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Clinical Trials/NCT04012034
NCT04012034
Unknown
N/A

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

Hospital Clinic of Barcelona1 site in 1 country26 target enrollmentFebruary 21, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Endometriosis
Sponsor
Hospital Clinic of Barcelona
Enrollment
26
Locations
1
Primary Endpoint
Pain: VAS score
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 21, 2019
End Date
May 30, 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Francisco Carmona

Head of gynecology department

Hospital Clinic of Barcelona

Eligibility Criteria

Inclusion Criteria

  • Chronic pelvic pain
  • Past surgery for endometriosis

Exclusion Criteria

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

Outcomes

Primary Outcomes

Pain: VAS score

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

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