Trial Outcomes & Findings for Role of Home-based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis (NCT NCT06015945)
NCT ID: NCT06015945
Last Updated: 2026-02-04
Results Overview
This outcome measured feasibility and willingness of individuals to participate, as opposed to any effects of the intervention. Therefore, the "participants" analyzed below include all of the individuals determined to be eligible as shown in Outcome Measure 1.
COMPLETED
NA
12 participants
Approximately 1 year (during the recruitment period)
2026-02-04
Participant Flow
Two consented, potentially eligible individuals did not complete the run-in period and, therefore, were determined to not be eligible to become participants.
Participant milestones
| Measure |
Transcutaneous Electrical Acustimulation (TEA)
Transcutaneous Electrical Acustimulation (TEA): The severity and frequency participants pain will be measured during a run-in period of 2 weeks to assess baseline pain severity and frequency. Eligible participants will have a 4-week treatment period at home. Stimulation with the TEA device will be performed for 30 minutes twice per day, in the morning and in the evening.
In addition to using the device, participants will have study visits, complete surveys, as well as provide medical information during the study.
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|---|---|
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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9
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Transcutaneous Electrical Acustimulation (TEA)
Transcutaneous Electrical Acustimulation (TEA): The severity and frequency participants pain will be measured during a run-in period of 2 weeks to assess baseline pain severity and frequency. Eligible participants will have a 4-week treatment period at home. Stimulation with the TEA device will be performed for 30 minutes twice per day, in the morning and in the evening.
In addition to using the device, participants will have study visits, complete surveys, as well as provide medical information during the study.
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|---|---|
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
Role of Home-based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis
Baseline characteristics by cohort
| Measure |
Transcutaneous Electrical Acustimulation (TEA)
n=10 Participants
Transcutaneous Electrical Acustimulation (TEA): The severity and frequency participants pain will be measured during a run-in period of 2 weeks to assess baseline pain severity and frequency. Eligible participants will have a 4-week treatment period at home. Stimulation with the TEA device will be performed for 30 minutes twice per day, in the morning and in the evening.
In addition to using the device, participants will have study visits, complete surveys, as well as provide medical information during the study.
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Age, Continuous
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51.6 years
STANDARD_DEVIATION 11.8 • n=41 Participants
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Sex: Female, Male
Female
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5 Participants
n=41 Participants
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Sex: Female, Male
Male
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5 Participants
n=41 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=41 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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0 Participants
n=41 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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10 Participants
n=41 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=41 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=41 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=41 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=41 Participants
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Race (NIH/OMB)
White
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10 Participants
n=41 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=41 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=41 Participants
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Region of Enrollment
United States
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10 Participants
n=41 Participants
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PRIMARY outcome
Timeframe: Approximately 1 year (during the recruitment period)Population: NOTE: 178 individuals were approached to determine whether they were eligible to participate in this trial.
This feasibility outcome measured eligibility of individuals to participate, as opposed to any effects of the intervention. Results reflect the total number of individuals who were approached as the number analyzed, and of that population, the number who were eligible to be consented and proceed to the run-in period.
Outcome measures
| Measure |
Transcutaneous Electrical Acustimulation (TEA)
n=178 Participants
Transcutaneous Electrical Acustimulation (TEA): The severity and frequency participants pain will be measured during a run-in period of 2 weeks to assess baseline pain severity and frequency. Eligible participants will have a 4-week treatment period at home. Stimulation with the TEA device will be performed for 30 minutes twice per day, in the morning and in the evening.
In addition to using the device, participants will have study visits, complete surveys, as well as provide medical information during the study.
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|---|---|
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Proportion of Approached Individuals Who Met Eligibility Criteria
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12 Participants
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PRIMARY outcome
Timeframe: Approximately 1 year (during the recruitment period)Population: All "participants" included in this outcome measure provided informed consent regardless of whether they completed the run-in period, which would allow them to proceed to become participants in the actual trial.
This outcome measured feasibility and willingness of individuals to participate, as opposed to any effects of the intervention. Therefore, the "participants" analyzed below include all of the individuals determined to be eligible as shown in Outcome Measure 1.
