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临床试验/NCT02837588
NCT02837588Unknown1 期

Endocavitary Radiofrequency Treatment in Patients Who Present With Chronic Pelvic Pain Compared to Usual Drug Therapy

Universidad Rey Juan Carlos2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
1 期
入组人数
60
试验地点
2
主要终点
NIH-CPSI questionnaire

研究概览

简要总结

  • Treatment at pelvic floor with hyperactivity with hyperthermy electrode MJS
  • MJS electrode is effective for transvaginal treatment at pelvic pain patients
  • Hyperthermy treatment with MJS electrode is more effective to usual drugs treatment

详细描述

This study analyzed the evolution of chronic pelvic pain, defined by the different map of myofascial trigger points assets presents the patient with medical treatment compared to treatment with radiofrequency endocavitary electrode MJS. The initial evaluator analyzed by the NIH-CPSI Scale questionnaire and symptoms of chronic pelvic pain Stanford Protocol for female or male quality of life of the patient before the doctor or radio frequency and a month since treatment. the patient to the Principal Investigator, specialist physiotherapist, who appreciates tenderness the presence of a taut band with a map of pain in endopelvic and exopelvic muscles, determining the activation of myofascial trigger points in each is derived. The Principal Investigator proceeds to address each active myofascial trigger points with the MJS electrode four 20-minute sessions twice a week. The MJS has a curved end pressure which favors the compression point plus the location and accurate approach Radiofrequency pathological point as outstanding feature. The high specificity of myofascial treatment offered by the MJS electrode involves no danger, besides having the computer screen conductivity meter and a temperature sensor on the head to control both parameters in real time during the treatment session

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 (Care Provider)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with chronic pelvic pain

排除标准

  • chronic pelvic pain or neurological degenerative etiology
  • Presence of pathology or infectious processes genitourinary level
  • possibility of pregnancy or lactating.
  • Lack of informed consent, mental disorders, dementia, dependent people who need tutor.

结局指标

主要结局

NIH-CPSI questionnaire

时间窗: four weeks

questions for pelvic pain evaluation

次要结局

  • pain measure questionnaire(four weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marta Jerez Sainz

Director, coordinator of Pelvic floor department, Principal Investigator, Clinical Professor

Universidad Rey Juan Carlos

研究点 (2)

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