Empower Opioid Misuse & Chronic Pain (RAP_EOM)
Primary Purpose
Chronic Pain, Opioid Use
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
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
Sites / Locations
- San Francisco VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Experimental group tested at the active treatment site
Control sham group tested at the sham control treatment site
Arm Description
The theranova empower device will be tested at the active treatment site.
The theranova empower device will be tested the sham control treatment site.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04184362
First Posted
October 23, 2019
Last Updated
July 13, 2023
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT04184362
Brief Title
Empower Opioid Misuse & Chronic Pain
Acronym
RAP_EOM
Official Title
Empower Opioid Misuse Theranova Study for Veterans With Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
March 21, 2022 (Actual)
Study Completion Date
March 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Opioid Use
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group tested at the active treatment site
Arm Type
Experimental
Arm Description
The theranova empower device will be tested at the active treatment site.
Arm Title
Control sham group tested at the sham control treatment site
Arm Type
Sham Comparator
Arm Description
The theranova empower device will be tested the sham control treatment site.
Intervention Type
Device
Intervention Name(s)
Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Intensity Score Measures
Description
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
Title
Opioid Craving Intensity With Empower Neuromodulation Active Treatment Versus Control Treatment
Description
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
Title
Mean Morphine Equivalent Doses: Opioid Use With Empower Active Treatment Versus Control Treatment
Description
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
Secondary Outcome Measure Information:
Title
General Health Monitored
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Herbst, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco VA Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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