ClinicalTrials.gg
Not yet recruitingNCT07820917COMFORTUpdated Sep 16, 2026

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

An interventional study of Transcutaneous Electrical Acustimulation (TEA) and Sham Transcutaneous Electrical Acustimulation (TEA) in Cirrhosis, sponsored by University of Michigan. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.

Primary conditionChronic PainRegistry: FibrosisReclassifiedWhy we changed it
Registry
Fibrosis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Chronic Pain
Why
  1. Fibrosis is a broad heading, used only when no more specific condition is named.
  2. The study's title name Chronic Pain.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Michigan · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cirrhosis

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Keywords

  • Transcutaneous Electrical Acustimulation
  • Chronic Pain
  • Depression
03

In context

Chronic Pain Reclassified

3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 2,388 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.

Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.

Compared within Chronic Pain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Fibrosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 >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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • 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)

  • 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)

Interventions

  • DeviceTranscutaneous 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.

  • DeviceSham 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

06

What researchers measure

Primary outcomes

  1. Retention

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

  2. Device adherence

    Reported as percent, reported from device utilization logs

    Time frame: Approximately week 8

  3. Questionnaire completion

    Reported as percent

    Time frame: Approximately week 8

  4. Acceptability of Intervention Measure (AIM) score

    AIM is a 6-item study-specific Likert battery with scores ranging from 0-5. Higher scores indicate lower acceptability.

    Time frame: Approximately week 8 and week 12

07

Study locations

2 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2029, 36 months later.

Of 1,295 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's planned 36 months is above that.

Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 9, 2026
First posted
Sep 15, 2026
StartEst.
Sep 2026
Primary completionEst.
Sep 2029
CompletionEst.
Sep 2029
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07820917
Responsible party
Elliot B. Tapper (Professor of Hepatology and Associate Professor of Internal Medicine, University of Michigan) — Principal investigator
First posted
Sep 15, 2026
Start date
Sep 2026 (estimated)
Primary completion
Sep 2029 (estimated)
Completion
Sep 2029 (estimated)
Last update
Sep 16, 2026

Study contacts

Andrea MacMichael
Contact
amacmi@umich.edu
734-232-4182
Elliot Tapper, MD
principal investigator · University of Michigan

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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