. Of 117 tectorial membranes 31 (26.5%) showed grade 2 or 3 lesions, in the uninjured group none were grade 3 and only three were grade 2. Pair-wise interobserver agreement (weighted kappa) was moderate (0.47-0.50), while the intraobserver agreement was moderate to good (0.51-0.70). Of 117 posterior atlanto-occipital membranes 20 (17.1%) had grade 2 or 3 lesions; there was no grade 3 and only one grade 2 lesion in the uninjured group. Inter- and intraobserver agreement was good (0.61-0.74 and 0.65-0.86, respectively). Reduced image quality was the main reason for disagreement, but partial thinning and lateral tapering, as normal tectorial membrane variations, created difficulties in some cases. This study strongly indicates that whiplash trauma can damage the tectorial and posterior atlanto-occipital membranes; this can be shown on high-resolution MRI. Better knowledge of normal anatomical variations and improved image quality should increase the reliability of lesion classification. (orig.)

Measures of spontaneous and movement-evoked pain are associated with disability in patients with whiplash injuries.

Science.gov (United States)

Mankovsky-Arnold, Tsipora; Wideman, Timothy H; Larivière, Christian; Sullivan, Michael J L

2014-09-01

This study examined the degree to which measures of spontaneous and movement-evoked pain accounted for shared or unique variance in functional disability associated with whiplash injury. The study also addressed the role of fear of movement as a mediator or moderator of the relation between different indices of pain and functional disability. Measures of spontaneous pain, single-point movement-evoked pain, repetition-induced summation of activity-related pain (RISP), and fear of movement and disability were obtained on a sample of 142 individuals who had sustained whiplash injuries. Participants' pain ratings, provided after lifting a weighted canister, were used as the index of single-point movement-evoked pain. RISP was computed as the increase in pain reported by participants over successive lifts of 18 weighted canisters. Measures of functional disability included physical lift tolerance and self-reported disability. Hierarchical regression analyses revealed that measures of single-point movement-evoked pain and RISP accounted for significant unique variance in self-reported disability, beyond the variance accounted for by the measure of spontaneous pain. Only RISP accounted for significant unique variance in lift tolerance. The results suggest that measures of movement-evoked pain represent a disability-relevant dimension of pain that is not captured by measures of spontaneous pain. The clinical and conceptual implications of the findings are discussed. This study examined the degree to which measures of spontaneous and movement-evoked pain accounted for shared or unique variance in functional disability associated with whiplash injury. The findings suggest that approaches to the clinical evaluation of pain would benefit from the inclusion of measures of movement-evoked pain. Copyright © 2014 American Pain Society. Published by Elsevier Inc. All rights reserved.

MRI of the tectorial and posterior atlanto-occipital membranes in the late stage of whiplash injury

International Nuclear Information System (INIS)

Krakenes, J.; Moen, G.; Nordli, H.; Rorvik, J.; Kaale, B.R.; Gilhus, N.E.

2003-01-01

Our aim was to characterise and classify permanent structural changes in the tectorial and posterior atlanto-occipital membranes several years after a whiplash injury, and to evaluate the reliability of our classification. We obtained sagittal proton density-weighted images of the craniovertebral junction of 92 whiplash-injured and 30 uninjured individuals. Structural abnormalities in the two membranes were classified as grades 1-3 independently by three radiologists blinded for clinical information. Grading criteria were based on reduced tectorial membrane thickness, and elongation or rupture of the posterior atlanto-occipital membrane/dura mater complex. The same images were reassessed 4 months later. Image quality was graded good in 104 cases, slightly reduced in 13 and unsatisfactory in five. Of 117 tectorial membranes 31 (26.5%) showed grade 2 or 3 lesions, in the uninjured group none were grade 3 and only three were grade 2. Pair-wise interobserver agreement (weighted kappa) was moderate (0.47-0.50), while the intraobserver agreement was moderate to good (0.51-0.70). Of 117 posterior atlanto-occipital membranes 20 (17.1%) had grade 2 or 3 lesions; there was no grade 3 and only one grade 2 lesion in the uninjured group. Inter- and intraobserver agreement was good (0.61-0.74 and 0.65-0.86, respectively). Reduced image quality was the main reason for disagreement, but partial thinning and lateral tapering, as normal tectorial membrane variations, created difficulties in some cases. This study strongly indicates that whiplash trauma can damage the tectorial and posterior atlanto-occipital membranes; this can be shown on high-resolution MRI. Better knowledge of normal anatomical variations and improved image quality should increase the reliability of lesion classification. (orig.)

Effects of Jungsongouhyul Herbal Acupuncture(JSO Multi-treatment for Whiplash Injury by Traffic Accident

Directory of Open Access Journals (Sweden)

Seol Hyun

2005-02-01

Full Text Available Objectives : To examine the effects of JSO multi-treatment for whiplash injury patients by traffic accident. Interventions : Nonrandomized, Nonblinded compartson of the JSO+Acupuncture and Acupuncture Treatment. Main Outcome Measures : Subjective evaluation was followed by Clinical Grade and VAS after 5 times treatments. The SPSS 10.0 for windows was used to analyze the date and the Wilcoxon signed rank test and Mann-Whitney U-testwere used to verify the results. Results : The following results were obtained ; 1. Clinical Grade of the JSO+Acupuncture treatment was centralized to Gr II(50% before treatment. After 5 times treatments, it was centralized to Gr I(58.3%. Also Clinical Grade was significantly changed from GR ll to Gr I(p<0.0002. 2. Clinical Grade of the Acupuncture treatment was centralize(d to Gr II(54.2% before treament. After 5 times treament, it was tend to cenualize to Gr I(50%. But Clinical Grade was still remained at Gr II(p<0.001 3. VAS of change between JSO+Acupuncture and Acupuncture treatment, Vas of JSO+Acupuncture was significantly decreased (p<0.003. C onclusion : It is suggested that JSO multi-treatment has development-effectiveness on whiplash injury patients by traffic accident.

Smertetilstand og psykologisk distress før uheldet prædikterer gener efter whiplash-traume - sekundærpublikation

DEFF Research Database (Denmark)

Carstensen, Tina Birgitte; Frostholm, Lisbeth; Ørnbøl, Eva

2009-01-01

Patients with acute whiplash trauma were followed to examine if pre-collision pain and psychological distress were associated with reduced work capability and neck pain at 12 month follow-up. Pre-collision unspecified pain was associated with reduced work capability, and neck pain and pre-collisi...

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...

Examination of the diagnostic validity of 'headache attributed to whiplash injury': a controlled, prospective study.

Science.gov (United States)

Schrader, H; Stovner, L J; Obelieniene, D; Surkiene, D; Mickeviciene, D; Bovim, G; Sand, T

2006-11-01

Acute and chronic headache attributed to whiplash injury are new diagnostic entities in the International Classification of Headache Disorders, second edition. A main objective of the present study was to assess the validity of these nosologic entities by studying the headache pattern in an inception cohort of 210 rear-end car collision victims and in 210 matched controls. Consecutive drivers involved in rear-end collisions were identified from the daily records of the Traffic Police Department of Kaunas, Lithuania. A standard self-report questionnaire was sent to the drivers between 2 and 7 days after the collision, and their passengers were recruited as well. Headache and neck pain were evaluated within 7 days of the collision, at 2 months and 1 year after the collision. A control group of non-traumatized subjects received questionnaires at the time of the selection and 1 year later. Of the 75 collision victims who developed headache within the first 7 days of the collision, 37 had a clinical picture in accordance with the criteria for acute whiplash headache (i.e., concomitant neck pain) and 38 did not. For acute headache after collision, concomitant neck pain was of no relevance to the headache type or its course. In both these subgroups, migraine and tension-type headache could be diagnosed in similar proportions and the prognosis after 2 months and 1 year was also similar. Preexisting headache was a strong prognostic factor in both groups for both acute and chronic pain. Compared with the non-traumatized control group, the 1-year incidence of new or worsened headache, or of headache improvement, was the same. A likely interpretation of the data is that acute headaches after rear-end car collisions mainly represent episodes of a primary headache precipitated by the stress of the situation. We conclude that the nosologic validity of both acute and chronic whiplash headache is poor as the headaches, in accordance with the criteria lack distinguishing clinical

A cluster randomised controlled trial of advice, exercise or multifactorial assessment to prevent falls and fractures in community-dwelling older adults: protocol for the prevention of falls injury trial (PreFIT).

