Evaluation of the Analgesic Effect of Direct Current Stimulation in the Treatment of Pelvic Pain, Comparing Three Groups: Trans-spinal Stimulation, Ganglionic Stimulation, and Placebo. A Randomized Double-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Evolution of Pain
研究概览
简要总结
The purpose of this study is to evaluate the analgesic effectiveness of direct current stimulation (tsDCS) in the treatment of pelvic pain by comparing three groups:
- Trans-spinal tsDCS stimulation,
- Ganglionic tsDCS stimulation,
- Placebo (sham) tsDCS stimulation.
详细描述
Conduct of study:
Entry into the study: After informed consent, patients will be randomised. The physician responsible for conducting neurostimulation sessions will make the randomization via Redcap. Only this physician will have the knowledge of the group allocated to the patient.
Baseline : Patients, will record on a diary form, a daily Visual Numeric Scale(VNS) of Pain Intensity for 1 week.
Treatment sessions: after the baseline, sessions of neurostimulation will begin for 5 weeks.
After the end of neurostimulation sessions, patients will be followed for 2 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 to 85 years, suffering from pelvic pain for more than one year (excluding musculoskeletal causes).
- •Patient with stable ongoing medication (analgesic or otherwise) for at least one month.
- •Patient for whom lack of response to conventional treatments has led the pain specialist or referring physician to consider non-pharmacological therapeutic options.
- •Patient reporting a pain intensity score >3 on the Numeric Visual Pain Scale (NVPS) during pre-screening.
- •Patient affiliated with the national health insurance system or an equivalent scheme.
- •Patient who has provided written informed consent.
排除标准
- •History of drug addiction.
- •History of psychiatric disorders likely to interfere with the proper conduct of the study.
- •Patient with skin lesions in the lumbar region.
- •Person unable to understand the study protocol.
- •Individuals covered by Articles L1121-5 to L1121-8 of the French Public Health Code, corresponding to all protected persons: pregnant women, women in labor, breastfeeding mothers, individuals deprived of liberty by judicial or administrative decision, or under legal protection.
- •Subject currently in the exclusion period of another clinical trial
结局指标
主要结局
Evolution of Pain
时间窗: Pain progression will be assessed from week 1 (before treatment) to week 7 (end of treatment)
Comparison between the 3 groups of the evolution of the weekly value of the Visual Numeric Pain Scale (VNPS): The patient will raise his pain level on a follow-up diary each day. The VNPS average will be calculated for each week. The VNS is a 10-point scale, ranging from 0 (worse) to 10 (better).
次要结局
- Rate of Responding Patients(week 7 compared with baseline)
- Evaluation of the analgesic effect maintenance(Between Week 5 (end of treatment) and Weeks 6 to 7 (post-treatment follow-up).)
- Assessment of Overall Patient Improvement.(Day 50 from the beginning of tsDCS treatment compared to baseline)
- Quality of Life Improvement.(Day 50 from the beginning of tsDCS stimulation treatment compared to baseline)
- Evolution of Anxiety and Depressive Traits.(Day 50 from the beginning of tsDCS treatment compared to baseline)
- Sympathetic Autonomic System Injury and Small Fiber Neuropathy.(Day 50 from the beginning of tsDCS treatment compared to baseline.)
- Autonomous System Assessement.(Day 50 from the beginning of tsDCS treatment compared to baseline.)
- Evolution of Symptomatological Profiles of Neuropathic Pain.(Day 50 from the beginning of tsDCS treatment compared to baseline)
- Evolution of the use of analgesic treatments.(From baseline to day 50.)