Outcome measures
| Measure |
Transcutaneous Electrical Acustimulation (TEA)
n=12 Participants
Transcutaneous Electrical Acustimulation (TEA): The severity and frequency participants pain will be measured during a run-in period of 2 weeks to assess baseline pain severity and frequency. Eligible participants will have a 4-week treatment period at home. Stimulation with the TEA device will be performed for 30 minutes twice per day, in the morning and in the evening.
In addition to using the device, participants will have study visits, complete surveys, as well as provide medical information during the study.
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Proportion of Approached and Eligible Participants Who Provided Informed Consent
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12 Participants
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PRIMARY outcome
Timeframe: Approximately 2 weeksPopulation: "Participants" analyzed in this outcome measure provided informed consent, even though some of them were subsequently determined to be ineligible at the end of the run-in period to participate in the actual trial.
This outcome measured feasibility and continued eligibility of individuals to allow them to begin to participate in the actual trial, as opposed to any effects of the intervention. Therefore, the "participants" analyzed below include all of the individuals who were determined to be eligible and who were consented, as shown in Outcome Measure 2. These "participants" began a 2-week run-in period to confirm baseline pain and trial eligibility. Results reflect participants who were determined to still be eligible after the run-in period.
Outcome measures
| Measure |
Transcutaneous Electrical Acustimulation (TEA)
n=12 Participants
Transcutaneous Electrical Acustimulation (TEA): The severity and frequency participants pain will be measured during a run-in period of 2 weeks to assess baseline pain severity and frequency. Eligible participants will have a 4-week treatment period at home. Stimulation with the TEA device will be performed for 30 minutes twice per day, in the morning and in the evening.
In addition to using the device, participants will have study visits, complete surveys, as well as provide medical information during the study.
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Proportion of Participants Who Met the Eligibility Criteria After the run-in Period for the Participants Who Provided Informed Consent.
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10 Participants
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PRIMARY outcome
Timeframe: Baseline visit (V1)Results reflect the participants who completed the run-in period and received the first TEA treatment.
Outcome measures
| Measure |
Transcutaneous Electrical Acustimulation (TEA)
n=10 Participants
Transcutaneous Electrical Acustimulation (TEA): The severity and frequency participants pain will be measured during a run-in period of 2 weeks to assess baseline pain severity and frequency. Eligible participants will have a 4-week treatment period at home. Stimulation with the TEA device will be performed for 30 minutes twice per day, in the morning and in the evening.
In addition to using the device, participants will have study visits, complete surveys, as well as provide medical information during the study.
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Proportion of Participants Who Started the Intervention Among Those Who Met run-in Period Criteria.
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9 Participants
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PRIMARY outcome
Timeframe: Weeks 1-4 (after the 4-week treatment period)Population: Adherence to the duration of TEA use, times of daily use, and stimulation intensity, were supposed to be automatically recorded by the device. However, these data did not download properly in any of the devices and, as a result, all the data was unusable, so no data was collected. There are no plans to collect this data in the future.
Adherence will be directly monitored through use of the TEA device. The TEA automatically records duration of use, time of the day, and stimulation intensity.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week 8Population: 1 participant withdrew prior to starting treatment.
Results reflect participants who started the TEA and who returned the follow-up questionnaires at week 4 and week 8 (end of the study).
Outcome measures
| Measure |
Transcutaneous Electrical Acustimulation (TEA)
n=9 Participants
Transcutaneous Electrical Acustimulation (TEA): The severity and frequency participants pain will be measured during a run-in period of 2 weeks to assess baseline pain severity and frequency. Eligible participants will have a 4-week treatment period at home. Stimulation with the TEA device will be performed for 30 minutes twice per day, in the morning and in the evening.
In addition to using the device, participants will have study visits, complete surveys, as well as provide medical information during the study.
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|---|---|
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Proportion of Participants Who Completed Follow up Visit at 4 Weeks and Return Complete Follow-up Questionnaires at Week 8, Among Participants Who Started the Intervention
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7 Participants
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PRIMARY outcome
Timeframe: Baseline visit (V1)Population: 1 participant withdrew prior to starting treatment.
Results reflect the time taken to complete visit 1 in minutes. Data was collected using time-stamp data from the Redcap system.
