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Completed

NCT Number: NCT03739307

Characterization & Treatment of Chronic Pain After Moderate to Severe TBI

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

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Craig Hospital

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 13, 2018
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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