The Efficacy and Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation on Abdominal Pain and Other Symptoms in Patients With Constipation-predominant Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in аbdominal pain between sham and active taVNS
研究概览
简要总结
This study aims to investigate the effects and possible mechanisms of transcutaneous auricular vagal nerve stimulation (taVNS) on abdominal pain and other symptoms in patients with IBS-C.
详细描述
This study is designed as an early-feasibility, single-center, single-blinded, randomized controlled trial (RCT), in which subjects are consented, undergo a baseline assessment, and receive taVNS or sham-taVNS treatment twice a day (8 a.m. and 8 p.m.) for 30 minutes each time for a period of 4 weeks. The taVNS and sham-taVNS treatment was applied using the commercially-available Transcutaneous Electrical Applicator device (Model SNM-FDC01, Ningbo MedKinetic Medical Device Co., Ltd.) with the skin electrodes placed bilaterally on auricular concha. The patients are requested to score the abdominal pain (using VAS) and complete BSFS, IBS-SSS, IBS-QOL, SAS, and SDS forms every week and fill out the bowel diary during taVNS or sham-taVNS. Emergency medications (Macrogol 4000 and pinaverium) are permitted for use when the patient cannot tolerate symptoms of constipation and abdominal pain.
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
- Single (Participant)
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
- 是
入选标准
- •willing to sign a written informed consent form
- •met the Rome IV diagnostic criteria for IBS-C
排除标准
- •history of previous abdominal surgery (other than appendectomy)
- •presence of carcinoma
- •any organic diseases causing constipation or neurologic diseases such as multiple sclerosis, rachischisis, Parkinson's disease, or spinal cord injury
- •taking antidepressant agents including tricyclic antidepressants and selective serotonin reuptake inhibitors
- •serious concomitant disease of the heart, liver, kidney, or diabetes
- •pregnancy or lactation
- •participating in another trial or enrolled in a trial during the past month
- •allergic reaction to surface electrodes
结局指标
主要结局
Change in аbdominal pain between sham and active taVNS
时间窗: 4 weeks
Weekly average of daily patient-assessed abdominal pain using the visual analog scale (VAS). VAS ranges from 0 to 10, with 0 indicating no abdominal pain and 10 indicating the maximal pain. Efficacy is evaluated as an improvement of ≥ 30%.
次要结局
- Change in IBS quality of life (IBS-QOL) between sham and active taVNS(4 weeks)
- Change in Self-Rating Depression Scale (SDS) score between sham and active taVNS(4 weeks)
- Change in complete spontaneous bowel movements per week between sham and active taVNS(4 weeks)
- Change in Bristol stool form scale (BSFS) between sham and active taVNS(4 weeks)
- Change in IBS symptom severity scale (IBS-SSS) between sham and active taVNS(4 weeks)
- Change in Self-Rating Anxiety Scale (SAS) score between sham and active taVNS(4 weeks)
研究者
Xiaodan Shi
Junior Physician
Shanghai East Hospital