Skip to content

Randomized WAD Study

Treating Selected Chronic WAD Patients: Cervical Fusion or Multidimensional Rehabilitation. A Randomized Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01994044
Enrollment
Unknown
Registered
2013-11-25
Start date
1999-07-31
Completion date
2013-10-31
Last updated
2013-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Whiplash Symptoms

Keywords

Whiplash, surgery, multimodal rehabilitation, independent examiners

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.

Interventions

Sponsors

Spinal Surgery Clinic, Strängnäs
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years

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

Design outcomes

Primary

MeasureTime frame
Complaints of WADIndependent examiners
SF-36 questionnaireFollow-up at 2 years

Secondary

MeasureTime frame
Complaints of WADSF-36
Range of neck movementFollow-up at 2 years

Other

MeasureTime frame
Complaints of WADBIS (Balanced Inventory for Spinal Disorders)
Quality of Life (Balanced Inventory for Spinal Disorders, questionnaire)Follow-up at 2 years

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026