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

Not Applicable

Completed

• Conditions: Urinary Incontinence
• Interventions: Other: HVLA; Other: pelvic floor muscle training; Other: global osteopathic protocol

• Registration Number: NCT04584359
• Lead Sponsor: Giselle Notini Arcanjo

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.

Study Timeline

• Study Start: 2018-01-20
• Primary Completion: 2019-01-20
• Study Completion: 2019-09-20
• Study First Submitted: 2020-08-24
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-05
• Last Update Submitted: 2020-10-13
• Study First Posted: 2020-10-14
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
HVLA techiniques (G1)	HVLA	Performed with thrust (also known as HVLA) in the sacroiliac joint and T10-L2 level
Pelvic floor muscle training (G3)	pelvic floor muscle training	Muscle Training for four weeks, with a weekly face-to-face visit lasting 10-20 minutes.
Global osteopathic protocol (G2)	global osteopathic protocol	Several elements were emphasized - myofascial, bone, and visceral.
HVLA techiniques (G1)	global osteopathic protocol	Performed with thrust (also known as HVLA) in the sacroiliac joint and T10-L2 level

Primary Outcome Measures

Name	Time	Method
electromyographic activity	Change from baseline versus immediately post-intervention	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.

Trial Locations

Locations (1)

Giselle Notini Arcanjo; 🇧🇷 Fortaleza, CE, Brazil