Effects of Different Exercise Programs for People With Chronic Whiplash Associated Disorders

Linkoeping University216 enrolled

Overview

Background: Costs of health care consumption and sick leave 2006 in Sweden for Whiplash Associated Disorders (WAD) was estimated to be 4 billion Swedish crowns. Despite tremendous costs and personal sufferings there are only a few prospective randomized studies (RCT) in patients with chronic WAD, and none of them evaluating return to work, or the role of neck specific exercises with or without a combination of a behavioral approach compared with prescribed physical activity. Aim: The general aim of this RCT is to examine what neck-specific training with or without a combination with behavioral approach adds to prescribed physical activity of persons with chronic WAD with regard to pain intensity, physical and psychological function, health care consumption and return to work. Another aim is to study predictive factors of importance for a good outcome of rehabilitation. Method: After informed consent patients in age 18-63 years of age with WAD II-III with more than 6 months duration will be randomized to one out of the three alternatives of physiotherapy, treatment with medical exercise therapy with neck specific exercises (A),treatment with a behavioral approach combined with neck specific exercises (B), prescribed physical activity (C). Randomisation will be done by the central project leader. 200 patients will be included in the study. All physiotherapists engaged in the structured and well described treatment will be introduced in the program by the project leader. The measurements with good clinometric properties will be performed before treatment, after 12 weeks, 6, 12 and 24 months after inclusion into the study. Clinical measurements will be performed by a blinded investigator. Background data, disease-specific and generic data will be measured by self-evaluated answered questionnaires by the patients. Days of sick-leave will be collected from the Social Insurance Agency. Main outcomes of the measurements are pain intensity, neck specific disability and return to work. Cost-effectiveness will be calculated.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Interventions

Neck Specific ExercisesOTHER

2 times a week for 3 months followed by encourages to continue on their own

Behavioral approach combined with neck specific exercisesBEHAVIORAL

Behavioral physiotherapeutic approach combined with neck specific exercises 2 times a week for 3 months. Exercises will be chosen from a well defined and structured frame of exercises.

Prescribed Physical activityOTHER

Physical activity without neck specific exercises for 3 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 63 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18-63 years * WAD II-III * Remaining problems (\>10mm on 100mm Visual Analogue Scale (VAS) or \>20% on Neck Disability Index (NDI) or at least moderate pin on NDI) at least 6 months but no more than 3 years after whiplash trauma Exclusion Criteria: * Myelopathy * Earlier fracture or luxation of the cervical column, earlier neck injury * Spinal tumour * Spinal infection * Surgery in the cervical column * Malignity * Systematic disease or another injury contraindicated to perform the treatment program or the measurements. * Diagnosed severe psychiatric disorder * Unconscious in connection to the trauma * Known drug abuse * Lack of familiarity with the Swedish language

Outcomes

Primary Outcomes

Neck Disability Index (NDI)

NDI will be measured at baseline before intervention. Change from baseline in NDI will be measured at 3,6,12,and 24 months to investigate change over time. Baseline and change after three and six months of exercises and to investigate if a potential change of the exercises remain at 12 month and 24 month from baseline.

Time frame: Baseline and change after 3 and 6 months of exercises, 3 month, 6 month, 12 month and 24 month follow-up. Change from baseline to follow-ups. Twelve month follow-up is the most important follow-up to investigate change over time from baseline.

Secondary Outcomes

Pain intensity on VAS

Pain intensity is measured on a 100mm Visual Analogue Scale (VAS).

Time frame: before intervention, 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.

Pain Disability Index