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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Other: HVLA
* Other: global osteopathic protocol
* Other: pelvic floor muscle training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HVLA techiniques (G1)<br>Performed with thrust (also known as HVLA) in the sacroiliac joint and T10-L2 level | Other: HVLA<br>* 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.<br>* Other names: thrust;Other: global osteopathic protocol<br>* 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.<br>|
| Experimental: Global osteopathic protocol (G2)<br>Several elements were emphasized - myofascial, bone, and visceral. | Other: global osteopathic protocol<br>* 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.<br>|
| Experimental: Pelvic floor muscle training (G3)<br>Muscle Training for four weeks, with a weekly face-to-face visit lasting 10-20 minutes. | Other: pelvic floor muscle training<br>* 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<br>|
| No Intervention: Control group (G4)<br>No intervention and was simply evaluated and re-evaluated. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline versus immediately post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pelvic floor training, osteopathy, urinary incontinence