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/NCT06031935</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00004289</org_study_id>
      <nct_id>NCT06031935</nct_id>
    </id_info>
    <brief_title>Yoga for Adolescent Knee Pain</brief_title>
    <official_title>Yoga for Adolescent Anterior Knee Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Texas at Austin</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Texas at Austin</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>
        Adolescent atraumatic anterior knee pain is a common yet cumbersome diagnosis that is&#xD;
        currently managed with home exercises and physical therapy. The goal of this project is to&#xD;
        present patients with an alternative treatment in the form of yoga available in an online&#xD;
        video format. This new treatment, in the form of online yoga videos, may be more preferred&#xD;
        for some patients and allow for higher compliance with home exercises aimed at treating&#xD;
        anterior knee pain.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Adolescent atraumatic anterior knee pain is a common yet cumbersome diagnosis that is&#xD;
        currently managed with home exercises and physical therapy. The goal of this project is to&#xD;
        test the compliance and efficacy of an alternative treatment in the form of yoga available in&#xD;
        an online video format. This study will help further the treatment understanding of one of&#xD;
        the most common patient clinical presentations, atraumatic anterior knee pain in adolescents.&#xD;
        This is a cumbersome patient presentation that is frustrating for both the patient and&#xD;
        treating team in that there is no concrete treatment algorithm that works for everyone.&#xD;
        Online yoga videos may be more preferred for some patients and allow for higher compliance&#xD;
        with home exercises aimed at treating anterior knee pain. With this study, the investigators&#xD;
        hope to ensure that the yoga videos provide equal, or more, pain relief and flexibility at&#xD;
        the completion of the program.&#xD;
  &#xD;
        It is hypothesized that patients completing the yoga program will have equivalent or greater&#xD;
        flexibility, compliance, and pain relief when compared with current treatment recommendations&#xD;
        for anterior knee pain.&#xD;
  &#xD;
        This study aims to assess the success of a video-based eight-week home yoga program at&#xD;
        improving compliance, increasing flexibility and functionality of knee movements. Compliance&#xD;
        will be tracked through recorded access to the specific YouTube videos hosted through the&#xD;
        CTPO YouTube Channel. Anterior knee pain patients will be given a link to two yoga videos and&#xD;
        will be asked to do them at home, or wherever convenient for 8 weeks, 3-4 times a week.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 31, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 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>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Patient Flexibility</measure>
      <time_frame>Baseline and 8 weeks</time_frame>
      <description>Popliteal angle to test hamstring flexibility. On a scale of 0-90. A popliteal angle of 90 would mean very tight hamstrings. Prone heel to buttocks measurement will be taken to determine how close the patient can get their heel to buttocks. It will be measured in inches. A larger measurement means less flexibility. 0&quot; is an ideal measurement.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of views of yoga videos</measure>
      <time_frame>Log will be recorded weekly for 8 weeks.</time_frame>
      <description>Patient will keep a log of the number of times they do the videos, and we will use YouTube analytics to confirm the number of views.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>International Knee Documentation Committee (pedi-IKDC) Survey Score</measure>
      <time_frame>baseline, 8 weeks and 4 months</time_frame>
      <description>Patient Reported Outcome survey. On a scale of 0-100. 100 means knee is fully functional.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Yoga video satisfaction survey</measure>
      <time_frame>8 weeks and 4 months</time_frame>
      <description>Satisfaction questions as defined by study team on a scale of 0-5. To determine if the yoga videos were useful to the patients.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-Reported Outcomes Measurement Information Systems (PROMIS) pain interference scale</measure>
      <time_frame>baseline, 8 weeks and 4 months</time_frame>
      <description>Measures the extent that pain is interfering with the patient's daily lifestyle. Pain is measured on a T-scale. 50 is the median. 20-55 is considered within the normal limits. 70+ is severe.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Anterior Knee Pain Syndrome</condition>
    <arm_group>
      <arm_group_label>Yoga study group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This is the only arm of the study. The patients will be given yoga videos to do at home for 8 weeks as a treatment for anterior knee pain.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Yoga</intervention_name>
      <description>The patients will receive links to two yoga videos. They will do each of these videos at home for 4 weeks.</description>
      <arm_group_label>Yoga study group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children with non-structural anterior knee pain&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any intra-articular injuries&#xD;
  &#xD;
            -  No access to internet&#xD;
  &#xD;
            -  Non-english speaking&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>10 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Matthew D Ellington, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Texas at Austin, Central Texas Pediatric Orthopedics</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Research Coordinator</last_name>
      <phone>(512) 478-8116</phone>
      <email>nmcmahon@ctpomd.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Central Texas Pediatric Orthopedics</name>
        <address>
          <city>Austin</city>
          <state>Texas</state>
          <zip>78723</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Matthew D Ellington, MD</last_name>
        <phone>512-478-8116</phone>
        <email>mellington@ctpomd.com</email>
      </contact>
      <contact_backup>
        <last_name>Niamh D McMahon, MS</last_name>
        <phone>5124788116</phone>
        <email>nmcmahon@ctpomd.com</email>
      </contact_backup>
      <investigator>
        <last_name>Matthew D Ellington, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Galantino ML, Galbavy R, Quinn L. Therapeutic effects of yoga for children: a systematic review of the literature. Pediatr Phys Ther. 2008 Spring;20(1):66-80. doi: 10.1097/PEP.0b013e31815f1208.</citation>
      <PMID>18300936</PMID>
    </reference>
    <reference>
      <citation>Donohue B, Miller A, Beisecker M, Houser D, Valdez R, Tiller S, Taymar T. Effects of brief yoga exercises and motivational preparatory interventions in distance runners: results of a controlled trial. Br J Sports Med. 2006 Jan;40(1):60-3; discussion 60-3. doi: 10.1136/bjsm.2005.020024.</citation>
      <PMID>16371493</PMID>
    </reference>
    <reference>
      <citation>Hainsworth KR, Liu XC, Simpson PM, Swartz AM, Linneman N, Tran ST, Medrano GR, Mascarenhas B, Zhang L, Weisman SJ. A Pilot Study of Iyengar Yoga for Pediatric Obesity: Effects on Gait and Emotional Functioning. Children (Basel). 2018 Jul 4;5(7):92. doi: 10.3390/children5070092.</citation>
      <PMID>29973555</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Adolescent</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Patellofemoral Pain Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>No individual participant data will be shared outside of the study team.</ipd_description>
    </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/NCT06031935
  org study id: STUDY00004289
  nct id: NCT06031935
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Adolescent atraumatic anterior knee pain is a common yet cumbersome diagnosis that is
        currently managed with home exercises and physical therapy. The goal of this project is to
        present patients with an alternative treatment in the form of yoga available in an online
        video format. This new treatment, in the form of online yoga videos, may be more preferred
        for some patients and allow for higher compliance with home exercises aimed at treating
        anterior knee pain.
