Chronic Pain Optimization and Management for Relief and Functionality With TEA in Cirrhosis
Not yet recruitingNot applicableNCT07820917
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- COMFORT: Chronic Pain Optimization and Management for Relief and Functionality With TEA in Cirrhosis
- Conditions
- Cirrhosis
- Interventions
- Device: Transcutaneous Electrical Acustimulation (TEA)
- Device: Sham Transcutaneous Electrical Acustimulation (TEA)
- Sponsor
- University of Michigan
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH); University of Pennsylvania
- Start date
- 2026-09
- Primary completion
- 2029-09
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07820917