Role of Home-based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis

Not Applicable

Completed

• Conditions: Chronic Pancreatitis
• Interventions: Device: Transcutaneous Electrical Acustimulation (TEA)

• Registration Number: NCT06015945
• Lead Sponsor: University of Michigan

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-22
• Study First Submitted QC: 2023-08-23
• Study First Posted: 2023-08-29
• Study Start: 2023-10-05
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transcutaneous Electrical Acustimulation (TEA)	Transcutaneous Electrical Acustimulation (TEA)	-

Primary Outcome Measures

Name	Time	Method
Proportion of approached and eligible participants that provide informed consent	Approximately 1 year (during the recruitment period)
Proportion of participants that complete follow up visit at 4 weeks and return complete follow-up questionnaires at week 8, among participants that started the intervention	Week 8
Proportion of study surveys that are completed per protocol	Baseline visit (V1) to 8 weeks (V3)
Proportion of participants that meet the eligibility criteria after the run-in period for the participants that provided informed consent.	Approximately 2 weeks
Proportion of participants that start the intervention among those that meet run-in period criteria.	Baseline visit (V1)
Proportion of approached participants that meet eligibility criteria	Approximately 1 year (during the recruitment period)
Median interquartile range (IQR) of the time that it takes to complete visit number one	Baseline visit (V1)
Median interquartile range (IQR) of the time that it takes to complete visit number two	4 weeks (after treatment period)
Proportion of participants that come for visit 1 and complete all the surveys involved in the study	Approximately 2 weeks
Proportion of participants that adhere to the intervention as prescribed among participants that start the intervention	Weeks 1-4 (after the 4-week treatment period)	Adherence will be directly monitored through use of the TEA device. The TEA automatically records duration of use, time of the day, and stimulation intensity.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States