Chronic Pain, Posttraumatic Stress Disorder, Traumatic Brain Injury
Conditions
Keywords
Military Veterans
Brief summary
Traumatic brain injury (TBI) and chronic pain are common and serious health problems for military veterans and often co-occur, leading to poor post-deployment adjustment. Pharmacological treatments for pain elevate risk of opioid abuse, and research suggests veterans perceive barriers to existing non-pharmacological, clinic-based treatments. Thus, there is an urgent need to develop pain management approaches that are effective, overcome barriers to care, and are readily usable by Veterans. Evidence suggests that neuromodulatory treatments, grounded in understanding of neurophysiological mechanisms of pain, reduce pain-related symptoms and have the potential to be developed into self-directed treatments through use of mobile technology.
Detailed description
This study is a prospective, three-arm, randomized controlled trial of neuromodulatory treatments for chronic pain, for post-9/11 veterans with co-occuring pain and TBI. Three hundred participants will be scheduled for a baseline interview at the Duke Behavioral Health and Technology Lab after passing a preliminary telephone screen. After providing informed consent, participants will provide data on clinical measures. Electroencephalography (EEG) will be used to measure brain activity. Following data collection, participants will be assigned to one of three groups (n=100 in each). Each group will receive an iPod Touch with a different mobile application (app), which participants will be instructed to use for 10 minute a day, 4 times a week for 12 weeks. Study coordinators will conduct two home visits (week 1 and week 6) and two phone calls (week 3 and week 9) to reinforce training, troubleshoot difficulties, and ask about intervention utilization. Follow-up data on clinical measures and EEG will be collected at 12 weeks and again at 24 weeks.
Interventions
DEVICEMindfulness
Neuromodulatory intervention for pain management
DEVICENeurofeedback
Neuromodulatory intervention for pain management
DEVICERelaxation
Neuromodulatory intervention for pain management
Sponsors
United States Department of Defense
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Served in one of the military branches (Army, Navy, Marines, Air Force, or Coast Guard) since October 2001. 2. Diagnosis of Traumatic Brain Injury (TBI), defined as a traumatically induced structural injury or physiological disruption of brain function, as a result of an external force, that is indicated by new or onset or worsening of at least one of the following signs immediately following the event: * Any alteration in mental status (e.g. confusion, disorientation, slowed thinking, etc.) * Any loss of memory for events immediately before or after the injury. * Any period of loss or a decreased level of consciousness, observed or self-reported. 3. Reports chronic musculoskeletal and/or neuropathic pain, defined as moderate or severe pain (≥ 4 on a 0-10 rating scale) in one or more body regions for the previous 3 months or more. For individuals on pain medication, inclusion criteria are that (a) their pain medication regimen has been stable for the past 4 weeks, (b) they do not expect any major changes in their pain medication regimen for the duration of the study, and (c) they do not expect to have surgery or to be hospitalized for pain treatment for the duration of the study.
Exclusion criteria
1. History of epilepsy, seizure disorder, or any seizure or epileptic fit. 2. Unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-reported Pain Intensity | Baseline and 12 weeks | Measured by the Defense and Veterans Pain Rating Scale (DVPRS), a graphic tool to facilitate self-reported pain rating using a scale from 0-10, 0 being no pain to 10 being as bad as it could be, nothing else matters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in EEG Alpha Power | 0 and 12 weeks | Average FFT (Fast Fourier Transform) Power (alpha 8-12 Hz) measured as sqrt(uV)/Hz. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-reported Pain Intensity | Baseline and 24 weeks | Measured by the Defense and Veterans Pain Rating Scale (DVPRS), a graphic tool to facilitate self-reported pain rating using a scale from 0-10, 0 being no pain to 10 being as bad as it could be, nothing else matters. This mean difference represents the mean change in pain intensity between 0 and 24 weeks. Please note that the analysis of results utilized a multilevel modeling (MLM) approach of all available data, which involved analyzing pain intensity data collected at 0, 12, and 24 weeks. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mobile App Mindfulness Participants engage in the use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Mindfulness: Neuromodulatory intervention for pain management | 84 |
