Chronic Pain, Opioid Use
Conditions
Brief summary
This study evaluates the effects of peripheral nerve stimulation on opioid craving and use and pain in participants with chronic non-cancer pain (NCP) and opioid misuse. Participants will be randomized to receive the active or sham control treatment for the duration of the study.
Detailed description
This pilot study aims to examine the feasibility, acceptability, and preliminarily examine efficacy of peripheral nerve stimulation with the Empower Neuromodulation System on reducing opioid craving and use and decreasing pain. Opioid prescribing for chronic pain has increased dramatically over the past several decades, with devastating public health consequences, including high rates of opioid misuse and overdose deaths. Safe nonpharmacological treatments are urgently needed. In this randomized, controlled study, thirty Veterans with chronic non-cancer pain (NCP) and opioid misuse will be recruited and randomly assigned (1:1) to either the Active or Control treatment. On Days 1-7, participants will undergo baseline monitoring, and on Days 8-21, participants will undergo daily nerve stimulation treatment. Pain scores, craving, and opioid use will be measured daily Days 0-21. Our goal is to provide an intervention that, alone or in conjunction with current treatments, reduces craving and reduces reliance on opioids in high-risk chronic pain patients.
Interventions
DEVICEEmpower Neuromodulation System Transcutaneous Electrical Nerve Stimulation
Participants will self-administer treatment with the Empower device two times daily for two weeks. Participants will complete surveys over the two-week period to evaluate the effects of the Empower treatment.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* VA-eligible Veterans * Ages 18-75 * Currently prescribed and taking chronic opioids (≥90 days dispensed in past 12 months) for non-malignant, non-palliative pain * Current (past 12 months) opioid misuse, defined as opioid use not as prescribed. Participants with COMM ≥ 9, SOAPP-R ≥ 18, and/or medical and pharmacy records reflective of opioid misuse in the past 12 months.
Exclusion criteria
* Injury or damage to the ulnar nerve, and/or neuropathy in the upper extremities * Pregnant or planning to become pregnant * Currently implanted with an electrical and/or neurostimulator device, including cardiac pacemaker or defibrillator, vagal neuro-stimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant * Use of an investigational drug/device therapy within the past 4 weeks * Current medical or psychiatric instability as determined by the participant's primary care provider and/or study PI * Severe opioid use disorder (OUD) requiring medication-assisted therapy (buprenorphine, methadone, or naltrexone IM) for OUD * Injury or nerve damage at the arm or palm that prevents safe use of Empower device at either site * Unable to provide informed written consent * Prone to epilepsy or seizures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Score Measures | Baseline to Week 3 | Each participant will be given the Empower app and trained on app use. They will record pain levels daily on the Empower app, with a 0-100 scale. 0 indicating a lack of pain outcome, and 100 indicating maximum pain score. Pain score measures will be taken throughout the study. The Empower App will prompt all participants daily to complete the Numeric Rating Scale to assess pain levels immediately before and after treatment. Participants complete daily measures of Visual Analog Scale for scores on Numeric Rating Pain Scale, to assess pain intensity before and after treatment or sham condition. The data reported is the mean average of all scores taken daily from baseline to week 3, and reflects scores from both before and after treatment. |
| Opioid Craving Intensity With Empower Neuromodulation Active Treatment Versus Control Treatment | Baseline to Week 3 | Each participant will be given the Empower app and trained on app use. They will record craving levels daily on the Empower app, with a 0-100 scale. 0 indicating an outcome with a lack of craving, and 100 indicating an outcome with maximum craving intensity. The Empower App will prompt all participants daily to complete the following measure of Visual Analog Scale, to assess craving intensity before and after treatment. Participants complete daily measures of Visual Analog Scale, to assess craving immediately before and after treatment or sham condition. The data reported is the mean average of all scores taken daily from baseline to week 3, and reflects scores from both before and after treatment. |
| Mean Morphine Equivalent Doses: Opioid Use With Empower Active Treatment Versus Control Treatment | Baseline to Week 3 | The Empower App will prompt all participants daily to complete the measure of prescribed and nonprescribed self-reported opioid use for the previous day, and morphine equivalents will be recorded weekly through timeline follow back reviews with staff. Population being treated at active and sham sites report opioid use, in Morphine Equivalent (mg) doses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| General Health Monitored | Treatment Time Frame: Week 1 to Week 3 | General health measures will be monitored through surveys administered through Qualtrics (except for Week 0 screening visit surveys). The surveys will be emailed to participants to measure multidimensional assessment of interoceptive awareness (MAIA-2) 0-5 scale, physical activity (PAS-2) records average activity time per week, brief anxiety inventory (BAI) 0-3 scale, insomnia severity index (ISI) with a 0-4 scale, and distress intolerance index (DII) with a 0-4 scale. Increased MAIA-2 & PAS2, or decreased BAI, ISI, and DII show improvement. |
Countries
United States
Participant flow
Recruitment details
245 potentials received outreach materials. 204 potentials connected with the study staff. 115 potentials consented for pre-screening.
