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/NCT05995210</url>
    </required_header>
    <id_info>
      <org_study_id>IstanbulMUH-DPTR-Yozdemir-0859</org_study_id>
      <nct_id>NCT05995210</nct_id>
    </id_info>
    <brief_title>Comparing the Effectiveness of Kinesio Taping and Knee Orthosis in Patients With Patellofemoral Pain Syndrome</brief_title>
    <official_title>Comparing the Effectiveness of Kinesio Taping and Knee Orthosis in Patients With Patellofemoral Pain Syndrome: Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul Medipol University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul Medipol University Hospital</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>
        The aim of the study is to compare the efficacy of kinesio taping treatment and knee orthosis&#xD;
        treatment in Patellofemoral Pain Syndrome (PFAS). 54 patients were included in the study and&#xD;
        the patients were divided into 3 groups as kinesio taping group (KTG) (n=18), orthotics group&#xD;
        (OG) (n=18) and control group (CG) (n=18). A progressive exercise program was applied to all&#xD;
        groups and patients were treated 2 days a week for 6 weeks.While kinesio taping was applied&#xD;
        to KTG in each session, knee orthosis was given to OG and they were asked to use it for 6&#xD;
        weeks. Visual Analogue Scale (VAS), Kujala Score, Knee injury and Osteoarthritis Outcome&#xD;
        Score (KOOS), isokinetic strength test (IST) and joint position sense (JPS) test were used in&#xD;
        the evaluation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients were divided into 3 groups as patellofemoral knee orthosis group, kinesio taping&#xD;
        group and control group. Randomization of group allocation was done using the website&#xD;
        &quot;https://www.randomizer.org&quot;. Patients were unaware of the other group's treatment program&#xD;
        and group allocation. All participants signed an informed consent form before the study. The&#xD;
        primary outcome measure of our study was the Kujala Score, and the secondary outcome measures&#xD;
        were the Knee Injury and Osteoarthritis Outcome Score (KOOS), Visual Analog Scale (VAS),&#xD;
        quadriceps and hamstring isokinetic muscle strength, and knee joint position sense. The&#xD;
        evaluations were performed before and after treatment. All patients were informed about the&#xD;
        disease and treatment process before treatment. Patients were informed about the things they&#xD;
        should pay attention to for pain management in daily life activities and suggestions were&#xD;
        made. In addition, all patients received at least 2 weeks of NSAID treatment by the&#xD;
        orthopedist. A progressive exercise program was applied to all treatment groups. The&#xD;
        progressive exercise program was continued under the supervision of a physiotherapist 2 days&#xD;
        a week for 6 weeks. The progressive exercise program consisted of strengthening exercises for&#xD;
        the muscles around the knee and hip, stretching exercises for the hamstring and gastrosoleus&#xD;
        muscles. The knee orthosis group received the OrthoCare® 6158 Genucare Luxa knee orthosis.&#xD;
        T-max Kinesiology Tape® (Tmax Medical Co., South Korea) brand kinesio tape was used in all&#xD;
        patients. In kinesio tape application, 2 Y-shaped tapes were used. The activation technique&#xD;
        was applied to the VMO muscle with the first band. In the second band, mechanical correction&#xD;
        technique was applied to the patella.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 9, 2021</start_date>
    <completion_date type="Actual">June 16, 2023</completion_date>
    <primary_completion_date type="Actual">May 5, 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>prospective randomized controlled single-blind</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in baseline Kujala scores of patients treated at week 6</measure>
      <time_frame>6 weeks</time_frame>
      <description>It is a score that evaluates symptoms and function in patients with patellofemoral pain syndrome. Patients were asked to complete this score before starting the treatment and again at the end of the 6-week treatment.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in baseline Visual Analogue Scale of patients treated at week 6</measure>
      <time_frame>6 weeks</time_frame>
      <description>It is a scale that evaluates pain. Patients were asked to complete this scale before starting the treatment and again at the end of the 6-week treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in baseline Knee Injury and Osteoarthritis Outcome Score of patients treated at week 6</measure>
      <time_frame>6 weeks</time_frame>
