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Preventing Chronic Whiplash Pain
This study has been completed.
Sponsored by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier: NCT00021476
  Purpose

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.


Condition Intervention Phase
Whiplash Injuries
Behavioral: Behavioral treatments
Behavioral: Physical therapy
Phase III

U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind, Active Control, Single Group Assignment, Safety Study
Official Title: Preventing Chronic Whiplash Pain: Biobehavioral Approach

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:
  • Pain [ Time Frame: Measured 3 months after the accident ] [ Designated as safety issue: No ]
  • Functional activity [ Time Frame: Measured 3 months after the accident ] [ Designated as safety issue: No ]
  • Mood [ Time Frame: Measured 3 months after the accident ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fear avoidance [ Time Frame: Measured 3 months after the accident ] [ Designated as safety issue: No ]
  • Range of motion/strength [ Time Frame: Measured 3 months after the accident ] [ Designated as safety issue: No ]
  • Physical symptoms [ Time Frame: Measured 3 months after the accident ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: May 2001
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have whiplash injury following a motor vehicle accident in the prior 4 to 10 weeks
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00021476

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195-6540
Sponsors and Collaborators
Investigators
Principal Investigator: Dennis C. Turk, PhD University of Washington
  More Information

Click here for the WADS Web site.  This link exits the ClinicalTrials.gov site

Responsible Party: University of Washington ( Dennis C. Turk, Ph.D. )
Study ID Numbers: R01 AR47298, NIAMS-064
Study First Received: July 16, 2001
Last Updated: March 28, 2008
ClinicalTrials.gov Identifier: NCT00021476  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Whiplash
Chronic pain
Motor vehicle accidents

Study placed in the following topic categories:
Wounds and Injuries
Disorders of Environmental Origin
Pain
Neck Injuries
Whiplash Injuries

ClinicalTrials.gov processed this record on January 14, 2009