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

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

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 Overview

• Status: Recruiting
• Conditions: Chronic Pancreatitis
• Intervention / Treatment: Device: Transcutaneous Electrical Acustimulation (TEA)

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Colin Burnett; Phone Number: 734-647-2806; Email: bucolin@med.umich.edu
• Study Contact Backup: Name: Jorge Machicado, MD; Phone Number: 734-647-9252; Email: machicad@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Colin Burnett; Phone Number: 734-647-2806; Email: bucolin@med.umich.edu
      • Principal Investigator: Jorge Machicado, MD
      • Contact: Jorge Machicado, MD; Phone Number: 734-647-9252; Email: machicad@umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Transcutaneous Electrical Acustimulation (TEA)

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of approached participants that meet eligibility criteria		Approximately 1 year (during the recruitment period)
Proportion of approached and eligible participants that provide informed consent		Approximately 1 year (during the recruitment period)
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 participants that adhere to the intervention as prescribed among participants that start the intervention	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.	Weeks 1-4 (after the 4-week treatment 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
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 study surveys that are completed per protocol		Baseline visit (V1) to 8 weeks (V3)

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Jorge Machicado, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: August 22, 2023
• First Submitted That Met QC Criteria: August 23, 2023
• First Posted (Actual): August 29, 2023

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Abdominal pain; Transcutaneous Acustimulation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Pancreatic Diseases; Chronic Disease; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: HUM00225786

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No