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

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04584359
Enrollment
40
Registered
2020-10-14
Start date
2018-01-20
Completion date
2019-09-20
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence

Keywords

pelvic floor training, osteopathy, urinary incontinence

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.

Interventions

OTHERHVLA

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.

OTHERglobal osteopathic protocol

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.

OTHERpelvic floor muscle training

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

Sponsors

Giselle Notini Arcanjo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention 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).

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
electromyographic activityChange from baseline versus immediately post-interventionThe 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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026