Role of Home-based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis
CompletedNot applicableNCT06015945
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)
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 details
- Official title
- Role of Home-based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis- A Pilot Study
- Conditions
- Interventions
- Device: Transcutaneous Electrical Acustimulation (TEA)
- Sponsor
- University of Michigan
- Start date
- 2023-10-05
- Primary completion
- 2024-12-01
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06015945