Trial Outcomes & Findings for Empower Opioid Misuse & Chronic Pain (NCT NCT04184362)
NCT ID: NCT04184362
Last Updated: 2023-08-03
Results Overview
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.
COMPLETED
NA
10 participants
Baseline to Week 3
2023-08-03
Participant Flow
245 potentials received outreach materials. 204 potentials connected with the study staff. 115 potentials consented for pre-screening.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Empower Opioid Misuse & Chronic Pain
Baseline characteristics by cohort
| Measure |
Experimental Group Tested at the Active Treatment Site
n=5 Participants
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.
|
Control Sham Group Tested at the Sham Control Treatment Site
n=5 Participants
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.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
64 years
STANDARD_DEVIATION 13 • n=7 Participants
|
67 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race: White
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race: Black or African American
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race: Unknown or Not Reported
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Unknown or Not Reported
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Not Hispanic or Latino
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 3Each 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.
Outcome measures
| Measure |
Experimental Group Tested at the Active Treatment Site
n=5 Participants
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.
|
Control Sham Group Tested at the Sham Control Treatment Site
n=5 Participants
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.
|
|---|---|---|
|
Pain Intensity Score Measures
|
55 Score on a scale
Standard Deviation 25
|
57 Score on a scale
Standard Deviation 22
|
PRIMARY outcome
Timeframe: Baseline to Week 3Each 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.
Outcome measures
| Measure |
Experimental Group Tested at the Active Treatment Site
n=5 Participants
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.
|
Control Sham Group Tested at the Sham Control Treatment Site
n=5 Participants
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.
|
|---|---|---|
|
Opioid Craving Intensity With Empower Neuromodulation Active Treatment Versus Control Treatment
|
29 score on a scale
Standard Deviation 20
|
33 score on a scale
Standard Deviation 35
|
PRIMARY outcome
Timeframe: Baseline to Week 3The 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.
Outcome measures
| Measure |
Experimental Group Tested at the Active Treatment Site
n=5 Participants
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.
|
Control Sham Group Tested at the Sham Control Treatment Site
n=5 Participants
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.
|
|---|---|---|
|
Mean Morphine Equivalent Doses: Opioid Use With Empower Active Treatment Versus Control Treatment
|
1882 Morphine Equivalents (mg)
Standard Deviation 3040
|
336 Morphine Equivalents (mg)
Standard Deviation 387
|
SECONDARY outcome
Timeframe: Treatment Time Frame: Week 1 to Week 3Population: Data for this outcome measure were not collected and therefore can not be reported here.
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.
Outcome measures
Outcome data not reported
Adverse Events
Experimental Group Tested at the Active Treatment Site
Control Sham Group Tested at the Sham Control Treatment Site
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place