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/NCT05988307</url>
    </required_header>
    <id_info>
      <org_study_id>percussion gun on Knee OA</org_study_id>
      <nct_id>NCT05988307</nct_id>
    </id_info>
    <brief_title>Effect of Percussion Massage Gun on Hamstrings Flexibility.</brief_title>
    <official_title>Effect Of Percussion Massage Gun On Hamstrings Flexibility In Patients With Knee Osteoarthritis.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo 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>
        The purpose of this study would be to investigate:&#xD;
  &#xD;
          -  The effect of using percussion massage gun on Hamstring flexibility in patients with&#xD;
             knee osteoarthritis.&#xD;
  &#xD;
          -  The effect of using percussion massage gun on pain in patients with knee osteoarthritis.&#xD;
  &#xD;
          -  The effect of using percussion massage gun on ROM in patients with knee osteoarthritis.&#xD;
  &#xD;
          -  The effect of using percussion massage gun on knee function in patients with knee&#xD;
             osteoarthritis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Knee osteoarthritis (OA) is present in about 65% of people with knee pain aged 50 years or&#xD;
        older. The condition is associated with knee pain and reduced function and those with&#xD;
        progression of tibiofemoral OA. OA are at increased risk of both incidence and Approximately&#xD;
        11 percent of adults with knee osteoarthritis need help with personal care.&#xD;
  &#xD;
        Conservative treatment consists of medication and various forms of physiotherapy including&#xD;
        heat, massage, electrotherapy and exercises.. The hamstring muscle group have tendency to&#xD;
        shorten and the tightening results in increased patello-femoral compressive force, which may&#xD;
        eventually lead to patello-femoral syndrome often associated with osteoarthritis .&#xD;
  &#xD;
        Percussion Therapy is a relatively new technique that uses a mechanical system, such as the&#xD;
        massage gun, to provide percussion massage. The application of percussive massage gun&#xD;
        activates the Golgi tendon organ, which triggers a relaxation response, improving circulation&#xD;
        and nutrition to the tissue, and reducing tightness and improving flexibility, It also&#xD;
        reduces pain perception through the pain gait theory process .&#xD;
  &#xD;
        Currently there are no evidence based clinical guidelines for the use of mechanical&#xD;
        percussion devices. Further laboratory-based and clinical outcomes studies are needed to best&#xD;
        guide clinical practice regarding these devices; however, research should also be informed&#xD;
        based on how the devices are utilized by clinicians when providing care to patients.&#xD;
        Understanding the knowledge and current trends in the use of mechanical percussion devices&#xD;
        among health care professionals may help guide researchers in developing guidelines for&#xD;
        research and/or practice. Thus, the purpose of this study was to document the knowledge,&#xD;
        clinical application methods, and use of mechanical percussion devices.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2024</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>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>hamstring flexibility</measure>
      <time_frame>baseline (1 month )</time_frame>
      <description>measuring flexibility of hamstrings through sit and reach test and active knee extension</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>measuring pain</measure>
      <time_frame>baseline (1 month )</time_frame>
      <description>through visual analogue scale .</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>measuring Function</measure>
      <time_frame>baseline (1 month)</time_frame>
      <description>through WOMAC questionnaire.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">42</enrollment>
    <condition>Knee Osteoarthritis</condition>
    <arm_group>
      <arm_group_label>receive percussion massage gun and conventional physical therapy program</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>receive conventional physical therapy program only for knee osteoarthrities</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Percussion massage gun</intervention_name>
      <description>Percussion massage gun on hamstrings flexibility in patients with knee Osteoarthritis.</description>
      <arm_group_label>receive conventional physical therapy program only for knee osteoarthrities</arm_group_label>
      <arm_group_label>receive percussion massage gun and conventional physical therapy program</arm_group_label>
      <other_name>conventional physical therapy program</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. Age - 40 years to 60 years patients of chronic knee OA (Culvenor et al., 2019).&#xD;
  &#xD;
               2. Patients with BMI &lt; 30 kg/m² (not being classified as obese) 3. Patients who are&#xD;
               able to walk with painful knee OA without assistive devices.&#xD;
  &#xD;
               4. Patients with knee pain intensity level at least &gt;3 cm on a 10 cm VAS scale in&#xD;
               activities such as going up-and downstairs, sitting and squatting.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Radiated pain from low back pain.&#xD;
  &#xD;
            2. Patients with no radiographic evidence of knee OA or with mild OA (grade I according&#xD;
               to K/L classification) or with severe OA (grade IV according to K/L classification).&#xD;
  &#xD;
            3. Loss of joint play in tibiofemoral and patellofemoral articulations.&#xD;
  &#xD;
            4. Lower extremity fracture and surgery or trauma to the knee joint.&#xD;
  &#xD;
            5. Neurological deficit or movement disorder related to lower limb.&#xD;
  &#xD;
            6. Those who were athletes or who had been treated with physiotherapy or medications&#xD;
               during the previous 6 weeks&#xD;
  &#xD;
               -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Heba Mohamed El-Berkawy, bachelor</last_name>
      <phone>1007955987</phone>
      <phone_ext>20</phone_ext>
      <email>hebaelberkawy2014@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Doaa raafat mohamed, PHD (lecturer)</last_name>
      <phone>1005591580</phone>
      <phone_ext>20</phone_ext>
      <email>doaa.rafat@pt.cu.edu.eg</email>
    </overall_contact_backup>
    <reference>
      <citation>Alghadir A, Anwer S, Iqbal ZA, Alsanawi HA. Cross-cultural adaptation, reliability and validity of the Arabic version of the reduced Western Ontario and McMaster Universities Osteoarthritis index in patients with knee osteoarthritis. Disabil Rehabil. 2016;38(7):689-94. doi: 10.3109/09638288.2015.1055380. Epub 2015 Jun 11.</citation>
      <PMID>26066566</PMID>
    </reference>
    <reference>
      <citation>49. Lakhwani, M., &amp; Phansopkar, P. (2021). Efficacy of Percussive Massage versus Calf Stretching on Pain, Range of Motion, Muscle Strength and Functional Outcomes in Patients with Plantar Fasciitis-A Research Protocol. Journal of Pharmaceutical Research International, 233(44B), 532-539.</citation>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 30, 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>Cairo University</investigator_affiliation>
      <investigator_full_name>heba mohamed moawed EL-berkawy</investigator_full_name>
      <investigator_title>demonstrator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
      <mesh_term>Osteoarthritis, Knee</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/NCT05988307
  org study id: percussion gun on Knee OA
  nct id: NCT05988307
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study would be to investigate:
  
