Randomized WAD Study

Not Applicable

Completed

• Conditions: Whiplash Symptoms
• Interventions: Procedure: Cervical fusion

• Registration Number: NCT01994044
• Lead Sponsor: Spinal Surgery Clinic, Strängnäs

Brief Summary

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

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.

Study Timeline

• Study Start: 1999-07
• Primary Completion: 2005-10
• Study Completion: 2013-10
• Status Verified: 2013-11
• Study First Submitted: 2013-11-13
• Study First Submitted QC: 2013-11-22
• Last Update Submitted: 2013-11-22
• Study First Posted: 2013-11-25
• Last Update Posted: 2013-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cervical fusion	Cervical fusion	-
Multimodal rehabilitation	Cervical fusion	-

Primary Outcome Measures

Name	Time	Method
Complaints of WAD	Independent examiners
SF-36 questionnaire	Follow-up at 2 years

Secondary Outcome Measures

Name	Time	Method
Range of neck movement	Follow-up at 2 years
Complaints of WAD	SF-36

Trial Locations

Locations (1)

Clinic of Spinal Surgery; 🇸🇪 Strängnäs, Sweden