Science.gov (United States)

Bruce, Julie; Lall, Ranjit; Withers, Emma J; Finnegan, Susanne; Underwood, Martin; Hulme, Claire; Sheridan, Ray; Skelton, Dawn A; Martin, Finbarr; Lamb, Sarah E

2016-01-18

Falls are the leading cause of accident-related mortality in older adults. Injurious falls are associated with functional decline, disability, healthcare utilisation and significant National Health Service (NHS)-related costs. The evidence base for multifactorial or exercise interventions reducing fractures in the general population is weak. This protocol describes a large-scale UK trial investigating the clinical and cost-effectiveness of alternative falls prevention interventions targeted at community dwelling older adults. A three-arm, pragmatic, cluster randomised controlled trial, conducted within primary care in England, UK. Sixty-three general practices will be randomised to deliver one of three falls prevention interventions: (1) advice only; (2) advice with exercise; or (3) advice with multifactorial falls prevention (MFFP). We aim to recruit over 9000 community-dwelling adults aged 70 and above. Practices randomised to deliver advice will mail out advice booklets. Practices randomised to deliver 'active' interventions, either exercise or MFFP, send all trial participants the advice booklet and a screening survey to identify participants with a history of falling or balance problems. Onward referral to 'active' intervention will be based on falls risk determined from balance screen. The primary outcome is peripheral fracture; secondary outcomes include number with at least one fracture, falls, mortality, quality of life and health service resource use at 18 months, captured using self-report and routine healthcare activity data. The study protocol has approval from the National Research Ethics Service (REC reference 10/H0401/36; Protocol V.3.1, 21/May/2013). User groups and patient representatives were consulted to inform trial design. Results will be reported at conferences and in peer-reviewed publications. A patient-friendly summary of trial findings will be published on the prevention of falls injury trial (PreFIT) website. This protocol adheres to the

Eye Movement Desensitization and Reprocessing (EMDR) bij verkeersslachtoffers met chronische whiplash-klachten: een exploratieve studie naar het verzachten van traumasymptomen.

NARCIS (Netherlands)

Renssen, M.; Winkel, F.W.

1999-01-01

Dit onderzoek bij verkeersslachtoffers met whiplash-klachten maakte deel uit van een omvangrijker studie naar de kwaliteit van hulpverlening aan slachtoffers van verkeersongevallen, in het kader van het Achmea-project ‘Kwaliteit Slachtofferhulp’. Gerapporteerd wordt een viertal gevalsbeschrijvingen

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...

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...

Blockchain protocols in clinical trials: Transparency and traceability of consent [version 3; referees: 1 approved, 2 approved with reservations, 1 not approved

Directory of Open Access Journals (Sweden)

Mehdi Benchoufi

2017-07-01

Full Text Available 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 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 revision of the protocol, consent was sought again. We obtained a single document, in a standard open format, that accounted for the whole consent collection process: timestamped consent status with regards to each version of the protocol. This document cannot be corrupted, and can be checked on any dedicated public website. It should be considered as a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened in order to remove the need for third parties, here the trial stakeholders, and give participative control to the peer-to-peer users. In the future, we think that the complex data flow of a clinical trial can be tracked using Blockchain, that a blockchain core functionality, named Smart Contract, could help prevent clinical trial events not to happen in the right chronological order: for example including patients before they consented or analysing case report forms data before freezing the database

Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees.

Science.gov (United States)

Li, Rebecca H; Wacholtz, Mary C; Barnes, Mark; Boggs, Liam; Callery-D'Amico, Susan; Davis, Amy; Digilova, Alla; Forster, David; Heffernan, Kate; Luthin, Maeve; Lynch, Holly Fernandez; McNair, Lindsay; Miller, Jennifer E; Murphy, Jacquelyn; Van Campen, Luann; Wilenzick, Mark; Wolf, Delia; Woolston, Cris; Aldinger, Carmen; Bierer, Barbara E

2016-04-01

A novel Protocol Ethics Tool Kit ('Ethics Tool Kit') has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. 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/

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.

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

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.

The role of tissue damage in whiplash associated disorders: Discussion paper 1

Science.gov (United States)

Bogduk, Nikolai; Ivancic, Paul C.; McLean, Samuel A.; Siegmund, Gunter P.; Winkelstein, Beth

2011-01-01

STUDY DESIGN Non-systematic review of cervical spine lesions in whiplash-associated disorders (WAD). OBJECTIVE To describe whiplash injury models in terms of basic and clinical science, to summarize what can and cannot be explained by injury models, and to highlight future research areas to better understand the role of tissue damage in WAD. SUMMARY OF BACKGROUND DATA The frequent lack of detectable tissue damage has raised questions about whether tissue damage is necessary for WAD and what role it plays in the clinical context of WAD. METHODS Non-systematic review. RESULTS Lesions of various tissues have been documented by numerous investigations conducted in animals, cadavers, healthy volunteers and patients. Most lesions are undetected by imaging techniques. For zygapophysial (facet) joints, lesions have been predicted by bioengineering studies and validated through animal studies; for zygapophysial joint pain, a valid diagnostic test and a proven treatment are available. Lesions of dorsal root ganglia, discs, ligaments, muscles and vertebral artery have been documented in biomechanical and autopsy studies, but no valid diagnostic test is available to assess their clinical relevance. The proportion of WAD patients in whom a persistent lesion is the major determinant of ongoing symptoms is unknown. Psychosocial factors, stress reactions and generalized hyperalgesia have also been shown to predict WAD outcomes. CONCLUSION There is evidence supporting a lesion-based model in WAD. Lack of macroscopically identifiable tissue damage does not rule out the presence of painful lesions. The best available evidence concerns zygapophysial joint pain. The clinical relevance of other lesions needs to be addressed by future research. PMID:22020601

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.

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.

Are cervical multifidus muscles active during whiplash and startle? An initial experimental study

Directory of Open Access Journals (Sweden)

Carpenter Mark G

2008-06-01

Full Text Available Abstract Background The cervical multifidus muscles insert onto the lower cervical facet capsular ligaments and the cervical facet joints are the source of pain in some chronic whiplash patients. Reflex activation of the multifidus muscle during a whiplash exposure could potentially contribute to injuring the facet capsular ligament. Our goal was to determine the onset latency and activation amplitude of the cervical multifidus muscles to a simulated rear-end collision and a loud acoustic stimuli. Methods Wire electromyographic (EMG electrodes were inserted unilaterally into the cervical multifidus muscles of 9 subjects (6M, 3F at the C4 and C6 levels. Seated subjects were then exposed to a forward acceleration (peak acceleration 1.55 g, speed change 1.8 km/h and a loud acoustic tone (124 dB, 40 ms, 1 kHz. Results Aside from one female, all subjects exhibited multifidus activity after both stimuli (8 subjects at C4, 6 subjects at C6. Neither onset latencies nor EMG amplitude varied with stimulus type or spine level (p > 0.13. Onset latencies and amplitudes varied widely, with EMG activity appearing within 160 ms of stimulus onset (for at least one of the two stimuli in 7 subjects. Conclusion These data indicate that the multifidus muscles of some individuals are active early enough to potentially increase the collision-induced loading of the facet capsular ligaments.

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.

The temporal development of fatty infiltrates in the neck muscles following whiplash injury: an association with pain and posttraumatic stress.

