Treatment With Radiofrequency in Patients With Chronic Pelvic Pain and History of Endometriosis

Not Applicable

• Conditions: Endometriosis; Chronic Pain; Quality of Life
• Interventions: Device: Radiofrequency B; Device: Radiofrequency A

• Registration Number: NCT04012034
• Lead Sponsor: Hospital Clinic of Barcelona

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.

Study Timeline

• Study Start: 2019-02-21
• Study First Submitted: 2019-05-25
• Study First Submitted QC: 2019-07-08
• Study First Posted: 2019-07-09
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-18
• Last Update Posted: 2021-03-19
• Primary Completion: 2022-02
• Study Completion: 2022-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Radiofrequency B	Treatment with radiofrequency without energy
Radiofrequency A	Radiofrequency A	Treatment with radiofrequency

Primary Outcome Measures

Name	Time	Method
Pain: VAS score	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 Outcome Measures

Name	Time	Method
Female Sexual Function Index (FSFI)	1 month after study completion	Female Sexual Function Index (FSFI), minimum score is 2 and maximum score is 36, meaning no disfunction at all
Quality of life: QoL SF-36	1 month after study completion	QoL SF-36, scale where 0 is maximum disability and a score of 100 is equivalent to no disability

Trial Locations

Locations (1)

Hospital Clinic; 🇪🇸 Barcelona, Spain