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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
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.
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
University of Michigan
Ann Arbor, Michigan, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Retention
Time frame: Approximately day -14, day 1, and day 56
Device adherence
Reported as percent, reported from device utilization logs
Time frame: Approximately week 8
Questionnaire completion
Reported as percent
Time frame: Approximately week 8
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
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