Directory of Open Access Journals (Sweden)

James Elliott

Full Text Available Radiological findings associated with poor recovery following whiplash injury remain elusive. Muscle fatty infiltrates (MFI in the cervical extensors on magnetic resonance imaging (MRI in patients with chronic pain have been observed. Their association with specific aspects of pain and psychological factors have yet to be explored longitudinally.44 subjects with whiplash injury were enrolled at 4 weeks post-injury and classified at 6 months using scores on the Neck Disability Index as recovered, mild and moderate/severe. A measure for MFI and patient self-report of pain, loss of cervical range of movement and posttraumatic stress disorder (PTSD were collected at 4 weeks, 3 months and 6 months post-injury. The effects of time and group and the interaction of time by group on MFI were determined. We assessed the mediating effect of posttraumatic stress and cervical range of movement on the longitudinal relationship between initial pain intensity and MFI. There was no difference in MFI across all groups at enrollment. MFI values increased in the moderate/severe group and were significantly higher in comparison to the recovered and mild groups at 3 and 6 months. No differences in MFI values were found between the mild and recovered groups. Initial severity of PTSD symptoms mediated the relationship between pain intensity and MFI at 6 months. Initial ROM loss did not.MFI in the cervical extensors occur soon following whiplash injury and suggest the possibility for the occurrence of a more severe injury with subsequent PTSD in patients with persistent symptoms.

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

Surgical fasciectomy of the trapezius muscle combined with neurolysis of the Spinal accessory nerve; results and long-term follow-up in 30 consecutive cases of refractory chronic whiplash syndrome

Directory of Open Access Journals (Sweden)

Freeman Michael

2010-04-01

Full Text Available Abstract Background Chronic problems from whiplash trauma generally include headache, pain and neck stiffness that may prove refractory to conservative treatment modalities. As has previously been reported, such afflicted patients may experience significant temporary relief with injections of local anesthetic to painful trigger points in muscles of the shoulder and neck, or lasting symptomatic improvement through surgical excision of myofascial trigger points. In a subset of patients who present with chronic whiplash syndrome, the clinical findings suggest an affliction of the spinal accessory nerve (CN XI, SAN by entrapment under the fascia of the trapezius muscle. The present study was undertaken to assess the effectiveness of SAN neurolysis in chronic whiplash syndrome. Methods A standardized questionnaire and a linear visual-analogue scale graded 0-10 was used to assess disability related to five symptoms (pain, headache, insomnia, weakness, and stiffness before, and one year after surgery in a series of thirty consecutive patients. Results The preoperative duration of symptoms ranged from seven months to 13 years. The following changes in disability scores were documented one year after surgery: Overall pain decreased from 9.5 +/- 0.9 to 3.2 +/- 2.6 (p Conclusions Entrapment of the spinal accessory nerve and/or chronic compartment syndrome of the trapezius muscle may cause chronic debilitating pain after whiplash trauma, without radiological or electrodiagnostic evidence of injury. In such cases, surgical treatment may provide lasting relief.

Disc pathology after whiplash injury. A prospective magnetic resonance imaging and clinical investigation

International Nuclear Information System (INIS)

Pettersson, K.; Hildingsson, C.; Toolanen, G.; Fagerlund, M.; Bjornebrink, J.

1997-01-01

Although disc pathology seems to be one contributing factor in the development of chronic symptoms after whiplash injury, it may be unnecessary to examine these patients in the acute phase with magnetic resonance imaging ; correlating initial symptoms and signs to magnetic resonance imaging findings is difficult because of the relatively high proportion of false-positive results. Magnetic resonance imaging is indicated later in the course of treatment in patients with persistent arm pain, neurologic deficits, or clinical signs of nerve root compression to diagnose disc herniations requiring surgery. (authors)

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

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

Directory of Open Access Journals (Sweden)

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

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.

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

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

From protocol to published report

DEFF Research Database (Denmark)

Berendt, Louise; Callréus, Torbjörn; Petersen, Lene Grejs

2016-01-01

and published reports of academic clinical drug trials. METHODS: A comparison was made between study protocols and their corresponding published reports. We assessed the overall consistency, which was defined as the absence of discrepancy regarding study type (categorized as either exploratory or confirmatory...... in 1999, 2001, and 2003, 95 of which fulfilled the eligibility criteria and had at least one corresponding published report reporting data on trial subjects. Overall consistency was observed in 39% of the trials (95% CI: 29 to 49%). Randomized controlled trials (RCTs) constituted 72% (95% CI: 63 to 81......%) of the sample, and 87% (95% CI: 80 to 94%) of the trials were hospital based. CONCLUSIONS: Overall consistency between protocols and their corresponding published reports was low. Motivators for the inconsistencies are unknown but do not seem restricted to economic incentives....

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.

Balance, dizziness and proprioception in patients with chronic whiplash associated disorders complaining of dizziness: A prospective randomized study comparing three exercise programs.

Science.gov (United States)

Treleaven, Julia; Peterson, Gunnel; Ludvigsson, Maria Landén; Kammerlind, Ann-Sofi; Peolsson, Anneli

2016-04-01

Dizziness and unsteadiness are common symptoms following a whiplash injury. To compare the effect of 3 exercise programs on balance, dizziness, proprioception and pain in patients with chronic whiplash complaining of dizziness. A sub-analysis of a randomized study. One hundred and forty subjects were randomized to either a physiotherapist-guided neck-specific exercise (NSE), physiotherapist-guided neck-specific exercise, with a behavioural approach (NSEB) or prescription of general physical activity (PPA) group. Pre intervention, 3, 6 and 12 months post baseline they completed the University of California Los Angeles Dizziness Questionnaire (UCLA-DQ), Visual Analogue Scales (VAS) for, dizziness at rest and during activity and physical measures (static and dynamic clinical balance tests and head repositioning accuracy (HRA)). There were significant time by group differences with respect to dizziness during activity and UCLA-Q favouring the physiotherapy led neck specific exercise group with a behavioural approach. Within group analysis of changes over time also revealed significant changes in most variables apart from static balance. Between and within group comparisons suggest that physiotherapist led neck exercise groups including a behavioural approach had advantages in improving measures of dizziness compared with the general physical activity group, although many still complained of dizziness and balance impairment. Future studies should consider exercises specifically designed to address balance, dizziness and cervical proprioception in those with persistent whiplash. Crown Copyright © 2015. Published by Elsevier Ltd. All rights reserved.

The pain drawing as an instrument for identifying cervical spine nerve involvement in chronic whiplash-associated disorders.

Science.gov (United States)

Bernhoff, Gabriella; Landén Ludvigsson, Maria; Peterson, Gunnel; Bertilson, Bo Christer; Elf, Madeleine; Peolsson, Anneli

2016-01-01

The aim of the study was to investigate the psychometric properties of a standardized assessment of pain drawing with regard to clinical signs of cervical spine nerve root involvement. This cross-sectional study included data collected in a randomized controlled study. Two hundred and sixteen patients with chronic (≥6 months) whiplash-associated disorders, grade 2 or 3, were included in this study. The validity, sensitivity, and specificity of a standardized pain drawing assessment for determining nerve root involvement were analyzed, compared to the clinical assessment. In addition, we analyzed the interrater reliability with 50 pain drawings. Agreement was poor between the standardized pain drawing assessment and the clinical assessment (kappa =0.11, 95% CI: -0.03 to 0.20). Sensitivity was high (93%), but specificity was low (19%). Interrater reliability was good (kappa =0.64, 95% CI: 0.53 to 0.76). The standardized pain drawing assessment of nerve root involvement in chronic whiplash-associated disorders was not in agreement with the clinical assessment. Further research is warranted to optimize the utilization of a pain/discomfort drawing as a supportive instrument for identifying nerve involvement in cervical spinal injuries.

