Characterization & Treatment of Chronic Pain After Moderate to Severe TBI

Pain Clinical Trial

Official title:

Characterization & Treatment of Chronic Pain After Moderate to Severe Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03739307
• Other study ID #: 90DPTB0017-01-00
• Status: Completed
• Start date: May 20, 2019
• Est. completion date: October 1, 2022

Study information

• Verified date: February 2023
• Source: Craig Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3805
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Chronic Pain
• Pain
• Traumatic Brain Injury

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama
United States	Spaulding Rehabilitation Institute	Charlestown	Massachusetts
United States	Baylor Research Institute	Dallas	Texas
United States	Wayne State University	Detroit	Michigan
United States	MOSS Rehabilitation Research Institute	Elkins Park	Pennsylvania
United States	Craig Hospital	Englewood	Colorado
United States	TIRR Memorial Hermann	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	New York University School of Medicine	New York	New York
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Washington	Seattle	Washington
United States	Tampa VA	Tampa	Florida

Sponsors (13)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Post-Traumatic Stress Disorder Checklist-5 (PCL-5)	The PCL-5 is a 20-item, self-rating scale that provides a quick and accurate measure of PTSD symptoms. Responses are scored on Likert scale (0 = "Not at All" to 4 = "Extremely"). Total score of 0 to 80 with higher scores indicating more PTSD symptomatology	Each participant will complete assessment one time during 4 years of data collection
Secondary	Pain Self Efficacy Questionnaire-2 (PSEQ-2)	PSEQ-2 is designed to assess the level of confidence the respondent has in their ability to accomplish daily activities despite their pain. items are rated on a 7-point scale (0 = not at all confident to 6 = completely confident).	Each participant will complete assessment one time during 4 years of data collection
Secondary	Coping Strategies Questionnaire (CSQ)	An abbreviated version of the CSQ will be used to reduce patient burden. This version uses only two items per domain to assess four coping strategies associated with adjustment to chronic pain: catastrophizing, ignoring pain sensations, increasing behavior, and using coping self-statements. Each item is scored from 0 to 6, with 0 representing 'no use' and 6 representing 'regular use' of the coping strategy. Scores for each domain are the mean score of the two items in that domain.	Each participant will complete assessment one time during 4 years of data collection