Sacral Transcutaneous Electrical Stimulation Efficacy in Chronic Pelvic Pain: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Visual Numeric Scale of Pain
研究概览
简要总结
The goal of this interventional study is to test of efficacy of sacral Transcutaneous Electrical Stimulation (TENS) in patients with chronic pelvic pain.
The main questions it aims to answer are:
- Is sacral transcutaneous electrical stimulation (TENS) effective to reduce/relief pain in patients with chronic pelvic pain?
- Is the effect of TENS comparable to sham stimulation therapy in patients with chronic pelvic pain?
详细描述
Our study aiming to test the efficacy of sacral transcutaneous electrical stimulation (TENS) intervention in patients with chronic pelvic pain. We aim to test the efficacy and compare it with sham stimulation therapy in chronic pelvic 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)
盲法说明
Only participants are blinded for the intervention. Care provider (physiotherapist), investigator (medical doctor, physiatrist) and outcomes assessor (medical doctor, physiatrist) are not blinded and they are know which intervention (TENS or sham stimulation) is provided to the patients.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female with chronic pelvic pain for ≥6 months
- •18-65 years old
- •Visual Numeric Scale of Pain score ≥4/10
- •Voluntarily participate to the study
排除标准
- •Pregnancy
- •Having severe medical and/or psychiatric disorder
- •Malignancy
- •Chronic infection
- •Inflammatory musculoskeletal system disease
- •Skin infection in sacral/pelvic area
- •Having implanted neuromodulatory device (such as pacemaker or defibrillator)
- •Refusing to participate the study
结局指标
主要结局
Visual Numeric Scale of Pain
时间窗: Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment
Patients with Chronic Pelvic Pain assessed their pain levels before, right after and 1 month after treatment
次要结局
- The Pelvic Pain Impact Questionnaire(Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment)
- Female Sexual Function Index(Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment)
- Patient Satisfaction Questionnaire(Immediately After Treatment and 1 Month After Treatment)
研究者
Nalan Capan Bolukbas
Associate Professor
Istanbul University