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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04012034
Recruitment Status : Recruiting
First Posted : July 9, 2019
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Francisco Carmona, Hospital Clinic of Barcelona

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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 : February 21, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Pain: VAS score [ Time Frame: 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.

  2. Pain: VAS score [ Time Frame: 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 :
  1. Quality of life: QoL SF-36 [ Time Frame: Before starting the study ]
    QoL SF-36, scale where 0 is maximum disability and a score of 100 is equivalent to no disability

  2. Quality of life: QoL SF-36 [ Time Frame: 1 month after study completion ]
    QoL SF-36, scale where 0 is maximum disability and a score of 100 is equivalent to no disability

  3. Female Sexual Function Index (FSFI) [ Time Frame: Before starting the study ]
    Female Sexual Function Index (FSFI), minimum score is 2 and maximum score is 36, meaning no disfunction at all

  4. Female Sexual Function Index (FSFI) [ Time Frame: 1 month after study completion ]
    Female Sexual Function Index (FSFI), minimum score is 2 and maximum score is 36, meaning no disfunction at all



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04012034


Contacts
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Contact: Mariona Rius, MD 0034932275534 marius@clinic.cat

Locations
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Spain
Hospital Clinic Recruiting
Barcelona, Spain, 08036
Contact: Francisco Carmona, PhD    34-93-227-5436    fcarmona@clinic.ub.es   
Principal Investigator: Francisco Carmona, MD         
Hospital Clinic Recruiting
Barcelona, Spain
Contact: Francisco Carmona    932275436    fcarmona@clinic.cat   
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
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Principal Investigator: Francisco Carmona, MD, PhD Hospital Clinic of Barcelona
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Responsible Party: Francisco Carmona, Head of gynecology department, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT04012034    
Other Study ID Numbers: RFDP
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: It is not intended to share IPD to other researchers since it is the first study of this kind in our setting.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometriosis
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Genital Diseases, Female