Outcome measures
| Measure |
Transcutaneous Electrical Acustimulation (TEA)
n=9 Participants
Transcutaneous Electrical Acustimulation (TEA): The severity and frequency participants pain will be measured during a run-in period of 2 weeks to assess baseline pain severity and frequency. Eligible participants will have a 4-week treatment period at home. Stimulation with the TEA device will be performed for 30 minutes twice per day, in the morning and in the evening.
In addition to using the device, participants will have study visits, complete surveys, as well as provide medical information during the study.
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|---|---|
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Median Interquartile Range (IQR) of the Time That it Takes to Complete Visit Number One
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22 minutes
Interval 13.0 to 56.5
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PRIMARY outcome
Timeframe: 4 weeks (after treatment period)Population: 1 participant withdrew prior to receiving treatment. 2 participants did not provide data at the second visit, as they did not complete the questionnaires.
Results reflect the time taken to complete visit 2 in minutes. Data was collected using time-stamp data from the Redcap system.
Outcome measures
| Measure |
Transcutaneous Electrical Acustimulation (TEA)
n=7 Participants
Transcutaneous Electrical Acustimulation (TEA): The severity and frequency participants pain will be measured during a run-in period of 2 weeks to assess baseline pain severity and frequency. Eligible participants will have a 4-week treatment period at home. Stimulation with the TEA device will be performed for 30 minutes twice per day, in the morning and in the evening.
In addition to using the device, participants will have study visits, complete surveys, as well as provide medical information during the study.
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|---|---|
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Median Interquartile Range (IQR) of the Time That it Takes to Complete Visit Number Two
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10 minutes
Interval 10.0 to 11.0
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PRIMARY outcome
Timeframe: Approximately 2 weeksResults reflect the participants who came for visit 1 and completed all the surveys involved in the study.
Outcome measures
| Measure |
Transcutaneous Electrical Acustimulation (TEA)
n=10 Participants
Transcutaneous Electrical Acustimulation (TEA): The severity and frequency participants pain will be measured during a run-in period of 2 weeks to assess baseline pain severity and frequency. Eligible participants will have a 4-week treatment period at home. Stimulation with the TEA device will be performed for 30 minutes twice per day, in the morning and in the evening.
In addition to using the device, participants will have study visits, complete surveys, as well as provide medical information during the study.
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Proportion of Participants Who Came for Visit 1 and Completed All the Surveys Involved in the Study
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0 Participants
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PRIMARY outcome
Timeframe: 8 weeksPopulation: 1 participant withdrew prior to starting treatment, so no survey data was collected.
Results reflect the percentage of surveys that participants completed during the treatment period (between visit 1 and visit 2) and the follow-up period (between visit 2 and visit 3). Each participant was sent 80 surveys total between visits 1 and 3, with 40 being sent between visit 1 and visit 2, and 40 being sent between visit 2 and visit 3. The time between visit 1 and visit 2 was 4 weeks, and the time between visit 2 and visit 3 was 4 weeks.
Outcome measures
| Measure |
Transcutaneous Electrical Acustimulation (TEA)
n=720 Surveys
Transcutaneous Electrical Acustimulation (TEA): The severity and frequency participants pain will be measured during a run-in period of 2 weeks to assess baseline pain severity and frequency. Eligible participants will have a 4-week treatment period at home. Stimulation with the TEA device will be performed for 30 minutes twice per day, in the morning and in the evening.
In addition to using the device, participants will have study visits, complete surveys, as well as provide medical information during the study.
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Percentage of Study Surveys That Were Completed Per Protocol
between visit 1 and visit 2
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71.3 percentage of surveys completed
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Percentage of Study Surveys That Were Completed Per Protocol
between visit 2 and visit 3
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63.2 percentage of surveys completed
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Adverse Events
Transcutaneous Electrical Acustimulation (TEA)
Serious adverse events
| Measure |
Transcutaneous Electrical Acustimulation (TEA)
n=10 participants at risk
Transcutaneous Electrical Acustimulation (TEA): The severity and frequency participants pain will be measured during a run-in period of 2 weeks to assess baseline pain severity and frequency. Eligible participants will have a 4-week treatment period at home. Stimulation with the TEA device will be performed for 30 minutes twice per day, in the morning and in the evening.
In addition to using the device, participants will have study visits, complete surveys, as well as provide medical information during the study.
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Infections and infestations
Pneumonia
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10.0%
1/10 • Up to 12 weeks
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place