'Be active, eat right', evaluation of an overweight prevention protocol among 5-year-old children: design of a cluster randomised controlled trial

Directory of Open Access Journals (Sweden)

Veldhuis Lydian

2009-06-01

Full Text Available Abstract Background The prevalence of overweight and obesity in children has at least doubled in the past 25 years with a major impact on health. In 2005 a prevention protocol was developed applicable within Youth Health Care. This study aims to assess the effects of this protocol on prevalence of overweight and health behaviour among children. Methods and design A cluster randomised controlled trial is conducted among 5-year-old children included by 44 Youth Health Care teams randomised within 9 Municipal Health Services. The teams are randomly allocated to the intervention or control group. The teams measure the weight and height of all children. When a child in the intervention group is detected with overweight according to the international age and gender specific cut-off points of BMI, the prevention protocol is applied. According to this protocol parents of overweight children are invited for up to three counselling sessions during which they receive personal advice about a healthy lifestyle, and are motivated for and assisted in behavioural change. The primary outcome measures are Body Mass Index and waist circumference of the children. Parents will complete questionnaires to assess secondary outcome measures: levels of overweight inducing/reducing behaviours (i.e. being physically active, having breakfast, drinking sweet beverages and watching television/playing computer games, parenting styles, parenting practices, and attitudes of parents regarding these behaviours, health-related quality of life of the children, and possible negative side effects of the prevention protocol. Data will be collected at baseline (when the children are aged 5 years, and after 12 and 24 months of follow-up. Additionally, a process and a cost-effectiveness evaluation will be conducted. Discussion In this study called 'Be active, eat right' we evaluate an overweight prevention protocol for use in the setting of Youth Health Care. It is hypothesized that the

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.

Natural evolution of late whiplash syndrome outside the medicolegal context.

Science.gov (United States)

Schrader, H; Obelieniene, D; Bovim, G; Surkiene, D; Mickeviciene, D; Miseviciene, I; Sand, T

1996-05-04

In Lithuania, few car drivers and passengers are covered by insurance and there is little awareness among the general public about the potentially disabling consequences of a whiplash injury. We took this opportunity to study the natural course of head and neck symptoms after rear-end car collisions. In a retrospective questionnaire-based cohort study, 202 individuals (157 men; 45 women) were identified from the records of the traffic police department in Kaunas, Lithuania. These individuals were interviewed 1-3 years after experiencing a rear-end car collision. Neck pain, headache, subjective cognitive dysfunction, psychological disorders, and low back pain in this group were compared with the same complaints in a sex-matched and age-matched control group of uninjured individuals selected randomly from the population register of the same geographic area. Neck pain was reported by 71 (35% [95% CI 29-42]) accident victims and 67 (33% [27-40]) controls. Headache was reported by 107 (53% [46-60]) accident victims and 100 (50% [42-57]) controls. Chronic neck pain and chronic headache (more than 7 days per month) were also reported in similar proportions (17 [8.4%; 5-13] vs 14 [6.9%; 4-12] and 19 [9.4%; 6-15] vs 12 [5.9%; 3-10]) by the two groups. Of those who reported chronic neck pain or daily headache after the accident, substantial proportions had had similar symptoms before the accident (7/17 for chronic neck pain; 10/12 for daily headache). There was no significant difference found. No one in the study group had disabling or persistent symptoms as a result of the car accident. There was no relation between the impact severity and degree of pain. A family history of neck pain was the most important risk factor for current neck symptoms in logistic regression analyses. Our results suggest that chronic symptoms were not usually caused by the car accident. Expectation of disability, a family history, and attribution of pre-existing symptoms to the trauma may be more

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.

The impact of subacute whiplash-associated disorders on functional self-efficacy: a cohort study.

Science.gov (United States)

Bunketorp-Käll, Lina Sofia; Andersson, Caroline; Asker, Barbita

2007-09-01

Self-efficacy is increasingly being recognized as an important factor to consider in medical research, especially in different pain conditions such as whiplash-associated disorders (WAD). When pain is not effectively treated or relieved, it may negatively affect patients' life situation and cause a decline in perceived self-efficacy. Knowledge of what level of self-efficacy can be considered an actual deficit in patients with WAD is, however, sparse. The purpose of this study is to analyze whether subacute WAD has an impact on self-efficacy beliefs. A cohort study was designed to identify the impact of WAD on self-efficacy beliefs. The exposed group consisted of 47 patients with subacute WAD following a whiplash trauma. The control group representing the general population consisted of 212 participants, and was randomly selected to match the distribution of age and sex in the exposed group. The Self-Efficacy Scale was used to assess the individuals' confidence in their ability to successfully carry out activities of daily living. In the exposed group, 47 responded (100%), and in the control group, 113 (53%) responded. The results show that the total scores on the Self-Efficacy Scale were significantly lower in the exposed group compared with the control group, concerning both the mean (P<0.001) and median (P<0.001) scores. In conclusion, patients with subacute WAD experience a decline in functional self-efficacy, which stresses the importance of incorporating these beliefs in clinical practice and research.

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.

An Overview of the International Congress on Whiplash Associated Disorders

Directory of Open Access Journals (Sweden)

Nikolai Bogduk

2003-01-01

Full Text Available Conferences such as the International Congress on Whiplash Associated Disorders, held in Berne on March 8-10, 2001, serve several purposes. Socially, they provide an opportunity for delegates to see, hear and meet leading experts in the field, and those experts get to meet one another. Academically, such conferences offer delegates a synopsis of current information, provided by plenary lectures, and the opportunity to hear or contribute new information, in the form of free papers. A measure of the success of such a conference is the extent to which new information presented advances knowledge and understanding in the field. This essay provides an overview of the congress at hand. It compares what was known before the congress with what more was known as a result of the congress.

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. ...

Prognosis of patients with whiplash-associated disorders consulting physiotherapy: development of a predictive model for recovery

OpenAIRE

Bohman, Tony; C?t?, Pierre; Boyle, Eleanor; Cassidy, J David; Carroll, Linda J; Skillgate, Eva

2012-01-01

Abstract 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. Therefore, we aimed to develop a prediction model for the recovery of WAD in a cohort of patients who consulted physical therapists within six weeks after the injury. Methods Our cohort inclu...

Exercise and Cognitive Functioning in People With Chronic Whiplash-Associated Disorders: A Controlled Laboratory Study.

Science.gov (United States)

Ickmans, Kelly; Meeus, Mira; De Kooning, Margot; De Backer, Annabelle; Kooremans, Daniëlle; Hubloue, Ives; Schmitz, Tom; Van Loo, Michel; Nijs, Jo

2016-02-01

Controlled laboratory study. In addition to persistent pain, people with chronic whiplash-associated disorders (WAD) commonly deal with cognitive dysfunctions. In healthy individuals, aerobic exercise has a positive effect on cognitive performance, and preliminary evidence in other chronic pain conditions reveals promising results as well. However, there is evidence that people with chronic WAD may show a worsening of the symptom complex following physical exertion. To examine postexercise cognitive performance in people with chronic WAD. People with chronic WAD (n = 27) and healthy, inactive, sex- and age-matched controls (n = 27) performed a single bout of an incremental submaximal cycling exercise. Before and after the exercise, participants completed 2 performance-based cognitive tests assessing selective and sustained attention, cognitive inhibition, and simple and choice reaction time. At baseline, people with chronic WAD displayed significantly lower scores on sustained attention and simple reaction time (Pselective attention, cognitive inhibition, and choice reaction time (P>.05), compared with healthy controls. Postexercise, both groups showed significantly improved selective attention and choice reaction time (chronic WAD, P = .001; control, Pattention, cognitive inhibition, pain, and fatigue were observed (P>.05). In the short term, postexercise cognitive functioning, pain, and fatigue were not aggravated in people with chronic WAD. However, randomized controlled trials are required to study the longer-term and isolated effects of exercise on cognitive functioning.

Are People With Whiplash-Associated Neck Pain Different from People With Nonspecific Neck Pain?

DEFF Research Database (Denmark)

Anstey, Ricci; Kongsted, Alice; Kamper, Steven

2016-01-01

Study Design Secondary analysis of a prospective cohort study with cross sectional and longitudinal analyses. Background The clinical importance of a history of whiplash associated disorder (WAD) in people with neck pain remains uncertain. Objective To compare people with WAD to people with non......-specific neck pain, in terms of their baseline characteristics, and pain and disability outcomes over 1 year. Methods Consecutive patients with neck pain presenting to a secondary care spine centre answered a comprehensive self-report questionnaire and underwent a physical examination. Patients were classified...

