Cirrhosis
Conditions
Keywords
Transcutaneous Electrical Acustimulation, Chronic Pain, Depression
Brief 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.
Interventions
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
Sponsors
University of Michigan
National Center for Complementary and Integrative Health (NCCIH)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
This is an 8-week, randomized, double-blind, sham-controlled pilot trial of TEA across two academic medical centers, in preparation for a subsequent multicenter efficacy trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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) * 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
* 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 bilirubin \>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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention | Approximately day -14, day 1, and day 56 | — |
| Device adherence | Approximately week 8 | Reported as percent, reported from device utilization logs |
| Questionnaire completion | Approximately week 8 | Reported as percent |
| Acceptability of Intervention Measure (AIM) score | Approximately week 8 and week 12 | AIM is a 6-item study-specific Likert battery with scores ranging from 0-5. Higher scores indicate lower acceptability. |
Countries
United States
Contacts
CONTACTAndrea MacMichael
PRINCIPAL_INVESTIGATORElliot Tapper, MD
University of Michigan
Outcome results
None listed