Characterization & Treatment of Chronic Pain After Moderate to Severe TBI

NCT ID: NCT03739307

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3805 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-20

Study Completion Date

2022-10-01

Brief Summary

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This is a five year multi-site, cross sectional, observational study designed to examine chronic pain and pain treatment after moderate to severe TBI.

Detailed Description

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The aims of this study are to: 1) Determine chronic pain classification (musculoskeletal, headache, central/neuropathic), prevalence, location, duration, and associations with demographic, injury severity, current level of functioning and comorbidities in participants followed in ten Centers participating in the National Institute on Disability, Independent Living and Rehabilitation Research and the Department of Veterans Affairs TBIMS Databases; 2) Identify extreme groups based on responses to pain (interference and perception of improvement with treatment), or chronic pain extreme phenotypes, in order to define the key differences between those who have a good outcome and those who do not, across factors related to injury, pain severity/location, demographics, and treatment history; and 3) Identify treatment practices by clinicians who treat comorbid TBI and chronic pain to determine gaps in availability/accessibility of guideline level treatment, highlighting underserved populations where applicable.

Results from this study will provide a more detailed picture of the problem of chronic pain after TBI by examining the types of pain that occur after TBI, which may be multiple types of pain for a subset of individuals, as well as the frequency of comorbid conditions. Identifying extreme phenotypes, such as demographic, individual, and treatment factors associated with those who have chronic pain but have minimal interference compared to those who are significantly impacted by pain, will allow us to identify treatment targets (behavioral, cognitive, biological, and molecular) to advance a personalized medicine approach to treatment unlike any approach in TBI and chronic pain to date. Outcomes from this study will include educational materials on chronic pain and pain treatment to benefit patients, family members, clinicians, and policymakers. Data from this study will have a direct impact on clinical practice, informing future work, and promoting understanding of constituent factors in extreme phenotypes.

Conditions

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Traumatic Brain Injury Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Participants must be enrolled in the TBI Model Systems National Database (TBNIMS NDB) at one of the collaborating sites and thus will meet the TBIMS NDB criteria which are: (1) medical documentation of TBI caused by external mechanical force with either loss of consciousness exceeding 30 minutes, post-traumatic amnesia lasting more than 24 hours, Glasgow Coma Scale score in ER of less than 13, or trauma related intracranial abnormality or neuroimaging abnormalities; (2) admitted to the TBI inpatient rehab program at study sites; and (3) minimum age of 16 \[18 for VA site\]

Exclusion Criteria

* Participants unable to participate in the surveys themselves will not be included (i.e. no proxy surveys).
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role collaborator

James A. Haley Veterans Administration Hospital

FED

Sponsor Role collaborator

Rehabilitation Hospital of Indiana

OTHER

Sponsor Role collaborator

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role collaborator

Wayne State University

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role collaborator

Baylor Institute for Rehabilitation

OTHER

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

Moss Rehabilitation Research Institute

OTHER

Sponsor Role collaborator

TIRR Memorial Hermann

OTHER

Sponsor Role collaborator

Craig Hospital

OTHER

Sponsor Role lead

Responsible Party

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Cynthia Harrison-Felix, PhD

Co-Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Alabama

Birmingham, Alabama, United States

Site Status

Craig Hospital

Englewood, Colorado, United States

Site Status

Tampa VA

Tampa, Florida, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

Spaulding Rehabilitation Institute

Charlestown, Massachusetts, United States

Site Status

Wayne State University

Detroit, Michigan, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

New York University School of Medicine

New York, New York, United States

Site Status

MOSS Rehabilitation Research Institute

Elkins Park, Pennsylvania, United States

Site Status

Baylor Research Institute

Dallas, Texas, United States

Site Status

TIRR Memorial Hermann

Houston, Texas, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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90DPTB0017-01-00

Identifier Type: -

Identifier Source: org_study_id

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