Health TrialsbyHealthPanel

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

ConditionCirrhosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Dementia and/or severe cognitive impairment

Unable or unwilling to provide consent

Expected to undergo liver transplant in next 24 weeks

No email address

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Transcutaneous Electrical Acustimulation (TEA)Experimental treatment 1 intervention
Group B: TEA ShamSham comparator 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

University of Pennsylvania

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: