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Manual Fascial Manipulation in Pregnant Women

Primary Purpose

Pelvic Floor Disorders

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Pelvic floor fascial mobilization
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Floor Disorders focused on measuring pelvic floor

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion criteria:

  1. Age 20-45 years old
  2. Gestational age 24-30 weeks gestation
  3. Singleton pregnancy
  4. Expected second-4ourth delivery

Exclusion criteria

  1. First delivery
  2. Gestational age at more than 30 weeks gestation at enrollment
  3. Premature contractions
  4. Cervical insufficiency
  5. Placenta previa
  6. Placenta accrete
  7. Multifetal pregnancy
  8. Maternal chronic illness including connective tissue disease, neurological illness

Sites / Locations

  • Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study group - Treatment with PFFM

Control group -

Arm Description

Manual treatment for the pelvic floor will be provided in two sessions two weeks apart as long as guidance towards exercise for strengthening of the pelvic floor

Guidance towards exercise for strengthening of the pelvic floor with no other interventional treatment.

Outcomes

Primary Outcome Measures

Contraction strength
Contraction strength assessed by Oxford grading scale
Contraction pressure
Contraction pressure measured by using Peritron perineometer

Secondary Outcome Measures

Symptoms associated with pelvic dysfunction
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
Forced expiratory volume 1
Voice Handicap Index - 10 among Hebrew speakers (VHI-10-HEB) questionaire
Evaluation of the validity of the voice handicap index that includes ten questions concerning voice usage among hebrew speakers

Full Information

First Posted
January 24, 2017
Last Updated
June 7, 2020
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03041246
Brief Title
Manual Fascial Manipulation in Pregnant Women
Official Title
The Influence of Manual Fascial Manipulation on the Function of the Pelvic Floor in Pregnant Women
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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) Oxford grading scale ≤3/5 Pelvic floor strength assessed by perineometer≤ 30 cm/h20 Clinical symptoms of urine, flatus or fecal incontinence 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders
Keywords
pelvic floor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group - Treatment with PFFM
Arm Type
Experimental
Arm Description
Manual treatment for the pelvic floor will be provided in two sessions two weeks apart as long as guidance towards exercise for strengthening of the pelvic floor
Arm Title
Control group -
Arm Type
No Intervention
Arm Description
Guidance towards exercise for strengthening of the pelvic floor with no other interventional treatment.
Intervention Type
Procedure
Intervention Name(s)
Pelvic floor fascial mobilization
Intervention Description
The manual manipulation of the pelvic floor involves intra vaginal superficial as well as pelvic skin area pressure points.
Primary Outcome Measure Information:
Title
Contraction strength
Description
Contraction strength assessed by Oxford grading scale
Time Frame
Change of contraction strength is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month )
Title
Contraction pressure
Description
Contraction pressure measured by using Peritron perineometer
Time Frame
Change of contraction pressure is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month )
Secondary Outcome Measure Information:
Title
Symptoms associated with pelvic dysfunction
Description
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)
Time Frame
Change of pelvic dysfunction is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month )
Title
FEV1
Description
Forced expiratory volume 1
Time Frame
Change of FEV1 is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month )
Title
Voice Handicap Index - 10 among Hebrew speakers (VHI-10-HEB) questionaire
Description
Evaluation of the validity of the voice handicap index that includes ten questions concerning voice usage among hebrew speakers
Time Frame
Change of VHI-10-HEB is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month )

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women that are pregnant
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Age 20-45 years old Gestational age 24-30 weeks gestation Singleton pregnancy Expected second-4ourth delivery Exclusion criteria First delivery Gestational age at more than 30 weeks gestation at enrollment Premature contractions Cervical insufficiency Placenta previa Placenta accrete Multifetal pregnancy Maternal chronic illness including connective tissue disease, neurological illness
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21500994
Citation
Batista EM, Conde DM, Do Amaral WN, Martinez EZ. Comparison of pelvic floor muscle strength between women undergoing vaginal delivery, cesarean section, and nulliparae using a perineometer and digital palpation. Gynecol Endocrinol. 2011 Nov;27(11):910-4. doi: 10.3109/09513590.2011.569603. Epub 2011 Apr 18.
Results Reference
background
PubMed Identifier
26880504
Citation
Hallock JL, Handa VL. The Epidemiology of Pelvic Floor Disorders and Childbirth: An Update. Obstet Gynecol Clin North Am. 2016 Mar;43(1):1-13. doi: 10.1016/j.ogc.2015.10.008.
Results Reference
background
PubMed Identifier
27634085
Citation
Navot S, Kalichman L. Hip and groin pain in a cyclist resolved after performing a pelvic floor fascial mobilization. J Bodyw Mov Ther. 2016 Jul;20(3):604-9. doi: 10.1016/j.jbmt.2016.04.005. Epub 2016 Apr 7.
Results Reference
background
PubMed Identifier
26294205
Citation
Okido MM, Valeri FL, Martins WP, Ferreira CH, Duarte G, Cavalli RC. Assessment of foetal wellbeing in pregnant women subjected to pelvic floor muscle training: a controlled randomised study. Int Urogynecol J. 2015 Oct;26(10):1475-81. doi: 10.1007/s00192-015-2719-4. Epub 2015 Aug 21.
Results Reference
background
PubMed Identifier
24877094
Citation
Petricelli CD, Resende AP, Elito Junior J, Araujo Junior E, Alexandre SM, Zanetti MR, Nakamura MU. Distensibility and strength of the pelvic floor muscles of women in the third trimester of pregnancy. Biomed Res Int. 2014;2014:437867. doi: 10.1155/2014/437867. Epub 2014 Apr 28.
Results Reference
background
PubMed Identifier
19997721
Citation
Talasz H, Kofler M, Kalchschmid E, Pretterklieber M, Lechleitner M. Breathing with the pelvic floor? Correlation of pelvic floor muscle function and expiratory flows in healthy young nulliparous women. Int Urogynecol J. 2010 Apr;21(4):475-81. doi: 10.1007/s00192-009-1060-1. Epub 2009 Dec 8.
Results Reference
background
PubMed Identifier
24436146
Citation
van Veelen GA, Schweitzer KJ, van der Vaart CH. Ultrasound imaging of the pelvic floor: changes in anatomy during and after first pregnancy. Ultrasound Obstet Gynecol. 2014 Oct;44(4):476-80. doi: 10.1002/uog.13301.
Results Reference
background
PubMed Identifier
32378735
Citation
Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.
Results Reference
derived

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Manual Fascial Manipulation in Pregnant Women

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