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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency A | Experimental | Treatment with radiofrequency |
|
| Placebo | Placebo Comparator | Treatment with radiofrequency without energy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency A | Device | Application of radiofrequency for 30 minutes per week during 8 weeks |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco Carmona, MD, PhD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic | Barcelona | 08036 | Spain | |||
| Hospital Clinic |
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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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Radiofrequency B | Device | Application of radiofrequency without energy for 30 minutes per week during 8 weeks |
|
| 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 |
| Barcelona |
| Spain |
| D000091662 | Genital Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |