NCT06209346 Multimodal Physiotherapy Based on Tele-rehabilitation in Chronic Pelvic Pain Associated With Endometriosis
| NCT ID | NCT06209346 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alcala |
| Condition | Endometriosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2023-11-27 |
| Primary Completion | 2025-01-17 |
Trial Parameters
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Brief Summary
* Objective: To determine if the tele-rehabilitation program for chronic pelvic pain associated with endometriosis composed of pain education, therapeutic exercise and respiratory control decreases pain according to the Visual Numerical Scale (EVN), catastrophizing with the Pain Catastrophizing Scale (PCS), kinesiophobia with the Tampa Scale of Kinesiophobia (TSK), improves sexual function according to the Female Sexual Function Index (FSFI) and QoL compared to the Control Group with the Health Status Questionnaire (SF-12). * Follow-up: four evaluated questionnaires: preintervention; postintervention, 3 months postintervention, 6 months postintervention * Participants: 66 women diagnosed with endometriosis with chronic pelvic pain in different Spanish endometriosis associations. * Randomization: women will be randomly assigned to two groups using the EpiData 3.1 software * Interventions: Experimental Group: therapeutic exercise + conscious breathing (16 sessions) and pain education (4 sessions) through the TRAK platform. Control Group: They will receive informative material in weeks 1, 3, 5 and 7 about their pathology and with recommendations for them to achieve healthy lifestyle habits that do not further damage their disease.
Eligibility Criteria
Inclusion Criteria: * Women with a medical diagnosis of endometriosis. * Age equal to or older than 18 years and up to 55 years. * Who are or have received medical and/or surgical treatment and with controlled disease. * Persistent pelvic pain for at least 3 months. * Pain greater than 4 on the EVN. * No cognitive limitation to understand the information sheet, instructions and freely sign the informed consent * Have any electronic device available (tablet, computer, cell phone). * Have a current email address. * Have a valid e-mail address. Exclusion Criteria: * Peri- and postmenopausal women. * Women pregnant or desiring gestation during the study. * Women with a history of gynecologic cancer and/or undergoing any systemic and/or localized oncologic treatment in the pelviperineal region * Women with a diagnosis of chronic fatigue or fibromyalgia▪. * Women concomitantly participating in another intervention study. * Women undergoing surgery during the study.