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临床试验/NCT05403424
NCT05403424已完成不适用

Investigation of Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnant Women With Pelvic Girdle Pain

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey2 个研究点 分布在 2 个国家目标入组 103 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
103
试验地点
2
主要终点
Evaluation of biomechanical properties of thoracolumbar fascia

研究概览

简要总结

It has not been objectively clarified how the thoracolumbar fascia (TLF) changes the biomechanical adaptations that occur in the lumbopelvic region during pregnancy and whether it is associated with pelvic girdle pain (PGP). Therefore, the aim of this study is to determine the biomechanical and viscoelastic properties of TLF, which adapts to the changes in the lumbopelvic region in pregnant women with pelvic girdle pain, and to investigate its relationship with PGP.

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • First-time pregnancy
  • Pregnant women diagnosed with pelvic girdle pain in 1st and 2nd trimesters
  • Pregnant women who do not have pelvic girdle pain in 1st and 2nd trimesters
  • Women not being pregnant
  • Pre-pregnancy Body-Mass-Index (BMI) < 30 kg/m2

排除标准

  • Presence of connective tissue disease
  • Deterioration of skin integrity in measurement areas
  • Presence of orthopedic, neurological, rheumatic problems that may cause musculoskeletal disorders and deviations from normal biomechanical alignment
  • History of spine, pelvis, or lower extremity surgery or fracture in the past 6 months
  • Definition of chronic low back-pelvic region pain (lasting for more than 3 months and pain severity >4 according to VAS) before pregnancy
  • Identification of metabolic disorders such as Type I, II diabetes, gestational diabetes mellitus (GDM), preeclampsia before and/or during pregnancy)

结局指标

主要结局

Evaluation of biomechanical properties of thoracolumbar fascia

时间窗: Measurement the change from baseline tone values of Thoracolumbar fascia at 12. week and at 22. week

Measuring of the tone (Hz) of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the prone position.

Evaluation of viscoelastic properties of thoracolumbar fascia

时间窗: Measurement the change from baseline relaxation time values of Thoracolumbar fascia at 12. week and at 22. week

Measuring of thethe relaxation time (ms) of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the prone position.

Evaluation of biomechanical properties of thoracolumbar fascia

时间窗: Measurement the change from baseline stiffness values of Thoracolumbar fascia at 12. week and at 22. week

Measuring of the stiffness (N/m) of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the prone position.

Evaluation of biomechanical properties of thoracolumbar fascia

时间窗: Measurement the change from baseline decrement values of Thoracolumbar fascia at 12. week and at 22. week

Measuring of the decrement of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the prone position.

Evaluation of viscoelastic properties of thoracolumbar fascia

时间窗: Measurement the change from baseline creep values of Thoracolumbar fascia at 12. week and at 22. week

Measuring of the creep of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the prone position.

次要结局

  • Determining of painful areas(Baseline)
  • Evaluation of pain(Baseline)
  • Application of Pelvic Girdle Pain (PGP) diagnostic tests(Baseline)
  • Pelvic Girdle Questionnaire(Baseline)
  • Evaluation of Body Weight(Measurement the change from baseline body weight (kg) at 12. and 22. weeks.)
  • Evaluation of Body Mass Index (BMI)(Measurement the change from baseline BMI values at 12.and 22. weeks)

研究者

发起方
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
申办方类型
Other
责任方
Sponsor

研究点 (2)

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