N/A
Completed N=10
Empower Opioid Misuse & Chronic Pain
Source: ClinicalTrials.gov NCT04184362 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Pain Intensity Score Measures — 55; 57 Score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity Score Measures |
55; 57 | — |
| PRIMARY Opioid Craving Intensity With Empower Neuromodulation Active Treatment Versus Control Treatment |
29; 33 | — |
| PRIMARY Mean Morphine Equivalent Doses: Opioid Use With Empower Active Treatment Versus Control Treatment |
1882; 336 | — |
| SECONDARY General Health Monitored |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT04184362). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.