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 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)
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Participants will be randomized 1:1 to either TEA or sham-control. At least half of the participants will have depression per study definition.
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) * 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 investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability Questionnaire at 10 weeks | 10 weeks | There are 7 questions that will be completed regarding the participant's experience with the study. There are six questions that participants will select strongly agree (5) - strongly disagree (1), with a range of 6-30. Additionally, participant's select from not very likely (1) -extremely likely (10). The last scale 1-10 asks "on a scale from 1-10, where 1 is not very likely and 10 is extremely likely, I am likely to recommend using the TEA device to a friend, colleague, or family member with cirrhosis and pain." |
| Feasibility based on the proportion of participants enrolled that were contacted | Enrollment period (2 years) | — |
| Feasibility based on the Proportion of enrolled participants that dropout (overall and during run in) | Run-in (-14 days to baseline) to 10 weeks | — |
| Feasibility based on time required to complete study assessments | Screening - 10 weeks | Time will be in minutes |
| Proportion of questionnaires completed at baseline and the final study visit (10 weeks) | Baseline, 10 weeks | — |
| TEA usage during the intervention period | Weeks 1-8 of TEA treatment | Time per day. |
Countries
United States
Contacts
CONTACTTasnuva Tarannum
CONTACTSamantha Nikirk
PRINCIPAL_INVESTIGATORElliot Tapper, MD
University of Michigan
Outcome results
None listed