Status:
COMPLETED
Role of Home-based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis
Lead Sponsor:
University of Michigan
Conditions:
Chronic Pancreatitis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06015945
Start Date
October 5 2023
End Date
December 1 2024
Last Update
January 23 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109