Chronic PancreatitisNCT06015945
Role of Home-based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis
A study testing Transcutaneous Electrical Acustimulation (TEA) in people with Chronic Pancreatitis, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- Transcutaneous Electrical Acustimulation (TEA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2023to 1 Dec 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic pancreatitis (CP), based on a score greater or equal to 4 using a previously validated Mayo scoring system that uses morphologic and functional criteria, or endosonographic features suggestive or consistent with CP based on Rosemont criteria.
- Abdominal pain present at least once within the last month
- Willing and able to provide written informed consent
Who cannot join
- Pregnancy or breastfeeding mother
- Imprisoned individuals
- Non-English speaking patients
- Scheduled for or with a history of pancreatic surgery (e.g. Total Pancreatectomy with Islet Auto Transplantation (TPIAT), Puestow, Frey, Whipple, other)
- Currently undergoing or about to start endoscopic therapy with Endoscopic retrograde cholangiopancreatography (ERCP) or Endoscopic ultrasound (EUS)
- Recent history of acute pancreatitis as defined by the Revised Atlanta Classification within a month prior to enrollment
Show all 16Show fewer
- Radiologic and clinical findings consistent with symptomatic pseudocyst, wall-off necrosis, infected pancreatic necrosis, or biliary obstruction within the last 6 months
- Self-reported daily use of opioids for > 12 months for weak opioids (codeine, tramadol and hydrocodone) or > 6 months for strong opioids (other opioids) in the last two years.
- -Self-reported ongoing illicit drug use or abuse-
- Suspected or diagnosed pancreatic cancer
- Receiving chemotherapy for cancer
- Known allergy to adhesive electrocardiogram (ECG) electrodes
- Patients with bilateral below the knee amputation
- Patients with lower extremity paralysis
- Patient is participating in another clinical trial
- Patients with an implantable electrical stimulation device.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Home-based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis- A Pilot Study
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.
- Conditions
- Chronic Pancreatitis
- Being tested
- Transcutaneous Electrical Acustimulation (TEA)
- Keywords
- Abdominal pain, Transcutaneous Acustimulation
- Medical subject headings
- Pancreatitis, Chronic, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Electrical Acustimulation (TEA) | Experimental | Not described Receives: Device: Transcutaneous Electrical Acustimulation (TEA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline visit (V1)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start5 Oct 2023
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
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 PancreatitisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Machicado, MD, MPH, University of Michigan
- Investigators
- Jorge Machicado, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015945
- Sponsor's protocol ID
- HUM00225786
- Status last verified
- Dec 2025
- First submitted
- 22 Aug 2023
- Last updated
- 4 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Home-based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis- A Pilot Study
- ClinicalTrials.gov ID
- NCT06015945
- Acronym / sponsor ID
- HUM00225786
- Conditions
- Chronic Pancreatitis
- Keywords
- Abdominal pain, Transcutaneous Acustimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 29 Aug 2023 (actual)
- Results
- Posted 4 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Electrical Acustimulation (TEA) | Experimental | Device: Transcutaneous Electrical Acustimulation (TEA) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of chronic pancreatitis (CP), based on a score greater or equal to 4 using a previously validated Mayo scoring system that uses morphologic and functional criteria, or endosonographic features suggestive or consistent with CP based on Rosemont criteria.
- Abdominal pain present at least once within the last month
- Willing and able to provide written informed consent
Key exclusion criteria (16 listed)
- Pregnancy or breastfeeding mother
- Imprisoned individuals
- Non-English speaking patients
- Scheduled for or with a history of pancreatic surgery (e.g. Total Pancreatectomy with Islet Auto Transplantation (TPIAT), Puestow, Frey, Whipple, other)
- Currently undergoing or about to start endoscopic therapy with Endoscopic retrograde cholangiopancreatography (ERCP) or Endoscopic ultrasound (EUS)
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 |
|---|---|---|
| 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. | Device | Transcutaneous Electrical Acustimulation (TEA) |
Primary outcome
Proportion of Approached Individuals Who Met Eligibility Criteria
Time frame: Approximately 1 year (during the recruitment period)
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.
Proportion of Approached and Eligible Participants Who Provided Informed Consent
Time frame: Approximately 1 year (during the recruitment period)
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.
Proportion of Participants Who Met the Eligibility Criteria After the run-in Period for the Participants Who Provided Informed Consent.
Time frame: Approximately 2 weeks
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.
Proportion of Participants Who Started the Intervention Among Those Who Met run-in Period Criteria.
Time frame: Baseline visit (V1)
Results reflect the participants who completed the run-in period and received the first TEA treatment.
Proportion of Participants That Adhere to the Intervention as Prescribed Among Participants That Start the Intervention
Time frame: Weeks 1-4 (after the 4-week treatment period)
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.
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
Time frame: Week 8
Results reflect participants who started the TEA and who returned the follow-up questionnaires at week 4 and week 8 (end of the study).
Median Interquartile Range (IQR) of the Time That it Takes to Complete Visit Number One
Time frame: Baseline visit (V1)
Results reflect the time taken to complete visit 1 in minutes. Data was collected using time-stamp data from the Redcap system.
Median Interquartile Range (IQR) of the Time That it Takes to Complete Visit Number Two
Time frame: 4 weeks (after treatment period)
Results reflect the time taken to complete visit 2 in minutes. Data was collected using time-stamp data from the Redcap system.
Proportion of Participants Who Came for Visit 1 and Completed All the Surveys Involved in the Study
Time frame: Approximately 2 weeks
Results reflect the participants who came for visit 1 and completed all the surveys involved in the study.
Percentage of Study Surveys That Were Completed Per Protocol
Time frame: 8 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jorge Machicado, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Acustimulation (TEA) in people with Chronic Pancreatitis, run by University of Michigan at 1 site in United States.
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 3 inclusion and 16 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 4 Feb 2026. 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. 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 4 Feb 2026). 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?
Proportion of Approached Individuals Who Met Eligibility Criteria (time frame: Approximately 1 year (during the recruitment period)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2026.