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This research is studying a new noninvasive device-based therapy called Transcutaneous Electrical Acustimulation (TEA) to learn about its safety and how well it works as a treatment of pain in chronic pancreatitis. The purpose of this study is to investigate the potential of TEA to treat abdominal pain in patients with chronic pancreatitis (CP).
The study hypothesizes that TEA can be used as a non-pharmaceutical opioid-free approach to treat pain in chronic pancreatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous Electrical Acustimulation (TEA) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Electrical Acustimulation (TEA) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Approached Individuals Who Met Eligibility Criteria | 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. | Approximately 1 year (during the recruitment period) |
| Proportion of Approached and Eligible Participants Who Provided Informed Consent | 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. | Approximately 1 year (during the recruitment period) |
| Proportion of Participants Who Met the Eligibility Criteria After the run-in Period for the Participants Who Provided Informed Consent. | 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. | Approximately 2 weeks |
| Proportion of Participants Who Started the Intervention Among Those Who Met run-in Period Criteria. | Results reflect the participants who completed the run-in period and received the first TEA treatment. | Baseline visit (V1) |
| Proportion of Participants That Adhere to the Intervention as Prescribed Among Participants That Start the Intervention |
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Inclusion Criteria:
Exclusion Criteria:
-Self-reported ongoing illicit drug use or abuse-
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| Name | Affiliation | Role |
|---|---|---|
| Jorge Machicado, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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Two consented, potentially eligible individuals did not complete the run-in period and, therefore, were determined to not be eligible to become participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline data was collected from all participants who were consented and, at the end of the 2-week run-in period, remained eligible to begin the trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Proportion of Approached Individuals Who Met Eligibility Criteria | 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. | NOTE: 178 individuals were approached to determine whether they were eligible to participate in this trial. | Posted | Count of Participants | Participants | Approximately 1 year (during the recruitment period) |
|
Up to 12 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 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | Non-systematic Assessment | One participant withdrew from the trial for an unrelated admission due to pneumonia prior to receiving any TEA session or starting treatment questionnaires. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jorge Machicado | University of Michigan | (734) 936-4979 | machicad@med.umich.edu |
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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 | Sep 26, 2024 | Nov 19, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
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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. |
| Weeks 1-4 (after the 4-week treatment period) |
| 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 | Results reflect participants who started the TEA and who returned the follow-up questionnaires at week 4 and week 8 (end of the study). | Week 8 |
| Median Interquartile Range (IQR) of the Time That it Takes to Complete Visit Number One | Results reflect the time taken to complete visit 1 in minutes. Data was collected using time-stamp data from the Redcap system. | Baseline visit (V1) |
| Median Interquartile Range (IQR) of the Time That it Takes to Complete Visit Number Two | Results reflect the time taken to complete visit 2 in minutes. Data was collected using time-stamp data from the Redcap system. | 4 weeks (after treatment period) |
| Proportion of Participants Who Came for Visit 1 and Completed All the Surveys Involved in the Study | Results reflect the participants who came for visit 1 and completed all the surveys involved in the study. | Approximately 2 weeks |
| Percentage of Study Surveys That Were Completed Per Protocol | 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. | 8 weeks |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | Proportion of Approached and Eligible Participants Who Provided Informed Consent | 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. | 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. | Posted | Count of Participants | Participants | Approximately 1 year (during the recruitment period) |
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| Primary | Proportion of Participants Who Met the Eligibility Criteria After the run-in Period for the Participants Who Provided Informed Consent. | 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. | "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. | Posted | Count of Participants | Participants | Approximately 2 weeks |
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| Primary | Proportion of Participants Who Started the Intervention Among Those Who Met run-in Period Criteria. | Results reflect the participants who completed the run-in period and received the first TEA treatment. | Posted | Count of Participants | Participants | Baseline visit (V1) |
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| Primary | Proportion of Participants That Adhere to the Intervention as Prescribed Among Participants That Start the Intervention | 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. | 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. | Posted | Weeks 1-4 (after the 4-week treatment period) |
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| Primary | 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 | Results reflect participants who started the TEA and who returned the follow-up questionnaires at week 4 and week 8 (end of the study). | 1 participant withdrew prior to starting treatment. | Posted | Count of Participants | Participants | Week 8 |
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| Primary | Median Interquartile Range (IQR) of the Time That it Takes to Complete Visit Number One | Results reflect the time taken to complete visit 1 in minutes. Data was collected using time-stamp data from the Redcap system. | 1 participant withdrew prior to starting treatment. | Posted | Median | Inter-Quartile Range | minutes | Baseline visit (V1) |
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| Primary | Median Interquartile Range (IQR) of the Time That it Takes to Complete Visit Number Two | Results reflect the time taken to complete visit 2 in minutes. Data was collected using time-stamp data from the Redcap system. | 1 participant withdrew prior to receiving treatment. 2 participants did not provide data at the second visit, as they did not complete the questionnaires. | Posted | Median | Inter-Quartile Range | minutes | 4 weeks (after treatment period) |
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| Primary | Proportion of Participants Who Came for Visit 1 and Completed All the Surveys Involved in the Study | Results reflect the participants who came for visit 1 and completed all the surveys involved in the study. | Posted | Count of Participants | Participants | Approximately 2 weeks |
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| Primary | Percentage of Study Surveys That Were Completed Per Protocol | 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. | 1 participant withdrew prior to starting treatment, so no survey data was collected. | Posted | Number | percentage of surveys completed | 8 weeks | Surveys | Surveys |
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| 0 |
| 10 |
| 1 |
| 10 |
| 0 |
| 10 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |