Characterization & Treatment of Chronic Pain After Moderate to Severe TBI

NCT03739307 | Completed

• 1 other identifier: 90DPTB0017-01-00
• Study Type: observational
• Target: 3,805
• Locations: 1 country
• Sites: 13

Brief Summary

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

Conditions

Traumatic Brain Injury; Pain

Outcome Measures

Primary Outcomes (2)

• Brief Pain Inventory (BPI)

  The BPI will be used to determine pain intensity as well as interference related to pain. Intensity of pain is rated by participant on a scale of 0 (no pain) to 10 (pain as bad as you can imagine) when the pain is at it's "worst," "least," "average," and "right now." Pain interference is assessed with seven items using a numeric rating scale ranging from 0 (no interference) to 10 (complete interference). Participants are asked to rate how much pain has interfered with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life

  Each participant will complete assessment one time during 4 years of data collection

• painDetect Questionnaire

  This self report survey consists of seven questions about location and quality of neuropathic pain. Scores range from 0-38 with scores above 18 indicating neuropathic pain and higher scores indicating more severity of pain.

  Each participant will complete assessment one time during 4 years of data collection

Secondary Outcomes (3)

• Post-Traumatic Stress Disorder Checklist-5 (PCL-5)

  Each participant will complete assessment one time during 4 years of data collection

• Pain Self Efficacy Questionnaire-2 (PSEQ-2)

  Each participant will complete assessment one time during 4 years of data collection

• Coping Strategies Questionnaire (CSQ)

  Each participant will complete assessment one time during 4 years of data collection

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All participants have sustained a moderate to severe TBI and are now being followed at the collaborating centers as part of the TBIMS NDB which is a study collecting observational data after TBI.

You may qualify if:

• 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 \[18 for VA site\]

You may not qualify if:

• Participants unable to participate in the surveys themselves will not be included (i.e. no proxy surveys).

Sponsors & Collaborators

• Craig Hospital: lead
• University of Washington: collaborator
• James A. Haley Veterans Administration Hospital: collaborator
• Rehabilitation Hospital of Indiana: collaborator
• Spaulding Rehabilitation Hospital: collaborator
• Wayne State University: collaborator
• Mayo Clinic: collaborator
• Baylor Institute for Rehabilitation: collaborator
• Virginia Commonwealth University: collaborator
• NYU Langone Health: collaborator
• University of Alabama at Birmingham: collaborator
• Moss Rehabilitation Research Institute: collaborator
• TIRR Memorial Hermann: collaborator

Study Sites (13)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Craig Hospital

Englewood, Colorado, 80113, United States

Location

Tampa VA

Tampa, Florida, 33612, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Spaulding Rehabilitation Institute

Charlestown, Massachusetts, 02129, United States

Location

Wayne State University

Detroit, Michigan, 78202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

New York University School of Medicine

New York, New York, 10016, United States

Location

MOSS Rehabilitation Research Institute

Elkins Park, Pennsylvania, 19027, United States

Location

Baylor Research Institute

Dallas, Texas, 75204, United States

Location

TIRR Memorial Hermann

Houston, Texas, 77030, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Pain

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 13, 2018
• Study Start: May 20, 2019
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

US (13)