Randomized WAD Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bo Nyström, Spinal Surgery Clinic, Strängnäs
ClinicalTrials.gov Identifier:
NCT01994044
First received: November 13, 2013
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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 Intervention
Whiplash Symptoms
Procedure: Cervical fusion

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Treating Selected Chronic WAD Patients: Cervical Fusion or Multidimensional Rehabilitation. A Randomized Study

Resource links provided by NLM:


Further study details as provided by Spinal Surgery Clinic, Strängnäs:

Primary Outcome Measures:
  • Complaints of WAD [ Time Frame: Independent examiners ] [ Designated as safety issue: Yes ]
  • SF-36 questionnaire [ Time Frame: Follow-up at 2 years ]

Secondary Outcome Measures:
  • Complaints of WAD [ Time Frame: SF-36 ] [ Designated as safety issue: Yes ]
  • Range of neck movement [ Time Frame: Follow-up at 2 years ]

Other Outcome Measures:
  • Complaints of WAD [ Time Frame: BIS (Balanced Inventory for Spinal Disorders) ] [ Designated as safety issue: Yes ]
  • Quality of Life (Balanced Inventory for Spinal Disorders, questionnaire) [ Time Frame: Follow-up at 2 years ]

Study Start Date: July 1999
Study Completion Date: October 2013
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Multimodal rehabilitation Procedure: Cervical fusion
Active Comparator: Cervical fusion 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01994044

Locations
Sweden
Clinic of Spinal Surgery
Strängnäs, Sweden, 64594
Sponsors and Collaborators
Spinal Surgery Clinic, Strängnäs
Investigators
Principal Investigator: Bo Nyström, MD, PhD Clinic of Spinal Surgery
  More Information

Additional Information:
Publications:
Responsible Party: Bo Nyström, MD, PhD, Spinal Surgery Clinic, Strängnäs
ClinicalTrials.gov Identifier: NCT01994044     History of Changes
Other Study ID Numbers: RKSWAD SpinalSC, SpinalSC
Study First Received: November 13, 2013
Last Updated: November 22, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Spinal Surgery Clinic, Strängnäs:
Whiplash, surgery, multimodal rehabilitation, independent examiners

ClinicalTrials.gov processed this record on October 28, 2014