Biomechanical Changes in Females with Poly Cystic Ovarian Syndrome

NCT ID: NCT06673901

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 95 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-03
• Study Completion Date: 2024-09-03

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

Conditions

Poly Cystic Ovarian Syndrome; Polycystic Ovary Syndrome (PCOS)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

study group (A)

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

Measurments

Intervention Type: DEVICE

Each angle was measured three times, and the mean was calculated to represent the data used for statistical analysis. The assessment position for all measurements was relaxed, comfortable standing position and wearing loose clothing, bare feet, and one foot apart between two feet on a level floor in the same room of the same building, at the same time of day. There was a fixed point in the wall, and the woman was instructed to look at it during the assessment; this point adjusts at the level of her eyes. No specific instructions were provided to the females regarding posture so that measurements during a normal standing position. Data was recorded in a data-collecting sheet.

control group (B).

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. Forty-three healthy females not suffering from any gynecological condition were referred by a gynecologist and considered the

Measurments

Intervention Type: DEVICE

Each angle was measured three times, and the mean was calculated to represent the data used for statistical analysis. The assessment position for all measurements was relaxed, comfortable standing position and wearing loose clothing, bare feet, and one foot apart between two feet on a level floor in the same room of the same building, at the same time of day. There was a fixed point in the wall, and the woman was instructed to look at it during the assessment; this point adjusts at the level of her eyes. No specific instructions were provided to the females regarding posture so that measurements during a normal standing position. Data was recorded in a data-collecting sheet.

Interventions

Measurments

Each angle was measured three times, and the mean was calculated to represent the data used for statistical analysis. The assessment position for all measurements was relaxed, comfortable standing position and wearing loose clothing, bare feet, and one foot apart between two feet on a level floor in the same room of the same building, at the same time of day. There was a fixed point in the wall, and the woman was instructed to look at it during the assessment; this point adjusts at the level of her eyes. No specific instructions were provided to the females regarding posture so that measurements during a normal standing position. Data was recorded in a data-collecting sheet.

Intervention Type: DEVICE

Other Intervention Names

the inclinometer; PALM inclinometer; LH/FSH

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)

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

rovan mohamed saad elbesh

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

rovan m saad, PHD

Role: PRINCIPAL_INVESTIGATOR

Misr University for Science and Technology

Locations

Rovan Elbesh

Giza, , Egypt

Countries

Egypt

Other Identifiers

NP.T.REC/012/001889

Identifier Type: -

Identifier Source: org_study_id