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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment With Punction and Radiofrequency of Active Trigger Points in Patients With Pelvic Chronic Pain and History of Endometriosis

Conditions
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Endometriosis, Chronic Pain, Quality of Life

Intervention / Treatment
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* Device: Radiofrequency A
* Device: Radiofrequency B


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiofrequency A<br>Treatment with radiofrequency | Device: Radiofrequency A<br>* Application of radiofrequency for 30 minutes per week during 8 weeks<br>|
| Placebo Comparator: Placebo<br>Treatment with radiofrequency without energy | Device: Radiofrequency B<br>* Application of radiofrequency without energy for 30 minutes per week during 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |