Principal Investigator(s):
* Cindy Harrison-Felix, PhD, Craig Hospital
* Risa Richardson, PhD, James Haley Veterans’ Hospital
* Jeanne Hoffman, PhD, Department of Rehabilitation Medicine, University
of Washington
Lead Site
* Craig Hospital
Collaborating Sites:
* University of Washington
* James A. Haley Veteran’s Administration
* Indiana School of Medicine
* Spaulding Rehabilitation Hospital
* Wayne State University
* Mayo Clinic
* Baylor Scott and White Institute for Rehabilitation
* Virginia Commonwealth University
* University of Alabama
* MossRehab Einstein Medical Center
* TIRR Memorial Hermann
* Ohio State University
* Kessler Foundation
* Carolinas Rehabilitation
* JFK Johnson Rehabilitation Institute
* Mount Sinai
Sponsor:
Department of Health and Human Services, Administration for Community
Living, National Institute on Disability, Independent Living and
Rehabilitation Research Disability and Rehabilitation Research Projects
(DRRP) Award #: 90DPTB0017-01-00
This is a multi-site, cross-sectional, observational study involving nine TBI Model Systems (TBIMS) centers and one Veteran’s Administration (VA) TBIMS center. Craig Hospital is the lead center and each collaborating site is responsible for their own IRB approval.
Scientific Rationale
After a traumatic brain injury (TBI), a large number of individuals
experience chronic pain (i.e., pain that lasts at least three months)
that may or may not be directly related to the TBI. Over 70% of
non-military individuals and 80% of active military and veterans have
reported chronic pain after TBI. Chronic pain after TBI is prevalent and
can be associated with poor outcomes. Living with chronic pain can
impact almost all aspects of a person’s life: physical function,
concentration and memory, sleep, and feelings of depression, anxiety and
irritability. Despite the impact and prevalence of chronic pain after
TBI, treatment of chronic pain is understudied and it is difficult to
identify effective treatments because large studies of individuals with
TBI and chronic pain have not been conducted. This study leverages an
existing successful research network (TBI Model Systems – TBIMS) that
has the largest number of individuals with TBI enrolled and followed in
a well-characterized database with long-term outcomes related to
TBI.
Study Objectives
The goal of the present study is to examine chronic pain and pain
treatment after moderate to severe TBI to improve the health and
function of these individuals, which through improved patient
stratification and treatment guidelines, could lead to improved
community participation and employment. Results from this study will not
only provide detailed information on chronic pain (e.g., identification
of the most common types of pain, co-occurring pain conditions,
beneficial treatments), but will also gather key information from
treatment providers on the facilitators and barriers to appropriate pain
treatment.
Participants with complicated mild to severe TBI who are already enrolled in the Traumatic Brain Injury Model System (TBIMS) National Database (NDB) from any of the participating TBIMS centers comprise the study population. Participating TBIMS centers include 17 civilian NIDILRR-funded TBIMS sites: Craig Hospital, Englewood, CO; Rehabilitation Hospital of Indiana, Indianapolis, IN; Spaulding Rehabilitation Hospital Network, Boston, MA; Rehabilitation Institute of Michigan/Wayne State University, Detroit, MI; Mayo Clinic, Rochester, MN; Baylor Scott and White Institute for Rehabilitation, Dallas, TX; Virginia Commonwealth University, Richmond, VA; University of Alabama, Birmingham, AL; Einstein Medical Center, Philadelphia, PA; TIRR Memorial Hermann, Houston, TX; Ohio State University, Columbus, OH; Kessler Foundation, East Hanover, NJ; Carolinas Rehabilitation, Charlotte, NC; Mount Sinai, New York, NY; JFK Johnson Rehabilitation Institute, Edison, NJ; and University of Washington, Seattle, WA and one VA TBIMS site, James A. Haley Veterans Hospital, Tampa, FL.
Study inclusion criteria. Participants must be enrolled in the TBIMS NDB at one of the participating sites. Inclusion criteria for the TBIMS NDB are: (1) meet the TBIMS case definition for TBI of medical documentation of damage to brain tissue caused by an external mechanical force; (2) meet at least one of the following criteria: (a) loss of consciousness (LOC) exceeding 30 minutes, (b) post-traumatic amnesia (PTA) lasting more than 24 hours, (c) Glasgow Coma Scale (GCS) score in the Emergency Department of less than 13, or (d) trauma related intracranial abnormalities or neuroimaging abnormalities; (3) admission to the TBI inpatient rehabilitation program at study sites; and (4) minimum age 16 years.
