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临床试验/NCT04012034
NCT04012034Unknown不适用

Treatment With Punction and Radiofrequency of Active Trigger Points in Patients With Pelvic Chronic Pain and History of Endometriosis

Hospital Clinic of Barcelona2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2019年2月21日最近更新:
适应症

试验速览

阶段
不适用
入组人数
26
试验地点
2
主要终点
Pain: VAS score

研究概览

简要总结

Managing chronic pelvic pain in patients with a past history of endometriosis might be a challenge for the gynaecologist.

The objective of this study is to evaluate pelvic pain after treatment with radiofrequency in patients with chronic pelvic pain and surgery for endometriosis.

详细描述

Patients with pelvic chronic pain and a past history of endometriosis without imaging evidence of endometriosis in the present will be enrolled in this study. The main objective of this study is to evaluate improvement of pelvic pain these patients. Moreover, quality of life and sexual function will be also assessed. Patients who are enrolled will come once a week per eight weeks to the hospital to have 30 minutes treatment with radiofrequency. They will be randomised in two groups, one receiving the radiofrequency and the other not (the device will be not give the energy). At the enrollement visit, the SF-36, VAS score, anxiety and depression tests and sexual function tests will be answered the patients. At the end of the treatment, and one month after the end, they will answer the same questionnaires.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Chronic pelvic pain
  • Past surgery for endometriosis

排除标准

  • Active endometriosis, diagnosed by imaging techniques
  • Presence of other diseases that can cause chronic pelvic pain
  • Contraindication for the radiofrequency use: pregnancy, metallic prothesis

结局指标

主要结局

Pain: VAS score

时间窗: 1 month after study completion

Visual Analogue Scale Score, from 0 to 10, where 0 is no pain at all and 10 is the worst pain ever.

次要结局

  • Female Sexual Function Index (FSFI)(1 month after study completion)
  • Quality of life: QoL SF-36(1 month after study completion)

研究者

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

Francisco Carmona

Head of gynecology department

Hospital Clinic of Barcelona

研究点 (2)

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