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

NCT ID: NCT06015945

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-05
• Study Completion Date: 2024-12-01

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.

Conditions

Chronic Pancreatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transcutaneous Electrical Acustimulation (TEA)

Group Type: EXPERIMENTAL

Transcutaneous Electrical Acustimulation (TEA)

Intervention Type: DEVICE

The severity and frequency participants pain will be measured during a run-in period of 2 weeks with to assess baseline pain severity and frequency. Eligible participants will have a 4-week treatment period at home. Stimulation with the TEA device will be performed for 30 minutes twice per day, in the morning and in the evening.

In addition to using the device, participants will have study visits, complete surveys, as well as provide medical information during the study.

Interventions

Transcutaneous Electrical Acustimulation (TEA)

The severity and frequency participants pain will be measured during a run-in period of 2 weeks with to assess baseline pain severity and frequency. Eligible participants will have a 4-week treatment period at home. Stimulation with the TEA device will be performed for 30 minutes twice per day, in the morning and in the evening.

In addition to using the device, participants will have study visits, complete surveys, as well as provide medical information during the study.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Jorge Machicado, MD, MPH

Assistant Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jorge Machicado, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00225786

Identifier Type: -

Identifier Source: org_study_id