      <description>Knee Injury and Osteoarthritis Outcome Score (KOOS) is a score used to evaluate symptoms and functional status related to knee injury and knee osteoarthritis. Patients were asked to complete this score before starting the treatment and again at the end of the 6-week treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in baseline isokinetic strength test of patients treated at week 6</measure>
      <time_frame>6 weeks</time_frame>
      <description>This test is a strength test performed with an isokinetic strength testing machine. This test was applied to the patients before starting the treatment and at the end of the 6-week treatment.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">54</enrollment>
    <condition>Patellofemoral Pain Syndrome</condition>
    <condition>Anterior Knee Pain Syndrome</condition>
    <condition>Patellofemoral Pain</condition>
    <condition>Patellofemoral Syndrome</condition>
    <condition>Orthotic Devices</condition>
    <condition>Kinesiotape</condition>
    <arm_group>
      <arm_group_label>Kinesio taping group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In addition to the standard exercise program, kinesio taping was applied to the knee for 6 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Orthosis group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In addition to the standard exercise program, they were asked to use a knee orthosis for 6 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>A standard exercise program was applied for 6 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Kinesio taping</intervention_name>
      <description>A corrective kinesio taping was applied to the patellofemoral joint for the knee. In addition, exercise therapy was taken.</description>
      <arm_group_label>Kinesio taping group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Orthosis</intervention_name>
      <description>They were asked to use a knee orthosis for a minimum of 6 hours a day. They also received exercise therapy.</description>
      <arm_group_label>Orthosis group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Control</intervention_name>
      <description>An exercise program focused on the knee and hip muscles was given two days a week.</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Kinesio taping group</arm_group_label>
      <arm_group_label>Orthosis group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Be between the ages of 18-45&#xD;
  &#xD;
            -  Patients with a body mass index (BMI) less than 29.9&#xD;
  &#xD;
            -  Anterior knee pain defined as 3 points on the 10 cm Visual Analogue Scale when&#xD;
               performing at least two activities of sitting for a long time, climbing/descending&#xD;
               stairs, squatting, running and jumping&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with knee osteoarthritis&#xD;
  &#xD;
            -  History of surgery involving the lower extremity&#xD;
  &#xD;
            -  Patellar or quadriceps tendinopathy&#xD;
  &#xD;
            -  Injury to the meniscus or knee ligaments&#xD;
  &#xD;
            -  Patients showing an allergic response to kinesio tape&#xD;
  &#xD;
            -  Patients previously treated with PFAS&#xD;
  &#xD;
            -  Existing hip pathologies&#xD;
  &#xD;
            -  History of patellar subluxation or dislocation&#xD;
  &#xD;
            -  Patients with neurological disorders&#xD;
  &#xD;
            -  Patients who did not fill out the voluntary consent form&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yunus Özdemir, MSc</last_name>
      <role>Study Chair</role>
      <affiliation>Medipol University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Istanbul Medipol University</name>
        <address>
          <city>Istanbul</city>
          <zip>34815</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul Medipol University Hospital</investigator_affiliation>
      <investigator_full_name>yunus ozdemır</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>Patellofemoral Pain Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Somatoform Disorders</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/NCT05995210
  org study id: IstanbulMUH-DPTR-Yozdemir-0859
  nct id: NCT05995210
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to compare the efficacy of kinesio taping treatment and knee orthosis
        treatment in Patellofemoral Pain Syndrome (PFAS). 54 patients were included in the study and
        the patients were divided into 3 groups as kinesio taping group (KTG) (n=18), orthotics group
        (OG) (n=18) and control group (CG) (n=18). A progressive exercise program was applied to all
        groups and patients were treated 2 days a week for 6 weeks.While kinesio taping was applied
        to KTG in each session, knee orthosis was given to OG and they were asked to use it for 6
        weeks. Visual Analogue Scale (VAS), Kujala Score, Knee injury and Osteoarthritis Outcome
        Score (KOOS), isokinetic strength test (IST) and joint position sense (JPS) test were used in
        the evaluation.
