Skip to main content
OpenTrials
Completed

NCT Number: NCT01994044

Randomized WAD Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Whiplash Symptoms Neck Injuries Whiplash Injuries Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinic of Spinal Surgery

Strängnäs, 64594, Sweden

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cervical fusion

Procedure

Primary outcomes

  1. Complaints of WAD

    Time frame: Independent examiners

  2. SF-36 questionnaire

    Time frame: Follow-up at 2 years

Secondary outcomes

  1. Complaints of WAD

    Time frame: SF-36

  2. Range of neck movement

    Time frame: Follow-up at 2 years

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

Spinal Surgery Clinic, Strängnäs

Other

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2005
Study completion
2013
First posted
Nov 25, 2013
Registry last updated
Nov 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.