Acute Effect of Osteopathic Visceral Mobilization Techniques

NCT05981339 | Unknown

• 1 other identifier: 2022/477
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Pelvic Floor Disorders; Urinary Incontinence; Visceral Mobilization; Osteopathic Manipulative Treatment

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Control Group

SHAM COMPARATOR

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

Study Group

EXPERIMENTAL

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; Other: osteopathic manual therapy techniques

Interventions

breathing exercises OTHER

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.

Control Group; Study Group

osteopathic manual therapy techniques OTHER

* 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).

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Gaziantep: lead

Study Sites (1)

Tuba Maden

Gaziantep, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Pelvic Floor Disorders; Urinary Incontinence

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Central Study Contacts

Tuba Maden

CONTACT

05319340249; tuba.kmaden@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstanf Profesor

Model Details: Randomized Controlled Trial Study and Control Group

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 8, 2023
• Study Start: August 7, 2023
• Primary Completion: September 15, 2023
• Study Completion: September 30, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-07

Locations

TU (1)