Randomized WAD Study

Study Overview
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Brief Summary
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Background: The majority of patients suffering a whiplash injury (WAD) will recover, but some may have symptoms for years despite all kinds of conservative treatment. The Neck Pain Task Force (2008) found no existing evidence for positive effects of fusion operations in such patients. Some of them, however, present with symptoms that might indicate pain from a motion segment, possibly the disc. Our aim was therefore to test this possibility by performing a randomized study comparing cervical fusion and multimodal rehabilitation in chronic WAD patients. Methods: Patients with a specified symptomatology, all with pronounced symptoms for long periods of time, were recruited and randomized to surgery (25 pat.) or to multimodal rehabilitation (24 pat.). All patients were investigated before start of the study and at follow-up approximately two years after treatment by four independent examiners from disciplines usually involved in treating WAD patients. The patients also gave their own assessments of the treatment results. Seven patients in each group did not undergo the allocated treatment for various reasons.

Detailed Description
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Outcomes: representing different disciplines: neurology, orthopedics, physical medicine and psychology. Each patient´s perceived change in outcome was also assessed. Assessment was made before treatment and at follow-up two years afterwards. In addition to the assessments of outcome made by the examiners, the patients completed the SF-36, EQ-5D and BIS (Balanced Inventory for Spinal Disorders) questionnaires before treatment and at follow-up. The results of these assessments will be given in a forthcoming paper. 6b. No changes in trial outcomes were made during the study.

Official Title
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Treating Selected Chronic WAD Patients: Cervical Fusion or Multidimensional Rehabilitation. A Randomized Study

Conditions
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Whiplash Symptoms

Intervention / Treatment
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* Procedure: Cervical fusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients were to have been involved in a traffic accident as the origin of their pain and to have had pronounced symptoms lasting for at least one year. They should be in the age group 18 to 60 years, have been actively working up until the accident, should not have had previous neck pain. All patients should have had a plain X-ray and an MRI showing no specific changes. The patients should present with pronounced neck pain with the origin in the midline. The character of the pain should be dull, aching, and, with sudden movements, stabbing in the same area. Palpation and pressure in that area should provoke deep pain.. Exclusion Criteria: - Previous pain in the neck, previous surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Multimodal rehabilitation<br> | Procedure: Cervical fusion<br> <br> |
| Active Comparator: Cervical fusion<br> | Procedure: Cervical fusion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complaints of WAD |  | Independent examiners | 
| SF-36 questionnaire |  | Follow-up at 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complaints of WAD |  | SF-36 | 
| Range of neck movement |  | Follow-up at 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Whiplash, surgery, multimodal rehabilitation, independent examiners