N/A
N=10
Role of Home-based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis
Chronic Pancreatitis
Bottom Line
View on ClinicalTrials.gov: NCT06015945 ↗Enrolled (actual)
10
Serious AEs
10.0%
Results posted
Feb 2026
Primary outcome: Primary: Proportion of Approached Individuals Who Met Eligibility Criteria — 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcutaneous Electrical Acustimulation (TEA) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Approached Individuals Who Met Eligibility Criteria |
12 | — |
| PRIMARY Proportion of Approached and Eligible Participants Who Provided Informed Consent |
12 | — |
| PRIMARY Proportion of Participants Who Met the Eligibility Criteria After the run-in Period for the Participants Who Provided Informed Consent. |
10 | — |
| PRIMARY Proportion of Participants Who Started the Intervention Among Those Who Met run-in Period Criteria. |
9 | — |
| PRIMARY Proportion of Participants That Adhere to the Intervention as Prescribed Among Participants That Start the Intervention |
— | — |
| 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 |
7 | — |
| PRIMARY Median Interquartile Range (IQR) of the Time That it Takes to Complete Visit Number One |
22 | — |
| PRIMARY Median Interquartile Range (IQR) of the Time That it Takes to Complete Visit Number Two |
10 | — |
| PRIMARY Proportion of Participants Who Came for Visit 1 and Completed All the Surveys Involved in the Study |
— | — |
| PRIMARY Percentage of Study Surveys That Were Completed Per Protocol |
71.3; 63.2 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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.
Data sourced from ClinicalTrials.gov (NCT06015945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.