Study exclusion criteria. Participants who are unable or unwilling to participate in the TBIMS follow-up interview themselves or who do not complete the interview in English will be excluded.
Study participants are recruited when they are contacted for one of their routine TBIMS follow-up interviews at 1, 2, 5 years, and every 5 years post-injury thereafter.
Data for this study are collected using three possible methods chosen by the study participants: (1) a web-based questionnaire independently, (2) a telephone interview with study staff, or (3) a paper questionnaire via mail. Data collected as part of the TBIMS follow-up interview are also used for this study.
A summary of data collected is presented below. Please note, data from the James A. Haley VA are only reported for pain location, opiate/marijuana use, and sleep.
To date, 3805 participants have completed data collection for this study. Of those, 1,762 (46%) are classified as having Current Pain, defined as persistent or recurring pain lasting longer than 3 months. This includes headaches or pain anywhere in the body occurring more than half of the days over a three-month period. 525 (14%) participants report having Past Pain, defined as having chronic pain after their TBI which has stopped or is resolved. 1,518 (40%) report having No Pain, defined has not having chronic pain since their TBI. Please see Figure 1 for a visual summary of this information.
Total | Current Pain | No Pain | Past Pain Only | |
---|---|---|---|---|
Age At Data Collection | ||||
Mean (SD) | NA ± 16.30 | NA ± 15.13 | NA ± 17.62 | NA ± 15.91 |
IQR | 44 (34, 59) | 45 (35, 57) | 45 (33, 62) | 42 (33, 57) |
Gender | ||||
Male | 2,833 (74%) | 1,284 (73%) | 1,180 (78%) | 369 (70%) |
Female | 971 (26%) | 478 (27%) | 337 (22%) | 156 (30%) |
Unknown | 1 (0%) | 0 (0%) | 1 (0%) | 0 (0%) |
TBI Severity | ||||
Severe | 2,977 (78%) | 1,368 (78%) | 1,194 (79%) | 415 (79%) |
Moderate | 463 (12%) | 201 (11%) | 194 (13%) | 68 (13%) |
Mild | 354 (9%) | 186 (11%) | 126 (8%) | 42 (8%) |
TBI Cause | ||||
Vehicular | 2,035 (59%) | 939 (59%) | 801 (58%) | 295 (61%) |
Violence | 448 (13%) | 263 (16%) | 132 (10%) | 53 (11%) |
Sports | 111 (3%) | 40 (3%) | 55 (4%) | 16 (3%) |
Falls | 877 (25%) | 357 (22%) | 397 (29%) | 123 (25%) |
Other | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
Years Post Injury | ||||
1 | 684 (18%) | 298 (17%) | 298 (20%) | 88 (17%) |
2 | 472 (12%) | 229 (13%) | 181 (12%) | 62 (12%) |
5 | 808 (21%) | 383 (22%) | 311 (20%) | 114 (22%) |
10 | 704 (19%) | 341 (19%) | 251 (17%) | 112 (21%) |
15 | 599 (16%) | 275 (16%) | 243 (16%) | 81 (15%) |
20 | 394 (10%) | 171 (10%) | 171 (11%) | 52 (10%) |
25 | 78 (2%) | 34 (2%) | 37 (2%) | 7 (1%) |
30 | 66 (2%) | 31 (2%) | 26 (2%) | 9 (2%) |
SD = Standard Deviation
IQR = Interquartile Range
N | %* | |
---|---|---|
Back | 1136 | 64.5 |
Legs and/or feet | 1064 | 60.4 |
Shoulder | 838 | 47.6 |
Head, such as headache or migraine | 828 | 47.0 |
Neck | 787 | 44.7 |
Arms and/or hands | 703 | 39.9 |
Hips | 623 | 35.4 |
Face or jaw | 310 | 17.6 |
Pelvic area or groin | 276 | 15.7 |
Buttocks | 214 | 12.1 |
Widespread pain or fibromyalgia | 185 | 10.5 |
Chest | 179 | 10.2 |
Abdomen | 179 | 10.2 |
(Note: Data from the James A. Haley VA included)
* Individuals can report multiple location sites
Information regarding substance use (drugs and/or alcohol consumption) is used to determine “Problem Use”.
Problem Use is defined as heavy drinking (defined below), binge drinking (>=5 drinks on occasion), or any use of illicit drugs.