  Adolescent atraumatic anterior knee pain is a common yet cumbersome diagnosis that is
        currently managed with home exercises and physical therapy. The goal of this project is to
        test the compliance and efficacy of an alternative treatment in the form of yoga available in
        an online video format. This study will help further the treatment understanding of one of
        the most common patient clinical presentations, atraumatic anterior knee pain in adolescents.
        This is a cumbersome patient presentation that is frustrating for both the patient and
        treating team in that there is no concrete treatment algorithm that works for everyone.
        Online yoga videos may be more preferred for some patients and allow for higher compliance
        with home exercises aimed at treating anterior knee pain. With this study, the investigators
        hope to ensure that the yoga videos provide equal, or more, pain relief and flexibility at
        the completion of the program.
  
        It is hypothesized that patients completing the yoga program will have equivalent or greater
        flexibility, compliance, and pain relief when compared with current treatment recommendations
        for anterior knee pain.
  
        This study aims to assess the success of a video-based eight-week home yoga program at
        improving compliance, increasing flexibility and functionality of knee movements. Compliance
        will be tracked through recorded access to the specific YouTube videos hosted through the
        CTPO YouTube Channel. Anterior knee pain patients will be given a link to two yoga videos and
        will be asked to do them at home, or wherever convenient for 8 weeks, 3-4 times a week.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Patient Flexibility
  time frame: Baseline and 8 weeks
  description: Popliteal angle to test hamstring flexibility. On a scale of 0-90. A popliteal angle of 90 would mean very tight hamstrings. Prone heel to buttocks measurement will be taken to determine how close the patient can get their heel to buttocks. It will be measured in inches. A larger measurement means less flexibility. 0" is an ideal measurement.
  measure: Number of views of yoga videos
  time frame: Log will be recorded weekly for 8 weeks.
  description: Patient will keep a log of the number of times they do the videos, and we will use YouTube analytics to confirm the number of views.
  measure: International Knee Documentation Committee (pedi-IKDC) Survey Score
  time frame: baseline, 8 weeks and 4 months
  description: Patient Reported Outcome survey. On a scale of 0-100. 100 means knee is fully functional.
  measure: Yoga video satisfaction survey
  time frame: 8 weeks and 4 months
  description: Satisfaction questions as defined by study team on a scale of 0-5. To determine if the yoga videos were useful to the patients.
  measure: Patient-Reported Outcomes Measurement Information Systems (PROMIS) pain interference scale
  time frame: baseline, 8 weeks and 4 months
  description: Measures the extent that pain is interfering with the patient's daily lifestyle. Pain is measured on a T-scale. 50 is the median. 20-55 is considered within the normal limits. 70+ is severe.
  arm group label: Yoga study group
  arm group type: Experimental
  description: This is the only arm of the study. The patients will be given yoga videos to do at home for 8 weeks as a treatment for anterior knee pain.
  intervention type: Behavioral
  intervention name: Yoga
  description: The patients will receive links to two yoga videos. They will do each of these videos at home for 4 weeks.
  arm group label: Yoga study group
  criteria: 
  gender: All
  minimum age: 10 Years
  maximum age: 17 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Matthew D Ellington, MD
  role: Principal Investigator
  affiliation: University of Texas at Austin, Central Texas Pediatric Orthopedics
  last name: Research Coordinator
  phone: (512) 478-8116
  email: nmcmahon@ctpomd.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  citation: Galantino ML, Galbavy R, Quinn L. Therapeutic effects of yoga for children: a systematic review of the literature. Pediatr Phys Ther. 2008 Spring;20(1):66-80. doi: 10.1097/PEP.0b013e31815f1208.
  PMID: 18300936
  citation: Donohue B, Miller A, Beisecker M, Houser D, Valdez R, Tiller S, Taymar T. Effects of brief yoga exercises and motivational preparatory interventions in distance runners: results of a controlled trial. Br J Sports Med. 2006 Jan;40(1):60-3; discussion 60-3. doi: 10.1136/bjsm.2005.020024.
  PMID: 16371493
  citation: Hainsworth KR, Liu XC, Simpson PM, Swartz AM, Linneman N, Tran ST, Medrano GR, Mascarenhas B, Zhang L, Weisman SJ. A Pilot Study of Iyengar Yoga for Pediatric Obesity: Effects on Gait and Emotional Functioning. Children (Basel). 2018 Jul 4;5(7):92. doi: 10.3390/children5070092.
  PMID: 29973555
  responsible party type: Sponsor
  mesh term: Patellofemoral Pain Syndrome
  sharing ipd: No
  ipd description: No individual participant data will be shared outside of the study team.