Participants by arm
| Arm | Count |
|---|---|
| Experimental Group Tested at the Active Treatment Site The theranova empower device will be tested at the active treatment site.
Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation: Participants will self-administer treatment with the Empower device two times daily for two weeks. Participants will complete surveys over the two-week period to evaluate the effects of the Empower treatment. | 5 |
| Control Sham Group Tested at the Sham Control Treatment Site The theranova empower device will be tested the sham control treatment site.
Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation: Participants will self-administer treatment with the Empower device two times daily for two weeks. Participants will complete surveys over the two-week period to evaluate the effects of the Empower treatment. | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Experimental Group Tested at the Active Treatment Site | Total | Control Sham Group Tested at the Sham Control Treatment Site |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 8 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Continuous | 70 years STANDARD_DEVIATION 4.6 | 67 years STANDARD_DEVIATION 9.6 | 64 years STANDARD_DEVIATION 13 |
| Race/Ethnicity, Customized Ethnicity: Not Hispanic or Latino | 4 participants | 9 participants | 5 participants |
| Race/Ethnicity, Customized Ethnicity: Unknown or Not Reported | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Race: Black or African American | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Race: Unknown or Not Reported | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Race: White | 3 participants | 8 participants | 5 participants |
| Region of Enrollment United States | 5 participants | 10 participants | 5 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 4 Participants | 9 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
Mean Morphine Equivalent Doses: Opioid Use With Empower Active Treatment Versus Control Treatment
The Empower App will prompt all participants daily to complete the measure of prescribed and nonprescribed self-reported opioid use for the previous day, and morphine equivalents will be recorded weekly through timeline follow back reviews with staff. Population being treated at active and sham sites report opioid use, in Morphine Equivalent (mg) doses.
Time frame: Baseline to Week 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group Tested at the Active Treatment Site | Mean Morphine Equivalent Doses: Opioid Use With Empower Active Treatment Versus Control Treatment | 1882 Morphine Equivalents (mg) | Standard Deviation 3040 |
| Control Sham Group Tested at the Sham Control Treatment Site | Mean Morphine Equivalent Doses: Opioid Use With Empower Active Treatment Versus Control Treatment | 336 Morphine Equivalents (mg) | Standard Deviation 387 |
Primary
Opioid Craving Intensity With Empower Neuromodulation Active Treatment Versus Control Treatment
Each participant will be given the Empower app and trained on app use. They will record craving levels daily on the Empower app, with a 0-100 scale. 0 indicating an outcome with a lack of craving, and 100 indicating an outcome with maximum craving intensity. The Empower App will prompt all participants daily to complete the following measure of Visual Analog Scale, to assess craving intensity before and after treatment. Participants complete daily measures of Visual Analog Scale, to assess craving immediately before and after treatment or sham condition. The data reported is the mean average of all scores taken daily from baseline to week 3, and reflects scores from both before and after treatment.
Time frame: Baseline to Week 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group Tested at the Active Treatment Site | Opioid Craving Intensity With Empower Neuromodulation Active Treatment Versus Control Treatment | 29 score on a scale | Standard Deviation 20 |
| Control Sham Group Tested at the Sham Control Treatment Site | Opioid Craving Intensity With Empower Neuromodulation Active Treatment Versus Control Treatment | 33 score on a scale | Standard Deviation 35 |
Primary
Pain Intensity Score Measures
Each participant will be given the Empower app and trained on app use. They will record pain levels daily on the Empower app, with a 0-100 scale. 0 indicating a lack of pain outcome, and 100 indicating maximum pain score. Pain score measures will be taken throughout the study. The Empower App will prompt all participants daily to complete the Numeric Rating Scale to assess pain levels immediately before and after treatment. Participants complete daily measures of Visual Analog Scale for scores on Numeric Rating Pain Scale, to assess pain intensity before and after treatment or sham condition. The data reported is the mean average of all scores taken daily from baseline to week 3, and reflects scores from both before and after treatment.
Time frame: Baseline to Week 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group Tested at the Active Treatment Site | Pain Intensity Score Measures | 55 Score on a scale | Standard Deviation 25 |
| Control Sham Group Tested at the Sham Control Treatment Site | Pain Intensity Score Measures | 57 Score on a scale | Standard Deviation 22 |
Secondary
General Health Monitored
General health measures will be monitored through surveys administered through Qualtrics (except for Week 0 screening visit surveys). The surveys will be emailed to participants to measure multidimensional assessment of interoceptive awareness (MAIA-2) 0-5 scale, physical activity (PAS-2) records average activity time per week, brief anxiety inventory (BAI) 0-3 scale, insomnia severity index (ISI) with a 0-4 scale, and distress intolerance index (DII) with a 0-4 scale. Increased MAIA-2 & PAS2, or decreased BAI, ISI, and DII show improvement.
Time frame: Treatment Time Frame: Week 1 to Week 3
Population: Data for this outcome measure were not collected and therefore can not be reported here.