Characterization and Treatment of Chronic Pain after Moderate to Severe Traumatic Brain Injury

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
* Rusk Rehabilitation
* Baylor Scott and White Institute for Rehabilitation
* Virginia Commonwealth University

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

Background

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.

Participant Selection Criteria

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 nine 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; Rusk Rehabilitation, New York, NY; Baylor Scott and White Institute for Rehabilitation, Dallas, TX; Virginia Commonwealth University, Richmond, VA; 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.

Recruitment of Study Participants

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 Collection

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.

Data Summary

A summary of data collected to date is presented below. Please note, data from the James A. Haley VA are only reported for pain location, opiate/marijuana use, and sleep.


Demographics

To date, 877 participants have completed data collection for this study. Of those, 391 (45%) 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. 126 (14%) participants report having Past Pain, defined as having chronic pain after their TBI which has stopped or is resolved. 360 (41%) report having No Pain, defined has not having chronic pain since their TBI. Please see Figure 1 for a visual summary of this information.

Figure 1: Chronic Pain Status

Table 1: Characteristics of Study Participants

Total Current Pain No Pain Past Pain Only
Age At Data Collection            
   Mean (SD) 45.98 ± 16.80 46.03 ± 16.01 45.94 ± 17.79 45.94 ± 16.05
   IQR 44 (32, 59) 45 (33, 58) 44 (30, 59) 45 (33, 57)
Race            
   White 582 (74%) 234 (72%) 262 (76%) 86 (72%)
   Black 115 (15%) 51 (16%) 47 (14%) 17 (14%)
   Asian/Pacific Islander 18 (2%) 6 (2%) 11 (3%) 1 (1%)
   Native American 5 (1%) 3 (1%) 0 (0%) 2 (2%)
   Hispanic 53 (7%) 22 (7%) 20 (6%) 11 (9%)
   Other 15 (2%) 8 (2%) 5 (1%) 2 (2%)
   Unknown 0 (0%) 0 (0%) 0 (0%) 0 (0%)
Gender            
   Male 572 (72%) 221 (68%) 267 (77%) 84 (71%)
   Female 217 (28%) 103 (32%) 79 (23%) 35 (29%)
   Unknown 0 (0%) 0 (0%) 0 (0%) 0 (0%)
TBI Severity            
   Severe 613 (78%) 253 (78%) 271 (78%) 89 (75%)
   Moderate 110 (14%) 47 (15%) 46 (13%) 17 (14%)
   Mild 65 (8%) 23 (7%) 29 (8%) 13 (11%)
TBI Cause            
   Vehicular 425 (60%) 195 (66%) 176 (57%) 54 (51%)
   Violence 72 (10%) 25 (8%) 32 (10%) 15 (14%)
   Sports 25 (4%) 7 (2%) 15 (5%) 3 (3%)
   Falls 190 (27%) 69 (23%) 87 (28%) 34 (32%)
   Other 0 (0%) 0 (0%) 0 (0%) 0 (0%)
Years Post Injury            
   1 193 (22%) 79 (20%) 88 (24%) 26 (21%)
   2 214 (24%) 96 (25%) 80 (22%) 38 (30%)
   5 160 (18%) 61 (16%) 78 (22%) 21 (17%)
   10 108 (12%) 61 (16%) 33 (9%) 14 (11%)
   15 98 (11%) 54 (14%) 28 (8%) 16 (13%)
   20 72 (8%) 27 (7%) 36 (10%) 9 (7%)
   25 16 (2%) 4 (1%) 11 (3%) 1 (1%)
   30 16 (2%) 9 (2%) 6 (2%) 1 (1%)

SD = Standard Deviation
IQR = Interquartile Range


Current Pain Location

Table 2: Pain Location(s) for Those Participants with Current Pain

N %*
Back 255 64.2
Legs and/or feet 230 57.9
Head, such as headache or migraine 198 49.9
Shoulder 195 49.1
Neck 184 46.3
Arms and/or hands 162 40.8
Hips 137 34.5
Face or jaw 78 19.6
Pelvic area or groin 75 18.9
Buttocks 52 13.1
Chest 46 11.6
Abdomen 40 10.1
Widespread pain or fibromyalgia 39 9.8

(Note: Data from the James A. Haley VA included)
* Individuals can report multiple location sites


Substance Use

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

Table 3: Substance Use

Total Current Pain No Pain Past Pain Only
Problem Use            
   Yes 272 (34%) 132 (40%) 102 (29%) 38 (31%)
   No 525 (66%) 197 (60%) 245 (70%) 83 (69%)
Amount of Drinking            
   Abstaining 362 (45%) 157 (48%) 155 (45%) 50 (41%)
   Light 204 (26%) 90 (27%) 81 (23%) 33 (27%)
   Moderate 179 (22%) 53 (16%) 93 (27%) 33 (27%)
   Heavy 52 (7%) 28 (9%) 19 (5%) 5 (4%)

