Acute Effect of Osteopathic Visceral Mobilization Techniques

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05981339
• Other study ID #: 2022/477
• Status: Recruiting
• Phase: N/A
• Start date: August 7, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: July 2023
• Source: University of Gaziantep
• Contact: Tuba Maden
• Phone: 05319340249
• Email: tuba.kmaden[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 30, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Osteopathic Manipulative Treatment
• Pelvic Floor Disorders
• Sclerosis
• Urinary Incontinence

Intervention

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.
• 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).

Locations

Country	Name	City	State
Turkey	Tuba Maden	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
University of Gaziantep

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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