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

NCT ID: NCT04012034

Last Updated: 2021-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-21

Study Completion Date

2022-05-30

Brief Summary

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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

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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.

Conditions

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Endometriosis Chronic Pain Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Radiofrequency A

Treatment with radiofrequency

Group Type EXPERIMENTAL

Radiofrequency A

Intervention Type DEVICE

Application of radiofrequency for 30 minutes per week during 8 weeks

Placebo

Treatment with radiofrequency without energy

Group Type PLACEBO_COMPARATOR

Radiofrequency B

Intervention Type DEVICE

Application of radiofrequency without energy for 30 minutes per week during 8 weeks

Interventions

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Radiofrequency A

Application of radiofrequency for 30 minutes per week during 8 weeks

Intervention Type DEVICE

Radiofrequency B

Application of radiofrequency without energy for 30 minutes per week during 8 weeks

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Francisco Carmona

Head of gynecology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francisco Carmona, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

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Hospital Clinic

Barcelona, , Spain

Site Status

Hospital Clinic

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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RFDP

Identifier Type: -

Identifier Source: org_study_id

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