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

Primary Purpose

Endometriosis, Chronic Pain, Quality of Life

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Radiofrequency A
Radiofrequency B
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Hospital Clinic
  • Hospital Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Radiofrequency A

Placebo

Arm Description

Treatment with radiofrequency

Treatment with radiofrequency without energy

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
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
Female Sexual Function Index (FSFI)
Female Sexual Function Index (FSFI), minimum score is 2 and maximum score is 36, meaning no disfunction at all
Female Sexual Function Index (FSFI)
Female Sexual Function Index (FSFI), minimum score is 2 and maximum score is 36, meaning no disfunction at all

Full Information

First Posted
May 25, 2019
Last Updated
March 18, 2021
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT04012034
Brief Title
Treatment With Radiofrequency in Patients With Chronic Pelvic Pain and History of Endometriosis
Official Title
Treatment With Punction and Radiofrequency of Active Trigger Points in Patients With Pelvic Chronic Pain and History of Endometriosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 21, 2019 (Actual)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
May 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Chronic Pain, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiofrequency A
Arm Type
Experimental
Arm Description
Treatment with radiofrequency
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Treatment with radiofrequency without energy
Intervention Type
Device
Intervention Name(s)
Radiofrequency A
Intervention Description
Application of radiofrequency for 30 minutes per week during 8 weeks
Intervention Type
Device
Intervention Name(s)
Radiofrequency B
Intervention Description
Application of radiofrequency without energy for 30 minutes per week during 8 weeks
Primary Outcome Measure Information:
Title
Pain: VAS score
Description
Visual Analogue Scale Score, from 0 to 10, where 0 is no pain at all and 10 is the worst pain ever.
Time Frame
Baseline (Before starting the study)
Title
Pain: VAS score
Description
Visual Analogue Scale Score, from 0 to 10, where 0 is no pain at all and 10 is the worst pain ever.
Time Frame
1 month after study completion
Secondary Outcome Measure Information:
Title
Quality of life: QoL SF-36
Description
QoL SF-36, scale where 0 is maximum disability and a score of 100 is equivalent to no disability
Time Frame
Before starting the study
Title
Quality of life: QoL SF-36
Description
QoL SF-36, scale where 0 is maximum disability and a score of 100 is equivalent to no disability
Time Frame
1 month after study completion
Title
Female Sexual Function Index (FSFI)
Description
Female Sexual Function Index (FSFI), minimum score is 2 and maximum score is 36, meaning no disfunction at all
Time Frame
Before starting the study
Title
Female Sexual Function Index (FSFI)
Description
Female Sexual Function Index (FSFI), minimum score is 2 and maximum score is 36, meaning no disfunction at all
Time Frame
1 month after study completion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Carmona, MD, PhD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Clinic
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It is not intended to share IPD to other researchers since it is the first study of this kind in our setting.

Learn more about this trial

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

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