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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Whiplash

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Neck Specific exercises

Neck Specific exercises from a structured frame of exercises

Group Type ACTIVE_COMPARATOR

Neck Specific Exercises

Intervention Type OTHER

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

Behavioral approach

Behavioral physiotherapeutic approach in combination with neck specific exercises from a structured well defined frame of exercises and how to treat the patient. 2 times a week for 3 months.

Group Type ACTIVE_COMPARATOR

Behavioral approach combined with neck specific exercises

Intervention Type BEHAVIORAL

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 activity

Prescribed physical activity from a physiotherapist without neck specific exercises

Group Type ACTIVE_COMPARATOR

Prescribed Physical activity

Intervention Type OTHER

Physical activity without neck specific exercises for 3 months

Interventions

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Neck Specific Exercises

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

Intervention Type OTHER

Behavioral approach combined with neck specific exercises

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.

Intervention Type BEHAVIORAL

Prescribed Physical activity

Physical activity without neck specific exercises for 3 months

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

63 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No