Opiates/Marijuana Use

Table 4: Opiate Use

Total Current Pain No Pain Past Pain Only
In the past, did a healthcare provider prescribe you an opioid pain medication?            
   Yes 490 (56%) 273 (70%) 139 (39%) 78 (62%)
Did you use the opioid pain medication that was prescribed?            
   Yes 435 (89%) 247 (91%) 121 (86%) 67 (86%)
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 40 (8%) 29 (11%) 5 (4%) 6 (8%)
In the past year, did you use prescription opioid pain medication that was NOT prescribed to you?            
   Yes 19 (2%) 11 (3%) 7 (2%) 1 (1%)
How helpful have opioids been for your pain?            
   Very Helpful 159 (36%) 99 (38%) 35 (30%) 25 (38%)
   Helpful 154 (35%) 88 (34%) 42 (37%) 24 (37%)
   Neutral 79 (18%) 39 (15%) 31 (27%) 9 (14%)
   Unhelpful 21 (5%) 13 (5%) 5 (4%) 3 (5%)
   Very Unhelpful 28 (6%) 22 (8%) 2 (2%) 4 (6%)

Table 5: Marijuana/Cannabis Use

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 16 (2%) 8 (2%) 6 (2%) 2 (2%)
   Once a year 16 (2%) 8 (2%) 6 (2%) 2 (2%)
   Once every 3-6 months (2-4 times/year) 10 (1%) 5 (1%) 3 (1%) 2 (2%)
   Once every 2 months (6 times/year) 18 (2%) 7 (2%) 8 (2%) 3 (2%)
   Once a month (12 times/year) 13 (1%) 4 (1%) 7 (2%) 2 (2%)
   2-3 times a month 20 (2%) 10 (3%) 7 (2%) 3 (2%)
   Once a week 26 (3%) 17 (4%) 5 (1%) 4 (3%)
   Twice a week 6 (1%) 2 (1%) 1 (0%) 3 (2%)
   3-4 times a week 12 (1%) 8 (2%) 3 (1%) 1 (1%)
   5-6 times a week 16 (2%) 11 (3%) 3 (1%) 2 (2%)
   Once a day 13 (1%) 10 (3%) 2 (1%) 1 (1%)
   More than once a day 40 (5%) 22 (6%) 13 (4%) 5 (4%)
   I do not use marijuana/cannabis 627 (72%) 251 (65%) 280 (78%) 96 (76%)
How helpful has marijuana/cannabis been for your pain?            
   Very Helpful 98 (39%) 63 (46%) 21 (26%) 14 (47%)
   Helpful 65 (26%) 49 (36%) 11 (14%) 5 (17%)
   Neutral 15 (6%) 9 (7%) 5 (6%) 1 (3%)
   Unhelpful 1 (0%) 1 (1%) 0 (0%) 0 (0%)
   Very Unhelpful 6 (2%) 5 (4%) 0 (0%) 1 (3%)
   Not used for pain 64 (26%) 11 (8%) 44 (54%) 9 (30%)
Has your use of marijuana/cannabis reduced your need to use other medications for pain?            
   Yes, completely 66 (27%) 44 (32%) 12 (15%) 10 (33%)
   Yes, somewhat reduced 71 (29%) 48 (35%) 13 (16%) 10 (33%)
   No change 39 (16%) 30 (22%) 8 (10%) 1 (3%)
   Not used for pain 0 (0%) 0 (0%) 0 (0%) 0 (0%)

(Note: Data from the James A. Haley VA included)


Depressive Symptoms

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.

30% of persons in the “Current Pain” group report clinically relevant depression symptoms, whereas 6% 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.

Figure 2: Current Depressive Symptoms


Anxiety

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).

23% of persons in the “Current Pain” group report clinically relevant anxiety symptoms, whereas 5% 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.

Figure 3: Current Anxiety Symptoms


Functional Independence

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.

Figure 4: Functional Independence


Disability

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.

Figure 5: Disability


Life Satisfaction

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.

Figure 6: Life Satisfaction


Sleep Quality

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.

47% 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.

Figure 7: Sleep Quality

(Note: Data from the James A. Haley VA included.)


Posttraumatic Stress

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.

30% of persons in the “Current Pain” group reported clinically relevant PTSD symptoms, whereas 5% 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.

Figure 8: Posttraumatic Stress