CompletedNot Applicable

Role of Home-Based Transcutaneous Electrical Acustimulation for Treatment of Pain in Subjects With Chronic Pancreatitis

United States42 participantsStarted 2025-01-13

Plain-language summary

Transcutaneous Electrical Acustimulation (TEA) is a noninvasive acupuncture method that can be self-administered at home without needles. TEA transmits a weak electrical current using electrodes placed at acupoints and has shown to safely reduce pain in other gastrointestinal conditions. This study will help elucidate if TEA is effective in treating abdominal pain in patients with painful chronic pancreatitis (CP).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of definite or suspected Chronic Pancreatitis (CP). Definite CP features include presence of pancreatic calcifications or Cambridge grade 3-4 on imaging. Suspected CP features include presence of Rosemont criteria suggestive of CP on endoscopic ultrasound or 2 documented attacks of acute pancreatitis separated by at least 1 month without other definite or suspected CP features. * Abdominal pain that is present for at least 3 months prior to enrollment and having experienced moderate intensity abdominal pain (rated as 4 or higher on a 0-10 Numeric Rating Scale) at least once in the last month. Exclusion Criteria: * Breastfeeding mother * Pregnant or intending to become pregnant within the next 3 months * Incarcerated individuals * Unwillingness or inability to consent * Unable to read and speak English precluding completion of questionnaires. * Familiarity with acupoints that limit blinding * Currently receiving acupuncture therapy * Participation in another clinical trial * Undergoing treatment for cancer or has a suspected or confirmed diagnosis of pancreatic cancer * Substantial cognitive impairment or mental illness that would prevent providing informed consent and completion of questionnaires. * Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study * History of total pancreatectomy with or without islet autotransplantation * Had during the past month or plan to have wi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Difference of the difference of the Pain Severity Score based the Brief Pain Inventory-Short Form (BPI-SF) between start and end of each treatment period

Timeframe: Baseline-4 weeks and weeks 6-10

Trial details

NCT IDNCT06721572

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-16

View on ClinicalTrials.gov More Chronic Pancreatitis trials