Chronic PainRAP_EOMNCT04184362

Empower Opioid Misuse & Chronic Pain

A study testing Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation in people with Chronic Pain and Opioid Use, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Pain, Opioid Use
What is being tested?: Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 20 Nov 2019to 21 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

San Francisco VA Medical Center
San Francisco, California, 94121

Other trials in United States

About this study

Official title: Empower Opioid Misuse Theranova Study for Veterans With Chronic Pain

Read the 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.

Conditions: Chronic Pain, Opioid Use
Being tested: Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Empower Neuromodulation System Transcutaneous Electrical Nerve StimulationDevice
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.

Study groups in NCT04184362
Study group	Role	What they receive
Experimental group tested at the active treatment site	Experimental	The theranova empower device will be tested at the active treatment site. Receives: 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. Receives: Device: Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 3

Secondary outcomes (1)

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.
Measured: Treatment Time Frame: Week 1 to Week 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 201921 Mar 2022

First posted3 Dec 2019
Study start20 Nov 2019
Primary completion21 Mar 2022
Study completion21 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic PainStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04184362
Sponsor's protocol ID: 19-27491
Acronym: RAP_EOM
Status last verified: Jul 2023
First submitted: 23 Oct 2019
Last updated: 3 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Empower Opioid Misuse Theranova Study for Veterans With Chronic Pain
ClinicalTrials.gov ID: NCT04184362
Acronym / sponsor ID: RAP_EOM / 19-27491
Conditions: Chronic Pain, Opioid Use
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Study start: 20 Nov 2019 (actual)
Primary completion: 21 Mar 2022 (actual)
Study completion: 21 Mar 2022 (actual)
First posted: 3 Dec 2019 (actual)
Results: Posted 3 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Experimental group tested at the active treatment site	Experimental	Device: Empower Neuromodulation System Transcutaneous Electrical Nerve StimulationThe theranova empower device will be tested at the active treatment site.
Control sham group tested at the sham control treatment site	Sham comparator	Device: Empower Neuromodulation System Transcutaneous Electrical Nerve StimulationThe theranova empower device will be tested the sham control treatment site.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Empower Neuromodulation System Transcutaneous Electrical Nerve StimulationParticipants 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.	Device	Control sham group tested at the sham control treatment site, Experimental group tested at the active treatment site

Primary outcome

Pain Intensity Score Measures
Time frame: 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.
Opioid Craving Intensity With Empower Neuromodulation Active Treatment Versus Control Treatment
Time frame: 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.
Mean Morphine Equivalent Doses: Opioid Use With Empower Active Treatment Versus Control Treatment
Time frame: 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.

1 secondary outcome

General Health Monitored
Time frame: Treatment Time Frame: Week 1 to Week 3

Results and safety

Results posted to the registry on 3 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental Group Tested at the Active Treatment Site	5	5
Control Sham Group Tested at the Sham Control Treatment Site	5	5

Primary outcome: Pain Intensity Score Measures

Time frame: Baseline to Week 3. Mean (Standard Deviation). Unit: Score on a scale

Measure	Experimental Group Tested at the Active Treatment Site n = 5	Control Sham Group Tested at the Sham Control Treatment Site n = 5
Value	55 (25)	57 (22)

Primary outcome: Opioid Craving Intensity With Empower Neuromodulation Active Treatment Versus Control Treatment

Time frame: Baseline to Week 3. Mean (Standard Deviation). Unit: score on a scale

Measure	Experimental Group Tested at the Active Treatment Site n = 5	Control Sham Group Tested at the Sham Control Treatment Site n = 5
Value	29 (20)	33 (35)

Primary outcome: Mean Morphine Equivalent Doses: Opioid Use With Empower Active Treatment Versus Control Treatment

Time frame: Baseline to Week 3. Mean (Standard Deviation). Unit: Morphine Equivalents (mg)

Measure	Experimental Group Tested at the Active Treatment Site n = 5	Control Sham Group Tested at the Sham Control Treatment Site n = 5
Value	1882 (3040)	336 (387)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental Group Tested at the Active Treatment Site	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Control Sham Group Tested at the Sham Control Treatment Site	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Chronic Pain

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ellen Herbst, MD principal investigator

University of California, San Francisco

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity Score Measures (time frame: Baseline to Week 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04184362.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.