Chronic Pain Optimization and Management for Relief and Functionality With TEA in Cirrhosis (COMFORT)

September 9, 2026 updated by: Elliot B. Tapper, University of Michigan

COMFORT: Chronic Pain Optimization and Management for Relief and Functionality With TEA in Cirrhosis

This study is being done to better understand how the study team can treat pain for people with cirrhosis and depression.

Enrolled participants on this feasibility study will be randomized to Transcutaneous Electrical Acustimulation (TEA) or sham TEA.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
        • Principal Investigator:
          • Elliot Tapper, MD
        • Contact:
    • Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of cirrhosis - must meet the criteria as outlined in the protocol
  • Chronic pain (Patient self-reports ≥ 4 on the 0-10 scale for >50% of days within 3- months)
  • Willing to use a Transcutaneous Electrical Acustimulation (TEA) device
  • Has access to Wi-Fi or a data plan
  • Has access to a laptop, computer, tablet, or smartphone

Exclusion Criteria:

  • Dementia and/or severe cognitive impairment
  • Unable or unwilling to provide consent
  • Expected to undergo liver transplant in next 24 weeks
  • No email address
  • Deemed unsuitable by the study investigator
  • Model for End-Stage Liver Diseas (MELD) score >25, or total bilirubin >4.0 in a patient on hemodialysis
  • Recent hospitalization (>24 hours) or episode of hepatic encephalopathy within the preceding 30 days
  • Implanted pacemaker/defibrillator, spinal implant, or cochlear implant
  • Known allergy to adhesive tape/electrode materials
  • Current active suicidal ideation, endorsed at screening (see Section 8.6)
  • Currently pregnant (self-reported)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcutaneous Electrical Acustimulation (TEA)
Participants will have a two-week run-in period and then 8 weeks of treatment.
Device: Transcutaneous Electrical Acustimulation (TEA)

Participant will apply TEA at home twice a day (approximately 45 minutes am/pm) for 8 weeks. The top electrode will be placed at an acupuncture point and the electrode patch will be placed vertically.

Additionally, participants will agree to allow medical records to be collected, complete various surveys and have follow-up after treatment.
Sham Comparator: TEA Sham
Participants will have a two-week run-in period and then 8 weeks of sham treatment.
Device: Sham Transcutaneous Electrical Acustimulation (TEA)
Participant will apply sham TEA at home twice a day (approximately 45 minutes am/pm) for 8 weeks. Sham TEA will be performed via one point on the leg and not on any meridian or acupoints that were used in previous gastrointestinal studies and did not yield any significant effects. Additionally, participants will agree to allow medical records to be collected, complete various surveys and have follow-up after treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention
Time Frame: Approximately day -14, day 1, and day 56
Approximately day -14, day 1, and day 56
Device adherence
Time Frame: Approximately week 8
Reported as percent, reported from device utilization logs
Approximately week 8
Questionnaire completion
Time Frame: Approximately week 8
Reported as percent
Approximately week 8
Acceptability of Intervention Measure (AIM) score
Time Frame: Approximately week 8 and week 12
AIM is a 6-item study-specific Likert battery with scores ranging from 0-5. Higher scores indicate lower acceptability.
Approximately week 8 and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

University of Pennsylvania
National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Elliot Tapper, MD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

September 9, 2026

First Submitted That Met QC Criteria

September 9, 2026

First Posted (Actual)

September 15, 2026

Study Record Updates

Last Update Posted (Actual)

September 15, 2026

Last Update Submitted That Met QC Criteria

September 9, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00299832
  • 1R01AT013417-01A1 (U.S. NIH Grant/Contract)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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