International Congress on Whiplash Associated Disorders - The Bern Symposium

Directory of Open Access Journals (Sweden)

Harold Merskey

2003-01-01

Full Text Available We take pleasure in this issue in presenting a series of plenary session lectures and some additional contributions from the Bern Symposium, a meeting held in Berne, Switzerland from March 8 to 10, 2001. The symposium was organized by Dr Bogdan Radanov and colleagues from that city where they had themselves undertaken an enormous amount of classical work in the investigation of cervical sprain syndrome. Radanov's work resolved a number of definitive issues in the investigation of whiplash, despite those who say otherwise for medicolegal reasons. He and his colleagues showed clearly that pain after cervical sprain injury was primarily correlated with the intensity of the initial pain, with the occurrence of premorbid injury and with age. Personality status before injury had no bearing on the outcome, and the intensity of pain at the beginning of injury was also correlated with depression or cognitive change later (1.

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

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

De-Orbiting of Space Debris by Means of a Towering Cable and a Single Thruster Spaceship: Whiplash and Tail Wagging Effects

Science.gov (United States)

da Cruz Pacheco, Gabriel Felippe; Carpentier, Benjamin; Petit, Nicolas

2013-08-01

This papers exposes two difficulties that are likely to take place during the towing of a space debris. These effects, which could trouble de-orbitation strategies, are visible on simple simulations based on a model of coupled rigid-bodies dynamics. We name them tail wagging and whiplash effects, respectively.

Mystery of alar ligament rupture: Value of MRI in whiplash injuries - biomechanical, anatomical and clinical studies

International Nuclear Information System (INIS)

Bitterling, H.; Brueckmann, H.; Staebler, A.

2007-01-01

Purpose: Whiplash injury of the cervical spine is a frequent issue in medical expertise and causes enormous consequential costs for motor insurance companies. Some authors accuse posttraumatic changes of alar ligaments to be causative for consequential disturbances. Materials and methods: Review of recent studies on biomechanics, anatomical and clinical MR imaging. Results: Biomechanical experiments can not induce according injuries of alar ligaments. Although MRI provides excellent visualization of alar ligaments, the range of normal variants is high. (orig.)

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

Multivariate analysis of ultrasound-recorded dorsal strain sequences: Investigation of dynamic neck extensions in women with chronic whiplash associated disorders

Science.gov (United States)

Peolsson, Anneli; Peterson, Gunnel; Trygg, Johan; Nilsson, David

2016-08-01

Whiplash Associated Disorders (WAD) refers to the multifaceted and chronic burden that is common after a whiplash injury. Tools to assist in the diagnosis of WAD and an increased understanding of neck muscle behaviour are needed. We examined the multilayer dorsal neck muscle behaviour in nine women with chronic WAD versus healthy controls during the entire sequence of a dynamic low-loaded neck extension exercise, which was recorded using real-time ultrasound movies with high frame rates. Principal component analysis and orthogonal partial least squares were used to analyse mechanical muscle strain (deformation in elongation and shortening). The WAD group showed more shortening during the neck extension phase in the trapezius muscle and during both the neck extension and the return to neutral phase in the multifidus muscle. For the first time, a novel non-invasive method is presented that is capable of detecting altered dorsal muscle strain in women with WAD during an entire exercise sequence. This method may be a breakthrough for the future diagnosis and treatment of WAD.

Assessing the existence of dissociative PTSD in sub-acute patients of whiplash.

Science.gov (United States)

Hansen, Maj; Hyland, Philip; Armour, Cherie; Andersen, Tonny E

2018-03-16

Numerous studies investigating dissociative posttraumatic stress disorder (D-PTSD) have emerged. However, there is a lack of studies investigating D-PTSD following a wider range of traumatic exposure. Thus, the present study investigates D-PTSD using latent class analysis (LCA) in sub-acute patients of whiplash and associated risk factors. The results of LCA showed a three-class solution primarily distributed according to posttraumatic stress disorder (PTSD) symptom severity and thus no indication of D-PTSD. Dissociative symptoms, psychological distress (i.e. anxiety/depression), and pain severity significantly predicted PTSD severity. Combined, the results support the component model of dissociation and PTSD, while still stressing the importance of dissociative symptoms when planning treatment for PTSD.

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...

Protocol for the BAG-RECALL clinical trial: a prospective, multi-center, randomized, controlled trial to determine whether a bispectral index-guided protocol is superior to an anesthesia gas-guided protocol in reducing intraoperative awareness with explicit recall in high risk surgical patients

Directory of Open Access Journals (Sweden)

Villafranca Alex

2009-11-01

Full Text Available Abstract Background Awareness with explicit recall of intra-operative events is a rare and distressing complication that may lead to severe psychological symptoms. Candidate depth of anesthesia monitors have been developed, partly with the aim of preventing this complication. Despite conflicting results from clinical trials and the lack of incisive validation, such monitors have enjoyed widespread clinical adoption, in particular the bispectral index. The American Society of Anesthesiologists has called for adequately powered and rigorously designed clinical trials to determine whether the use of such monitors decreases the incidence of awareness in various settings. The aim of this study is to determine with increased precision whether incorporating the bispectral index into a structured general anesthesia protocol decreases the incidence of awareness with explicit recall among a subset of surgical patients at increased risk for awareness and scheduled to receive an inhalation gas-based general anesthetic. Methods/Design BAG-RECALL is a multi-center, randomized, controlled clinical trial, in which 6,000 patients are being assigned to bispectral index-guided anesthesia (target range, 40 to 60 or end-tidal anesthetic gas-guided anesthesia (target range, 0.7 to 1.3 age-adjusted minimum alveolar concentration. Postoperatively, patients are being assessed for explicit recall at two intervals (0 to 72 hours, and 30 days after extubation. The primary outcome of the trial is awareness with explicit recall. Secondary outcomes include postoperative mortality, psychological symptoms, intensive care and hospital length of stay, average anesthetic gas administration, postoperative pain and nausea and vomiting, duration of stay in the recovery area, intra-operative dreaming, and postoperative delirium. Discussion This trial has been designed to complement two other clinical trials: B-Unaware and MACS (ClinicalTrials.gov numbers, NCT00281489 and NCT00689091

Factors associated with pain and disability reduction following exercise interventions in chronic whiplash.

Science.gov (United States)

Ludvigsson, M L; Peterson, G; Dedering, Å; Falla, D; Peolsson, A

2016-02-01

Some studies support the prescription of exercise for people with whiplash-associated disorders (WAD); however, the response is highly variable. Further research is necessary to identify factors which predict response. This is a secondary analysis of a randomized, multicentre controlled clinical trial of 202 volunteers with chronic WAD (grades 2 and 3). They received either neck-specific exercise with, or without a behavioural approach, or prescription of physical activity for 12 weeks. Treatment response, defined as a clinical important reduction in pain or disability, was registered after 3 and 12 months, and factors associated with treatment response were explored using logistic regression. Participation in the neck-specific exercise group was the only significant factor associated with both neck pain and neck disability reduction both at 3 and 12 months. Patients in this group had up to 5.3 times higher odds of disability reduction and 3.9 times higher odds of pain reduction compared to those in the physical activity group. Different baseline features were identified as predictors of response depending on the time point examined and the outcome measure selected (pain vs. disability). Factors associated with treatment response after exercise interventions differ in the short and long term and differ depending on whether neck pain or disability is considered as the primary outcome. Participation in a neck-specific exercise intervention, in contrast to general physical activity, was the only factor that consistently indicated higher odds of treatment success. These results support the prescription of neck-specific exercise for individuals with chronic WAD. © 2015 European Pain Federation - EFIC®

Analysis of right anterolateral impacts: the effect of trunk flexion on the cervical muscle whiplash response

Directory of Open Access Journals (Sweden)

Narayan Yogesh

2006-05-01

Full Text Available Abstract Background The cervical muscles are considered a potential site of whiplash injury, and there is a need to understand the cervical muscle response under non-conventional whiplash impact scenarios, including variable body position and impact direction. There is no data, however, on the effect of occupant position on the muscle response to frontal impacts. Therefore, the objective of the study was to measure cervical muscle response to graded right anterolateral impacts. Methods Twenty volunteers were subjected to right anterolateral impacts of 4.3, 7.8, 10.6, and 12.8 m/s2 acceleration with their trunk flexed forward 45 degrees and laterally flexed right or left by 45 degrees. Bilateral EMG of the sternocleidomastoids, trapezii, and splenii capitis and acceleration of the sled, torso, and head were measured. Results and discussion With either direction of trunk flexion at impact, the trapezius EMGs increased with increasing acceleration (p Conclusion When the subject sits with trunk flexed out of neutral posture at the time of anterolateral impact, the cervical muscle response is dramatically reduced compared to frontal impacts with the trunk in neutral posture. In the absence of bodily impact, the flexed trunk posture appears to produce a biomechanical response that would decrease the likelihood of cervical muscle injury in low velocity impacts.

