Treatment With Radiofrequency in Patients With Chronic Pelvic Pain and History of Endometriosis
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|ClinicalTrials.gov Identifier: NCT04012034|
Recruitment Status : Recruiting
First Posted : July 9, 2019
Last Update Posted : February 17, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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
- 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.
- 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.
- 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
- 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
- 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
- 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
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
|Contact: Mariona Rius, MDemail@example.com|
|Barcelona, Spain, 08036|
|Contact: Francisco Carmona, PhD 34-93-227-5436 firstname.lastname@example.org|
|Principal Investigator: Francisco Carmona, MD|
|Contact: Francisco Carmona 932275436 email@example.com|
|Principal Investigator:||Francisco Carmona, MD, PhD||Hospital Clinic of Barcelona|