NCT01994044

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1999

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 13, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

6.3 years

First QC Date

November 13, 2013

Last Update Submit

November 22, 2013

Conditions

Whiplash Symptoms

Keywords

Whiplash, surgery, multimodal rehabilitation, independent examiners

Outcome Measures

Primary Outcomes (2)

  • Complaints of WAD

    Independent examiners

  • SF-36 questionnaire

    Follow-up at 2 years

Secondary Outcomes (2)

  • Complaints of WAD

    SF-36

  • Range of neck movement

    Follow-up at 2 years

Other Outcomes (2)

  • Complaints of WAD

    BIS (Balanced Inventory for Spinal Disorders)

  • Quality of Life (Balanced Inventory for Spinal Disorders, questionnaire)

    Follow-up at 2 years

Study Arms (2)

Multimodal rehabilitation

ACTIVE COMPARATOR
Procedure: Cervical fusion

Cervical fusion

ACTIVE COMPARATOR
Procedure: Cervical fusion

Interventions

Cervical fusionPROCEDURE
Cervical fusionMultimodal rehabilitation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)

You may qualify if:

  • 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..

You may not qualify if:

  • \- Previous pain in the neck, previous surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic of Spinal Surgery

Strängnäs, 64594, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 18204388BACKGROUND

Related Links

MeSH Terms

Conditions

Whiplash Injuries

Condition Hierarchy (Ancestors)

Neck InjuriesWounds and Injuries

Study Officials

  • Bo Nyström, MD, PhD

    Clinic of Spinal Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 13, 2013

First Posted

November 25, 2013

Study Start

July 1, 1999

Primary Completion

October 1, 2005

Study Completion

October 1, 2013

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

SE(1)