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/NCT05967923</url>
    </required_header>
    <id_info>
      <org_study_id>P.T- ORTH-06/2023-516</org_study_id>
      <nct_id>NCT05967923</nct_id>
    </id_info>
    <brief_title>Effectiveness of Shock Wave Therapy Versus Low Level Lazer Therapy in Diabetic Frozen Shoulder Patients.</brief_title>
    <official_title>Effectiveness of Shock Wave Therapy Versus Low Level Lazer Therapy in Diabetic</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>South Valley University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>South Valley 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>
        Patients will be divided randomly into 3 groups.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients will be allocated from out patient clinics of Qena university hospitals Then they&#xD;
        will be randomly assigned to three groups, every one will contain 30 patients of both gender,&#xD;
        with age range between 45 and 60 years old&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 5, 2023</start_date>
    <completion_date type="Anticipated">November 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 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>Group (a) Group (b) Group (c)</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Shoulder joint Pain</measure>
      <time_frame>4 weeks</time_frame>
      <description>By using visual analogue scale</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Range of motion of the shoulder</measure>
      <time_frame>4 weeks</time_frame>
      <description>Range of shoulder internal and external rotation and shoulder flexion</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Shoulder and hand disability</measure>
      <time_frame>4 weeks</time_frame>
      <description>By using quick DASH questionnaire</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Diabetes Complications</condition>
    <arm_group>
      <arm_group_label>Group (a)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients in this group will receive shock wave therapy once a week for four weeks in addition to routine physical therapy program.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group (b)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients in this group will receive low level lazer therapy three times per week for four weeks in addition to routine physical therapy program.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group (c)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients in this group will receive only routine physical therapy program.</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Shock wave therapy</intervention_name>
      <description>Patients in this group will receive shock wave therapy once a week for four weeks in addition to routine physical therapy program.</description>
      <arm_group_label>Group (a)</arm_group_label>
      <other_name>Non</other_name>
    </intervention>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Low level lazer therapy</intervention_name>
      <description>Patients in this group will receive low level lazer therapy three times a week week for four weeks in addition to routine physical therapy program.</description>
      <arm_group_label>Group (b)</arm_group_label>
      <other_name>Non</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Routine physical therapy program</intervention_name>
      <description>Patients in this group will receive only routine physical therapy program three times a week for four weeks.</description>
      <arm_group_label>Group (a)</arm_group_label>
      <arm_group_label>Group (b)</arm_group_label>
      <arm_group_label>Group (c)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients with diabetes mellitus.&#xD;
  &#xD;
            -  patients with frozen shoulder due to diabetes mellitus.&#xD;
  &#xD;
            -  patients age ranged between 45 and 60 years old.&#xD;
  &#xD;
            -  cooperative patients.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients with un-controlled hypertension.&#xD;
  &#xD;
            -  patients sensetive to shock wave or lazer irradiation.&#xD;
  &#xD;
            -  Patients with infectious skin diseases.&#xD;
  &#xD;
            -  un-cooperative patients.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Shymaa Yussuf Abo zaid</last_name>
      <phone>01010941685</phone>
      <phone_ext>01091631018</phone_ext>
      <email>shaymaayoussef397@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Shymaa yussuf abo zaid</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Shymaa Y Abo zaid</last_name>
        <phone>01010941685</phone>
        <phone_ext>01091631018</phone_ext>
        <email>shaymaayoussef397@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Shymaa Y Abo zaid, Doctoral</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 15, 2023</study_first_submitted>
    <study_first_submitted_qc>July 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 22, 2023</last_update_submitted>
    <last_update_submitted_qc>July 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>South Valley University</investigator_affiliation>
      <investigator_full_name>Shymaa yussuf abo zaid</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <keyword>Diabetes</keyword>
    <keyword>Frozen shoulder</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Complications</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/NCT05967923
  org study id: P.T- ORTH-06/2023-516
  nct id: NCT05967923
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Patients will be divided randomly into 3 groups.
  Patients will be allocated from out patient clinics of Qena university hospitals Then they
        will be randomly assigned to three groups, every one will contain 30 patients of both gender,
        with age range between 45 and 60 years old
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Group (a) Group (b) Group (c)
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Shoulder joint Pain
  time frame: 4 weeks
  description: By using visual analogue scale
  measure: Range of motion of the shoulder
  time frame: 4 weeks
  description: Range of shoulder internal and external rotation and shoulder flexion
  measure: Shoulder and hand disability
  time frame: 4 weeks
  description: By using quick DASH questionnaire
  arm group label: Group (a)
  arm group type: Experimental
  description: Patients in this group will receive shock wave therapy once a week for four weeks in addition to routine physical therapy program.
  arm group label: Group (b)
  arm group type: Experimental
  description: Patients in this group will receive low level lazer therapy three times per week for four weeks in addition to routine physical therapy program.
  arm group label: Group (c)
  arm group type: Experimental
  description: Patients in this group will receive only routine physical therapy program.
  intervention type: Radiation
  intervention name: Shock wave therapy
  description: Patients in this group will receive shock wave therapy once a week for four weeks in addition to routine physical therapy program.
  arm group label: Group (a)
  other name: Non
  intervention type: Radiation
  intervention name: Low level lazer therapy
  description: Patients in this group will receive low level lazer therapy three times a week week for four weeks in addition to routine physical therapy program.
  arm group label: Group (b)
  other name: Non
  intervention type: Other
  intervention name: Routine physical therapy program
  description: Patients in this group will receive only routine physical therapy program three times a week for four weeks.
  arm group label: Group (a)
  arm group label: Group (b)
  arm group label: Group (c)
  criteria: 
  gender: All
  minimum age: 45 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Shymaa Yussuf Abo zaid
  phone: 01010941685
  phone ext: 01091631018
  email: shaymaayoussef397@gmail.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: South Valley University
  investigator full name: Shymaa yussuf abo zaid
  investigator title: Lecturer
  mesh term: Diabetes Complications
  sharing ipd: No