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Characterization & Treatment of Chronic Pain After Moderate to Severe TBI

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ClinicalTrials.gov Identifier: NCT03739307
Recruitment Status : Enrolling by invitation
First Posted : November 13, 2018
Last Update Posted : August 20, 2020
Sponsor:
Collaborators:
University of Washington
James A. Haley Veterans Administration Hospital
Rehabilitation Hospital of Indiana
Spaulding Rehabilitation Hospital
Wayne State University
Mayo Clinic
Baylor Institute for Rehabilitation
Virginia Commonwealth University
NYU Langone Health
University of Alabama at Birmingham
Moss Rehabilitation Research Institute
TIRR Memorial Hermann
Information provided by (Responsible Party):
Cynthia Harrison-Felix, PhD, Craig Hospital

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.

Condition or disease
Traumatic Brain Injury Pain

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.

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Study Type : Observational
Estimated Enrollment : 3800 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Characterization & Treatment of Chronic Pain After Moderate to Severe Traumatic Brain Injury
Actual Study Start Date : May 20, 2019
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain




Primary Outcome Measures :
  1. Brief Pain Inventory (BPI) [ Time Frame: Each participant will complete assessment one time during 4 years of data collection ]
    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

  2. painDetect Questionnaire [ Time Frame: Each participant will complete assessment one time during 4 years of data collection ]
    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.


Secondary Outcome Measures :
  1. Post-Traumatic Stress Disorder Checklist-5 (PCL-5) [ Time Frame: Each participant will complete assessment one time during 4 years of data collection ]
    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

  2. Pain Self Efficacy Questionnaire-2 (PSEQ-2) [ Time Frame: Each participant will complete assessment one time during 4 years of data collection ]
    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).

  3. Coping Strategies Questionnaire (CSQ) [ Time Frame: Each participant will complete assessment one time during 4 years of data collection ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739307


Locations
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United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, Colorado
Craig Hospital
Englewood, Colorado, United States, 80113
United States, Florida
Tampa VA
Tampa, Florida, United States, 33612
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Spaulding Rehabilitation Institute
Charlestown, Massachusetts, United States, 02129
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 78202
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
United States, Pennsylvania
MOSS Rehabilitation Research Institute
Elkins Park, Pennsylvania, United States, 19027
United States, Texas
Baylor Research Institute
Dallas, Texas, United States, 75204
TIRR Memorial Hermann
Houston, Texas, United States, 77030
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Craig Hospital
University of Washington
James A. Haley Veterans Administration Hospital
Rehabilitation Hospital of Indiana
Spaulding Rehabilitation Hospital
Wayne State University
Mayo Clinic
Baylor Institute for Rehabilitation
Virginia Commonwealth University
NYU Langone Health
University of Alabama at Birmingham
Moss Rehabilitation Research Institute
TIRR Memorial Hermann
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Responsible Party: Cynthia Harrison-Felix, PhD, Co-Principal Investigator, Craig Hospital
ClinicalTrials.gov Identifier: NCT03739307    
Other Study ID Numbers: 90DPTB0017-01-00
First Posted: November 13, 2018    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Chronic Pain
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Pain
Neurologic Manifestations