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

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

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).

Cerebrospinal fluid volume depletion in chronic whiplash-associated disorders from motor vehicle-related spinal injuries

International Nuclear Information System (INIS)

Takeshita, Iwao; Ohta, Masaru; Samoto, Ken; Hamamura, Takeshi; Watanabe, Hideyuki

2007-01-01

To evaluate cerebrospinal fluid (CSF) volume depletion in chronic cases of whiplash-associated disorders, 111 In radioisotope (RI) cisternography, brain magnetic resonance imaging (MRI) and lumbar MR myelography were consecutively conducted on 460 individuals with chronic whiplash-associated disorders resulting from motor vehicle collision (Group A, n=225) and other traumatic injuries (Group B, n=57), spontaneous intracranial hypotension syndromes and other miscellaneous disorders (Group C, n=155), iatrogenic intracranial hypotension syndrome (Group D, n=11), and communicating hydrocephalus (Group E, n=12). Movement of intrathecally administered RI via a lumbar puncture was sequentially scanned at 1, 2 or 3, 5 and 24 hours. A whole body neuroaxis scanned figure showing high spinal parathecal activity at any time was considered to be a CSF leak, if small enough meningeal diverticula evidenced by MR myelography were present. Retention rate (%) of intrathecal RI for each scan was calculated using the formula: (whole body count-urinary bladder count)/whole body count (cpm) at 1 h x 100. All CSF leaks, although having single to multiple poles, were located in the spinal canal. CSF leakage was observed in 99/225 (44%), 24/57 (42%), 61/155 (39%), 9/11 (82%), and 4/12 (33%), in Groups A, B, C, D and E respectively. All CSF leakages was involved with the lumbar spine in Group A, although 20 cases extended to mid-thoracic levels. In Group A, spinal vertebrae were concomitantly injured in 7 cases (1 cervical spine dislocation, 1 cervical spine fracture, 2 thoracic and 1 lumbar compression fracture (s), and 2 lumbar disc hernia). CSF leakage for 2 cervical spine injuries was not at the injured site but at the lumbar spinal canal. CSF leakage limited to the lumbar spine involved 22 and 43 cases in groups B and C, respectively. Of all CSF leaks, 24 h retention rates less than 30% accounted for 90% of cases. In Group A, early CSF excretion and less than a 30% retention rate at 24

Clinical Trials

Medline Plus

Full Text Available ... criteria differ from trial to trial. They include factors such as a patient's age and gender, the ... bias. "Bias" means that human choices or other factors not related to the protocol affect the trial's ...

Clinical Trials

Medline Plus

Full Text Available ... protocol affect the trial's results. Comparison Groups In most clinical trials, researchers use comparison groups. This means ... study before you agree to take part. Randomization Most clinical trials that have comparison groups use randomization. ...

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.

Study protocol

DEFF Research Database (Denmark)

Smith, Benjamin E; Hendrick, Paul; Bateman, Marcus

2017-01-01

avoidance behaviours, catastrophising, self-efficacy, sport and leisure activity participation, and general quality of life. Follow-up will be 3 and 6 months. The analysis will focus on descriptive statistics and confidence intervals. The qualitative components will follow a thematic analysis approach....... DISCUSSION: This study will evaluate the feasibility of running a definitive large-scale trial on patients with patellofemoral pain, within the NHS in the UK. We will identify strengths and weaknesses of the proposed protocol and the utility and characteristics of the outcome measures. The results from...... this study will inform the design of a multicentre trial. TRIAL REGISTRATION: ISRCTN35272486....

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

Directory of Open Access Journals (Sweden)

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.

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.

Using mobile technology to deliver a cognitive behaviour therapy-informed intervention in early psychosis (Actissist): study protocol for a randomised controlled trial.

Science.gov (United States)

Bucci, Sandra; Barrowclough, Christine; Ainsworth, John; Morris, Rohan; Berry, Katherine; Machin, Matthew; Emsley, Richard; Lewis, Shon; Edge, Dawn; Buchan, Iain; Haddock, Gillian

2015-09-10

Cognitive behaviour therapy (CBT) is recommended for the treatment of psychosis; however, only a small proportion of service users have access to this intervention. Smartphone technology using software applications (apps) could increase access to psychological approaches for psychosis. This paper reports the protocol development for a clinical trial of smartphone-based CBT. We present a study protocol that describes a single-blind randomised controlled trial comparing a cognitive behaviour therapy-informed software application (Actissist) plus Treatment As Usual (TAU) with a symptom monitoring software application (ClinTouch) plus TAU in early psychosis. The study consists of a 12-week intervention period. We aim to recruit and randomly assign 36 participants registered with early intervention services (EIS) across the North West of England, UK in a 2:1 ratio to each arm of the trial. Our primary objective is to determine whether in people with early psychosis the Actissist app is feasible to deliver and acceptable to use. Secondary aims are to determine whether Actissist impacts on predictors of first episode psychosis (FEP) relapse and enhances user empowerment, functioning and quality of life. Assessments will take place at baseline, 12 weeks (post-treatment) and 22-weeks (10 weeks post-treatment) by assessors blind to treatment condition. The trial will report on the feasibility and acceptability of Actissist and compare outcomes between the randomised arms. The study also incorporates semi-structured interviews about the experience of participating in the Actissist trial that will be qualitatively analysed to inform future developments of the Actissist protocol and app. To our knowledge, this is the first controlled trial to test the feasibility, acceptability, uptake, attrition and potential efficacy of a CBT-informed smartphone app for early psychosis. Mobile applications designed to deliver a psychologically-informed intervention offer new possibilities to

A Research Synthesis of Therapeutic Interventions for Whiplash-Associated Disorder (WAD: Part 3 – Interventions for Subacute WAD

Directory of Open Access Journals (Sweden)

Robert W Teasell

2010-01-01

Full Text Available Whiplash-associated disorder (WAD represents a significant public health problem, resulting in substantial social and economic costs throughout the industrialized world. While many treatments have been advocated for patients with WAD, scientific evidence supporting their effectiveness is often lacking. A systematic review was conducted to evaluate the strength of evidence associated with 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 third in a five-part series, evaluates the evidence for interventions initiated during the subacute phase of WAD. Thirteen studies that met the inclusion criteria were identified, six of which were randomized controlled trials with ‘good’ overall methodology (median Physiotherapy Evidence Database score of 6. Although some evidence was identified to support the use of interdisciplinary interventions and chiropractic manipulation, the evidence was not strong for any of the evaluated treatments. There is a clear need for further research to evaluate interventions aimed at treating patients with subacute WAD because there are currently no interventions satisfactorily supported by the research literature.

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

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

The Course of Serum Inflammatory Biomarkers Following Whiplash Injury and Their Relationship to Sensory and Muscle Measures: a Longitudinal Cohort Study

Science.gov (United States)

Sterling, Michele; Elliott, James M.; Cabot, Peter J.

