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

Urinary Incontinence Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04584359
• Other study ID #: Utras1
• Status: Completed
• Phase: N/A
• Start date: January 20, 2018
• Est. completion date: September 20, 2019

Study information

• Verified date: October 2020
• Source: University of Trás-os-Montes and Alto Douro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 20, 2019
• Est. primary completion date: January 20, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Other:
• HVLA
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.
• global 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.
• pelvic 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

Locations

Country	Name	City	State
Brazil	Giselle Notini Arcanjo	Fortaleza	CE

Sponsors (1)

Lead Sponsor	Collaborator
Giselle Notini Arcanjo

Country where clinical trial is conducted

Brazil, 

References & Publications (25)

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Felicíssimo, M.F., Carneiro, M.M., Souza, E.L.B.L. de, Alipio, V.G., Franco, M.R.C., Silva, R. G. O., Filho, A.L.S. (2016). Fatores limitadores à reabilitação da musculatura do assoalho pélvico em pacientes com incontinência urinária de esforço. Acta Fisiátrica, 14(4), 233-236

Fernandes, W.V.B., Bicalho, E.S., Capote, A.E., Manffra E.F. (2016). Duration of the effects of spinal manipulation on pain intensity and electromyographic activity of paravertebral parts of individuals with chronic mechanical low back pain. Fisioterapia Pesquisa, 23(2),155-62

Franke H, Hoesele K. Osteopathic manipulative treatment (OMT) for lower urinary tract symptoms (LUTS) in women. J Bodyw Mov Ther. 2013 Jan;17(1):11-8. doi: 10.1016/j.jbmt.2012.05.001. Epub 2012 Jun 17. Review. Erratum in: J Bodyw Mov Ther. 2014 Jan;18(1):92. — View Citation

Glazer, H. I.; Hacad, C. R. (2012). The Glazer Protocol: Evidence-Based Medicine Pelvic Floor Muscle (PFM) Surface Electromyography (SEMG). Biofeedback, 40(2), 75-79

Haavik H, Murphy BA, Kruger J. Effect of Spinal Manipulation on Pelvic Floor Functional Changes in Pregnant and Nonpregnant Women: A Preliminary Study. J Manipulative Physiol Ther. 2016 Jun;39(5):339-347. doi: 10.1016/j.jmpt.2016.04.004. Epub 2016 May 6. — View Citation

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Resende, A. P. M., Nakamura, M. U., Ferreira, E. A. G., Petricelli, C. D., Alexandre, S. M., Zanetti, M. R. D. (2011). Evaluation of female pelvic floor muscles using surface electromyography: literature review. Fisioterapia e Pesquisa, 18(3), 292-297

Santos MD, Palmezoni VP, Torelli L, Baldon VSP, Sartori MGF, Resende APM. Evaluation of pelvic floor muscle strength and its correlation with sexual function in primigravid and non-pregnant women: A cross-sectional study. Neurourol Urodyn. 2018 Feb;37(2): — View Citation

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Thomaz RP, Colla C, Darski C, Paiva LL. Influence of pelvic floor muscle fatigue on stress urinary incontinence: a systematic review. Int Urogynecol J. 2018 Feb;29(2):197-204. doi: 10.1007/s00192-017-3538-6. Epub 2017 Dec 20. Review. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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