Role of Home-based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis- A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Proportion of Approached Individuals Who Met Eligibility Criteria
研究概览
简要总结
This research is studying a new noninvasive device-based therapy called Transcutaneous Electrical Acustimulation (TEA) to learn about its safety and how well it works as a treatment of pain in chronic pancreatitis. The purpose of this study is to investigate the potential of TEA to treat abdominal pain in patients with chronic pancreatitis (CP).
The study hypothesizes that TEA can be used as a non-pharmaceutical opioid-free approach to treat pain in chronic pancreatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic pancreatitis (CP), based on a score greater or equal to 4 using a previously validated Mayo scoring system that uses morphologic and functional criteria, or endosonographic features suggestive or consistent with CP based on Rosemont criteria.
- •Abdominal pain present at least once within the last month
- •Willing and able to provide written informed consent
排除标准
- •Pregnancy or breastfeeding mother
- •Imprisoned individuals
- •Non-English speaking patients
- •Scheduled for or with a history of pancreatic surgery (e.g. Total Pancreatectomy with Islet Auto Transplantation (TPIAT), Puestow, Frey, Whipple, other)
- •Currently undergoing or about to start endoscopic therapy with Endoscopic retrograde cholangiopancreatography (ERCP) or Endoscopic ultrasound (EUS)
- •Recent history of acute pancreatitis as defined by the Revised Atlanta Classification within a month prior to enrollment
- •Radiologic and clinical findings consistent with symptomatic pseudocyst, wall-off necrosis, infected pancreatic necrosis, or biliary obstruction within the last 6 months
- •Self-reported daily use of opioids for > 12 months for weak opioids (codeine, tramadol and hydrocodone) or > 6 months for strong opioids (other opioids) in the last two years.
- •Self-reported ongoing illicit drug use or abuse-
- •Suspected or diagnosed pancreatic cancer
- •Receiving chemotherapy for cancer
- •Known allergy to adhesive electrocardiogram (ECG) electrodes
- •Patients with bilateral below the knee amputation
- •Patients with lower extremity paralysis
- •Patient is participating in another clinical trial
- •Patients with an implantable electrical stimulation device.
研究组 & 干预措施
Transcutaneous Electrical Acustimulation (TEA)
干预措施: Transcutaneous Electrical Acustimulation (TEA) (Device)
结局指标
主要结局
Proportion of Approached Individuals Who Met Eligibility Criteria
时间窗: Approximately 1 year (during the recruitment period)
This feasibility outcome measured eligibility of individuals to participate, as opposed to any effects of the intervention. Results reflect the total number of individuals who were approached as the number analyzed, and of that population, the number who were eligible to be consented and proceed to the run-in period.
Proportion of Approached and Eligible Participants Who Provided Informed Consent
时间窗: Approximately 1 year (during the recruitment period)
This outcome measured feasibility and willingness of individuals to participate, as opposed to any effects of the intervention. Therefore, the "participants" analyzed below include all of the individuals determined to be eligible as shown in Outcome Measure 1.
Proportion of Participants Who Met the Eligibility Criteria After the run-in Period for the Participants Who Provided Informed Consent.
时间窗: Approximately 2 weeks
This outcome measured feasibility and continued eligibility of individuals to allow them to begin to participate in the actual trial, as opposed to any effects of the intervention. Therefore, the "participants" analyzed below include all of the individuals who were determined to be eligible and who were consented, as shown in Outcome Measure 2. These "participants" began a 2-week run-in period to confirm baseline pain and trial eligibility. Results reflect participants who were determined to still be eligible after the run-in period.
Proportion of Participants Who Started the Intervention Among Those Who Met run-in Period Criteria.
时间窗: Baseline visit (V1)
Results reflect the participants who completed the run-in period and received the first TEA treatment.
Proportion of Participants That Adhere to the Intervention as Prescribed Among Participants That Start the Intervention
时间窗: Weeks 1-4 (after the 4-week treatment period)
Adherence will be directly monitored through use of the TEA device. The TEA automatically records duration of use, time of the day, and stimulation intensity.
Proportion of Participants Who Completed Follow up Visit at 4 Weeks and Return Complete Follow-up Questionnaires at Week 8, Among Participants Who Started the Intervention
时间窗: Week 8
Results reflect participants who started the TEA and who returned the follow-up questionnaires at week 4 and week 8 (end of the study).
Median Interquartile Range (IQR) of the Time That it Takes to Complete Visit Number One
时间窗: Baseline visit (V1)
Results reflect the time taken to complete visit 1 in minutes. Data was collected using time-stamp data from the Redcap system.
Median Interquartile Range (IQR) of the Time That it Takes to Complete Visit Number Two
时间窗: 4 weeks (after treatment period)
Results reflect the time taken to complete visit 2 in minutes. Data was collected using time-stamp data from the Redcap system.
Proportion of Participants Who Came for Visit 1 and Completed All the Surveys Involved in the Study
时间窗: Approximately 2 weeks
Results reflect the participants who came for visit 1 and completed all the surveys involved in the study.
Percentage of Study Surveys That Were Completed Per Protocol
时间窗: 8 weeks
Results reflect the percentage of surveys that participants completed during the treatment period (between visit 1 and visit 2) and the follow-up period (between visit 2 and visit 3). Each participant was sent 80 surveys total between visits 1 and 3, with 40 being sent between visit 1 and visit 2, and 40 being sent between visit 2 and visit 3. The time between visit 1 and visit 2 was 4 weeks, and the time between visit 2 and visit 3 was 4 weeks.
次要结局
未报告次要终点
研究者
Jorge Machicado, MD, MPH
Assistant Professor of Internal Medicine
University of Michigan