Empower Opioid Misuse & Chronic Pain

Not Applicable

Completed

• Conditions: Chronic Pain; Opioid Use
• Interventions: Device: Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation

• Registration Number: NCT04184362
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2019-10-23
• Study Start: 2019-11-20
• Study First Submitted QC: 2019-12-02
• Study First Posted: 2019-12-03
• Primary Completion: 2022-03-21
• Study Completion: 2022-03-21
• Results First Submitted: 2023-03-21
• Status Verified: 2023-07
• Results First Submitted QC: 2023-07-13
• Last Update Submitted: 2023-07-13
• Results First Posted: 2023-08-03
• Last Update Posted: 2023-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group tested at the active treatment site	Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation	The theranova empower device will be tested at the active treatment site.
Control sham group tested at the sham control treatment site	Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation	The theranova empower device will be tested the sham control treatment site.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

San Francisco VA Medical Center; 🇺🇸 San Francisco, California, United States