Amount of Drinking:
Abstaining = 0 drinks per week
Light = <3 drinks per week
Moderate (males) = 3 -14 drinks per week
Moderate (females) = 3 -7 drinks per week
Heavy (males) = >14 drinks per week
Heavy (females) = >7 drinks per week
Total | Current Pain | No Pain | Past Pain Only | |
---|---|---|---|---|
Problem Use | ||||
Yes | 1,047 (29%) | 504 (30%) | 407 (29%) | 136 (27%) |
No | 2,512 (70%) | 1,148 (69%) | 1,004 (71%) | 360 (73%) |
Amount of Drinking | ||||
Abstaining | 1,712 (45%) | 856 (49%) | 633 (42%) | 223 (43%) |
Light | 931 (25%) | 407 (23%) | 393 (26%) | 131 (25%) |
Moderate | 843 (22%) | 343 (20%) | 370 (25%) | 130 (25%) |
Heavy | 287 (8%) | 139 (8%) | 110 (7%) | 38 (7%) |
Total | Current Pain | No Pain | Past Pain Only | |
---|---|---|---|---|
In the past, did a healthcare provider prescribe you an opioid pain medication? | ||||
Yes | 2,002 (53%) | 1,131 (66%) | 567 (38%) | 304 (59%) |
Did you use the opioid pain medication that was prescribed? | ||||
Yes | 1,772 (89%) | 1,021 (90%) | 481 (85%) | 270 (89%) |
The last time you filled a prescription for opioid pain medication, did you use any of the pain medication more frequently or in higher doses than directed by a healthcare provider? | ||||
Yes | 155 (8%) | 113 (10%) | 18 (3%) | 24 (8%) |
In the past year, did you use prescription opioid pain medication that was NOT prescribed to you? | ||||
Yes | 90 (2%) | 67 (4%) | 13 (1%) | 10 (2%) |
How helpful have opioids been for your pain? | ||||
Very Helpful | 591 (33%) | 367 (35%) | 142 (30%) | 82 (30%) |
Helpful | 676 (38%) | 384 (37%) | 191 (40%) | 101 (37%) |
Neutral | 332 (19%) | 174 (17%) | 107 (22%) | 51 (19%) |
Unhelpful | 103 (6%) | 64 (6%) | 22 (5%) | 17 (6%) |
Very Unhelpful | 90 (5%) | 56 (5%) | 15 (3%) | 19 (7%) |
Total | Current Pain | No Pain | Past Pain Only | |
---|---|---|---|---|
Which of the following best captures the average frequency you currently use marijuana/cannabis? | ||||
Less than once a year | 44 (1%) | 21 (1%) | 17 (1%) | 6 (1%) |
Once a year | 44 (1%) | 21 (1%) | 17 (1%) | 6 (1%) |
Once every 3-6 months (2-4 times/year) | 36 (1%) | 18 (1%) | 13 (1%) | 5 (1%) |
Once every 2 months (6 times/year) | 79 (2%) | 29 (2%) | 38 (3%) | 12 (2%) |
Once a month (12 times/year) | 35 (1%) | 15 (1%) | 14 (1%) | 6 (1%) |
2-3 times a month | 52 (1%) | 23 (1%) | 22 (1%) | 7 (1%) |
Once a week | 107 (3%) | 68 (4%) | 24 (2%) | 15 (3%) |
Twice a week | 36 (1%) | 13 (1%) | 14 (1%) | 9 (2%) |
3-4 times a week | 58 (2%) | 27 (2%) | 20 (1%) | 11 (2%) |
5-6 times a week | 92 (2%) | 55 (3%) | 25 (2%) | 12 (2%) |
Once a day | 50 (1%) | 32 (2%) | 13 (1%) | 5 (1%) |
More than once a day | 157 (4%) | 86 (5%) | 53 (4%) | 18 (3%) |
I do not use marijuana/cannabis | 2,687 (72%) | 1,141 (66%) | 1,156 (77%) | 390 (75%) |
How helpful has marijuana/cannabis been for your pain? | ||||
Very Helpful | 436 (41%) | 292 (50%) | 81 (23%) | 63 (48%) |
Helpful | 260 (24%) | 170 (29%) | 64 (18%) | 26 (20%) |
Neutral | 70 (7%) | 54 (9%) | 8 (2%) | 8 (6%) |
Unhelpful | 10 (1%) | 8 (1%) | 2 (1%) | 0 (0%) |
Very Unhelpful | 17 (2%) | 13 (2%) | 0 (0%) | 4 (3%) |
Not used for pain | 275 (26%) | 48 (8%) | 198 (56%) | 29 (22%) |
Has your use of marijuana/cannabis reduced your need to use other medications for pain? | ||||
Yes, completely | 298 (28%) | 183 (31%) | 67 (19%) | 48 (37%) |
Yes, somewhat reduced | 323 (30%) | 232 (40%) | 51 (14%) | 40 (31%) |
No change | 143 (13%) | 105 (18%) | 28 (8%) | 10 (8%) |
Not used for pain | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
(Note: Data from the James A. Haley VA included)
Depressive symptoms are assessed using the Patient Health Questionnaire-9 (PHQ-9). Each item is scored on a four-point scale from 0 (“not at all”) to 3 (“nearly every day”). Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. Cut points of 5, 10, and 15 correspond to mild, moderate, and severe depressive symptoms. A score of 10 or above on the PHQ-9 suggests depressive symptoms severe enough to consider a diagnosis of Major Depressive Disorder.
