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/NCT05988476</url>
    </required_header>
    <id_info>
      <org_study_id>SuleymanDUmesutergan01</org_study_id>
      <nct_id>NCT05988476</nct_id>
    </id_info>
    <brief_title>Investıgatıon of The Effıciency of Pulsed Electromagnetıc Field Therapy and Stretching Exercises</brief_title>
    <official_title>Investigation of The Efficiency of Pulsed Electromagnetic Field Treatment and Stretching Exercise In Experimental Skeletal Muscle Injury Model</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Suleyman Demirel University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Suleyman Demirel University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In this study, a total of 69 Wistar Albino rats were used, five of which were in the&#xD;
        preliminary study. The preliminary study was planned to determine the ideal PEMF treatment&#xD;
        time. In the study, animals were divided into 5 groups (Control, INJ, INJ+Exercise, INJ+PEMF,&#xD;
        INJ+Exercise+PEMF). Experimental animals were sacrificed on the 7th and 14th days to see the&#xD;
        effects of the treatments. At the end of the experiment, genetic, histopathological, and&#xD;
        immunohistochemical evaluations were made in the muscle tissue.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Purpose: The aim of this study was to evaluate the efficacy of stretching exercise and the&#xD;
        pulsed electromagnetic field (PEMF) method in the treatment of muscle injury (INJ).&#xD;
  &#xD;
        Methods: In this study, a total of 69 Wistar Albino rats were used, five of which were in the&#xD;
        preliminary study. The preliminary study was planned to determine the ideal PEMF treatment&#xD;
        time. In the study, animals were divided into 5 groups (Control, INJ, INJ+Exercise, INJ+PEMF,&#xD;
        INJ+Exercise+PEMF). Experimental animals were sacrificed on the 7th and 14th days to see the&#xD;
        effects of the treatments. At the end of the experiment, genetic, histopathological, and&#xD;
        immunohistochemical evaluations were made in the muscle tissue.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 5, 2022</start_date>
    <completion_date type="Actual">November 7, 2022</completion_date>
    <primary_completion_date type="Actual">October 2, 2022</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>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mononuclear cell infiltration, Atrophy and necrosis, Pyknotic nucleus assesment at the end of two weeks</measure>
      <time_frame>two week</time_frame>
      <description>hematoxylin-eosin staining</description>
    </primary_outcome>
    <primary_outcome>
      <measure>VEGF and FGF assesment at the end of two weeks</measure>
      <time_frame>two week</time_frame>
      <description>immunohischemical staining</description>
    </primary_outcome>
    <primary_outcome>
      <measure>TGF-β1, eNOS assesment at the end of two weeks</measure>
      <time_frame>two week</time_frame>
      <description>Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-qPCR)</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Actual">64</enrollment>
    <condition>Muscle Injury</condition>
    <condition>Pulsed Electromagnetic Therapy</condition>
    <condition>Muscle Stretching Exercise</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Stretching Exercise</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Pulsed Electromagnetic Field</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Pulsed Electromagnetic Field and Stretching Exercise</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Exercise</intervention_name>
      <description>5 day/week, two week, one session stretching exercises consisting of ten repetitions of one minute</description>
      <arm_group_label>Pulsed Electromagnetic Field</arm_group_label>
      <arm_group_label>Pulsed Electromagnetic Field and Stretching Exercise</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Pulsed Electromagnetic Field Therapy</intervention_name>
      <description>5 day/week, two week,two sessions consisting of 180 minutes</description>
      <arm_group_label>Pulsed Electromagnetic Field and Stretching Exercise</arm_group_label>
      <arm_group_label>Stretching Exercise</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy young wistar albino rats&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  not having any injury&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>10 Months</minimum_age>
      <maximum_age>11 Months</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>SuleymanDU</name>
        <address>
          <city>Isparta</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Suleyman Demirel University</investigator_affiliation>
      <investigator_full_name>Mesut ERGAN</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Muscle Injury</keyword>
    <keyword>TGF-Beta 1</keyword>
    <keyword>Fibrosis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Wounds and Injuries</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/NCT05988476
  org study id: SuleymanDUmesutergan01
  nct id: NCT05988476
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  In this study, a total of 69 Wistar Albino rats were used, five of which were in the
        preliminary study. The preliminary study was planned to determine the ideal PEMF treatment
        time. In the study, animals were divided into 5 groups (Control, INJ, INJ+Exercise, INJ+PEMF,
        INJ+Exercise+PEMF). Experimental animals were sacrificed on the 7th and 14th days to see the
        effects of the treatments. At the end of the experiment, genetic, histopathological, and
        immunohistochemical evaluations were made in the muscle tissue.
  Purpose: The aim of this study was to evaluate the efficacy of stretching exercise and the
        pulsed electromagnetic field (PEMF) method in the treatment of muscle injury (INJ).
  
        Methods: In this study, a total of 69 Wistar Albino rats were used, five of which were in the
        preliminary study. The preliminary study was planned to determine the ideal PEMF treatment
        time. In the study, animals were divided into 5 groups (Control, INJ, INJ+Exercise, INJ+PEMF,
        INJ+Exercise+PEMF). Experimental animals were sacrificed on the 7th and 14th days to see the
        effects of the treatments. At the end of the experiment, genetic, histopathological, and
        immunohistochemical evaluations were made in the muscle tissue.
  allocation: Randomized
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Mononuclear cell infiltration, Atrophy and necrosis, Pyknotic nucleus assesment at the end of two weeks
  time frame: two week
  description: hematoxylin-eosin staining
  measure: VEGF and FGF assesment at the end of two weeks
  time frame: two week
  description: immunohischemical staining
  measure: TGF-β1, eNOS assesment at the end of two weeks
  time frame: two week
  description: Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-qPCR)
  arm group label: Control
  arm group type: No Intervention
  arm group label: Stretching Exercise
  arm group type: Experimental
  arm group label: Pulsed Electromagnetic Field
  arm group type: Experimental
  arm group label: Pulsed Electromagnetic Field and Stretching Exercise
  arm group type: Experimental
  intervention type: Other
  intervention name: Exercise
  description: 5 day/week, two week, one session stretching exercises consisting of ten repetitions of one minute
  arm group label: Pulsed Electromagnetic Field
  arm group label: Pulsed Electromagnetic Field and Stretching Exercise
  intervention type: Device
  intervention name: Pulsed Electromagnetic Field Therapy
  description: 5 day/week, two week,two sessions consisting of 180 minutes
  arm group label: Pulsed Electromagnetic Field and Stretching Exercise
  arm group label: Stretching Exercise
  criteria: 
  gender: Female
  minimum age: 10 Months
  maximum age: 11 Months
  healthy volunteers: No
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Suleyman Demirel University
  investigator full name: Mesut ERGAN
  investigator title: Assistant Professor
  mesh term: Wounds and Injuries
  sharing ipd: No