Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07820917

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Cirrhosis Behavior Behavioral Symptoms Chronic Pain Depression Fibrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Ann Arbor, Michigan, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Transcutaneous Electrical Acustimulation (TEA)

Device

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 Transcutaneous Electrical Acustimulation (TEA)

Device

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

Primary outcomes

  1. Retention

    Time frame: Approximately day -14, day 1, and day 56

  2. Device adherence

    Time frame: Approximately week 8

    Reported as percent, reported from device utilization logs

  3. Questionnaire completion

    Time frame: Approximately week 8

    Reported as percent

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea MacMichael

CONTACT

[email protected]

734-232-4182

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

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

Registry information

Official study title

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

Acronym: COMFORT

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 15, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.