Randomized WAD Study

NCT01994044 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL

Last updated 2013-11-25

No results posted yet for this study

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.

Conditions

  • Whiplash Symptoms

Interventions

PROCEDURE

Cervical fusion

Sponsors & Collaborators

  • Spinal Surgery Clinic, Strängnäs

    lead OTHER

Principal Investigators

  • Bo Nyström, MD, PhD · Clinic of Spinal Surgery

Study Design

Purpose
TREATMENT

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-07-31
Primary Completion
2005-10-31
Completion
2013-10-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01994044 on ClinicalTrials.gov