Randomized WAD Study

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

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.

Study Overview

• Status: Completed
• Conditions: Whiplash Symptoms
• Intervention / Treatment: Procedure: Cervical fusion

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Strängnäs, Sweden, 64594
    • Clinic of Spinal Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Multimodal rehabilitation	Procedure: Cervical fusion
Active Comparator: Cervical fusion	Procedure: Cervical fusion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Complaints of WAD	BIS (Balanced Inventory for Spinal Disorders)
Quality of Life (Balanced Inventory for Spinal Disorders, questionnaire)	Follow-up at 2 years

Collaborators and Investigators

• Sponsor: Spinal Surgery Clinic, Strängnäs
• Investigators: Principal Investigator: Bo Nyström, MD, PhD, Clinic of Spinal Surgery

Publications and helpful links

General Publications

• Carragee EJ, Hurwitz EL, Cheng I, Carroll LJ, Nordin M, Guzman J, Peloso P, Holm LW, Cote P, Hogg-Johnson S, van der Velde G, Cassidy JD, Haldeman S; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Treatment of neck pain: injections and surgical interventions: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S153-69. doi: 10.1097/BRS.0b013e31816445ea.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 1999
• Primary Completion (Actual): October 1, 2005
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: November 13, 2013
• First Submitted That Met QC Criteria: November 22, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): November 25, 2013
• Last Update Submitted That Met QC Criteria: November 22, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Whiplash, surgery, multimodal rehabilitation, independent examiners
• Additional Relevant MeSH Terms: Wounds and Injuries; Neck Injuries; Whiplash Injuries
• Other Study ID Numbers: RKSWAD SpinalSC; SpinalSC (Other Identifier: SpinalSC)