Home-based transcutaneous electrical acustimulation for abdominal pain

家庭经皮电针治疗腹痛

• 批准号: 10045379
• 负责人: Jiande Chen
• 金额: $ 128.4万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-30 至 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10045379
• 关键词: Abdominal Pain; Acupuncture Points; Acupuncture Therapy; Acustimulation; Acute; Adult; Affect; Analgesics; Animal Model; Basic Science; Clinical; Clinical Data; Clinical Research; Clinical Trials; Collaborations; Constipation; Country; Data; Development; Device or Instrument Development; Devices; Diarrhea; Electric Stimulation; Electroacupuncture; Electrodes; Esthesia; Financial cost; Future; Gastrointestinal Diseases; Gastroparesis; Grant; Healthcare; Heroin; Home environment; Hospitals; Hypersensitivity; Impairment; Irritable Bowel Syndrome; Location; Medical; Medical center; Methodology; Methods; Monitor; Morphine; Narcotics; Nausea and Vomiting; Needles; Neuromodulator; Opioid; Outcome; Pain; Pain management; Patients; Peripheral Nerves; Pharmacology; Phase; Physicians; Physiological; Population; Randomized; Recording of previous events; Regulatory Affairs; Surface; Symptoms; Testing; Therapeutic; Time; Treatment Efficacy; Treatment Protocols; Treatment outcome; United States National Institutes of Health; Visceral; Visceral pain; Work; base; chronic abdominal pain; cloud platform; compliance behavior; computerized; cost; data mining; design; improved; neuroregulation; novel; novel therapeutics; opioid epidemic; opioid use; pain score; patient health information; patient population; patient subsets; pressure; primary outcome; recruit; rectal; research study; side effect; smartphone Application; success; therapy outcome

Abdominal pain is the main symptom in patients with the irritable bowel syndrome (IBS) that is the most common gastrointestinal disorder affecting 14-20% of the US population. More than 40% of patients with IBS regularly use opioid narcotics. Currently no adequate therapies are available for pain in patients with IBS. Acupuncture or electroacupuncture (EA) has been shown to be effective for pain management and may have a potential for treating pain against opioid crisis; however, it has drawbacks of infrequent administration, lack of optimization in methodology and unclear mechanisms. In this study, we propose a noninvasive method of transcutaneous electrical acustimulation (TEA) by replacing needles with surface electrodes and by choosing a few acupoints in the vicinity of peripheral nerves. The proposed TEA is based on a number of previous basic mechanistic researches and clinical studies. Methodologically, two effective sets of stimulation parameters and two effective acupoints have been derived for treating visceral hypersensitivity. Mechanistically, appropriate TEA has been shown to improve autonomic functions that are impaired in IBS. Clinically, the proposed TEA can be self-administrated at home/work and therefore daily treatment is feasible, which greatly improves its efficacy. During the UG3 phase, an existing TEA device will be modified for treating chronic abdominal pain in IBS. First, a special cellphone app will be developed 1) to keep a history of each treatment, which is critical in assessing therapy compliance, and 2) to collect and store major treatment outcomes daily and weekly, and transit these information (de-identified) to a server automatically; this will minimize missing or loss of critical treatment outcome information and will be useful for future data mining and therapy refinement. Secondly, an acute clinical physiological test will be performed to derive best stimulation locations and parameters. During the UH3 phase, an early feasibility clinical study will be performed in 160 patients with IBS. While the primary aim is to investigate the therapeutic potential of the proposed TEA in treating abdominal pain in IBS, the study is also designed to identify subgroups of patients (mild pain vs. moderate pain; constipation vs. diarrhea) who may respond to TEA for a future large scale clinical study and to compare the analgesic effect and autonomic mechanisms between the electrical neuromodulation therapy (TEA) and a medical neuromodulation therapy (pharmacological neuromodulators). A comprehensive team has been assembled, including experts in neuromodulation, abdominal pain, IBS, device development and regulatory affairs. The project results from a close collaboration between a strong academic center in managing visceral pain and IBS, and a start-up company devoted to bringing the proposed novel therapy to patients and hospitals.

腹痛是肠易激综合征（IBS）患者的主要症状 常见的胃肠道疾病影响了14-20％的美国人口。超过40％的IBS患者 定期使用阿片类药物。目前，没有足够的疗法可用于IBS患者的疼痛。 针灸或电针（EA）已证明对疼痛管理有效，可能有 一种治疗阿片类药物危机疼痛的潜力；但是，它具有不经常管理的缺点，缺乏 方法论和不清机制的优化。在这项研究中，我们提出了一种无创的方法 通过用表面电极代替针头并选择一个针头，并选择一个 周围神经附近很少有穴位。拟议的茶基于许多以前的基本 机械研究和临床研究。从方法上讲，两组有效的刺激参数和 为治疗内脏超敏反应而得出了两个有效的穴位。机械上，适当的茶 已证明可以改善IBS中受损的自主功能。临床上，建议的茶可能是 在家/工作中自我管理，因此每日治疗是可行的，这大大提高了其功效。 在UG3阶段，将修改现有的茶具，以治疗IBS的慢性腹痛。 首先，将开发一个特殊的手机应用程序1）保留每种治疗的病史，这在 评估治疗依从性，2）每天和每周收集和存储主要治疗结果，以及 将这些信息（去识别）自动传输到服务器；这将最大程度地减少缺失或失去关键 治疗结果信息，将有助于将来的数据挖掘和治疗改进。其次，一个 将进行急性临床生理测试，以得出最佳的刺激位置和参数。 在UH3阶段，将对160例IBS患者进行早期可行性临床研究。而 主要目的是研究拟议茶在治疗IBS腹痛的治疗潜力， 研究还旨在鉴定患者的亚组（轻度疼痛与中度疼痛；便秘与腹泻） 谁可能对茶进行反应，以进行将来的大规模临床研究，并比较镇痛作用和自主神经 电神经调节疗法（TEA）与医学神经调节疗法之间的机制 （药理神经调节剂）。 一支全面的团队已经组装了，包括神经调节，腹痛，IBS， 设备开发和监管事务。该项目是由于强大之间的密切合作而产生的 管理内脏疼痛和IBS的学术中心，以及一家专门用于带来拟议的初创公司 对患者和医院的新疗法。