Chronic Pain, Endometriosis, Quality of Life
Conditions
Brief 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.
Detailed 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.
Interventions
DEVICERadiofrequency A
Application of radiofrequency for 30 minutes per week during 8 weeks
DEVICERadiofrequency B
Application of radiofrequency without energy for 30 minutes per week during 8 weeks
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain: VAS score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life: QoL SF-36 | Before starting the study | QoL SF-36, scale where 0 is maximum disability and a score of 100 is equivalent to no disability |
| Female Sexual Function Index (FSFI) | Before starting the study | Female Sexual Function Index (FSFI), minimum score is 2 and maximum score is 36, meaning no disfunction at all |
Countries
Spain
Outcome results
None listed