Empower Opioid Misuse & Chronic Pain

NCT04184362 | Completed Results FDA Device

• 1 other identifier: 19-27491
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Opioid Use

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• General Health Monitored

  Treatment Time Frame: Week 1 to Week 3

Study Arms (2)

Experimental group tested at the active treatment site

EXPERIMENTAL

The theranova empower device will be tested at the active treatment site.

Device: Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation

Control sham group tested at the sham control treatment site

SHAM COMPARATOR

The theranova empower device will be tested the sham control treatment site.

Device: Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation

Interventions

Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation DEVICE

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.

Control sham group tested at the sham control treatment site; Experimental group tested at the active treatment site

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

We enrolled our first 5 participants before March 2020. During March 2020, the UCSF and SFVAHCS Research Offices announced that all non-essential in-person clinical activities had to be suspended effective immediately due to the COVID-19 pandemic and shelter-in-place order in the San Francisco Bay Area. In 2021, we received IRB approval to conduct remote study visits. This older population with chronic pain also faced a lot of technical issues, dealing with virtual meetings and measures.

Results Point of Contact

• Title: Joannalyn Delacruz, Ph.D.
• Organization: SFVA

Joannalyn.Delacruz@va.gov

415-375-5748

Study Officials

• Ellen Herbst, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: December 3, 2019
• Study Start: November 20, 2019
• Primary Completion: March 21, 2022
• Study Completion: March 21, 2022
• Last Updated: August 3, 2023
• Results First Posted: August 3, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)