Home-based electrical stimulation for pain relief in chronic pancreatitis
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
NA · University of Michigan · NCT06721572
This study is testing if a small, wearable device that uses mild electrical currents can help relieve abdominal pain in people with chronic pancreatitis while they go about their daily activities.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan (other) |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06721572 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Transcutaneous Electrical Acustimulation (TEA), a noninvasive acupuncture method, in alleviating abdominal pain in patients with chronic pancreatitis. Participants will use a small, wearable device that delivers mild electrical currents to acupoints at home while engaging in daily activities. The study employs a randomized, sham-controlled, 2x2 crossover design to compare the effects of active TEA against a placebo. Over 12 weeks, subjects will report on pain severity and overall pain experience through online questionnaires, with study visits conducted either at the University of Michigan or virtually.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with chronic pancreatitis who experience moderate to severe abdominal pain.
Not a fit: Patients who are currently receiving acupuncture therapy or have conditions that preclude participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-pharmacological and non-invasive alternative for managing chronic abdominal pain in patients with pancreatitis.
How similar studies have performed: Previous studies have shown that similar noninvasive electrical stimulation techniques can effectively reduce pain in other gastrointestinal conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)
Study contacts
- Principal investigator: Jorge D Machicado, MD, MPH — University of Michigan
- Study coordinator: Benson Hang
- Email: behang@umich.edu
- Phone: 734-764-5753
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Pancreatitis, Pancreatitis, Abdominal Pain, Transcutaneous Electrical Acustimulation, Acupuncture, Chronic Pain