          -  The effect of using percussion massage gun on Hamstring flexibility in patients with
             knee osteoarthritis.
  
          -  The effect of using percussion massage gun on pain in patients with knee osteoarthritis.
  
          -  The effect of using percussion massage gun on ROM in patients with knee osteoarthritis.
  
          -  The effect of using percussion massage gun on knee function in patients with knee
             osteoarthritis.
  Knee osteoarthritis (OA) is present in about 65% of people with knee pain aged 50 years or
        older. The condition is associated with knee pain and reduced function and those with
        progression of tibiofemoral OA. OA are at increased risk of both incidence and Approximately
        11 percent of adults with knee osteoarthritis need help with personal care.
  
        Conservative treatment consists of medication and various forms of physiotherapy including
        heat, massage, electrotherapy and exercises.. The hamstring muscle group have tendency to
        shorten and the tightening results in increased patello-femoral compressive force, which may
        eventually lead to patello-femoral syndrome often associated with osteoarthritis .
  
        Percussion Therapy is a relatively new technique that uses a mechanical system, such as the
        massage gun, to provide percussion massage. The application of percussive massage gun
        activates the Golgi tendon organ, which triggers a relaxation response, improving circulation
        and nutrition to the tissue, and reducing tightness and improving flexibility, It also
        reduces pain perception through the pain gait theory process .
  
        Currently there are no evidence based clinical guidelines for the use of mechanical
        percussion devices. Further laboratory-based and clinical outcomes studies are needed to best
        guide clinical practice regarding these devices; however, research should also be informed
        based on how the devices are utilized by clinicians when providing care to patients.
        Understanding the knowledge and current trends in the use of mechanical percussion devices
        among health care professionals may help guide researchers in developing guidelines for
        research and/or practice. Thus, the purpose of this study was to document the knowledge,
        clinical application methods, and use of mechanical percussion devices.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: hamstring flexibility
  time frame: baseline (1 month )
  description: measuring flexibility of hamstrings through sit and reach test and active knee extension
  measure: measuring pain
  time frame: baseline (1 month )
  description: through visual analogue scale .
  measure: measuring Function
  time frame: baseline (1 month)
  description: through WOMAC questionnaire.
  arm group label: receive percussion massage gun and conventional physical therapy program
  arm group type: Experimental
  arm group label: receive conventional physical therapy program only for knee osteoarthrities
  arm group type: Other
  intervention type: Device
  intervention name: Percussion massage gun
  description: Percussion massage gun on hamstrings flexibility in patients with knee Osteoarthritis.
  arm group label: receive conventional physical therapy program only for knee osteoarthrities
  arm group label: receive percussion massage gun and conventional physical therapy program
  other name: conventional physical therapy program
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Heba Mohamed El-Berkawy, bachelor
  phone: 1007955987
  phone ext: 20
  email: hebaelberkawy2014@gmail.com
  last name: Doaa raafat mohamed, PHD (lecturer)
  phone: 1005591580
  phone ext: 20
  email: doaa.rafat@pt.cu.edu.eg
  citation: Alghadir A, Anwer S, Iqbal ZA, Alsanawi HA. Cross-cultural adaptation, reliability and validity of the Arabic version of the reduced Western Ontario and McMaster Universities Osteoarthritis index in patients with knee osteoarthritis. Disabil Rehabil. 2016;38(7):689-94. doi: 10.3109/09638288.2015.1055380. Epub 2015 Jun 11.
  PMID: 26066566
  citation: 49. Lakhwani, M., & Phansopkar, P. (2021). Efficacy of Percussive Massage versus Calf Stretching on Pain, Range of Motion, Muscle Strength and Functional Outcomes in Patients with Plantar Fasciitis-A Research Protocol. Journal of Pharmaceutical Research International, 233(44B), 532-539.
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: heba mohamed moawed EL-berkawy
  investigator title: demonstrator
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee