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Randomized WAD Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01994044
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Information provided by (Responsible Party):
Bo Nyström, 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.

Condition or disease Intervention/treatment Phase
Whiplash Symptoms Procedure: Cervical fusion Not Applicable

Detailed Description:


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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Treating Selected Chronic WAD Patients: Cervical Fusion or Multidimensional Rehabilitation. A Randomized Study
Study Start Date : July 1999
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: Multimodal rehabilitation Procedure: Cervical fusion
Active Comparator: Cervical fusion Procedure: Cervical fusion

Primary Outcome Measures :
  1. Complaints of WAD [ Time Frame: Independent examiners ]
  2. SF-36 questionnaire [ Time Frame: Follow-up at 2 years ]

Secondary Outcome Measures :
  1. Complaints of WAD [ Time Frame: SF-36 ]
  2. Range of neck movement [ Time Frame: Follow-up at 2 years ]

Other Outcome Measures:
  1. Complaints of WAD [ Time Frame: BIS (Balanced Inventory for Spinal Disorders) ]
  2. Quality of Life (Balanced Inventory for Spinal Disorders, questionnaire) [ Time Frame: Follow-up at 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01994044

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Clinic of Spinal Surgery
Strängnäs, Sweden, 64594
Sponsors and Collaborators
Spinal Surgery Clinic, Strängnäs
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Principal Investigator: Bo Nyström, MD, PhD Clinic of Spinal Surgery
Additional Information:
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Responsible Party: Bo Nyström, MD, PhD, Spinal Surgery Clinic, Strängnäs Identifier: NCT01994044    
Other Study ID Numbers: RKSWAD SpinalSC
SpinalSC ( Other Identifier: SpinalSC )
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Keywords provided by Bo Nyström, Spinal Surgery Clinic, Strängnäs:
Whiplash, surgery, multimodal rehabilitation, independent examiners
Additional relevant MeSH terms:
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Whiplash Injuries
Neck Injuries
Wounds and Injuries