Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous Electrical Acustimulation (TEA) | Experimental | Participants will have a two-week run-in period and then 8 weeks of treatment. |
|
| TEA Sham | Sham Comparator | Participants will have a two-week run-in period and then 8 weeks of sham treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability Questionnaire at 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." | 10 weeks |
| 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 | Time will be in minutes | Screening - 10 weeks |
| Proportion of questionnaires completed at baseline and the final study visit (10 weeks) | Baseline, 10 weeks | |
| TEA usage during the intervention period | Time per day. | Weeks 1-8 of TEA treatment |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tasnuva Tarannum | Contact | 734-232-4182 | tasnuvat@med.umich.edu | |
| Samantha Nikirk | Contact | 734-232-4182 | samjwalk@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elliot Tapper, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D059350 | Chronic Pain |
| D003863 | Depression |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
Participants will be randomized 1:1 to either TEA or sham-control. At least half of the participants will have depression per study definition.
Not provided
Not provided
Not provided
|
| 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 (approximately 9-10 weeks) |
|
| D012816 | Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |