Clinical trial NCT05981339: Acute Effect of Osteopathic Visceral Mobilization Techniques
Official title: Acute Effect of Osteopathic Visceral Mobilization Techniques on Adductor Spasticity, Incontinence and Constipation in Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Pelvic Floor Disorders
Urinary Incontinence
Visceral Mobilization
Osteopathic Manipulative Treatment
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial Study and Control Group
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Spasticity Assessment
timeFrame: Change from MAS scale at one week
measure: Evaluation of Pelvic Floor Muscle Activity
timeFrame: Change from Muscle Activity scale at one week
measure: International Consultation on Incontinence Questionnaire Short Form ICIQ-SF
timeFrame: Change from ICIQ-SF at one week
measure: Constipation Quality of Life Scale: Constipation Quality of Life Scale (CIQS)
timeFrame: Change from CIQS at one week
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Tuba Maden
Study officials:
References: