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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at ways to treat pain in people with cirrhosis (liver scarring) and depression. People are assigned by chance to use either TEA, a device that sends electrical signals through the skin, or a sham (inactive) version.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have cirrhosis that meets the study’s rules.
  • Report pain of 4 or higher on a 0–10 scale on more than half of the days over 3 months.
  • Be willing to use a TEA device.
  • Have Wi-Fi or a data plan.
  • Have a laptop, computer, tablet, or smartphone.

Who can't join

  • Have dementia or severe trouble thinking, cannot or will not agree to join, or are judged unsuitable by the study doctor.
  • Have no email address.
  • Expect a liver transplant within 24 weeks, have a MELD score (a measure of liver disease severity) above 25, or have total bilirubin above 4.0 while on hemodialysis (a blood-filtering treatment).
  • Within the past 30 days, had a hospital stay longer than 24 hours or hepatic encephalopathy (brain problems caused by liver disease).
  • Have an implanted heart pacemaker or defibrillator, a spinal implant, or a cochlear implant (a hearing device).
  • Have a known allergy to adhesive tape or electrode materials used on the skin.
  • Report current, active thoughts of suicide during screening.
  • Report being pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (2)

MI

PA