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

Hospital Clinic of Barcelona

Status: Unknown

Conditions: Quality of Life; Chronic Pain; Endometriosis

Treatments: Device: Radiofrequency B; Device: Radiofrequency A

Study type: Interventional

Funder types: Other

Identifiers

NCT04012034

RFDP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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26 participants in 2 patient groups, including a placebo group

Radiofrequency A

Experimental group

Description:

Treatment with radiofrequency

Treatment:

Device: Radiofrequency A

Placebo

Placebo Comparator group

Description:

Treatment with radiofrequency without energy

Treatment:

Device: Radiofrequency B