Manual Fascial Manipulation in Pregnant Women
Condition: Pelvic Floor Disorders
MeSH terms: Pelvic Floor Disorders
Study type: Interventional

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 description: 
      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

      The study will involve number of phases:

      Phase one: Screening and enrollment of patients Women followed at the high risk pregnancy
      clinic at the Sheba medical center, who carry singleton pregnancy at the ages of 20-45 years
      old and about to have their 2nd to 4th delivery (primiparous and multiparous women) will be
      examined for the following parameters: demographic and medical data, focused interview for
      symptoms of pelvic floor dysfunction including urination and fecal function as well as pelvic
      floor pain, manual assessment according the Oxford grading scale will be performed, and the
      strength of the pelvic floor measured by the use of Perineometer (Peritron 'AV' Combined Anal
      & Vaginal Perineometer NEW MODEL). Other parameters that will be measured include:
      mobilization of the pelvic-femoral joint, Forced expiratory volume 1 (FEV1) (a connection was
      shown between FEV1, intraabdominal pressure and the strength of the pelvic floor, assessment
      of vocal quality ( analyzed by communication clinician, repeat assessment will be performed
      after two weeks and after 4 weeks, estimated assessment time - 20 Min) 80 women are expected
      to be enrolled.

      Phase Two Women who will fulfill one or more of the following parameters will be enrolled to
      the second phase of the study . (n=40)

        1. Oxford grading scale ≤3/5

        2. Pelvic floor strength assessed by perineometer≤ 30 cm/h20

        3. Clinical symptoms of urine, flatus or fecal incontinence

        4. Pelvic floor, hip joint or pelvic joints pain

      Randomization will be performed to one of two groups:

      Group A-Control group (n=20) Group B-Study group (n=20) Guidance towards exercise for
      strengthening of the pelvic floor will be provided for both groups. Study group will be
      treated manually for the pelvic floor in two sessions two weeks apart. The manual
      manipulation of the pelvic floor will involve intra vaginal superficial as well as pelvic
      skin area pressure points. The manipulation will not involve the cervix uterus or rectum.
      Each session will lasts one hour

      Both groups will be assessed by ultrasound for blood flow in the middle cerebral artery,
      umbilical artery and uterine artery as part of the parameters that may show benefit to the
      fetus due to pelvic floor mobilization.

      Reassessment of all the women and repeat treatment for the study group will be performed
      after two and four weeks from the primary assessment.

      The study will be performed at a high risk pregnancy clinic at the Sheba medical center.
      Women will be enrolled voluntarily with no financial benefit.
    

Intervention name(s): Pelvic floor fascial mobilization
Intervention type(s): Procedure
Intervention description(s): The manual manipulation of the pelvic floor involves intra vaginal superficial as well as pelvic skin area pressure points.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: On enrollment, dividing the healthy ( n=40) from the pathological function of the pelvic floor ( n=40). From the second group, randomizing the groups to study group: recieving pelvic floor fascial mobilization (PFFM) treatment (n=20)compared to control group (n=20).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pelvic floor