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Completed

NCT Number: NCT06673901

Biomechanical Changes in Females with Poly Cystic Ovarian Syndrome

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.

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Key information

Conditions

Poly Cystic Ovarian Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Polycystic Ovary Syndrome (PCOS) Urogenital Diseases

Age range

25 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Rovan Elbesh

Giza, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Measurments

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.

Other names: the inclinometer, PALM inclinometer, LH/FSH

Primary outcomes

  1. I) Pelvic tilt angle

    Time frame: months 6

    While 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°)

  2. ) Lumbar angle

    Time frame: month 6

    Before 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 outcomes

  1. LH/FSH

    Time frame: month 6

    Statistical 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 5, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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