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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Quality of Life; Chronic Pain; Endometriosis
• Intervention / Treatment: Device: Radiofrequency A; Device: Radiofrequency B

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clínic
  • Barcelona, Spain
    • Hospital Clínic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiofrequency A; Treatment with radiofrequency	Device: Radiofrequency A; Application of radiofrequency for 30 minutes per week during 8 weeks
Placebo Comparator: Placebo; Treatment with radiofrequency without energy	Device: Radiofrequency B; Application of radiofrequency without energy for 30 minutes per week during 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Investigators: Principal Investigator: Francisco Carmona, MD, PhD, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2019
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): May 30, 2022

Study Registration Dates

• First Submitted: May 25, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Actual): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Endometriosis
• Other Study ID Numbers: RFDP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: It is not intended to share IPD to other researchers since it is the first study of this kind in our setting.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No