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Completed

NCT Number: NCT00021476

Preventing Chronic Whiplash Pain

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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Washington

Seattle, Washington, 98195-6540, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have whiplash injury following a motor vehicle accident in the prior 4 to 10 weeks

Treatment and study plan

Behavioral treatments

Behavioral

Physical Therapy

Behavioral

Primary outcomes

  1. Pain

    Time frame: Measured 3 months after the accident

  2. Functional activity

    Time frame: Measured 3 months after the accident

  3. Mood

    Time frame: Measured 3 months after the accident

Secondary outcomes

  1. Fear avoidance

    Time frame: Measured 3 months after the accident

  2. Range of motion/strength

    Time frame: Measured 3 months after the accident

  3. Physical symptoms

    Time frame: Measured 3 months after the accident

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

Preventing Chronic Whiplash Pain: Biobehavioral Approach

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Jul 18, 2001
Registry last updated
Aug 13, 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.

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