Preventing Chronic Whiplash Pain
Primary Purpose
Whiplash Injuries
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Behavioral treatments
Physical therapy
Sponsored by
About this trial
This is an interventional prevention trial for Whiplash Injuries focused on measuring Whiplash, Chronic pain, Motor vehicle accidents
Eligibility Criteria
Inclusion Criteria: Have whiplash injury following a motor vehicle accident in the prior 4 to 10 weeks
Sites / Locations
- University of Washington
Outcomes
Primary Outcome Measures
Pain
Functional activity
Mood
Secondary Outcome Measures
Fear avoidance
Range of motion/strength
Physical symptoms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00021476
Brief Title
Preventing Chronic Whiplash Pain
Official Title
Preventing Chronic Whiplash Pain: Biobehavioral Approach
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
5. Study Description
Brief Summary
This study is aimed at developing ways to prevent acute pain from becoming chronic pain--specifically, pain associated with whiplash-associated disorders (WADs) from motor vehicle accidents. Research on the development of chronic pain due to musculoskeletal injury suggests that a person's initial emotional reactions, particularly fear of reinjury and subsequent avoidance of activity, contribute significantly to chronic pain and persistent disability. This study will treat people with WADs during the first three months after a motor vehicle accident with a behavioral and physical exercise program designed to encourage activity and discourage continued fear of movement, pain, and disability. The study will compare the effectiveness of two anxiety-reduction treatments to standard care in reducing pain and activity limitations in people with WADs in the 2 to 3 months after motor vehicle accidents.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Whiplash Injuries
Keywords
Whiplash, Chronic pain, Motor vehicle accidents
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Behavioral treatments
Intervention Type
Behavioral
Intervention Name(s)
Physical therapy
Primary Outcome Measure Information:
Title
Pain
Time Frame
Measured 3 months after the accident
Title
Functional activity
Time Frame
Measured 3 months after the accident
Title
Mood
Time Frame
Measured 3 months after the accident
Secondary Outcome Measure Information:
Title
Fear avoidance
Time Frame
Measured 3 months after the accident
Title
Range of motion/strength
Time Frame
Measured 3 months after the accident
Title
Physical symptoms
Time Frame
Measured 3 months after the accident
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have whiplash injury following a motor vehicle accident in the prior 4 to 10 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis C. Turk, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6540
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23318127
Citation
Robinson JP, Theodore BR, Dansie EJ, Wilson HD, Turk DC. The role of fear of movement in subacute whiplash-associated disorders grades I and II. Pain. 2013 Mar;154(3):393-401. doi: 10.1016/j.pain.2012.11.011. Epub 2012 Dec 1.
Results Reference
derived
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Preventing Chronic Whiplash Pain
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