Whiplash Symptoms Clinical Trial
Official title:
Treating Selected Chronic WAD Patients: Cervical Fusion or Multidimensional Rehabilitation. A Randomized Study
| Verified date | November 2013 |
| Source | Spinal Surgery Clinic, Strängnäs |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Regional Ethical Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | October 2013 |
| Est. primary completion date | October 2005 |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
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 |
Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Clinic of Spinal Surgery | Strängnäs |
| Lead Sponsor | Collaborator |
|---|---|
| Spinal Surgery Clinic, Strängnäs |
Sweden,
Carragee EJ, Hurwitz EL, Cheng I, Carroll LJ, Nordin M, Guzman J, Peloso P, Holm LW, Côté 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. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Complaints of WAD | BIS (Balanced Inventory for Spinal Disorders) | Yes | |
| Other | Quality of Life (Balanced Inventory for Spinal Disorders, questionnaire) | Follow-up at 2 years | ||
| Primary | Complaints of WAD | Independent examiners | Yes | |
| Primary | SF-36 questionnaire | Follow-up at 2 years | ||
| Secondary | Complaints of WAD | SF-36 | Yes | |
| Secondary | Range of neck movement | Follow-up at 2 years |