Clinical trial NCT03739307: Characterization & Treatment of Chronic Pain After Moderate to Severe TBI
Official title: Characterization & Treatment of Chronic Pain After Moderate to Severe Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Pain
Lead sponsor: Craig Hospital
Sponsor class: OTHER
Collaborators: name: University of Washington
name: James A. Haley Veterans Administration Hospital
name: Rehabilitation Hospital of Indiana
name: Spaulding Rehabilitation Hospital
name: Wayne State University
name: Mayo Clinic
name: Baylor Institute for Rehabilitation
name: Virginia Commonwealth University
name: NYU Langone Health
name: University of Alabama at Birmingham
name: Moss Rehabilitation Research Institute
name: TIRR Memorial Hermann
First posted: 2018-11-13
Enrollment: 3805
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Brief Pain Inventory (BPI)
timeFrame: Each participant will complete assessment one time during 4 years of data collection
measure: painDetect Questionnaire
timeFrame: Each participant will complete assessment one time during 4 years of data collection
Secondary outcomes:
measure: Post-Traumatic Stress Disorder Checklist-5 (PCL-5)
timeFrame: Each participant will complete assessment one time during 4 years of data collection
measure: Pain Self Efficacy Questionnaire-2 (PSEQ-2)
timeFrame: Each participant will complete assessment one time during 4 years of data collection
measure: Coping Strategies Questionnaire (CSQ)
timeFrame: Each participant will complete assessment one time during 4 years of data collection
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Englewood
country: United States
facility: Craig Hospital
state: Colorado
city: Tampa
country: United States
facility: Tampa VA
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Charlestown
country: United States
facility: Spaulding Rehabilitation Institute
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: Elkins Park
country: United States
facility: MOSS Rehabilitation Research Institute
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Houston
country: United States
facility: TIRR Memorial Hermann
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References: