Transcutaneous Electrical Acustimulation for Chronic Pain in Liver Cirrhosis

(COMFORT Trial)

Not yet recruiting at 1 trial location
AM
Overseen ByAndrea MacMichael
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Michigan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

ET

Elliot Tapper, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for adults with liver cirrhosis who also have chronic pain and depression. People with certain other health issues or conditions that could interfere with the study may not be able to join.

Inclusion Criteria

Has access to Wi-Fi or a data plan
Has access to a laptop, computer, tablet, or smartphone
I have been diagnosed with cirrhosis as defined by the study.
See 2 more

Exclusion Criteria

I have dementia or severe problems with memory and thinking.
No email address
Model for End-Stage Liver Disease (MELD) score >25, or total bilirubin >4.0 in a patient on hemodialysis
See 8 more

What Are the Treatments Tested in This Trial?

Interventions

  • Transcutaneous Electrical Acustimulation (TEA)

Trial Overview

The study compares real Transcutaneous Electrical Acustimulation (TEA), a device that uses mild electrical stimulation on the skin, to a sham (inactive) version. Participants are randomly assigned to one of these groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Transcutaneous Electrical Acustimulation (TEA)Experimental Treatment1 Intervention
Group II: TEA ShamPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials
886
Recruited
677,000+

University of Pennsylvania

Collaborator

Trials
2,118
Recruited
45,270,000+