| Mobile App Neurofeedback Participants engage in use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Neurofeedback: Neuromodulatory intervention for pain management | 85 |
| Mobile App Relaxation Participants engage in use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Relaxation: Neuromodulatory intervention for pain management | 85 |
| Total | 254 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 20 | 15 |
| Overall Study | Withdrawal by Subject | 3 | 6 | 4 |
Baseline characteristics
| Characteristic | Mobile App Mindfulness | Total | Mobile App Relaxation | Mobile App Neurofeedback |
|---|---|---|---|---|
| Age, Continuous | 41.45 years STANDARD_DEVIATION 8.78 | 41.38 years STANDARD_DEVIATION 8.88 | 40.69 years STANDARD_DEVIATION 8.63 | 41.99 years STANDARD_DEVIATION 9.27 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 25 Participants | 7 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 70 Participants | 196 Participants | 61 Participants | 65 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 33 Participants | 17 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 10 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 40 Participants | 13 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 5 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 9 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) White | 63 Participants | 186 Participants | 58 Participants | 65 Participants |
| Region of Enrollment United States | 84 Participants | 254 Participants | 85 Participants | 85 Participants |
| Sex: Female, Male Female | 13 Participants | 50 Participants | 17 Participants | 20 Participants |
| Sex: Female, Male Male | 71 Participants | 204 Participants | 68 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 84 | 0 / 85 | 0 / 85 |
| other Total, other adverse events | 24 / 84 | 27 / 85 | 36 / 85 |
| serious Total, serious adverse events | 5 / 84 | 5 / 85 | 3 / 85 |
Outcome results
Primary
Change in Self-reported Pain Intensity
Measured by the Defense and Veterans Pain Rating Scale (DVPRS), a graphic tool to facilitate self-reported pain rating using a scale from 0-10, 0 being no pain to 10 being as bad as it could be, nothing else matters.
Time frame: Baseline and 12 weeks
Population: Participants who completed the DVPRS at 0 and 12 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile App Mindfulness | Change in Self-reported Pain Intensity | -1.02 score on a scale | Standard Deviation 1.32 |
| Mobile App Neurofeedback | Change in Self-reported Pain Intensity | -0.78 score on a scale | Standard Deviation 1.27 |
| Mobile App Relaxation | Change in Self-reported Pain Intensity | -1.03 score on a scale | Standard Deviation 1.36 |
p-value: 0.2852ANCOVA
p-value: 0.8861ANCOVA
Secondary
Change in EEG Alpha Power
Average FFT (Fast Fourier Transform) Power (alpha 8-12 Hz) measured as sqrt(uV)/Hz.
Time frame: 0 and 12 weeks
Population: EEG measurement was discontinued in March 2020 due to the COVID pandemic. Data not collected on 127 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile App Mindfulness | Change in EEG Alpha Power | -0.21 sqrt(uV)/Hz | Standard Deviation 0.4 |
| Mobile App Neurofeedback | Change in EEG Alpha Power | -0.1 sqrt(uV)/Hz | Standard Deviation 0.41 |
| Mobile App Relaxation | Change in EEG Alpha Power | -0.07 sqrt(uV)/Hz | Standard Deviation 0.35 |
p-value: 0.6842ANOVA
p-value: 0.132ANOVA
Other Pre-specified
Change in Self-reported Pain Intensity
Measured by the Defense and Veterans Pain Rating Scale (DVPRS), a graphic tool to facilitate self-reported pain rating using a scale from 0-10, 0 being no pain to 10 being as bad as it could be, nothing else matters. This mean difference represents the mean change in pain intensity between 0 and 24 weeks. Please note that the analysis of results utilized a multilevel modeling (MLM) approach of all available data, which involved analyzing pain intensity data collected at 0, 12, and 24 weeks.
Time frame: Baseline and 24 weeks
Population: Participants who completed the DVPRS at baseline, 12 weeks, and 24 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile App Mindfulness | Change in Self-reported Pain Intensity | -1.22 score on a scale | Standard Deviation 1.73 |
| Mobile App Neurofeedback | Change in Self-reported Pain Intensity | -0.98 score on a scale | Standard Deviation 1.36 |
| Mobile App Relaxation | Change in Self-reported Pain Intensity | -0.86 score on a scale | Standard Deviation 1.56 |
p-value: 0.4542ANCOVA
p-value: 0.1261ANCOVA