NCT06209346Recruiting
Multimodal Physiotherapy Based on Tele-rehabilitation in Chronic Pelvic Pain Associated With Endometriosis
Source: ClinicalTrials.gov · Last updated 17 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
* 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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 5 Dec 2023
- Start date
- 27 Nov 2023
- Primary completion date
- 17 Jan 2025
- Lead sponsor
- University of Alcala
- Diseases
- Endometriosis
- NCT number
- NCT06209346
What you commit to
- Study type: Interventional
- Planned participants: 66
- From 27 Nov 2023 to the primary completion date, 17 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Women undergoing surgery during the study.
Other illness
- Women with a history of gynecologic cancer and/or undergoing any systemic and/or localized oncologic treatment in the pelviperineal region
Other
- Peri- and postmenopausal women.
- Women pregnant or desiring gestation during the study.
- Women with a diagnosis of chronic fatigue or fibromyalgia▪.
- Women concomitantly participating in another intervention study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Physiotherapy in women´s health research group. University of Alcalà Coordinator of this site? Confirm its status | Alcalà de Henares | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.