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

NCT ID
NCT07820917
Registry status
Not yet recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
University of Michigan
Conditions
Cirrhosis

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

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

Enrollment: 100 participants (Estimated).

What is being studied

  • Device: Sham Transcutaneous Electrical Acustimulation (TEA)
  • Device: Transcutaneous Electrical Acustimulation (TEA)

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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 locations

2 study locations are listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: United States

  • Michigan, United States: 1
  • Pennsylvania, United States: 1

Sample of listed locations

  • University of Michigan — Ann Arbor, Michigan, 48109, United States — Site recruitment status not specified in the registry data
  • University of Pennsylvania — Philadelphia, Pennsylvania, 19104, United States — Site recruitment status not specified in the registry data

Study details

Start date
September 1, 2026
Primary completion date
September 1, 2029
Completion date
September 1, 2029
First posted
September 15, 2026
Collaborators
National Center for Complementary and Integrative Health (NCCIH), University of Pennsylvania

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07820917
Registry last updated
September 16, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT07820917 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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