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/NCT06018779</url>
    </required_header>
    <id_info>
      <org_study_id>MFR0032023</org_study_id>
      <nct_id>NCT06018779</nct_id>
    </id_info>
    <brief_title>Effectiveness of Physical Therapy for Pain Relief in Footballers With Muscle Injuries: a Prospective Study</brief_title>
    <official_title>Effectiveness of Cryo Plus Ultrasound Therapy Versus Diathermy in Combination With High-intensity Laser Therapy for Pain Relief in Footballers With Muscle Injuries: a Prospective Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Palermo</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Palermo</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The objective of this study was to evaluate the efficacy of cryoultrasound therapy versus&#xD;
        diathermy in combination with high-intensity laser therapy for pain relief in male&#xD;
        professional soccer players with muscle injuries. The main questions it intends to answer&#xD;
        are:&#xD;
  &#xD;
        • Is this combination of treatments effective in these patients in terms of pain relief?&#xD;
  &#xD;
        Participants will receive a rehabilitation treatment consisting of cryo-ultrasound therapy&#xD;
        and high intensity laser. Researchers will compare the group of participants, called the&#xD;
        treatment group, with a control group to see if:&#xD;
  &#xD;
        • Is the combined treatment of cryoultrasound therapy and high intensity laser more effective&#xD;
        in these patients than the combination of diathermy and high intensity laser?&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 1, 2022</start_date>
    <completion_date type="Actual">April 15, 2023</completion_date>
    <primary_completion_date type="Actual">March 13, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>entity of the pain</measure>
      <time_frame>2 weeks</time_frame>
      <description>numerical rating scale; the total score ranges from 0 to 10, with higher scores indicating more pain.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>size of the muscle tear</measure>
      <time_frame>2 weeks</time_frame>
      <description>measurement in centimeters by ultrasound.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>frequency of relapses</measure>
      <time_frame>3 months after the injury</time_frame>
      <description>number of relapses</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>return to play</measure>
      <time_frame>3 months after the injury</time_frame>
      <description>number of days</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">31</enrollment>
    <condition>Athletic Injuries</condition>
    <condition>Physical Therapies</condition>
    <arm_group>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group A will include patients who will receive a rehabilitation treatment consisting of: cryo-ultrasound therapy and high-intensity laser therapy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Group B will include patients who will receive a rehabilitation treatment consisting of: cryo-ultrasound therapy and diathermy</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Cryoultrasound therapy plus high-intensity laser therapy</intervention_name>
      <description>Group A received a daily rehabilitation treatment lasting 10 sessions for 10 consecutive sessions, consisting of high-intensity laser therapy and cryo-sound therapy.</description>
      <arm_group_label>Group A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>diathermy plus high-intensity laser therapy</intervention_name>
      <description>Group B received a daily rehabilitation treatment lasting 10 sessions for 10 consecutive sessions, consisting of high-intensity laser therapy and diathermy.</description>
      <arm_group_label>Group B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age 18-21 years;&#xD;
  &#xD;
            -  professional footballer in a competitive club;&#xD;
  &#xD;
            -  presence of a grade III A muscle lesion, according to the Mueller-Wohlfart&#xD;
               classification, confirmed by ultrasound examination and occurring during sports&#xD;
               activity at least 5 days before inclusion in the present study;&#xD;
  &#xD;
            -  no previous muscle injuries in the last 6 months;&#xD;
  &#xD;
            -  signature of the written informed consent for participating in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  previous muscle injuries or bone fractures of the lower limbs in the last 6 months;&#xD;
  &#xD;
            -  knee instability due to previous rupture of knee ligaments;&#xD;
  &#xD;
            -  active neoplastic or infectious diseases;&#xD;
  &#xD;
            -  congenital anomalies of the lower limbs.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>21 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone</name>
        <address>
          <city>Palermo</city>
          <zip>90127</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Palermo</investigator_affiliation>
      <investigator_full_name>Prof.ssa Giulia Letizia Mauro</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Wounds and Injuries</mesh_term>
      <mesh_term>Athletic Injuries</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/NCT06018779
  org study id: MFR0032023
  nct id: NCT06018779
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The objective of this study was to evaluate the efficacy of cryoultrasound therapy versus
        diathermy in combination with high-intensity laser therapy for pain relief in male
        professional soccer players with muscle injuries. The main questions it intends to answer
        are:
  
        • Is this combination of treatments effective in these patients in terms of pain relief?
  
        Participants will receive a rehabilitation treatment consisting of cryo-ultrasound therapy
        and high intensity laser. Researchers will compare the group of participants, called the
        treatment group, with a control group to see if:
  
        • Is the combined treatment of cryoultrasound therapy and high intensity laser more effective
        in these patients than the combination of diathermy and high intensity laser?
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Investigator)
  measure: entity of the pain
  time frame: 2 weeks
  description: numerical rating scale; the total score ranges from 0 to 10, with higher scores indicating more pain.
  measure: size of the muscle tear
  time frame: 2 weeks
  description: measurement in centimeters by ultrasound.
  measure: frequency of relapses
  time frame: 3 months after the injury
  description: number of relapses
  measure: return to play
  time frame: 3 months after the injury
  description: number of days
  arm group label: Group A
  arm group type: Experimental
  description: Group A will include patients who will receive a rehabilitation treatment consisting of: cryo-ultrasound therapy and high-intensity laser therapy
  arm group label: Group B
  arm group type: Placebo Comparator
  description: Group B will include patients who will receive a rehabilitation treatment consisting of: cryo-ultrasound therapy and diathermy
  intervention type: Other
  intervention name: Cryoultrasound therapy plus high-intensity laser therapy
  description: Group A received a daily rehabilitation treatment lasting 10 sessions for 10 consecutive sessions, consisting of high-intensity laser therapy and cryo-sound therapy.
  arm group label: Group A
  intervention type: Other
  intervention name: diathermy plus high-intensity laser therapy
  description: Group B received a daily rehabilitation treatment lasting 10 sessions for 10 consecutive sessions, consisting of high-intensity laser therapy and diathermy.
  arm group label: Group B
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 21 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: University of Palermo
  investigator full name: Prof.ssa Giulia Letizia Mauro
  investigator title: Professor
  mesh term: Wounds and Injuries
  mesh term: Athletic Injuries