Empower Opioid Misuse & Chronic Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Empower Opioid Misuse Theranova Study for Veterans With Chronic Pain

Conditions
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Chronic Pain, Opioid Use

Intervention / Treatment
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* Device: Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group tested at the active treatment site<br>The theranova empower device will be tested at the active treatment site. | Device: Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation<br>* 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.<br>|
| Sham Comparator: Control sham group tested at the sham control treatment site<br>The theranova empower device will be tested the sham control treatment site. | Device: Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to Week 3 | 
| 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. | Baseline to Week 3 | 
| 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. | Baseline to Week 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Treatment Time Frame: Week 1 to Week 3 |