Acute Effect of Osteopathic Visceral Mobilization Techniques

Acute Effect of Osteopathic Visceral Mobilization Techniques on Adductor Spasticity, Incontinence and Constipation in Multiple Sclerosis Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis; Urinary Incontinence; Pelvic Floor Disorders; Osteopathic Manipulative Treatment; Visceral Mobilization
• Intervention / Treatment: Other: breathing exercises; Other: osteopathic manual therapy techniques

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tuba Maden; Phone Number: 05319340249; Email: tuba.kmaden@gmail.com

Study Locations

• Turkey
  • Gaziantep, Turkey
    • Recruiting
    • Tuba Maden
    • Contact: Tuba Maden; Phone Number: 05319340249; Email: tuba.kmaden@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control Group; In 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.	Other: breathing exercises; For the diaphragmatic breathing exercise, patients are asked to perform a nasal inspiration and expiration that moves predominantly the abdomen by reducing the movement of the thorax in the semi-supine position. To give tactile stimulation, one hand of the patient is placed on the chest with the other hand on the abdominal region. Continue this exercise for three minutes.
Experimental: Study Group; In 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.	Other: breathing exercises; For the diaphragmatic breathing exercise, patients are asked to perform a nasal inspiration and expiration that moves predominantly the abdomen by reducing the movement of the thorax in the semi-supine position. To give tactile stimulation, one hand of the patient is placed on the chest with the other hand on the abdominal region. Continue this exercise for three minutes.; Other: osteopathic manual therapy techniques; Sacral release: While the patient is in the side lying position, the physiotherapist goes behind the patient, one hand is placed on the lower abdominal area, and the thenar and hypothenar areas of the other hand are placed on the basis of the sacrum. It is waited until a general relaxation is felt in the tissue under the hands (Stone, C., 2006).; Bladder mobilization: Two hands are placed just above the pubic region and gently pressed down first to test the surface protrusion of the uterus. During the application, the pressure of the hand is adjusted according to the tension of the tissue. Hand contact is not interrupted until the fascial tissue under the hand is relaxed (Stone, C., 2006).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spasticity Assessment	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.	Change from MAS scale at one week
Evaluation of Pelvic Floor Muscle Activity	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.	Change from Muscle Activity scale at one week
International Consultation on Incontinence Questionnaire Short Form ICIQ-SF	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.	Change from ICIQ-SF at one week
Constipation Quality of Life Scale: Constipation Quality of Life Scale (CIQS)	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.	Change from CIQS at one week

Collaborators and Investigators

• Sponsor: University of Gaziantep

Study record dates

Study Major Dates

• Study Start (Estimated): August 7, 2023
• Primary Completion (Estimated): September 15, 2023
• Study Completion (Estimated): September 30, 2023

Study Registration Dates

• First Submitted: July 31, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Pregnancy Complications; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Multiple Sclerosis; Sclerosis; Urinary Incontinence; Pelvic Floor Disorders
• Other Study ID Numbers: 2022/477

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No