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/NCT06009263</url>
    </required_header>
    <id_info>
      <org_study_id>REC/007/002763</org_study_id>
      <nct_id>NCT06009263</nct_id>
    </id_info>
    <brief_title>Effect of Open Chain Versus Closed Chain Segmental Control Exercises on CSA of Lumbar Multifidus Muscle in Chronic MLBP</brief_title>
    <official_title>Effect of Open Chain Versus Closed Chain Segmental Control Exercises on Cross Sectional Area of Lumbar Multifidus Muscle in Chronic Mechanical Low Back Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</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>
        To investigate the effect of adding open versus closed chain segmental control exercises to&#xD;
        conventional treatment program on pain intensity, lumbar ROM, and CSA of multifidus muscle.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        -  To investigate the effect of adding open versus closed chain segmental control exercises&#xD;
             to conventional treatment program on pain intensity.&#xD;
  &#xD;
          -  To investigate the effect of adding open versus closed chain segmental control exercises&#xD;
             to conventional treatment program on lumber ROM.&#xD;
  &#xD;
          -  To investigate the effect of adding open versus closed chain segmental control exercises&#xD;
             to conventional treatment program on CSA of multifidus muscle.&#xD;
  &#xD;
          -  To investigate the effect of adding open versus closed chain segmental control exercises&#xD;
             to conventional treatment program on lumber function.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 2, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 13, 2024</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>Group will receive ultrasound and TENS as conventional treatment</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Group will receive open chain segmental control exercises versus closed chain segmental control exercises</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Cross sectional area of multifidus muscle</measure>
      <time_frame>Pre and Post measurement (12 weeks)</time_frame>
      <description>Cross sectional area of multifidus muscle</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain intensity</measure>
      <time_frame>Pre and Post measurement (12 weeks)</time_frame>
      <description>Measured by VAS (from 0 to 10; 0 means no pain and 10 means worst pain)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>ROM of lumbar spine</measure>
      <time_frame>Pre and Post measurement (12 weeks)</time_frame>
      <description>Measuring ROM of lumbar spine</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional ability of lumbar spine</measure>
      <time_frame>Pre and Post measurement (12 weeks)</time_frame>
      <description>Questionnaire for measuring lumbar activities (lower score means better and higher score means worse)</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Mechanical Low Back Pain</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>The participants will receive conventional treatment in the form of TENS and Ultrasound.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The participants will receive &quot;open chain segmental control exercises&quot; plus conventional treatment in the form of TENS and Ultrasound.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The participants will receive &quot;closed chain segmental control exercises&quot; plus conventional treatment in the form of TENS and Ultrasound.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Conventional treatment</intervention_name>
      <description>Application of ultrasound and transcutaneous electrical nerve stimulation &quot;TENS&quot; for mechanical low back pain.</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Open chain segmental control</intervention_name>
      <description>Application of &quot;open chain segmental control exercises&quot; As well as, application of ultrasound and transcutaneous electrical nerve stimulation &quot;TENS&quot; for mechanical low back pain.</description>
      <arm_group_label>Intervention 1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Closed chain segmental control</intervention_name>
      <description>Application of &quot;closed chain segmental control exercises&quot; As well as, application of ultrasound and transcutaneous electrical nerve stimulation &quot;TENS&quot; for mechanical low back pain.</description>
      <arm_group_label>Intervention 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients with chronic low back pain from both genders their age will be ranged and&#xD;
               divided into three groups from 25-55 years.&#xD;
  &#xD;
            2. Participants with chronic low back pain lasting for more than 6 Months.&#xD;
  &#xD;
            3. A patient who can follow the command.&#xD;
  &#xD;
            4. A patient who can do exercise.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Low back pain patients with a history of severe neurological disease or orthopedic&#xD;
               disease.&#xD;
  &#xD;
            2. History of Psychological Disorder.&#xD;
  &#xD;
            3. Unhealthy Patient.&#xD;
  &#xD;
            4. Pregnant women.&#xD;
  &#xD;
            5. Patient with a spinal tumor.&#xD;
  &#xD;
            6. History of any operation related to spine. Ex. Vertebral fracture or dislocation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Haytham M Elhafez, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cairo University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Haytham M Elhafez, PhD</last_name>
      <phone>+201001909630</phone>
      <email>elhafez@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Faculty of Physical Therapy</name>
        <address>
          <city>Giza</city>
          <state>Dokki</state>
          <zip>12612</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Haytham M Elhafez</last_name>
        <phone>+201001909630</phone>
        <email>elhafez@yahoo.com</email>
      </contact>
      <investigator>
        <last_name>Mona E Hassan, Msc</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Hend H Ahmed, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ghada A Abdallah, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>September 9, 2023</last_update_submitted>
    <last_update_submitted_qc>September 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Haytham M Elhafez</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Mechanical LBP</keyword>
    <keyword>Cross Sectional Area</keyword>
    <keyword>Multifidus muscle</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Back Pain</mesh_term>
      <mesh_term>Low Back Pain</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/NCT06009263
  org study id: REC/007/002763
  nct id: NCT06009263
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To investigate the effect of adding open versus closed chain segmental control exercises to
        conventional treatment program on pain intensity, lumbar ROM, and CSA of multifidus muscle.
  -  To investigate the effect of adding open versus closed chain segmental control exercises
             to conventional treatment program on pain intensity.
  
