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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04012034
• Other study ID #: RFDP
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 21, 2019
• Est. completion date: May 30, 2022

Study information

• Verified date: March 2021
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: May 30, 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Endometriosis
• Quality of Life

Intervention

Device:
• Radiofrequency A
Application of radiofrequency for 30 minutes per week during 8 weeks
• Radiofrequency B
Application of radiofrequency without energy for 30 minutes per week during 8 weeks

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona
Spain	Hospital Clinic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain: VAS score	Visual Analogue Scale Score, from 0 to 10, where 0 is no pain at all and 10 is the worst pain ever.	Baseline (Before starting the study)
Primary	Pain: VAS score	Visual Analogue Scale Score, from 0 to 10, where 0 is no pain at all and 10 is the worst pain ever.	1 month after study completion
Secondary	Quality of life: QoL SF-36	QoL SF-36, scale where 0 is maximum disability and a score of 100 is equivalent to no disability	Before starting the study
Secondary	Quality of life: QoL SF-36	QoL SF-36, scale where 0 is maximum disability and a score of 100 is equivalent to no disability	1 month after study completion
Secondary	Female Sexual Function Index (FSFI)	Female Sexual Function Index (FSFI), minimum score is 2 and maximum score is 36, meaning no disfunction at all	Before starting the study
Secondary	Female Sexual Function Index (FSFI)	Female Sexual Function Index (FSFI), minimum score is 2 and maximum score is 36, meaning no disfunction at all	1 month after study completion