2013-01-01

Tissue damage or pathological alterations are not detectable in the majority of people with whiplash associated disorders (WAD). Widespread hyperalgisa, morphological muscle changes and psychological distress are common features of WAD. However little is known about the presence of inflammation and its association with symptom persistence or the clinical presentation of WAD. This study aimed to prospectively investigate changes in serum inflammatory biomarker levels from the acute (3 months) stages of whiplash injury. It also aimed to determine relationships between biomarker levels and hyperalgesia, fatty muscle infiltrates of the cervical extensors identified on MRI and psychological factors. 40 volunteers with acute WAD and 18 healthy controls participated. Participants with WAD were classified at 3 months as recovered/mild disability or having moderate/severe disability using the Neck Disability Index. At baseline both WAD groups showed elevated serum levels of CRP but by 3 months levels remained elevated only in the moderate/severe group. The recovered/mild disability WAD group had higher levels of TNF-α at both time points than both the moderate/severe WAD group and healthy controls. There were no differences found in serum IL-1β. Moderate relationships were found between hyperalgesia and CRP at both time points and between hyperalgesia and IL-1β 3 months post injury. There was a moderate negative correlation between TNF-α and amount of fatty muscle infiltrate and pain intensity at 3 months. Only a weak relationship was found between CRP and pain catastrophising and no relationship between biomarker levels and posttraumatic stress symptoms. The results of the study indicate that inflammatory biomarkers may play a role in outcomes following whiplash injury as well as being associated with hyperalgesia and fatty muscle infiltrate in the cervical extensors. PMID:24147095

The course of serum inflammatory biomarkers following whiplash injury and their relationship to sensory and muscle measures: a longitudinal cohort study.

Directory of Open Access Journals (Sweden)

Michele Sterling

Full Text Available Tissue damage or pathological alterations are not detectable in the majority of people with whiplash associated disorders (WAD. Widespread hyperalgisa, morphological muscle changes and psychological distress are common features of WAD. However little is known about the presence of inflammation and its association with symptom persistence or the clinical presentation of WAD. This study aimed to prospectively investigate changes in serum inflammatory biomarker levels from the acute (3 months stages of whiplash injury. It also aimed to determine relationships between biomarker levels and hyperalgesia, fatty muscle infiltrates of the cervical extensors identified on MRI and psychological factors. 40 volunteers with acute WAD and 18 healthy controls participated. Participants with WAD were classified at 3 months as recovered/mild disability or having moderate/severe disability using the Neck Disability Index. At baseline both WAD groups showed elevated serum levels of CRP but by 3 months levels remained elevated only in the moderate/severe group. The recovered/mild disability WAD group had higher levels of TNF-α at both time points than both the moderate/severe WAD group and healthy controls. There were no differences found in serum IL-1β. Moderate relationships were found between hyperalgesia and CRP at both time points and between hyperalgesia and IL-1β 3 months post injury. There was a moderate negative correlation between TNF-α and amount of fatty muscle infiltrate and pain intensity at 3 months. Only a weak relationship was found between CRP and pain catastrophising and no relationship between biomarker levels and posttraumatic stress symptoms. The results of the study indicate that inflammatory biomarkers may play a role in outcomes following whiplash injury as well as being associated with hyperalgesia and fatty muscle infiltrate in the cervical extensors.

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

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.

Personalised Hip Therapy: development of a non-operative protocol to treat femoroacetabular impingement syndrome in the FASHIoN randomised controlled trial.

Science.gov (United States)

Wall, Peter Dh; Dickenson, Edward J; Robinson, David; Hughes, Ivor; Realpe, Alba; Hobson, Rachel; Griffin, Damian R; Foster, Nadine E

2016-10-01

Femoroacetabular impingement (FAI) syndrome is increasingly recognised as a cause of hip pain. As part of the design of a randomised controlled trial (RCT) of arthroscopic surgery for FAI syndrome, we developed a protocol for non-operative care and evaluated its feasibility. In phase one, we developed a protocol for non-operative care for FAI in the UK National Health Service (NHS), through a process of systematic review and consensus gathering. In phase two, the protocol was tested in an internal pilot RCT for protocol adherence and adverse events. The final protocol, called Personalised Hip Therapy (PHT), consists of four core components led by physiotherapists: detailed patient assessment, education and advice, help with pain relief and an exercise-based programme that is individualised, supervised and progressed over time. PHT is delivered over 12-26 weeks in 6-10 physiotherapist-patient contacts, supplemented by a home exercise programme. In the pilot RCT, 42 patients were recruited and 21 randomised to PHT. Review of treatment case report forms, completed by physiotherapists, showed that 13 patients (62%) received treatment that had closely followed the PHT protocol. 13 patients reported some muscle soreness at 6 weeks, but there were no serious adverse events. PHT provides a structure for the non-operative care of FAI and offers guidance to clinicians and researchers in an evolving area with limited evidence. PHT was deliverable within the National Health Service, is safe, and now forms the comparator to arthroscopic surgery in the UK FASHIoN trial (ISRCTN64081839). ISRCTN 09754699. 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/

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

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

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

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

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

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

Whiplash-associated disorders--predicting disability from a process-oriented perspective of coping.

Science.gov (United States)

Söderlund, Anne; Lindberg, Per

2003-02-01

To describe the coping process over time for patients with whiplash-associated disorders (WAD). The study was conducted by following patients prospectively for 12 months. The orthopaedic clinic at a university hospital. Fifty-three patients out of 59 had complete data-sets. Two measures were used: the Pain Disability Index (PDI) and the Coping Strategies Questionnaire (CSQ). The results showed that the proportion of variance in disability shared with coping increased over time. The importance of coping as an explanatory factor for disability increased during the one year follow-up. Thus, coping has a crucial role for disability. The possibility of a positive long-term outcome could therefore be improved by teaching patients to use active and adaptive coping strategies shortly after an accident.

Effect of tranexamic acid on coagulation and fibrinolysis in women with postpartum haemorrhage (WOMAN-ETAC): protocol and statistical analysis plan for a randomized controlled trial.

Science.gov (United States)

Shakur, Haleema; Fawole, Bukola; Kuti, Modupe; Olayemi, Oladapo; Bello, Adenike; Ogunbode, Olayinka; Kotila, Taiwo; Aimakhu, Chris O; Huque, Sumaya; Gregg, Meghann; Roberts, Ian

2016-12-16

Background : Postpartum haemorrhage (PPH) is a leading cause of maternal death. Tranexamic acid has the potential to reduce bleeding and a large randomized controlled trial of its effect on maternal health outcomes in women with PPH (The WOMAN trial) is ongoing. We will examine the effect of tranexamic acid on fibrinolysis and coagulation in a subset of WOMAN trial participants. Methods . Adult women with clinically diagnosed primary PPH after vaginal or caesarean delivery are eligible for inclusion in the WOMAN trial. In a sub-group of trial participants, blood samples will be collected at baseline and 30 minutes after the first dose of tranexamic acid or matching placebo.  Our primary objective is to evaluate the effect of tranexamic acid on fibrinolysis. Fibrinolysis will be assessed by measuring D-dimers and by rotational thromboelastometry (ROTEM). Secondary outcomes are international normalized ratio (INR), prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, haemoglobin and platelets. We aim to include about 180 women from the University College Hospital, Ibadan in Nigeria. Discussion:  This sub-study of WOMAN trial participants should provide information on the mechanism of action of tranexamic acid in women with postpartum haemorrhage. We present the trial protocol and statistical analysis plan. The trial protocol was registered prior to the start of patient recruitment. The statistical analysis plan was completed before un-blinding. Trial registration: The trial was registered: ClinicalTrials.gov, Identifier NCT00872469 https://clinicaltrials.gov/ct2/show/NCT00872469; ISRCTN registry, Identifier ISRCTN76912190 http://www.isrctn.com/ISRCTN76912190 (Registration date: 22/03/2012).

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

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...

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.

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

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

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

Jail-to-community treatment continuum for adults with co-occurring substance use and mental disorders: study protocol for a pilot randomized controlled trial.

