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临床试验/NCT03041246
NCT03041246已完成不适用

The Influence of Manual Fascial Manipulation on the Function of the Pelvic Floor in Pregnant Women

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年7月1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
80
试验地点
1
主要终点
Contraction pressure

研究概览

简要总结

Pregnancy and vaginal delivery are considered as the main risk factors for damage to the pelvic floor. There are various ways to measure the strength of the pelvic floor and to evaluate functional problems. Manual mobilization of the pelvic floor is a well-known treatment modality, however, ample knowledge exists on the efficacy of physiotherapy and exercise for improvement of pelvic floor function and strength. The aim of this study is to analyze the influence of pelvic floor fascial mobilization (PFFM) technique on the function and strength of the pelvic floor muscles as well as parameters presumed to be influenced by the strength of the pelvic floor in pregnant women.

详细描述

Pregnancy and vaginal delivery are considered as the main risk factors for damage to the pelvic floor at various degrees, starting at mild stress incontinence and up to fool fecal incontinence as well as pelvic pains or urination difficulties.

There are various ways to measure the strength of the pelvic floor and to evaluate functional problems. Measured the strength of the pelvic floor muscles by physical examination according to Oxford Grading Scale (scale of 0-5) as well as by using Perineometer device, were equally efficient and well correlated. Other modalities such as the use of surface electro myography (EMG), that presents the level of the muscle electrical activity and expiration volumes and the strength of the pelvic floor muscles were also positively correlated to the strength of the pelvic floor. Recent studies presented dysfunction of pelvic floor during pregnancy as well as in the postpartum period by the use of pelvic floor disability index 20 (PFDI20) questionnaire validated in Hebrew.

Ample knowledge exists on the efficacy of physiotherapy and exercise for improvement of pelvic floor function and strength, however, prolonged and continuous exercise is needed to achieve good results as well as compliance and perseverance. The long-term effect is unwieldly.

Manual mobilization of the pelvic floor is a well-known treatment modality. However the literature regarding the effect of this technique is sparse. A recent series of case reports presented immediate and major improvement of pelvic floor dysfunction after manual mobilization. The peripartum period is critical for the function of the pelvic floor however the yield of manual therapy on function and strength of the pelvic floor was not evaluated in pregnant women. We hypothesize that manual therapy can improve the strength and the function of the pelvic floor within a short time span and this can be objectively measured by common and well used parameters The aim of this study is to analyze the influence of pelvic floor fascial mobilization (PFFM) on the function and strength of the pelvic floor muscles as well as parameters presumed to be influenced by the strength of the pelvic floor in pregnant women

Materials and methods

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Contraction pressure

时间窗: Change of contraction pressure is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month )

Contraction pressure measured by using Peritron perineometer

Contraction strength

时间窗: Change of contraction strength is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month )

Contraction strength assessed by Oxford grading scale

次要结局

  • FEV1(Change of FEV1 is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month ))
  • Voice Handicap Index - 10 among Hebrew speakers (VHI-10-HEB) questionaire(Change of VHI-10-HEB is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month ))
  • Symptoms associated with pelvic dysfunction(Change of pelvic dysfunction is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month ))

研究者

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

Dr. Aya Mohr-Sasson

Principal Investigator

Sheba Medical Center

研究点 (1)

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