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/NCT06025175</url>
    </required_header>
    <id_info>
      <org_study_id>P.T_int_08/2023_519</org_study_id>
      <nct_id>NCT06025175</nct_id>
    </id_info>
    <brief_title>Low Level Lazer Therapy Effect on Vertebral Artery Blood Flow in Elderly With Cervical Disc Degeneration</brief_title>
    <official_title>Low Level Lazer Therapy Effect on Vertebral Artery Blood Flow in Elderly With Cervical Disc Degeneration</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>
        This study will include 60 elderly patients with cervical disc degeneration, from both gender&#xD;
        who are aged from 60 - 75 years old.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The 60 patients will divided into two groups, with 30 patients in each group. group(A): will&#xD;
        receive low level lazer and exercises for three times per week for 12 weeks.&#xD;
  &#xD;
        Group (B): will receive only exercises. Resistivity index of both right and left vertebral&#xD;
        arteries will be measured before and after the 12 weeks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 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>
      <intervention_model_description>Two groups Group (A) and group(B)</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Resistivity index of both right and left vertebral arteries</measure>
      <time_frame>12 weeks</time_frame>
      <description>Resistivity index of both right and left vertebral arteries will be measured before and after the 12 weeks.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Disc Degeneration</condition>
    <arm_group>
      <arm_group_label>Lazer group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>30 patients will receive low level lazer therapy 3 times per week for 12 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>30 patients will receive only exercises.</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Low level Lazer therapy</intervention_name>
      <description>30 patients will receive low level lazer therapy 3 times a week for 12 weeks.</description>
      <arm_group_label>Lazer group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Routine exercises</intervention_name>
      <description>30 patients will receive only routine exercises 3 times a week for 12 weeks.</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Lazer group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. elderly patients with age range between 60 and 75 years old.&#xD;
  &#xD;
            2. with cervical disc degeneration.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. patients with uncontrolled hypertension.&#xD;
  &#xD;
            2. Patients with uncontrolled diabetes mellitus.&#xD;
  &#xD;
            3. Patients with severe cardiac or chest diseases.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Shymaa Y 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>Qinā</city>
          <country>Egypt</country>
        </address>
      </facility>
      <contact>
        <last_name>Shymaa Y Abo zaid, Doctoral</last_name>
        <phone>01010941685</phone>
        <phone_ext>01091631018</phone_ext>
        <email>shaymaayoussef397@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Shymaa Y Abo zaid, Doctoral</last_name>
        <phone>01010941685</phone>
        <phone_ext>01010941685</phone_ext>
      </contact_backup>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 20, 2023</study_first_submitted>
    <study_first_submitted_qc>September 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 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>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Intervertebral Disc Degeneration</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/NCT06025175
  org study id: P.T_int_08/2023_519
  nct id: NCT06025175
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study will include 60 elderly patients with cervical disc degeneration, from both gender
        who are aged from 60 - 75 years old.
  The 60 patients will divided into two groups, with 30 patients in each group. group(A): will
        receive low level lazer and exercises for three times per week for 12 weeks.
  
        Group (B): will receive only exercises. Resistivity index of both right and left vertebral
        arteries will be measured before and after the 12 weeks.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Two groups Group (A) and group(B)
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Resistivity index of both right and left vertebral arteries
  time frame: 12 weeks
  description: Resistivity index of both right and left vertebral arteries will be measured before and after the 12 weeks.
  arm group label: Lazer group
  arm group type: Experimental
  description: 30 patients will receive low level lazer therapy 3 times per week for 12 weeks.
  arm group label: Control group
  arm group type: Other
  description: 30 patients will receive only exercises.
  intervention type: Radiation
  intervention name: Low level Lazer therapy
  description: 30 patients will receive low level lazer therapy 3 times a week for 12 weeks.
  arm group label: Lazer group
  intervention type: Other
  intervention name: Routine exercises
  description: 30 patients will receive only routine exercises 3 times a week for 12 weeks.
  arm group label: Control group
  arm group label: Lazer group
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Shymaa Y Abo zaid
  phone: 01010941685
  phone ext: 01091631018
  email: shaymaayoussef397@gmail.com
  facility: 
  contact: 
  contact backup: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: South Valley University
  investigator full name: Shymaa yussuf abo zaid
  investigator title: Lecturer
  mesh term: Intervertebral Disc Degeneration