- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00021476
Preventing Chronic Whiplash Pain
Preventing Chronic Whiplash Pain: Biobehavioral Approach
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
More than 1.8 million people in the United States suffer from chronic pain and disability following motor vehicle accidents (MVAs) each year. The majority of these cases start with a relatively minor neck injury. The Quebec Task Force Study on Whiplash Associated Disorders (WAD) was created in 1989 to determine the clinical, public health, social, and financial determinants of WAD. Multiple studies have described the clinical features of WAD, which include neck, shoulder, arm, low back, and head pain; tinnitus; visual symptoms; dizziness; temporomandibular joint pain; and paraesthesias. Onset of these symptoms after the injury is usually delayed for several hours and worsens within 24 to 48 hours. Neck pain is the most frequent symptom, and between 14% and 42% of patients with WAD develop chronic neck pain symptoms. Studies suggest that the neck pain will either resolve in the first few months or persist indefinitely. One variable that may predict outcome after an MVA is the acute emotional response immediately after the MVA.
A severe emotional reaction accompanied by neck pain and stiffness after an MVA could lead an injured person to avoid subsequent physical activity through such mechanisms as fear avoidance and fear of reinjury. Research investigating the evolution of chronic pain due to musculoskeletal injury suggests that initial emotional reactivity, particularly fear of reinjury and subsequent activity avoidance, contributes significantly to unremitting pain and persistent disability. Research based on this model has shown that early interventions targeting normalization of excessive emotionality and restriction of activities associated with fear following injury effectively prevent chronic pain due to back injury. No previous study has sought to intervene during the first three months after an MVA with a behavioral and physical exercise program to encourage activity and discourage continued fear of movement, pain and disability.
This study consists of two primary components: (1) To compare the effectiveness of two anxiety-reduction treatments with standard care in reducing pain and activity limitations in patients with WADs 2 to 3 months following MVAs. (2) To test whether psychological responses to the initial trauma, such as fear avoidance, fear of injury, and negative affectivity, discriminate between symptomatic WAD patients and WAD sufferers whose symptoms had resolved 2 to 3 months post-MVA.
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98195-6540
- University of Washington
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Have whiplash injury following a motor vehicle accident in the prior 4 to 10 weeks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pain
Time Frame: Measured 3 months after the accident
|
Measured 3 months after the accident
|
|
Functional activity
Time Frame: Measured 3 months after the accident
|
Measured 3 months after the accident
|
|
Mood
Time Frame: Measured 3 months after the accident
|
Measured 3 months after the accident
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Fear avoidance
Time Frame: Measured 3 months after the accident
|
Measured 3 months after the accident
|
|
Range of motion/strength
Time Frame: Measured 3 months after the accident
|
Measured 3 months after the accident
|
|
Physical symptoms
Time Frame: Measured 3 months after the accident
|
Measured 3 months after the accident
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dennis C. Turk, PhD, University of Washington
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01AR047298 (U.S. NIH Grant/Contract)
- NIAMS-064
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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