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Effects of Osteopathic Manipulations and Muscle Training on the Myoelectric Activity of the Pelvic Floor

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
HVLA
global osteopathic protocol
pelvic floor muscle training
Sponsored by
Giselle Notini Arcanjo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring pelvic floor training, osteopathy, urinary incontinence

Eligibility Criteria

30 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • symptoms of urine loss due to exertion in the last six months.

Exclusion Criteria:

  • urgent or mixed urinary incontinency
  • overactive bladder
  • neurological disorder
  • urinary or anal infection
  • urogenital atrophy
  • pelvic organ prolapse grade 3 or 4
  • sensory pathways and motor not intact
  • spine fracture

Sites / Locations

  • Giselle Notini Arcanjo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

HVLA techiniques (G1)

Global osteopathic protocol (G2)

Pelvic floor muscle training (G3)

Control group (G4)

Arm Description

Performed with thrust (also known as HVLA) in the sacroiliac joint and T10-L2 level

Several elements were emphasized - myofascial, bone, and visceral.

Muscle Training for four weeks, with a weekly face-to-face visit lasting 10-20 minutes.

No intervention and was simply evaluated and re-evaluated.

Outcomes

Primary Outcome Measures

electromyographic activity
The primary outcome measure will be the RMS (root means square) collected by surface. First, the basal tonus activity of PFM was recorded for 20 seconds; participants were instructed to avoid any body movements or speech. Next, the participants performed two fast and consecutive contractions (three seconds each) and relaxed for ten seconds (test for phasic fibers). Third, participants were told to sustain the contraction for ten seconds, followed by a ten-second rest (test for tonic fibers). Finally, the myoelectrical activity was captured during a cough to assess PFM reflex contraction.

Secondary Outcome Measures

Full Information

First Posted
August 24, 2020
Last Updated
October 13, 2020
Sponsor
Giselle Notini Arcanjo
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1. Study Identification

Unique Protocol Identification Number
NCT04584359
Brief Title
Effects of Osteopathic Manipulations and Muscle Training on the Myoelectric Activity of the Pelvic Floor
Official Title
Comparasion of the Effects of Osteopathic Manipulations and Muscle Training on the Myoelectric Activity of the Pelvic Floor in Women With Stress Urinary Incontinence: a Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 20, 2018 (Actual)
Primary Completion Date
January 20, 2019 (Actual)
Study Completion Date
September 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Giselle Notini Arcanjo

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
The objective of this study was to compare the effects of four different interventions on pelvic floor muscle electromyographic activity in women with stress urinary incontinece: i) a global osteopathic protocol (myofascial, visceral, and articular techniques), ii) one manipulation technique (high velocity, low amplitude (HVLA)/thrust) of the sacroiliac joint and T10-L2, iii) Pelvic Floor Muscle training, and iv) a control group with no intervention. The hypothesis is that the global osteopathic protocol and HVLA technique can increase pelvic floor muscle electromyographic activity to a level greater than or equal to the standard care established in the literature (pelvic floor muscle training).
Detailed Description
Participants represented a convenience sample and were recruited from hospitals, urogynecology doctors' clinics, invitations via social networks, gyms, clubs, and sports consultants. Women had to be between 30 and 60 years old and report symptoms of urine loss due to exertion in the last six months.The participants were randomly allocated into four groups (G1 = intervention using an HVLA/thrust technique for the sacroiliac and T10-L2 joints, G2 = global osteopathic protocol, G3 = PFT, and G4 = control) by a blinded researcher with a spreadsheet of random numbers.The primary outcome measure was surface electromyography (EMG) performed at five different times: before the intervention and immediately, 30 minutes, 60 minutes, and four weeks after. This evaluation was performed by a physiotherapist with ten years of experience in urogynecology and expertise in PFM electromyographic evaluation who was blinded to the group allocation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
pelvic floor training, osteopathy, urinary incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
This study randomized 40 women with symptoms of stress uriray incontinence who were divided into four intervention groups of ten women each (G1: only the high velocity, low amplitude manipulation for the sacroiliac joint and T10-L2; G2: global osteopathic protocol with myofascial, visceral, and articular techniques; G3: pelvic floor muscle training; and G4: control).
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HVLA techiniques (G1)
Arm Type
Experimental
Arm Description
Performed with thrust (also known as HVLA) in the sacroiliac joint and T10-L2 level
Arm Title
Global osteopathic protocol (G2)
Arm Type
Experimental
Arm Description
Several elements were emphasized - myofascial, bone, and visceral.
Arm Title
Pelvic floor muscle training (G3)
Arm Type
Experimental
Arm Description
Muscle Training for four weeks, with a weekly face-to-face visit lasting 10-20 minutes.
Arm Title
Control group (G4)
Arm Type
No Intervention
Arm Description
No intervention and was simply evaluated and re-evaluated.
Intervention Type
Other
Intervention Name(s)
HVLA
Other Intervention Name(s)
thrust
Intervention Description
High velocity, low amplitude manipulation for the sacroiliac joint and T10-L2. The interventions were performed once a week for four weeks by a physiotherapist with a degree in in osteopathy and ten years of clinical experience. Each visit lasted about 5 minutes.
Intervention Type
Other
Intervention Name(s)
global osteopathic protocol
Intervention Description
Myofascial, visceral, and articular techniques. Complete treatment in order to restore and rebalance internal tensions and improve the visceral mobility: muscle inhibition techniques for the psoas muscle; deep massage in the obturator foramen; stretching for the greater omentum; lift of the uterus, ovary, and bladder ; abdominal maneuver; and thrust of sacroiliac joint and T12-L1. The interventions were performed once a week for four weeks by a physiotherapist with a degree in in osteopathy and ten years of clinical experience. Each visit lasted about 15 minutes.
Intervention Type
Other
Intervention Name(s)
pelvic floor muscle training
Intervention Description
Pelvic floor muscle training for four weeks, with a weekly face-to-face visit lasting 10-20 minutes. In this intervention, participants were instructed to perform three sequences of exercises: contractions and relaxations (three seconds of sustained contractions and six seconds of rest), ten sustained contractions (ten seconds of sustained contractions and 20 seconds of rest), and five contractions associated with a cough. These exercises were performed in the standing, sitting, and lying positions
Primary Outcome Measure Information:
Title
electromyographic activity
Description
The primary outcome measure will be the RMS (root means square) collected by surface. First, the basal tonus activity of PFM was recorded for 20 seconds; participants were instructed to avoid any body movements or speech. Next, the participants performed two fast and consecutive contractions (three seconds each) and relaxed for ten seconds (test for phasic fibers). Third, participants were told to sustain the contraction for ten seconds, followed by a ten-second rest (test for tonic fibers). Finally, the myoelectrical activity was captured during a cough to assess PFM reflex contraction.
Time Frame
Change from baseline versus immediately post-intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: symptoms of urine loss due to exertion in the last six months. Exclusion Criteria: urgent or mixed urinary incontinency overactive bladder neurological disorder urinary or anal infection urogenital atrophy pelvic organ prolapse grade 3 or 4 sensory pathways and motor not intact spine fracture
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giselle N Arcanjo
Organizational Affiliation
Tras dos Montes Alto Douro University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Giselle Notini Arcanjo
City
Fortaleza
State/Province
CE
ZIP/Postal Code
60115-282
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Effects of Osteopathic Manipulations and Muscle Training on the Myoelectric Activity of the Pelvic Floor

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