          -  To investigate the effect of adding open versus closed chain segmental control exercises
             to conventional treatment program on lumber ROM.
  
          -  To investigate the effect of adding open versus closed chain segmental control exercises
             to conventional treatment program on CSA of multifidus muscle.
  
          -  To investigate the effect of adding open versus closed chain segmental control exercises
             to conventional treatment program on lumber function.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Group will receive ultrasound and TENS as conventional treatment
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: Group will receive open chain segmental control exercises versus closed chain segmental control exercises
  measure: Cross sectional area of multifidus muscle
  time frame: Pre and Post measurement (12 weeks)
  description: Cross sectional area of multifidus muscle
  measure: Pain intensity
  time frame: Pre and Post measurement (12 weeks)
  description: Measured by VAS (from 0 to 10; 0 means no pain and 10 means worst pain)
  measure: ROM of lumbar spine
  time frame: Pre and Post measurement (12 weeks)
  description: Measuring ROM of lumbar spine
  measure: Functional ability of lumbar spine
  time frame: Pre and Post measurement (12 weeks)
  description: Questionnaire for measuring lumbar activities (lower score means better and higher score means worse)
  arm group label: Control
  arm group type: Sham Comparator
  description: The participants will receive conventional treatment in the form of TENS and Ultrasound.
  arm group label: Intervention 1
  arm group type: Experimental
  description: The participants will receive "open chain segmental control exercises" plus conventional treatment in the form of TENS and Ultrasound.
  arm group label: Intervention 2
  arm group type: Experimental
  description: The participants will receive "closed chain segmental control exercises" plus conventional treatment in the form of TENS and Ultrasound.
  intervention type: Other
  intervention name: Conventional treatment
  description: Application of ultrasound and transcutaneous electrical nerve stimulation "TENS" for mechanical low back pain.
  arm group label: Control
  intervention type: Other
  intervention name: Open chain segmental control
  description: Application of "open chain segmental control exercises" As well as, application of ultrasound and transcutaneous electrical nerve stimulation "TENS" for mechanical low back pain.
  arm group label: Intervention 1
  intervention type: Other
  intervention name: Closed chain segmental control
  description: Application of "closed chain segmental control exercises" As well as, application of ultrasound and transcutaneous electrical nerve stimulation "TENS" for mechanical low back pain.
  arm group label: Intervention 2
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 55 Years
  healthy volunteers: No
  last name: Haytham M Elhafez, PhD
  role: Principal Investigator
  affiliation: Cairo University
  last name: Haytham M Elhafez, PhD
  phone: +201001909630
  email: elhafez@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Haytham M Elhafez
  investigator title: Professor
  mesh term: Back Pain
  mesh term: Low Back Pain