Science.gov (United States)

Van Dorn, Richard A; Desmarais, Sarah L; Rade, Candalyn B; Burris, Elizabeth N; Cuddeback, Gary S; Johnson, Kiersten L; Tueller, Stephen J; Comfort, Megan L; Mueser, Kim T

2017-08-04

Adults with co-occurring mental and substance use disorders (CODs) are overrepresented in jails. In-custody barriers to treatment, including a lack of evidence-based treatment options and the often short periods of incarceration, and limited communication between jails and community-based treatment agencies that can hinder immediate enrollment into community care once released have contributed to a cycle of limited treatment engagement, unaddressed criminogenic risks, and (re)arrest among this vulnerable and high-risk population. This paper describes a study that will develop research and communication protocols and adapt two evidence-based treatments, dual-diagnosis motivational interviewing (DDMI) and integrated group therapy (IGT), for delivery to adults with CODs across a jail-to-community treatment continuum. Adaptations to DDMI and IGT were guided by the Risk-Need-Responsivity model and the National Institute of Corrections' implementation competencies; the development of the implementation framework and communication protocols were guided by the Evidence-Based Interagency Implementation Model for community corrections and the Inter-organizational Relationship model, respectively. Implementation and evaluation of the protocols and adapted interventions will occur via an open trial and a pilot randomized trial. The clinical intervention consists of two in-jail DDMI sessions and 12 in-community IGT sessions. Twelve adults with CODs and four clinicians will participate in the open trial to evaluate the acceptability and feasibility of, and fidelity to, the interventions and research and communication protocols. The pilot controlled trial will be conducted with 60 inmates who will be randomized to either DDMI-IGT or treatment as usual. A baseline assessment will be conducted in jail, and four community-based assessments will be conducted during a 6-month follow-up period. Implementation, clinical, public health, and treatment preference outcomes will be evaluated

Rehabilitation for the management of knee osteoarthritis using comprehensive traditional Chinese medicine in community health centers: study protocol for a randomized controlled trial

Science.gov (United States)

2013-01-01

Background It is becoming increasingly necessary for community health centers to make rehabilitation services available to patients with osteoarthritis of the knee. However, for a number of reasons, including a lack of expertise, the small size of community health centers and the availability of only simple medical equipment, conventional rehabilitation therapy has not been widely used in China. Consequently, most patients with knee osteoarthritis seek treatment in high-grade hospitals. However, many patients cannot manage the techniques that they were taught in the hospital. Methods such as acupuncture, tuina, Chinese medical herb fumigation-washing and t’ai chi are easy to do and have been reported to have curative effects in those with knee osteoarthritis. To date, there have been no randomized controlled trials validating comprehensive traditional Chinese medicine for the rehabilitation of knee osteoarthritis in a community health center. Furthermore, there is no standard rehabilitation protocol using traditional Chinese medicine for knee osteoarthritis. The aim of the current study is to develop a comprehensive rehabilitation protocol using traditional Chinese medicine for the management of knee osteoarthritis in a community health center. Method/design This will be a randomized controlled clinical trial with blinded assessment. There will be a 4-week intervention utilizing rehabilitation protocols from traditional Chinese medicine and conventional therapy. Follow-up will be conducted for a period of 12 weeks. A total of 722 participants with knee osteoarthritis will be recruited. Participants will be randomly divided into two groups: experimental and control. Primary outcomes will include range of motion, girth measurement, the visual analogue scale, and results from the manual muscle, six-minute walking and stair-climbing tests. Secondary outcomes will include average daily consumption of pain medication, ability to perform daily tasks and health

Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials

Energy Technology Data Exchange (ETDEWEB)

Logan, Jennifer K.; Tang, Chad; Liao, Zhongxing [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Lee, J. Jack [Department of Biostatistics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Heymach, John V. [Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Swisher, Stephen G. [Department of Surgical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Welsh, James W. [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Zhang, Jianjun [Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Lin, Steven H. [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Gomez, Daniel R., E-mail: dgomez@mdanderson.org [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States)

2017-03-15

Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. Methods and Materials: From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results: A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Conclusion: Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.

Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials

International Nuclear Information System (INIS)

Logan, Jennifer K.; Tang, Chad; Liao, Zhongxing; Lee, J. Jack; Heymach, John V.; Swisher, Stephen G.; Welsh, James W.; Zhang, Jianjun; Lin, Steven H.; Gomez, Daniel R.

2017-01-01

Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. Methods and Materials: From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results: A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Conclusion: Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.

Statistical analysis of 4 types of neck whiplash injuries based on classical meridian theory.

Science.gov (United States)

Chen, Yemeng; Zhao, Yan; Xue, Xiaolin; Li, Hui; Wu, Xiuyan; Zhang, Qunce; Zheng, Xin; Wang, Tianfang

2015-01-01

As one component of the Chinese medicine meridian system, the meridian sinew (Jingjin, (see text), tendino-musculo) is specially described as being for acupuncture treatment of the musculoskeletal system because of its dynamic attributes and tender point correlations. In recent decades, the therapeutic importance of the sinew meridian has become revalued in clinical application. Based on this theory, the authors have established therapeutic strategies of acupuncture treatment in Whiplash-Associated Disorders (WAD) by categorizing four types of neck symptom presentations. The advantage of this new system is to make it much easier for the clinician to find effective acupuncture points. This study attempts to prove the significance of the proposed therapeutic strategies by analyzing data collected from a clinical survey of various WAD using non-supervised statistical methods, such as correlation analysis, factor analysis, and cluster analysis. The clinical survey data have successfully verified discrete characteristics of four neck syndromes, based upon the range of motion (ROM) and tender point location findings. A summary of the relationships among the symptoms of the four neck syndromes has shown the correlation coefficient as having a statistical significance (P < 0.01 or P < 0.05), especially with regard to ROM. Furthermore, factor and cluster analyses resulted in a total of 11 categories of general symptoms, which implies syndrome factors are more related to the Liver, as originally described in classical theory. The hypothesis of meridian sinew syndromes in WAD is clearly supported by the statistical analysis of the clinical trials. This new discovery should be beneficial in improving therapeutic outcomes.

Acceleration-caused injury of the cervical spine. Whiplash injury; Beschleunigungsverletzung der Halswirbelsaeule. HWS-Schleudertrauma

Energy Technology Data Exchange (ETDEWEB)

Wedig, Hans-Dieter (eds.) [Kanzlei Dr. W.G. Schmidt, Sonthofen (Germany); Graf, Michael; Grill, Christian

2009-07-01

Acceleration injuries of the cervical spine are mostly caused by car accidents. Due to the high traffic density and the increasing number of car accidents with personal injuries the number of concerned persons is also increasing. A large percentage of injured persons suffer ongoing troubles following ineffective therapy trials up to occupational disability. Therefore the whiplash injury is a significant medical and legal problem. The book includes contributions of international experts on the latest state of research and the actual knowledge on the controversial discussed field. An interdisciplinary forum discusses medical, injury-mechanical, consultant-related and legal questions and therapeutic approaches that might be successful. [German] Beschleunigungsverletzungen der Halswirbelsaeule treten ueberwiegend nach Autounfaellen auf. Aufgrund der hohen Verkehrsdichte und der steigenden Anzahl an Verkehrsunfaellen mit Personenschaeden steigt auch die Zahl der Betroffenen stetig an. Einer grossen Zahl von Unfallgeschaedigten, die nach kurzer Zeit beschwerdefrei leben koennen, steht leider eine wachsende Zahl von Betroffenen mit anhaltenden Beschwerden, erfolglosen Therapieversuchen bis hin zur Berufsunfaehigkeit gegenueber. Das 'HWS-Schleudertrauma' stellt nach wie vor ein erhebliches medizinisches und rechtliches Problem dar. In diesem Buch beschreiben international ausgewiesene Experten den neuesten Forschungsstand, das aktuelle Wissen und die Lehrmeinungen auf diesem kontrovers diskutierten und komplexen Gebiet. In einem interdisziplinaeren Ansatz werden medizinische, verletzungsmechanische, gutachterliche und gerichtliche Fragestellungen diskutiert und Erfolg versprechende Therapieansaetze eroertert. Aerzte, Juristen, Versicherungen und Betroffene werden in einen gemeinsamen Dialog gebracht, mit dem Ziel, konstruktive Loesungen zu erarbeiten. Eine praktische Arbeitshilfe - das Buch fuer alle, die mit dieser Problematik befasst sind. (orig.)

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

Directory of Open Access Journals (Sweden)

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

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...

Implementation of the Additional Protocol in Japan