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临床试验/NCT06673901
NCT06673901已完成不适用

Biomechanical Changes in Females with Poly Cystic Ovarian Syndrome

Cairo University1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2023年4月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
95
试验地点
1
主要终点
I) Pelvic tilt angle

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
25 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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)

结局指标

主要结局

I) Pelvic tilt angle

时间窗: 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°)

) Lumbar angle

时间窗: 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).

次要结局

  • LH/FSH(month 6)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

rovan mohamed saad elbesh

lecturer

Misr University for Science and Technology

研究点 (1)

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