EndoGym Progetto di Riabilitazione Del Pavimento Pelvico e Trattamento Del Dolore Miofasciale e Dispareunia Tramite la Pratica Dello Yoga in Pazienti Con Diagnosi di Endometriosi.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Evaluate the combined effects of Yoga practice and pelvic floor physiotherapy (PFP) on chronic pelvic pain (CPP) in endometriosis patients
Study Overview
Brief Summary
The aim of this study is to evaluate the combined effects of Yoga practice and pelvic floor physiotherapy (PFP) on chronic pelvic pain (CPP) and dyspareunia in endometriosis patients.
This is a retrospective study carried out from April 2024 to November 2024 conducted by University Hospital Modena (Italy). A total of 82 women with confirmed diagnosis of endometriosis were initially enrolled in the ENDOGYM program. Among them, 50 patients (61%) were therefore included in the final analysis. ENDOGYM consists of 12 weekly sessions over a period of 3 months. It includes two PFP sessions, lasting 1 hour each (one at the start and one at the end of the program), and 12 Yoga sessions, once a week, each lasting 60 minutes. EHP-30 questionnaire was used before and after the program to evaluate women's QoL; NRS scale was used before, half-way and after the program to evaluate CPP and dyspareunia.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •women with an ultrasound and/or post-operative histological diagnosis of endometriosis
- •aged between 18-50 years
- •currently undergoing medical treatment (for at least 3 months before the start of the study), and/or who have previously undergone surgical treatment
- •with myofascial pain ≥ 7 (NRS scale) and deep dyspareunia ≥ 7 (NRS scale).
Exclusion Criteria
- •being pregnant
- •undergoing surgery in the past 6 months
- •concurrent diagnosis of fibromyalgia
- •documented pelvic and/or spine trauma within 5 years of recruitment
- •patients with interstitial cystitis and > 2 urinary tract infections per year, unless possibly related to endometriosis (non-bacterial)
- •patients with recurrent vaginal infections, mucocutaneous inflammations of the vulva and vagina.
Outcomes
Primary Outcomes
Evaluate the combined effects of Yoga practice and pelvic floor physiotherapy (PFP) on chronic pelvic pain (CPP) in endometriosis patients
Time Frame: From enrollment to the end of the lessons at 3 months
Before the start of the project, a disease-specific questionnaire to measure the QoL of women with endometriosis, the Endometriosis Health Profile-30 (EHP-30) questionnaire, was used to collect data about pain, control and powerlessness, emotional well-being, social support, self-image, work life, sexual intercourse, relationship with children, the medical profession, treatment, and infertility. Response categories are evaluated using a five-point Likert scale (0-4), and each EHP-30 scale is converted into a scoring system ranging from 0 to 100, where 0 indicates the best possible health status and 100 represents the worst possible health status. The Italian version of EHP-30 was used. Finally, at the end of the project, the women completed the EHP-30 questionnaire again. Comparisons of EHP-30 total and domain scores before and after the ENDOGYM program were performed using paired t-tests (two-tailed).
Secondary Outcomes
- Evaluate the combined effects of Yoga practice and pelvic floor physiotherapy (PFP) on dyspareunia in endometriosis patients(From the enrollment till the end of the lessons at 3 months)
Investigators
Carlo Alboni, MD, PhD
MD
Azienda Ospedaliero-Universitaria di Modena