Role of Home-Based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis (TEA-CuP): A Double-Blind, Sham-Controlled Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Difference of the difference of the Pain Severity Score based the Brief Pain Inventory-Short Form (BPI-SF) between start and end of each treatment period
研究概览
简要总结
Transcutaneous Electrical Acustimulation (TEA) is a noninvasive acupuncture method that can be self-administered at home without needles. TEA transmits a weak electrical current using electrodes placed at acupoints and has shown to safely reduce pain in other gastrointestinal conditions. This study will help elucidate if TEA is effective in treating abdominal pain in patients with painful chronic pancreatitis (CP).
详细描述
Pain in patients with CP is debilitating and impairs quality of life. Despite using medical, endoscopic, or surgical treatments, many patients continue experiencing substantial pain and some are prescribed long-term opioids. This clinical trial aims to assess the analgesic effect of a mild electrical stimulator called TEA. TEA consists of a small, wearable device that can be used at-home while doing daily activities. If effective, this could be an alternative non-pharmacological and non-invasive option to manage pain related to CP.
In this study, the investigators will conduct a randomized, sham-controlled, 2x2 crossover trial in patients with painful CP. Subjects will be randomized to receive either active TEA first followed by sham TEA, or sham TEA first followed by active TEA. Other than the application point in the skin, active and sham TEA will be identical. The study will examine the effect of TEA on pain severity (primary outcome), pain interference and overall pain experience (secondary outcomes). The study will be conducted over 12 weeks in 5 periods: run-in (1 week), treatment period 1 (4 weeks), washout (2 weeks), treatment period 2 (4 weeks), and close-out visit (1 week). Subjects will complete online questionnaires about pain and health throughout the duration of the study. There will be a total of 3 study visits that will be conducted at the main Ann Arbor Hospital or virtually. All the study tasks can be completed remotely. The study will recruit patients from a single clinical center and from self-referral from patients with CP in the US. The proposed study will advance our understanding on the role of TEA for non-opioid pain management of CP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Subjects will receive sham or active TEA with an identical device and set of electrodes. Outcomes will be assessed via self-reported surveys. The study coordinator will be unblinded to the randomized treatment assignment. The study coordinator will implement the randomization, conduct the active and sham TEA instruction sessions, and answer study-related questions to patients. The study coordinator will not be involved in the data analysis and will not reveal treatment assignment.
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 definite or suspected Chronic Pancreatitis (CP). Definite CP features include presence of pancreatic calcifications or Cambridge grade 3-4 on imaging. Suspected CP features include presence of Rosemont criteria suggestive of CP on endoscopic ultrasound or 2 documented attacks of acute pancreatitis separated by at least 1 month without other definite or suspected CP features.
- •Abdominal pain that is present for at least 3 months prior to enrollment and having experienced moderate intensity abdominal pain (rated as 4 or higher on a 0-10 Numeric Rating Scale) at least once in the last month.
排除标准
- •Breastfeeding mother
- •Pregnant or intending to become pregnant within the next 3 months
- •Incarcerated individuals
- •Unwillingness or inability to consent
- •Unable to read and speak English precluding completion of questionnaires.
- •Familiarity with acupoints that limit blinding
- •Currently receiving acupuncture therapy
- •Participation in another clinical trial
- •Undergoing treatment for cancer or has a suspected or confirmed diagnosis of pancreatic cancer
- •Substantial cognitive impairment or mental illness that would prevent providing informed consent and completion of questionnaires.
- •Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study
- •History of total pancreatectomy with or without islet autotransplantation
- •Had during the past month or plan to have within the next 3 months at least one of the following procedures: endoscopic retrograde cholangiopancreatography, pancreatic pseudocyst drainage, celiac plexus block or neurolysis, extracorporeal shock wave lithotripsy, or surgical pancreatic resection or drainage procedure
- •Presence of obstructed pancreatic duct that has not yet undergone an attempt for ductal decompression.
- •Known allergy to adhesive Electrocardiogram (ECG) electrodes
- •History of vagal nerve surgery
- •History of bilateral below the knee amputation
- •History of lower extremity paralysis
- •Presence of an implantable electrical stimulation device
研究组 & 干预措施
Active TEA first followed by sham TEA
Subjects will undergo active TEA for 4 weeks (week 1-4) followed by a 2-week washout period and then sham TEA for 4 weeks (week 7-10). Subjects will have two instruction visits, one before starting active TEA and one before starting sham TEA.
干预措施: TEA (Device)
Sham TEA first followed by active TEA
Subjects will undergo sham TEA for 4 weeks (week 1-4) followed by a 2-week washout period and then active TEA for 4 weeks (week 7-10). Subjects will have two instruction visits, one before starting active TEA and one before starting sham TEA.
干预措施: TEA (Device)
结局指标
主要结局
Difference of the difference of the Pain Severity Score based the Brief Pain Inventory-Short Form (BPI-SF) between start and end of each treatment period
时间窗: Baseline-4 weeks and weeks 6-10
The 4 pain intensity items (worst, least, average, and current pain) are rated on an 11-point numerical rating scale (0 = no pain, 10 = worst possible pain). A Pain Severity Score is calculated by adding the scores for the 4 items pertaining to pain intensity and then dividing this by 4. A higher number indicates higher levels of pain.
次要结局
- Difference of the difference of the Pain Interference Score on BPI-SF between start and end of each treatment period(Baseline-4 weeks and weeks 6-10)
- Difference of the difference of the average worst daily abdominal pain using a numeric rating scale (0-10) between start and end of each treatment period (baseline-4 weeks and weeks 6-10)(Baseline-4 weeks and weeks 6-10)
- Difference of the difference of the Change of Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) score between start and end of each treatment period(Baseline-4 weeks and weeks 6-10)
- Patient Global Impression of Change (PGIC) at end of each treatment period between the intervention group and sham group(4 weeks and 10 week)
- Predict difference of the difference of Pain Severity Score using pain widespreadedness at beginning of each treatment period(Baseline-4 weeks and weeks 6-10)
研究者
Jorge Machicado, MD, MPH
Assistant Professor of Internal Medicine
University of Michigan