Acute Effect of Osteopathic Visceral Mobilization Techniques

NCT ID: NCT05981339

Last Updated: 2023-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-07

Study Completion Date

2023-09-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial Study and Control Group
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type SHAM_COMPARATOR

breathing exercises

Intervention Type 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.

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.

Group Type EXPERIMENTAL

breathing exercises

Intervention Type 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.

osteopathic manual therapy techniques

Intervention Type 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).

Interventions

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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.

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Gaziantep

OTHER

Sponsor Role lead

Responsible Party

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Ogr Uyesi Tuba MADEN

Assisstanf Profesor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tuba Maden

Gaziantep, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Tuba Maden

Role: CONTACT

05319340249

Facility Contacts

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Tuba Maden

Role: primary

05319340249

Other Identifiers

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2022/477

Identifier Type: -

Identifier Source: org_study_id

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