NCT00021476

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2001

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2001

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

August 13, 2013

Status Verified

August 1, 2013

Enrollment Period

5.8 years

First QC Date

July 16, 2001

Last Update Submit

August 9, 2013

Conditions

Keywords

WhiplashChronic painMotor vehicle accidents

Outcome Measures

Primary Outcomes (3)

  • Pain

    Measured 3 months after the accident

  • Functional activity

    Measured 3 months after the accident

  • Mood

    Measured 3 months after the accident

Secondary Outcomes (3)

  • Fear avoidance

    Measured 3 months after the accident

  • Range of motion/strength

    Measured 3 months after the accident

  • Physical symptoms

    Measured 3 months after the accident

Interventions

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195-6540, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Whiplash InjuriesChronic Pain

Interventions

Behavior TherapyPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

Neck InjuriesWounds and InjuriesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesTherapeuticsRehabilitation

Study Officials

  • Dennis C. Turk, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

July 16, 2001

First Posted

July 18, 2001

Study Start

May 1, 2001

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

August 13, 2013

Record last verified: 2013-08

Locations