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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group tested at the active treatment site | Experimental | The theranova empower device will be tested at the active treatment site. |
|
| Control sham group tested at the sham control treatment site | Sham Comparator | The theranova empower device will be tested the sham control treatment site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Herbst, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco VA Medical Center | San Francisco | California | 94121 | United States |
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245 potentials received outreach materials. 204 potentials connected with the study staff. 115 potentials consented for pre-screening.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Group Tested at the Active Treatment Site | The theranova empower device will be tested at the active treatment site. Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation: 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. |
| FG001 | Control Sham Group Tested at the Sham Control Treatment Site | The theranova empower device will be tested the sham control treatment site. Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Group Tested at the Active Treatment Site | The theranova empower device will be tested at the active treatment site. Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to Week 3 |
|
3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Group Tested at the Active Treatment Site | The theranova empower device will be tested at the active treatment site. Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation: 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joannalyn Delacruz, Ph.D. | SFVA | 415-375-5748 | Joannalyn.Delacruz@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2023 | May 1, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Treatment Time Frame: Week 1 to Week 3 |
| BG001 | Control Sham Group Tested at the Sham Control Treatment Site | The theranova empower device will be tested the sham control treatment site. Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control Sham Group Tested at the Sham Control Treatment Site | The theranova empower device will be tested the sham control treatment site. Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation: 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 3 |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Morphine Equivalents (mg) | Baseline to Week 3 |
|
|
|
| Secondary | 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. | Data for this outcome measure were not collected and therefore can not be reported here. | Posted | Treatment Time Frame: Week 1 to Week 3 |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Control Sham Group Tested at the Sham Control Treatment Site | The theranova empower device will be tested the sham control treatment site. Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation: 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. | 0 | 5 | 0 | 5 | 0 | 5 |
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