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

Linköping University (LiU)

Status: Completed

Conditions: Whiplash

Treatments: Behavioral: Behavioral approach combined with neck specific exercises; Other: Prescribed Physical activity; Other: Neck Specific Exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT01528579

PeolssonAWADlong-term

Details and patient eligibility

About

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.

Enrollment: 216 patients

Sex: All

Ages: 18 to 63 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

216 participants in 3 patient groups

Neck Specific exercises

Active Comparator group

Description:

Neck Specific exercises from a structured frame of exercises

Treatment:

Other: Neck Specific Exercises

Behavioral approach

Active Comparator group

Description:

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.

Treatment:

Behavioral: Behavioral approach combined with neck specific exercises

Prescribed physical activity

Active Comparator group

Description:

Prescribed physical activity from a physiotherapist without neck specific exercises

Treatment:

Other: Prescribed Physical activity