Data are summarized in boxplots – a way to show a five-number summary in a chart. The main part of the chart (the “box”) shows the middle portion of the data: the interquartile range (IQR). At the ends of the box, you will find the first quartile (the 25% mark) and the third quartile (the 75% mark). The bottom of the chart (at the end of the bottom “whisker”) is the minimum (the smallest number in the set) and the upper is the maximum (the largest number in the set). Finally, the mean (average) is represented by a horizontal bar in the center of the box.
Since PHQ-9 scores can be deemed “clinically relevant” or meaningful for diagnosis of a Major Depressive Disorder, the percent for each group (those reporting Current Chronic Pain versus those reporting No Chronic Pain versus those reporting Past Chronic Pain) is listed.
36% of persons in the “Current Pain” group report clinically relevant depression symptoms, whereas 8% of people in the “No Pain” Group endorsed clinically relevant depressive symptoms. In general, the “Current Pain” group reports more severe depressive symptoms than the other two Pain groups.
Symptoms of anxiety are assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7). Each item on the GAD-7 is scored on a four-point scale from 0 (“not at all”) to 3 (“nearly every day”). Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. Cut points of 5, 10, and 15 correspond to mild, moderate, and severe anxiety. A score of 10 or above on the GAD-7 suggests anxiety symptoms severe enough to consider a clinical diagnosis.
Data are summarized in boxplots – a way to show a five-number summary in a chart. The main part of the chart (the “box”) shows the middle portion of the data: the interquartile range (IQR). At the ends of the box, you will find the first quartile (the 25% mark) and the third quartile (the 75% mark). The bottom of the chart (at the end of the bottom “whisker”) is the minimum (the smallest number in the set) and the upper is the maximum (the largest number in the set). Finally, the mean (average) is represented by a horizontal bar in the center of the box.
Since GAD-7 scores can be deemed “clinically relevant” or meaningful for a clinical diagnosis, the percent for each group (those reporting Current Chronic Pain versus those reporting No Chronic Pain versus those reporting Past Chronic Pain).
28% of persons in the “Current Pain” group report clinically relevant anxiety symptoms, whereas 7% of people in the “No Pain” Group endorsed clinically relevant anxiety symptoms. In general, the “Current Pain” group reports more severe anxiety symptoms than the other two Pain groups.
The Functional Independence Measure (FIM) is an 18-item, interviewer-reported scale that assesses function in six areas including self-care, continence, mobility, transfers, communication, and cognition. Each of the 18 items is graded on a seven-point scale of 1-7 based on level of independence in that item from 1 = (“total assistance required”) to, 7 = (“complete independence”). FIM scores range from 18 to 126, with higher scores indicating greater functional independence. The FIM has two subscales: (1) motor with 13 items and a score range of 13-91, and (2) cognitive with five items and a score range of 5-35.
Data are summarized in boxplots – a way to show a five-number summary in a chart. The main part of the chart (the “box”) shows the middle portion of the data: the interquartile range (IQR). At the ends of the box, you will find the first quartile (the 25% mark) and the third quartile (the 75% mark). The bottom of the chart (at the end of the bottom “whisker”) is the minimum (the smallest number in the set) and the upper is the maximum (the largest number in the set). Finally, the mean (average) is represented by a horizontal bar in the center of the box.
In general, the “Current Pain” group has lower functional independence, or is more functionally dependent on others than the other two Pain groups.
The Disability Rating Scale (DRS) is used to assess total disability. The first three items (“Eye Opening”, “Communication Ability” and “Motor Response”) are slight modifications of the Glasgow Coma Scale and reflect impairment ratings. Cognitive ability for “Feeding”, “Toileting,” and “Grooming” reflect level of disability. The “Level of Functioning” and “Employability” items reflect handicap. A score of zero on the DRS indicates the absence of disability. The maximum score on the DRS is 29 and represents an extreme vegetative state.