  Patients were divided into 3 groups as patellofemoral knee orthosis group, kinesio taping
        group and control group. Randomization of group allocation was done using the website
        "https://www.randomizer.org". Patients were unaware of the other group's treatment program
        and group allocation. All participants signed an informed consent form before the study. The
        primary outcome measure of our study was the Kujala Score, and the secondary outcome measures
        were the Knee Injury and Osteoarthritis Outcome Score (KOOS), Visual Analog Scale (VAS),
        quadriceps and hamstring isokinetic muscle strength, and knee joint position sense. The
        evaluations were performed before and after treatment. All patients were informed about the
        disease and treatment process before treatment. Patients were informed about the things they
        should pay attention to for pain management in daily life activities and suggestions were
        made. In addition, all patients received at least 2 weeks of NSAID treatment by the
        orthopedist. A progressive exercise program was applied to all treatment groups. The
        progressive exercise program was continued under the supervision of a physiotherapist 2 days
        a week for 6 weeks. The progressive exercise program consisted of strengthening exercises for
        the muscles around the knee and hip, stretching exercises for the hamstring and gastrosoleus
        muscles. The knee orthosis group received the OrthoCare® 6158 Genucare Luxa knee orthosis.
        T-max Kinesiology Tape® (Tmax Medical Co., South Korea) brand kinesio tape was used in all
        patients. In kinesio tape application, 2 Y-shaped tapes were used. The activation technique
        was applied to the VMO muscle with the first band. In the second band, mechanical correction
        technique was applied to the patella.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: prospective randomized controlled single-blind
  primary purpose: Supportive Care
  masking: Single (Participant)
  measure: Change in baseline Kujala scores of patients treated at week 6
  time frame: 6 weeks
  description: It is a score that evaluates symptoms and function in patients with patellofemoral pain syndrome. Patients were asked to complete this score before starting the treatment and again at the end of the 6-week treatment.
  measure: Change in baseline Visual Analogue Scale of patients treated at week 6
  time frame: 6 weeks
  description: It is a scale that evaluates pain. Patients were asked to complete this scale before starting the treatment and again at the end of the 6-week treatment.
  measure: Change in baseline Knee Injury and Osteoarthritis Outcome Score of patients treated at week 6
  time frame: 6 weeks
  description: Knee Injury and Osteoarthritis Outcome Score (KOOS) is a score used to evaluate symptoms and functional status related to knee injury and knee osteoarthritis. Patients were asked to complete this score before starting the treatment and again at the end of the 6-week treatment.
  measure: Change in baseline isokinetic strength test of patients treated at week 6
  time frame: 6 weeks
  description: This test is a strength test performed with an isokinetic strength testing machine. This test was applied to the patients before starting the treatment and at the end of the 6-week treatment.
  arm group label: Kinesio taping group
  arm group type: Experimental
  description: In addition to the standard exercise program, kinesio taping was applied to the knee for 6 weeks.
  arm group label: Orthosis group
  arm group type: Experimental
  description: In addition to the standard exercise program, they were asked to use a knee orthosis for 6 weeks.
  arm group label: Control group
  arm group type: Active Comparator
  description: A standard exercise program was applied for 6 weeks.
  intervention type: Procedure
  intervention name: Kinesio taping
  description: A corrective kinesio taping was applied to the patellofemoral joint for the knee. In addition, exercise therapy was taken.
  arm group label: Kinesio taping group
  intervention type: Procedure
  intervention name: Orthosis
  description: They were asked to use a knee orthosis for a minimum of 6 hours a day. They also received exercise therapy.
  arm group label: Orthosis group
  intervention type: Procedure
  intervention name: Control
  description: An exercise program focused on the knee and hip muscles was given two days a week.
  arm group label: Control group
  arm group label: Kinesio taping group
  arm group label: Orthosis group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yunus Özdemir, MSc
  role: Study Chair
  affiliation: Medipol University
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul Medipol University Hospital
  investigator full name: yunus ozdemır
  investigator title: Lecturer
  mesh term: Patellofemoral Pain Syndrome
  mesh term: Syndrome
  mesh term: Somatoform Disorders
  sharing ipd: No