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Effects of neck-specific exercise with or without a behavioural approach in addition to prescribed physical activity for individuals with chronic whiplash-associated disorders: a prospective randomised study.

ABSTRACT: Up to 50% of chronic whiplash associated disorders (WAD) patients experience considerable pain and disability and remain on sick-leave. No evidence supports the use of physiotherapy treatment of chronic WAD, although exercise is recommended. Previous randomised controlled studies did not evaluate the value of adding a behavioural therapy intervention to neck-specific exercises, nor did they compare these treatments to prescription of general physical activity. Few exercise studies focus on patients with chronic WAD, and few have looked at patients' ability to return to work and the cost-effectiveness of treatments. Thus, there is a great need to develop successful evidence-based rehabilitation models. The study aim is to investigate whether neck-specific exercise with or without a behavioural approach (facilitated by a single caregiver per patient) improves functioning compared to prescription of general physical activity for individuals with chronic WAD.The study is a prospective, randomised, controlled, multi-centre study with a 2-year follow-up that includes 216 patients with chronic WAD (> 6 months and < 3 years). The patients (aged 18 to 63) must be classified as WAD grade 2 or 3. Eligibility will be determined with a questionnaire, telephone interview and clinical examination. The participants will be randomised into one of three treatments: (A) neck-specific exercise followed by prescription of physical activity; (B) neck-specific exercise with a behavioural approach followed by prescription of physical activity; or (C) prescription of physical activity alone without neck-specific exercises. Treatments will be performed for 3 months. We will examine physical and psychological function, pain intensity, health care consumption, the ability to resume work and economic health benefits. An independent, blinded investigator will perform the measurements at baseline and 3, 6, 12 and 24 months after inclusion. The main study outcome will be improvement in neck-specific disability as measured with the Neck Disability Index. All treatments will be recorded in treatment diaries and medical records.The study findings will help improve the treatment of patients with chronic WAD.ClinicalTrials.gov identifier: NCT01528579.

SUBMITTER: Peolsson A

PROVIDER: S-EPMC4228445 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature

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Effects of neck-specific exercise with or without a behavioural approach in addition to prescribed physical activity for individuals with chronic whiplash-associated disorders: a prospective randomised study.

Peolsson Anneli A Landén Ludvigsson Maria M Overmeer Thomas T Dedering Åsa Å Bernfort Lars L Johansson Gun G Kammerlind Ann-Sofi AS Peterson Gunnel G

BMC musculoskeletal disorders 20131030

<h4>Background</h4>Up to 50% of chronic whiplash associated disorders (WAD) patients experience considerable pain and disability and remain on sick-leave. No evidence supports the use of physiotherapy treatment of chronic WAD, although exercise is recommended. Previous randomised controlled studies did not evaluate the value of adding a behavioural therapy intervention to neck-specific exercises, nor did they compare these treatments to prescription of general physical activity. Few exercise stu ...[more]

PMID: 24171699

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Project description:BackgroundNeck-specific exercises (NSE) supervised by a physiotherapist twice a week for 12 weeks have shown good results in chronic whiplash-associated disorders (WADs), but the effect of exercise delivered via the internet is unknown.ObjectiveThis study examined whether NSE with internet support (NSEIT) and 4 physiotherapy sessions for 12 weeks were noninferior to the same exercises supervised by a physiotherapist twice a week for 12 weeks (NSE).MethodsIn this multicenter randomized controlled noninferiority trial with masked assessors, we recruited adults aged 18-63 years with chronic WAD grade II (ie, neck pain and clinical musculoskeletal signs) or III (ie, grade II plus neurological signs). Outcomes were measured at baseline and at 3- and 15-month follow-ups. The primary outcome was change in neck-related disability, measured with the Neck Disability Index (NDI; 0%-100%), with higher percentages indicating greater disability. Secondary outcomes were neck and arm pain intensity (Visual Analog Scale [VAS]), physical function (Whiplash Disability Questionnaire [WDQ] and Patient-Specific Functional Scale [PSFS]), health-related quality of life (EQ-5D-3L and EQ VAS), and self-rated recovery (Global Rating Scale [GRS]). The analyses were conducted on an intention-to-treat basis and with the per-protocol approach as sensitivity analyses.ResultsBetween April 6, 2017, and September 15, 2020, 140 participants were randomly assigned to the NSEIT group (n=70) or the NSE group (n=70); 63 (90%) and 64 (91%), respectively, were followed up at 3 months, and 56 (80%) and 58 (83%), respectively, at 15 months. NSEIT demonstrated noninferiority to NSE in the primary outcome NDI, as the 1-sided 95% CI of the mean difference in change did not cross the specified noninferiority margin (7 percentage units). There were no significant between-group differences in change in NDI at the 3- or 15-month follow-up, with a mean difference of 1.4 (95% CI -2.5 to 5.3) and 0.9 (95% CI -3.6 to 5.3), respectively. In both groups, the NDI significantly decreased over time (NSEIT: mean change -10.1, 95% CI -13.7 to -6.5, effect size=1.33; NSE: mean change -9.3, 95% CI -12.8 to -5.7, effect size=1.19 at 15 months; P<.001). NSEIT was noninferior to NSE for most of the secondary outcomes except for neck pain intensity and EQ VAS, but post hoc analyses showed no differences between the groups. Similar results were seen in the per-protocol population. No serious adverse events were reported.ConclusionsNSEIT was noninferior to NSE in chronic WAD and required less physiotherapist time. NSEIT could be used as a treatment for patients with chronic WAD grades II and III.Trial registrationClinicalTrials.gov NCT03022812; https://clinicaltrials.gov/ct2/show/NCT03022812.

Project description: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.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 (intervention)group. 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 (0-1), craniocervical flexion test (22 mmHg - 30 mmHg), joint position error test and cervical range of movement. The SF36 scales are scored using norm-based methods with PCS and MCS having a mean score of 50 with a standard deviation of 10.The perspectives of this study are discussed, in addition to the strengths and weaknesses.The study is registered in http://www.ClinicalTrials.gov identifier NCT01431261.

Project description:BACKGROUND: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. OBJECTIVE: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. METHODS: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. RESULTS: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. CONCLUSION:Neck-specific exercise was cost-effective from a societal perspective in the treatment of chronic WAD compared with the other exercise interventions. ICERS varied depending on health-related quality of life questionnaires used, but the addition of a behavioral approach was not cost-effective from a societal perspective. The prescription of physical activity did not result in any QALY gain and was thus not considered a relevant option.

Dataset Information

Effects of neck-specific exercise with or without a behavioural approach in addition to prescribed physical activity for individuals with chronic whiplash-associated disorders: a prospective randomised study.

Publications

Effects of neck-specific exercise with or without a behavioural approach in addition to prescribed physical activity for individuals with chronic whiplash-associated disorders: a prospective randomised study.

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