Randomized WAD Study
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|ClinicalTrials.gov Identifier: NCT01994044|
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : November 25, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Whiplash Symptoms||Procedure: Cervical fusion||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Treating Selected Chronic WAD Patients: Cervical Fusion or Multidimensional Rehabilitation. A Randomized Study|
|Study Start Date :||July 1999|
|Actual Primary Completion Date :||October 2005|
|Actual Study Completion Date :||October 2013|
|Active Comparator: Multimodal rehabilitation||
Procedure: Cervical fusion
|Active Comparator: Cervical fusion||
Procedure: Cervical fusion
- Complaints of WAD [ Time Frame: Independent examiners ]
- SF-36 questionnaire [ Time Frame: Follow-up at 2 years ]
- Complaints of WAD [ Time Frame: SF-36 ]
- Range of neck movement [ Time Frame: Follow-up at 2 years ]
- Complaints of WAD [ Time Frame: BIS (Balanced Inventory for Spinal Disorders) ]
- Quality of Life (Balanced Inventory for Spinal Disorders, questionnaire) [ Time Frame: Follow-up at 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994044
|Clinic of Spinal Surgery|
|Strängnäs, Sweden, 64594|
|Principal Investigator:||Bo Nyström, MD, PhD||Clinic of Spinal Surgery|