Data are summarized in boxplots – a way to show a five-number summary in a chart. The main part of the chart (the “box”) shows the middle portion of the data: the interquartile range (IQR). At the ends of the box, you will find the first quartile (the 25% mark) and the third quartile (the 75% mark). The bottom of the chart (at the end of the bottom “whisker”) is the minimum (the smallest number in the set) and the upper is the maximum (the largest number in the set). Finally, the mean (average) is represented by a horizontal bar in the center of the box.
In general, the “Current Pain” group has greater disability than the other two pain groups.
The Satisfaction with Life Scale (SWLS) is used to measure global assessment of satisfaction with one’s life. The SWLS uses a 7-point Likert-type scale. Total score ranges from 5-35, with a score of 20 representing a neutral point on the scale. Scores between 5 and 9 indicate the respondent is extremely dissatisfied with life, whereas scores between 31 and 35 indicate the respondent is extremely satisfied.
Data are summarized in boxplots – a way to show a five-number summary in a chart. The main part of the chart (the “box”) shows the middle portion of the data: the interquartile range (IQR). At the ends of the box, you will find the first quartile (the 25% mark) and the third quartile (the 75% mark). The bottom of the chart (at the end of the bottom “whisker”) is the minimum (the smallest number in the set) and the upper is the maximum (the largest number in the set). Finally, the mean (average) is represented by a horizontal bar in the center of the box.
In general, the “Current Pain” group is less satisfied with life than the other two Pain groups.
The Pittsburgh Sleep Quality Index (PSQI) is used to measure the quality and patterns of sleep. It differentiates “poor” from “good” sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. Higher scores indicate poorer sleep quality with scores over 8 indicative of clinically significant sleep issues.
Data are summarized in boxplots – a way to show a five-number summary in a chart. The main part of the chart (the “box”) shows the middle portion of the data: the interquartile range (IQR). At the ends of the box, you will find the first quartile (the 25% mark) and the third quartile (the 75% mark). The bottom of the chart (at the end of the bottom “whisker”) is the minimum (the smallest number in the set) and the upper is the maximum (the largest number in the set). Finally, the mean (average) is represented by a horizontal bar in the center of the box.
48% of persons in the “Current Pain” group reported clinically relevant poor sleep symptoms, whereas 14% of people in the “No Pain” group endorsed clinically relevant poor sleep symptoms. In general, the “Current Pain” group has greater poor sleep symptoms than the other two Pain groups.
(Note: Data from the James A. Haley VA included.)
The Posttraumatic Stress Disorder Check List (PCL) is a 20-item self-report measure used to assess symptoms of Posttraumatic Stress Disorder (PTSD). Scores range from 0 to 80 with higher scores indicating more symptoms. Initial research suggests that a cutoff score between 31-33 on the PCL is indicative of probable PTSD.
Data are summarized in boxplots – a way to show a five-number summary in a chart. The main part of the chart (the “box”) shows the middle portion of the data: the interquartile range (IQR). At the ends of the box, you will find the first quartile (the 25% mark) and the third quartile (the 75% mark). The bottom of the chart (at the end of the bottom “whisker”) is the minimum (the smallest number in the set) and the upper is the maximum (the largest number in the set). Finally, the mean (average) is represented by a horizontal bar in the center of the box.
27% of persons in the “Current Pain” group reported clinically relevant PTSD symptoms, whereas 6% of people in the “No Pain” group endorsed clinically relevant PTSD symptoms. In general, the “Current Pain” group has greater PTSD symptoms than the other two Pain groups.
The 17-item Participation Assessment with Recombined Tools-Objective (PART-O) is used to measure participation and functioning at the societal level. The PART-O measures three domains of post-rehabilitation community participation: Productivity, Out and About, and Social Relations. The PART-O also yields a summary score. Domain and summary scores range from 0 to 5 with higher scores reflecting greater participation.
Data are summarized in boxplots – a way to show a five-number summary in a chart. The main part of the chart (the “box”) shows the middle portion of the data: the interquartile range (IQR). At the ends of the box, you will find the first quartile (the 25% mark) and the third quartile (the 75% mark). The bottom of the chart (at the end of the bottom “whisker”) is the minimum (the smallest number in the set) and the upper is the maximum (the largest number in the set). Finally, the mean (average) is represented by a horizontal bar in the center of the box.
In general the “Current Pain” group has slightly less societal participation than the other two Pain groups.