Traumatic Brain InjuryNCT03739307
Characterization & Treatment of Chronic Pain After Moderate to Severe TBI
An observational study of Traumatic Brain Injury and Pain, run by Craig Hospital at 13 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Traumatic Brain Injury, Pain
- How many people
- 3,805 participants
- Where
- 13 sitesUnited States
- Study dates
- 20 May 2019to 1 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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]
Who cannot join
- Participants unable to participate in the surveys themselves will not be included (i.e. no proxy surveys).
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of Alabama
Birmingham, Alabama, 35294
Spaulding Rehabilitation Institute
Charlestown, Massachusetts, 02129
Baylor Research Institute
Dallas, Texas, 75204
Wayne State University
Detroit, Michigan, 78202
MOSS Rehabilitation Research Institute
Elkins Park, Pennsylvania, 19027
Craig Hospital
Englewood, Colorado, 80113
TIRR Memorial Hermann
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
New York University School of Medicine
New York, New York, 10016
Virginia Commonwealth University
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55905
University of Washington
Seattle, Washington, 98195
Tampa VA
Tampa, Florida, 33612
About this study
Official title: Characterization & Treatment of Chronic Pain After Moderate to Severe Traumatic Brain Injury
This is a five year multi-site, cross sectional, observational study designed to examine chronic pain and pain treatment after moderate to severe TBI.
Read the 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.
- Conditions
- Traumatic Brain Injury, Pain
- Medical subject headings
- Brain Injuries, Traumatic, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Each participant will complete assessment one time during 4 years of data collection
Secondary outcomes (3)
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
Measured: Each participant will complete assessment one time during 4 years of data collection
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).
Measured: Each participant will complete assessment one time during 4 years of data collection
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.
Measured: Each participant will complete assessment one time during 4 years of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start20 May 2019
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,805 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Cynthia Harrison-Felix, PhD, Craig Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739307
- Sponsor's protocol ID
- 90DPTB0017-01-00
- Status last verified
- Feb 2023
- First submitted
- 8 Nov 2018
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization & Treatment of Chronic Pain After Moderate to Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03739307
- Acronym / sponsor ID
- 90DPTB0017-01-00
- Conditions
- Traumatic Brain Injury, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,805 participants (actual)
- Lead sponsor
- Craig HospitalUniversity, hospital or other
- 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
- Study start
- 20 May 2019 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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]
Key exclusion criteria (1 listed)
- Participants unable to participate in the surveys themselves will not be included (i.e. no proxy surveys).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
3 secondary outcomes
Post-Traumatic Stress Disorder Checklist-5 (PCL-5)
Time frame: Each participant will complete assessment one time during 4 years of data collection
Pain Self Efficacy Questionnaire-2 (PSEQ-2)
Time frame: Each participant will complete assessment one time during 4 years of data collection
Coping Strategies Questionnaire (CSQ)
Time frame: Each participant will complete assessment one time during 4 years of data collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Pain, run by Craig Hospital at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory (BPI) (time frame: Each participant will complete assessment one time during 4 years of data collection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023; AzTrials last refreshed its copy on 8 Nov 2026.