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Acute Effect of Osteopathic Visceral Mobilization Techniques

Not Applicable
Recruiting
Conditions
Pelvic Floor Disorders
Urinary Incontinence
Visceral Mobilization
Multiple Sclerosis
Osteopathic Manipulative Treatment
Interventions
Other: breathing exercises
Other: osteopathic manual therapy techniques
Registration Number
NCT05981339
Lead Sponsor
University of Gaziantep
Brief Summary

Multiple Sclerosis (MS), caused by lesions in the white matter of the central nervous system, is an autoimmune inflammatory demyelinating chronic disease.

The disease may present with many findings from fatigue, spasticity, balance and gait disturbances to bladder-bowel dysfunction (Ferreira, A.P.S., et al., 2019). When the rehabilitation methods for incontinence were examined, pelvic floor muscle training, tibial nerve stimulation and sacral neuromodulation were frequently encountered (Rahnama'I, MS., 2020). Pelvic floor muscle training should create an effective result in MS patients, and the training should be done for a long time, such as 8-12 weeks. No study has been found examining the effects of manual therapy techniques and diaphragmatic breathing exercise in the acute phase in functional or neurogenic bladder-intestinal dysfunctions.

Detailed Description

The study was planned as a randomized controlled trial. MS patients included in the study will be divided into two groups according to inclusion and exclusion criteria. Diaphragmatic breathing exercises and sacral relaxation, bladder mobilization, which are osteopathic manual therapy techniques, will be applied to the study group. On the other hand, only diaphragmatic breathing exercises will be applied to the control group.

Individuals will be treated in a single session. The acute effect of intervention will be examined by making a total of 3 evaluations, pre-intervention, post-intervention, and 1 week after the intervention.

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
20
Inclusion Criteria
  • Diagnosis of Multiple Sclerosis
  • The age of 18 years and the older
  • Individuals with stable medical condition
  • Having complaints of urinary dysfunction for at least 6 months,
  • Mini Mental test score > 24 points
  • EDDS less than 6.5 (0-6.5 points will be)
  • Volunteering to participate in the study
Exclusion Criteria
  • Having cognitive problems
  • Presence of pelvic organ prolapse or prostate
  • Pregnancy
  • Abdominal surgery history
  • Presence of urinary system infection
  • Continuing drug use for overactive bladder
  • Having received pelvic floor muscle training
  • Concomitant other neurological or kidney disease

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Control Groupbreathing exercisesIn the control group, diaphragmatic breathing exercises will be performed together with the physiotherapist. Osteopathic manual therapy techniques will be applied as sham. The physiotherapist will not touch the appropriate anatomical points while performing the loosening.
Study Groupbreathing exercisesIn addition to breathing exercises, sacral release and bladder mobilization, which are osteopathic manual therapy techniques, will be applied to the patients in the study group.
Study Grouposteopathic manual therapy techniquesIn addition to breathing exercises, sacral release and bladder mobilization, which are osteopathic manual therapy techniques, will be applied to the patients in the study group.
Primary Outcome Measures
NameTimeMethod
Constipation Quality of Life Scale: Constipation Quality of Life Scale (CIQS)Change from CIQS at one week

CIQS is a self-assessment scale consisting of 28 items in total, consisting of "anxiety/anxiety" (11 items), "physical discomfort" (4 items), "psycho-social discomfort" (8 items), "satisfaction" (five items). The highest score that can be obtained from the five-point Likert scale is 140, and the lowest score is 28. It is thought that the quality of life is negatively affected as the scores obtained from the scale increase.

Spasticity AssessmentChange from MAS scale at one week

The Modified Ashworth Scale (MAS), the most common test used in clinical and research, will be used to assess spasticity. The reliability of the scale has been proven among raters in the lower extremities. According to the resistance to passive movement, the lowest score of the manual scale is 0 and the highest score is 4. The higher the score, the higher the spasticity.

Evaluation of Pelvic Floor Muscle ActivityChange from Muscle Activity scale at one week

easurements are performed with surface electrodes and a device similar to a biofeedback device (NeuroTrac ETS™; Verity Medical, Romsey, UK) to evaluate pelvic floor muscle activity. The biofeedback device is used to train and test the pelvic floor muscles. As the values increase, so does the muscular activity.

International Consultation on Incontinence Questionnaire Short Form ICIQ-SFChange from ICIQ-SF at one week

To evaluate urinary incontinence and the effect of urinary incontinence on quality of life, Avery et al. The Turkish validity and reliability of the scale developed by Çetinel et al. Made by in 2004. The scale has four dimensions, in the first dimension how often urinary incontinence is, in the second dimension the amount of urinary incontinence, in the third dimension the effects of urinary incontinence on daily life and in the fourth dimension the conditions that cause urinary incontinence are questioned. The first three dimensions are scored in the evaluation. The answers given to the fourth dimension, which is not scored, are used to determine the type of urinary incontinence based on the individual's complaints. A score between 0 and 21 is obtained from the scale. A low score indicates that urinary incontinence affects the quality of life little, while a high score indicates that it affects the quality of life very much.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Tuba Maden

🇹🇷

Gaziantep, Turkey

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