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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04012034
Other study ID # RFDP
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 21, 2019
Est. completion date May 30, 2022

Study information

Verified date March 2021
Source Hospital Clinic of Barcelona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 26
Est. completion date May 30, 2022
Est. primary completion date February 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Radiofrequency A
Application of radiofrequency for 30 minutes per week during 8 weeks
Radiofrequency B
Application of radiofrequency without energy for 30 minutes per week during 8 weeks

Locations

Country Name City State
Spain Hospital Clinic Barcelona
Spain Hospital Clinic Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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 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 Before starting the study
Secondary 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 1 month after study completion
Secondary Female Sexual Function Index (FSFI) Female Sexual Function Index (FSFI), minimum score is 2 and maximum score is 36, meaning no disfunction at all Before starting the study
Secondary Female Sexual Function Index (FSFI) Female Sexual Function Index (FSFI), minimum score is 2 and maximum score is 36, meaning no disfunction at all 1 month after study completion
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