Clinical trial NCT06673901: Biomechanical Changes in Females with Poly Cystic Ovarian Syndrome
Official title: Biomechanical Changes in Females with Poly Cystic Ovarian Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Poly Cystic Ovarian Syndrome
Polycystic Ovary Syndrome (PCOS)
Keywords: Biomechanical Changes
Spinopelvic alignment
Polycystic Ovarian Syndrome
Hormonal Imbalance
Low-grade Inflammation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 95
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study enrolled 95 females (52 PCOS, 43 Controls) who agreed to participate in this research. They signed an informed consent after explaining the existence, purpose, and advantages of the study, notifying them of their right to refuse or withdraw at any time. Patients were excluded from the study if they suffered from skeletal deformities (one case), had previous spinal surgeries (one case), had leg length discrepancy (one case) and two cases received hormone replacement therapy

Brief summary: Polycystic ovarian syndrome (PCOS) is a prevalent endocrine disorder that causes an inversion of the normal luteinizing hormone (LH) to follicle-stimulating hormone (FSH) ratio. Females with PCOS also experience chronic inflammation. This hormonal imbalance and persistent inflammation can reduce muscle strength and mass. Consequently, this may affect the lumbopelvic muscles, potentially leading to postural abnormalities and spinopelvic misalignment.

Detailed description: 1.1. Study design This was an observational case-control study. Participants This study enrolled 95 females (52 PCOS, 43 Controls) who agreed to participate in this research. They signed an informed consent after explaining the existence, purpose, and advantages of the study, notifying them of their right to refuse or withdraw at any time. Patients were excluded from the study if they suffered from skeletal deformities (one case), had previous spinal surgeries (one case), had leg length discrepancy (one case) and two cases received hormone replacement therapy

Eligibility criteria: Inclusion Criteria:

* Patients were referred by the gynecologist, based on Rotterdam PCOS Diagnostic Criteria in adults (14), having irregular menstrual cycles (less than 8 menstrual cycles/year or more than 35 days between cycles), painful menses and premenstrual abdominal bloating, and headaches.

Exclusion Criteria:

* were excluded from this study if they were obese with BMI \> 30 Kg/m2 (obesity induces an increase in anterior pelvic tilt and increased sacral inclination) (15), suffered from musculoskeletal deformities, previous gynecological and spinal surgeries, spinal deformities, leg length discrepancy, orthopedic and neurological disorders, receive hormone replacement therapy (affect functional biomechanical properties by increasing tensile stiffness in the uterosacral ligament and decreasing it in the round ligament)

Primary outcomes:
measure: I) Pelvic tilt angle
timeFrame: months 6
measure: ) Lumbar angle
timeFrame: month 6
Secondary outcomes:
measure: LH/FSH
timeFrame: month 6
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Rovan Elbesh
Study officials:
affiliation: Misr University for Science and Technology
name: rovan m saad, PHD
role: PRINCIPAL_INVESTIGATOR
References: