Clinical Trial: Manual Fascial Manipulation in Pregnant Women

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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 impro
Sponsor: Sheba Medical Center

Current Primary Outcome:

• Contraction strength [ Time Frame: 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
• Contraction pressure [ Time Frame: 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

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Symptoms associated with pelvic dysfunction [ Time Frame: Change of pelvic dysfunction is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month ) ]
  Assessment of symptoms associated with pelvic dysfunction: urinary incontinence, fecal incontinence, frequency and urgency (by the use of pelvic floor disability index 20 - a questionaire including 20 questions on pelvic floor function)
• FEV1 [ Time Frame: Change of FEV1 is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month ) ]
  Forced expiratory volume 1
• Voice Handicap Index - 10 among Hebrew speakers (VHI-10-HEB) questionaire [ Time Frame: Change of VHI-10-HEB is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month ) ]
  Evaluation of the validity of the voice handicap index that includes ten questions concerning voice usage among hebrew speakers

Original Secondary Outcome: Same as current

Information By: Sheba Medical Center

Dates:
Date Received: January 24, 2017
Date Started: February 1, 2017
Date Completion: February 1, 2019
Last Updated: February 1, 2017
Last Verified: February 2017