Role of Home-Based Transcutaneous Electrical Acustimulation for Treatment of Pain in Subjects With Chronic Pancreatitis
CompletedNot applicableNCT06721572
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- Official title
- Role of Home-Based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis (TEA-CuP): A Double-Blind, Sham-Controlled Crossover Trial
- Conditions
- Chronic Pancreatitis
- Pancreatitis
- Interventions
- Device: TEA
- Sponsor
- University of Michigan
- Collaborators
- American College of Gastroenterology
- Start date
- 2025-01-13
- Primary completion
- 2026-02-16
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 within the next 3 months at least one of the following procedures: endoscopic retrograde cholangiopancreatography, pancreatic pseudocyst drainage, celiac plexus block or neurolysis, extracorporeal shock wave lithotripsy, or surgical pancreatic resection or drainage procedure * Presence of obstructed pancreatic duct that has not yet undergone an attempt for ductal decompression. * Known allergy to adhesive Electrocardiogram (ECG) electrodes * History of vagal nerve surgery * History of bilateral below the knee amputation * History of lower extremity paralysis * Presence of an implantable electrical stimulation device
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06721572