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Biomechanical Changes in Females with Poly Cystic Ovarian Syndrome

Biomechanical Changes in Females with Poly Cystic Ovarian Syndrome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06673901
Enrollment
95
Registered
2024-11-05
Start date
2023-04-03
Completion date
2024-09-03
Last updated
2024-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poly Cystic Ovarian Syndrome, Polycystic Ovary Syndrome (PCOS)

Keywords

Biomechanical Changes, Spinopelvic alignment, Polycystic Ovarian Syndrome, Hormonal Imbalance, Low-grade Inflammation

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

Interventions

DEVICEMeasurments

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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 35 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
I) Pelvic tilt anglemonths 6While the female was upright, the physiotherapist recorded accurate measurements of the anterior superior iliac spine (ASIS) and posterior superior iliac spine (PSIS). As a result, the therapist adjusted the PALM inclinometer's one end arm on ASIS and the other on PSIS. As detected by the bubble level in the PALM inclinometer, the pelvic sagittal inclination angle was the angle between a horizontal line and a line passing between the ASIS and PSIS. The previous measurement was taken on the right and left sides of the pelvis. This approach has intra-tester solid reliability (ICC = 0.87) and accuracy and validity (17). The mean pelvic tilt angle value ranges from (13° ± 6°)
) Lumbar anglemonth 6Before the examination, the physiotherapist identifies and applies a skin marker on the spinous processes of the T12 and L5. The inclinometer dial measured the lumbar angle at zero degrees at the wall. Then put the inclinometer kindly but firmly into the inter-spinal spaces at T12 and position at L5, so obtaining the lumbar angle. Neutral values of the lumbar angle are 20º-40º (19). The baseline inclinometer was used with high intra-rater reliability (ICC=0.92) of the bubble inclinometer (20).

Secondary

MeasureTime frameDescription
LH/FSHmonth 6Statistical analysis was conducted using SPSS for Windows, version 26 (SPSS, Inc., Chicago, IL). Variances and covariances were homogeneous (p\> 0.05), as assessed by Levene's test of homogeneity of variances. Accordingly, parametric statistics were used. Quantitative variables were presented as mean ± standard deviation (X ± SD). An unpaired t-test was used to compare the physical characteristics of both groups. One-way between-subject MANOVA was conducted to determine the differences between both groups in the degree of pelvic inclination, lumbar curve angle, and hormones (LH &FSH). Pearson's correlation coefficient was used to investigate the relationship between pelvic inclination, lumbar curve angle, and hormones (LH &FSH) in females with PCOS. The alpha level was set at 0.05, and the correlation coefficients were interpreted as 0-0.1 = extremely low, 0.10-0.30 = low, 0.30-0.50 = moderate, 0.50-0.70 = high, 0.70-0.90 = extremely high, and 0.90-1.0 = strong

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026