Repetitive Transcranial Magnetic Stimulation as an Analgesic Treatment in Endometriosis Chronic Pain : Feasibility Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Percentage of patients tolerant 5 sessions of stimulation and with no increase in pain
研究概览
简要总结
Endometriosis is associated with different types of pain (acute, chronic, excess nociception, neuropathic) generated by different mechanisms in the nervous system. The rTMS could provide significant analgesia for refractory endometriosis pain.
The aim of the study is to evaluate the feasibility of transcranial magnetic stimulation (rTMS) for analgesia on chronic refractory endometriosis pain.
详细描述
The first step consists of the inclusion of 12 patients followed by the filling by each patient of the RedCap software of five simple numerical scales for 4 weeks . Realization of a brain and medullary MRI to allow neuronavigation. Realization of 5 sessions of rTMS in 5 days during the first week then evaluation (physical examination, questionnaires) in consultation on post-stimulation. Then followed for 28 days in total through self-assessment of pain that will be filled daily on REDCap and last consultation on D28 for further evaluation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal (presence of at least one of the two ovaries and absence of clinical signs of menopause),
- •Not pregnant or breastfeeding;
- •At least one painful symptoms related to the existence of endometriosis (dyspareunia, dysmenorrhea, pain with defecation or urination, neuropathic pain);
- •Average VAS> 4/10, at least 4 days out of 7 for at least 3 months;
- •Hormonal treatment failure continued in association or not for pain control;
- •A level of understanding and satisfying expression in French;
- •Monitoring possible during the duration of the study (4 weeks).
- •These patients should be affiliated to the French social security and should have signed a written consent after receiving clear information.
排除标准
- •Prior treatment with rTMS,
- •Industrial accident or notion of litigation
- •Cons-indication for rTMS (cortical lesion within 2cm of the motor cortex, ECT treatment during previous month, epilepsy and / or a history of epilepsy, history of head trauma, intracranial hypertension;
- •Metal clip; pacemaker,
- •Pregnant or breastfeeding women;
- •Pain lasting less than 3 months;
- •Another pain more severe than that associated with endometriosis;
- •Lack of filling of the computerized questionnaires on Redcap;
- •Incapable of understanding about informed consent,
- •Patient under guardianship.
研究组 & 干预措施
Patients with chronic refractory endometriosis pain
The aim of the study is to evaluate the feasibility of transcranial magnetic stimulation (rTMS) for analgesia on chronic refractory endometriosis pain.
干预措施: Repetitive transcranial magnetic stimulation (Device)
结局指标
主要结局
Percentage of patients tolerant 5 sessions of stimulation and with no increase in pain
时间窗: at day 8
The feasibility of rTMS treatment was defined if 7 patients or more over 12 tolerate the 5 sessions of stimulation showed no increase in pain
次要结局
- Endometriosis Health Profile Questionnaire (EPH-30);(at day 8)
- Brief Pain Inventory (BPI): digital(at day 8)
- Migraine criteria (ICHD3)(at day 8)
- Gastrointestinal quality of Life Index (GICLI)(at day 8)
- Change in pain between the mean pain evaluated before inclusion(at day 8)
- Beck Questionnaire (Depression)(at day 8)
- STAI of Anxiety Scale; Scale of alexythymie of Toronto(at day 8)
- Catastrophizing Pain Scale (personality)(at day 8)
- Quality of Life Questionnaire SF-36(at day 8)