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/NCT05965050</url>
    </required_header>
    <id_info>
      <org_study_id>DPT/Batch-Fall18/541</org_study_id>
      <nct_id>NCT05965050</nct_id>
    </id_info>
    <brief_title>Effect Of Myofascial Release Technique With Ultrasound Therapy in Adults With Nonspecific Low Back Pain.</brief_title>
    <official_title>Effect Of Myofascial Release Technique With Ultrasound Therapy in Adults With Nonspecific Low Back Pain.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Superior University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Superior University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Low back pain is common problem the purpose of this research will be to determine the&#xD;
        comparison of ultrasound therapy and myofascial release technique for treatment of low back&#xD;
        pain in adults.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Low back pain is common problem the purpose of this research will be to determine the&#xD;
        comparison of ultrasound therapy and myofascial release technique for treatment of low back&#xD;
        pain in adults. To increase lumbar spine range of motion chest wall mobility and flexibility,&#xD;
        reduction in level of lumbar disability&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 1, 2023</start_date>
    <completion_date type="Actual">July 10, 2023</completion_date>
    <primary_completion_date type="Actual">June 1, 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>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Modified Oswestry disability index</measure>
      <time_frame>6 Months</time_frame>
      <description>Oswestry Disability Index [ODI] (an outcome measure that was designed to assess function in activities of daily living for those with acute or chronic back pain)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>Low Back Pain</condition>
    <arm_group>
      <arm_group_label>Myofascial Release Technique</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>myofascial release therapy, the therapist applies light pressure by hand to find myofascial areas that feel stiff instead of elastic and movable. These stiff areas, or trigger points, are thought to limit muscle and joint movements, which can play a part in widespread muscle pain.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Ultrasound Therap</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Ultrasound physical therapy is a branch of ultrasound, alongside diagnostic ultrasound and pregnancy imaging. It's used to detect and treat various musculoskeletal issues you may have including pain, tissue injury, and muscle spasms</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Myofascial Release Technique</intervention_name>
      <description>myofascial release therapy, the therapist applies light pressure by hand to find myofascial areas that feel stiff instead of elastic and movable. These stiff areas, or trigger points, are thought to limit muscle and joint movements, which can play a part in widespread muscle pain.</description>
      <arm_group_label>Myofascial Release Technique</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Ultrasound Therapy</intervention_name>
      <description>Ultrasound physical therapy is a branch of ultrasound, alongside diagnostic ultrasound and pregnancy imaging. It's used to detect and treat various musculoskeletal issues you may have including pain, tissue injury, and muscle spasms</description>
      <arm_group_label>Ultrasound Therap</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Both male and female&#xD;
  &#xD;
            -  between age of 18 and 60 reported with chronic low back pain (lasting more than 3&#xD;
               months)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  unresponsive psychologically disturbed patient&#xD;
  &#xD;
            -  people under 18&#xD;
  &#xD;
            -  Following coexisting conditions cancer, diabetes, pregnancy, cardiovascular system,&#xD;
               gynecological disease.&#xD;
  &#xD;
            -  Neurological conditions, spine injury contraindicated to MFR treatment (infectious&#xD;
               disease, viral and bacterial infections, active malignant disease, aneurysm&#xD;
  &#xD;
            -  Arthrodesis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Abdul Wahab</last_name>
      <role>Study Chair</role>
      <affiliation>Superior Uni</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Azra Naheed Medical College, Superior University</name>
        <address>
          <city>Lahore</city>
          <state>Punjab</state>
          <country>Pakistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>March 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Superior University</investigator_affiliation>
      <investigator_full_name>Muhammad Naveed Babur</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05965050
  org study id: DPT/Batch-Fall18/541
  nct id: NCT05965050
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Low back pain is common problem the purpose of this research will be to determine the
        comparison of ultrasound therapy and myofascial release technique for treatment of low back
        pain in adults.
  Low back pain is common problem the purpose of this research will be to determine the
        comparison of ultrasound therapy and myofascial release technique for treatment of low back
        pain in adults. To increase lumbar spine range of motion chest wall mobility and flexibility,
        reduction in level of lumbar disability
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Modified Oswestry disability index
  time frame: 6 Months
  description: Oswestry Disability Index [ODI] (an outcome measure that was designed to assess function in activities of daily living for those with acute or chronic back pain)
  arm group label: Myofascial Release Technique
  arm group type: Other
  description: myofascial release therapy, the therapist applies light pressure by hand to find myofascial areas that feel stiff instead of elastic and movable. These stiff areas, or trigger points, are thought to limit muscle and joint movements, which can play a part in widespread muscle pain.
  arm group label: Ultrasound Therap
  arm group type: Experimental
  description: Ultrasound physical therapy is a branch of ultrasound, alongside diagnostic ultrasound and pregnancy imaging. It's used to detect and treat various musculoskeletal issues you may have including pain, tissue injury, and muscle spasms
  intervention type: Diagnostic Test
  intervention name: Myofascial Release Technique
  description: myofascial release therapy, the therapist applies light pressure by hand to find myofascial areas that feel stiff instead of elastic and movable. These stiff areas, or trigger points, are thought to limit muscle and joint movements, which can play a part in widespread muscle pain.
  arm group label: Myofascial Release Technique
  intervention type: Other
  intervention name: Ultrasound Therapy
  description: Ultrasound physical therapy is a branch of ultrasound, alongside diagnostic ultrasound and pregnancy imaging. It's used to detect and treat various musculoskeletal issues you may have including pain, tissue injury, and muscle spasms
  arm group label: Ultrasound Therap
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Abdul Wahab
  role: Study Chair
  affiliation: Superior Uni
  facility: 
  country: Pakistan
  responsible party type: Principal Investigator
  investigator affiliation: Superior University
  investigator full name: Muhammad Naveed Babur
  investigator title: Principal Investigator
  mesh term: Back Pain
  mesh term: Low Back Pain
  sharing ipd: No