RESTORE: Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis
University of Michigan
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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) * Depression (in at least half of participants) - must meet the criteria as outlined in the protocol * English speaking * Willing to use a Transcutaneous Electrical Acustimulation device 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 in…
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 ST36 (via 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 (approximately 9-10 weeks).
- 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 (approximately 9-10 weeks)
Location
- University of MichiganAnn Arbor, Michigan