Randomized WAD Study
Primary Purpose
Whiplash Symptoms
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cervical fusion
Sponsored by
About this trial
This is an interventional treatment trial for Whiplash Symptoms focused on measuring Whiplash, surgery, multimodal rehabilitation, independent examiners
Eligibility 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
Sites / Locations
- Clinic of Spinal Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Multimodal rehabilitation
Cervical fusion
Arm Description
Outcomes
Primary Outcome Measures
Complaints of WAD
SF-36 questionnaire
Secondary Outcome Measures
Complaints of WAD
Range of neck movement
Full Information
NCT ID
NCT01994044
First Posted
November 13, 2013
Last Updated
November 22, 2013
Sponsor
Spinal Surgery Clinic, Strängnäs
1. Study Identification
Unique Protocol Identification Number
NCT01994044
Brief Title
Randomized WAD Study
Official Title
Treating Selected Chronic WAD Patients: Cervical Fusion or Multidimensional Rehabilitation. A Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spinal Surgery Clinic, Strängnäs
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Whiplash Symptoms
Keywords
Whiplash, surgery, multimodal rehabilitation, independent examiners
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Arm Title
Multimodal rehabilitation
Arm Type
Active Comparator
Arm Title
Cervical fusion
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Cervical fusion
Primary Outcome Measure Information:
Title
Complaints of WAD
Time Frame
Independent examiners
Title
SF-36 questionnaire
Time Frame
Follow-up at 2 years
Secondary Outcome Measure Information:
Title
Complaints of WAD
Time Frame
SF-36
Title
Range of neck movement
Time Frame
Follow-up at 2 years
Other Pre-specified Outcome Measures:
Title
Complaints of WAD
Time Frame
BIS (Balanced Inventory for Spinal Disorders)
Title
Quality of Life (Balanced Inventory for Spinal Disorders, questionnaire)
Time Frame
Follow-up at 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Nyström, MD, PhD
Organizational Affiliation
Clinic of Spinal Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic of Spinal Surgery
City
Strängnäs
ZIP/Postal Code
64594
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
18204388
Citation
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.
Results Reference
background
Links:
URL
http://www.ryggkirurgiska.se
Description
Related Info
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Randomized WAD Study
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