COMFORT: Chronic Pain Optimization and Management for Relief and Functionality With TEA in Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Retention
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Transcutaneous Electrical Acustimulation (TEA)
Participants will have a two-week run-in period and then 8 weeks of treatment.
干预措施: Transcutaneous Electrical Acustimulation (TEA) (Device)
TEA Sham
Participants will have a two-week run-in period and then 8 weeks of sham treatment.
干预措施: Sham Transcutaneous Electrical Acustimulation (TEA) (Device)
结局指标
主要结局
Retention
时间窗: Approximately day -14, day 1, and day 56
Device adherence
时间窗: Approximately week 8
Reported as percent, reported from device utilization logs
Questionnaire completion
时间窗: Approximately week 8
Reported as percent
Acceptability of Intervention Measure (AIM) score
时间窗: 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.
次要结局
未报告次要终点
研究者
Elliot B. Tapper
Professor of Hepatology and Associate Professor of Internal Medicine
University of Michigan