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
1 other identifier
interventional
26
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2019
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 21, 2019
CompletedFirst Submitted
Initial submission to the registry
May 25, 2019
CompletedFirst Posted
Study publicly available on registry
July 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2022
CompletedMarch 19, 2021
March 1, 2021
2.9 years
May 25, 2019
March 18, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Quality of life: QoL SF-36
Before starting the study
Quality of life: QoL SF-36
1 month after study completion
Female Sexual Function Index (FSFI)
Before starting the study
Female Sexual Function Index (FSFI)
1 month after study completion
Study Arms (2)
Radiofrequency A
EXPERIMENTALTreatment with radiofrequency
Placebo
PLACEBO COMPARATORTreatment with radiofrequency without energy
Interventions
Application of radiofrequency for 30 minutes per week during 8 weeks
Application of radiofrequency without energy for 30 minutes per week during 8 weeks
Eligibility Criteria
You may qualify if:
- Chronic pelvic pain
- Past surgery for endometriosis
You may not qualify if:
- Active endometriosis, diagnosed by imaging techniques
- Presence of other diseases that can cause chronic pelvic pain
- Contraindication for the radiofrequency use: pregnancy, metallic prothesis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hospital Clinic
Barcelona, 08036, Spain
Hospital Clinic
Barcelona, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francisco Carmona, MD, PhD
Hospital Clinic of Barcelona
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of gynecology department
Study Record Dates
First Submitted
May 25, 2019
First Posted
July 9, 2019
Study Start
February 21, 2019
Primary Completion
February 1, 2022
Study Completion
May 30, 2022
Last Updated
March 19, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share
It is not intended to share IPD to other researchers since it is the first study of this kind in our setting.