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临床试验/NCT02958423
NCT02958423Unknown1 期

Transcranial Direct Current Stimulation (tDCS) vs Trans-spinal Direct Current Stimulation (tsDCS) for Endometriosis-related Chronic Pelvic Pain Treatment: A Single Center, Prospective, Randomized, Controlled, Parallel Group Pilot Study

Jean Schoenen2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
1 期
发起方
入组人数
20
试验地点
2
主要终点
Antalgic effect of direct current stimulation by measuring Quantitative Sensory Testing (QST)

研究概览

简要总结

The purpose of the study is to compare the analgesic effect of 2 mA anodal direct current stimulation on the right primary motor cortex (M1) (tDCS) with a similar stimulation on the spine (D10) (tsDCS) in healthy volunteers (HV) followed by a pilot study in patients suffering of endometriosis-related chronic pelvic pain (CPP)

详细描述

  • 2 groups of 5 HV will receive tDCS or tsDCS (2mA, anodal, 20min) and the thermonociceptive threshold will be measured before and after the stimulation over the abdomen (hypogastric). The HAD scale and SF-36 will also be tested.

The treatment(s) that produces the greatest increase in pain thresholds will be chosen to treat 10 patients.

  • 10 patients suffering from endometriosis-related chronic pelvic pain will be treated by the most efficient treatment (tDCS or tsDCS) for 4 weeks (5 daily 20-min sessions per week), or, if no treatment modality was superior in HV, 5 patients will be treated by tDCS and 5 by tsDCS. Patients will fill in daily a dedicated diary 2 weeks before treatment, during the4-week treatment period and after this period as long as their pain level remains below 80% of their baseline pain intensity (VAS). Analgesic intake will also be monitored as well as HAD and SF-36 scores.

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 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • HV: good health.
  • CPP patients: surgical diagnosis of endometriosis within the last 10 years; diagnosis of chronic pelvic pain (according to ACOG); mean VAS pain score >4 during severe episodes.

排除标准

  • HV: chronic pain disorder; no regular medication or illicit drug use.
  • CPP patients: pregnancy; other medical or psychiatric condition interfering with pelvic pain assessment.

结局指标

主要结局

Antalgic effect of direct current stimulation by measuring Quantitative Sensory Testing (QST)

时间窗: 30 minutes

次要结局

未报告次要终点

研究者

发起方
Jean Schoenen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jean Schoenen

Professor

University of Liege

研究点 (2)

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