xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05981339</url>
    </required_header>
    <id_info>
      <org_study_id>2022/477</org_study_id>
      <nct_id>NCT05981339</nct_id>
    </id_info>
    <brief_title>Acute Effect of Osteopathic Visceral Mobilization Techniques</brief_title>
    <official_title>Acute Effect of Osteopathic Visceral Mobilization Techniques on Adductor Spasticity, Incontinence and Constipation in Multiple Sclerosis Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Gaziantep</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Gaziantep</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Multiple Sclerosis (MS), caused by lesions in the white matter of the central nervous system,&#xD;
        is an autoimmune inflammatory demyelinating chronic disease.&#xD;
  &#xD;
        The disease may present with many findings from fatigue, spasticity, balance and gait&#xD;
        disturbances to bladder-bowel dysfunction (Ferreira, A.P.S., et al., 2019). When the&#xD;
        rehabilitation methods for incontinence were examined, pelvic floor muscle training, tibial&#xD;
        nerve stimulation and sacral neuromodulation were frequently encountered (Rahnama'I, MS.,&#xD;
        2020). Pelvic floor muscle training should create an effective result in MS patients, and the&#xD;
        training should be done for a long time, such as 8-12 weeks. No study has been found&#xD;
        examining the effects of manual therapy techniques and diaphragmatic breathing exercise in&#xD;
        the acute phase in functional or neurogenic bladder-intestinal dysfunctions.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study was planned as a randomized controlled trial. MS patients included in the study&#xD;
        will be divided into two groups according to inclusion and exclusion criteria. Diaphragmatic&#xD;
        breathing exercises and sacral relaxation, bladder mobilization, which are osteopathic manual&#xD;
        therapy techniques, will be applied to the study group. On the other hand, only diaphragmatic&#xD;
        breathing exercises will be applied to the control group.&#xD;
  &#xD;
        Individuals will be treated in a single session. The acute effect of intervention will be&#xD;
        examined by making a total of 3 evaluations, pre-intervention, post-intervention, and 1 week&#xD;
        after the intervention.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 7, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 15, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Randomized Controlled Trial Study and Control Group</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Spasticity Assessment</measure>
      <time_frame>Change from MAS scale at one week</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Evaluation of Pelvic Floor Muscle Activity</measure>
      <time_frame>Change from Muscle Activity scale at one week</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>International Consultation on Incontinence Questionnaire Short Form ICIQ-SF</measure>
      <time_frame>Change from ICIQ-SF at one week</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Constipation Quality of Life Scale: Constipation Quality of Life Scale (CIQS)</measure>
      <time_frame>Change from CIQS at one week</time_frame>
      <description>CIQS is a self-assessment scale consisting of 28 items in total, consisting of &quot;anxiety/anxiety&quot; (11 items), &quot;physical discomfort&quot; (4 items), &quot;psycho-social discomfort&quot; (8 items), &quot;satisfaction&quot; (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.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Multiple Sclerosis</condition>
    <condition>Pelvic Floor Disorders</condition>
    <condition>Urinary Incontinence</condition>
    <condition>Visceral Mobilization</condition>
    <condition>Osteopathic Manipulative Treatment</condition>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Study Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>breathing exercises</intervention_name>
      <description>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.</description>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_label>Study Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>osteopathic manual therapy techniques</intervention_name>
      <description>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).&#xD;
  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).</description>
      <arm_group_label>Study Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of Multiple Sclerosis&#xD;
  &#xD;
            -  The age of 18 years and the older&#xD;
  &#xD;
            -  Individuals with stable medical condition&#xD;
  &#xD;
            -  Having complaints of urinary dysfunction for at least 6 months,&#xD;
  &#xD;
            -  Mini Mental test score &gt; 24 points&#xD;
  &#xD;
            -  EDDS less than 6.5 (0-6.5 points will be)&#xD;
  &#xD;
            -  Volunteering to participate in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having cognitive problems&#xD;
  &#xD;
            -  Presence of pelvic organ prolapse or prostate&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Abdominal surgery history&#xD;
  &#xD;
            -  Presence of urinary system infection&#xD;
  &#xD;
            -  Continuing drug use for overactive bladder&#xD;
  &#xD;
            -  Having received pelvic floor muscle training&#xD;
  &#xD;
            -  Concomitant other neurological or kidney disease&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Tuba Maden</last_name>
      <phone>05319340249</phone>
      <email>tuba.kmaden@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Tuba Maden</name>
        <address>
          <city>Gaziantep</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tuba Maden</last_name>
        <phone>05319340249</phone>
        <email>tuba.kmaden@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Gaziantep</investigator_affiliation>
      <investigator_full_name>Ogr Uyesi Tuba MADEN</investigator_full_name>
      <investigator_title>Assisstanf Profesor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Multiple Sclerosis</mesh_term>
      <mesh_term>Urinary Incontinence</mesh_term>
      <mesh_term>Pelvic Floor Disorders</mesh_term>
      <mesh_term>Sclerosis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05981339
  org study id: 2022/477
  nct id: NCT05981339
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized Controlled Trial Study and Control Group
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Spasticity Assessment
  time frame: Change from MAS scale at one week
  description: 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.
  measure: Evaluation of Pelvic Floor Muscle Activity
  time frame: Change from Muscle Activity scale at one week
  description: 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.
  measure: International Consultation on Incontinence Questionnaire Short Form ICIQ-SF
  time frame: Change from ICIQ-SF at one week
  description: 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.
  measure: Constipation Quality of Life Scale: Constipation Quality of Life Scale (CIQS)
  time frame: Change from CIQS at one week
  description: 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.
  arm group label: Control Group
  arm group type: Sham Comparator
  description: 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.
  arm group label: Study Group
  arm group type: Experimental
  description: 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.
  intervention type: Other
  intervention name: breathing exercises
  description: 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.
  arm group label: Control Group
  arm group label: Study Group
  intervention type: Other
  intervention name: osteopathic manual therapy techniques
  description: 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).
  arm group label: Study Group
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Tuba Maden
  phone: 05319340249
  email: tuba.kmaden@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: University of Gaziantep
  investigator full name: Ogr Uyesi Tuba MADEN
  investigator title: Assisstanf Profesor
  mesh term: Multiple Sclerosis
  mesh term: Urinary Incontinence
  mesh term: Pelvic Floor Disorders
  mesh term: Sclerosis