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

Sponsor

Hospital Clinic of Barcelona (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04012034

Collaborator

(none)

Enrollment

Locations

Arms

39.2

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis Chronic Pain Quality of Life	Device: Radiofrequency A Device: Radiofrequency B	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 21, 2019

Anticipated Primary Completion Date :

Feb 1, 2022

Anticipated Study Completion Date :

May 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pain: VAS score [Baseline (Before starting the study)]
Visual Analogue Scale Score, from 0 to 10, where 0 is no pain at all and 10 is the worst pain ever.
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

Quality of life: QoL SF-36 [Before starting the study]
QoL SF-36, scale where 0 is maximum disability and a score of 100 is equivalent to no disability
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
Female Sexual Function Index (FSFI) [Before starting the study]
Female Sexual Function Index (FSFI), minimum score is 2 and maximum score is 36, meaning no disfunction at all
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clinic	Barcelona		Spain	08036
2	Hospital Clinic	Barcelona		Spain

Sponsors and Collaborators

Hospital Clinic of Barcelona

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Francisco Carmona, Head of gynecology department, Hospital Clinic of Barcelona

ClinicalTrials.gov Identifier:

NCT04012034

Other Study ID Numbers:

RFDP

First Posted:

Jul 9, 2019

Last Update Posted:

Mar 19, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Endometriosis

Chronic Pain

Study Results

No Results Posted as of Mar 19, 2021