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/NCT06003010</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00003670</org_study_id>
      <nct_id>NCT06003010</nct_id>
    </id_info>
    <brief_title>Yoga for Adolescent Idiopathic Scoliosis (AIS) Patients</brief_title>
    <official_title>Efficacy of Perioperative Yoga at Reducing Pain in Surgical AIS Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Texas at Austin</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Pediatric Orthopaedic Society of North America</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </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 Idiopathic Scoliosis (AIS) is defined as a three-dimensional lateral deformity of&#xD;
        the spine. It is described with a cobb angle of greater than 10 degrees. There is no known&#xD;
        etiology of AIS. Once the degrees of curvature become severe (greater than 45 degrees),&#xD;
        surgical intervention (posterior spinal fusion - PSF) is often discussed. Most adolescent&#xD;
        patients and their families opt for surgical correction to decrease future complications of&#xD;
        severe scoliosis, such as decreased vital capacity of the lungs, potential future activity&#xD;
        restrictions, cosmetic appearance, and self-esteem. While the patient and family are eager to&#xD;
        undergo PSF, they do have concerns. The major concerns are pain control and their ability to&#xD;
        return to activities.&#xD;
  &#xD;
        In current literature, there are many studies completed regarding pharmacologic pain control&#xD;
        management with the use of IV patient-controlled analgesia (PCA) with opioids, narcotics,&#xD;
        non-steroidal anti-inflammatories, muscle relaxers, Tylenol, and gabapentin. However, there&#xD;
        is not a well-established multimodal pain management plan for postoperative PSF patients.&#xD;
        There is also no current literature discussing nonpharmacologic pain management methods, such&#xD;
        as stretching, strengthening and yoga, for patients undergoing PSF. There are multiple&#xD;
        studies discussing core stabilization used for helping AIS patients non-operatively. There is&#xD;
        no literature discussing the use of nonpharmacologic pain management methods for improved&#xD;
        pain control (including decreased use of pharmacologic agents) and quicker return to&#xD;
        activities.&#xD;
  &#xD;
        The aim of this study is to determine if patients with AIS undergoing PSF require fewer pain&#xD;
        medications and have an earlier return to activities if completing a yoga program six weeks&#xD;
        prior to their surgery.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">December 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>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Morphine Equivalent Units</measure>
      <time_frame>7 weeks</time_frame>
      <description>Number of narcotics taken after surgery</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time to first ambulation</measure>
      <time_frame>1 week</time_frame>
      <description>How long it takes patient to walk after surgery</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Length of hospital stay</measure>
      <time_frame>1 week</time_frame>
      <description>How long before the patient was discharged after surgery</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Return to school/activities</measure>
      <time_frame>7 weeks</time_frame>
      <description>How long before the patient returned to school/activities after surgery</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain scores</measure>
      <time_frame>14 weeks</time_frame>
      <description>Pain scores before and various times after surgery using Faces Pain Scale-Revised. Range is from 0-10. 10 being most severe pain.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Compliance with yoga videos</measure>
      <time_frame>14 weeks</time_frame>
      <description>How often patients did yoga videos via patient recorded log and YouTube Analytics</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Adolescent Idiopathic Scoliosis</condition>
    <condition>Spinal Fusion</condition>
    <arm_group>
      <arm_group_label>Study group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This group will be given standard pre- and post-surgery movement instructions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Yoga group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group will be asked to do a 6 week series of yoga videos at home pre- and post-surgery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Yoga</intervention_name>
      <description>6 yoga videos to be done 2-3x a week for 6 weeks before and after surgery.</description>
      <arm_group_label>Yoga group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Idiopathic Scoliosis patients&#xD;
  &#xD;
            -  English speaking patient and parents&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Non idiopathic scoliosis diagnosis&#xD;
  &#xD;
            -  no access to internet or computer&#xD;
  &#xD;
            -  non-English speaking parents and/or patient&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>10 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Dell Children's Medical Center</name>
        <address>
          <city>Austin</city>
          <state>Texas</state>
          <zip>78731</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>February 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Scoliosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>All participants will be assigned a study number. Any identifiable information will be stored separately from study data and will only be accessed by authorized team members.</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/NCT06003010
  org study id: STUDY00003670
  nct id: NCT06003010
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Adolescent Idiopathic Scoliosis (AIS) is defined as a three-dimensional lateral deformity of
        the spine. It is described with a cobb angle of greater than 10 degrees. There is no known
        etiology of AIS. Once the degrees of curvature become severe (greater than 45 degrees),
        surgical intervention (posterior spinal fusion - PSF) is often discussed. Most adolescent
        patients and their families opt for surgical correction to decrease future complications of
        severe scoliosis, such as decreased vital capacity of the lungs, potential future activity
        restrictions, cosmetic appearance, and self-esteem. While the patient and family are eager to
        undergo PSF, they do have concerns. The major concerns are pain control and their ability to
        return to activities.
  
        In current literature, there are many studies completed regarding pharmacologic pain control
        management with the use of IV patient-controlled analgesia (PCA) with opioids, narcotics,
        non-steroidal anti-inflammatories, muscle relaxers, Tylenol, and gabapentin. However, there
        is not a well-established multimodal pain management plan for postoperative PSF patients.
        There is also no current literature discussing nonpharmacologic pain management methods, such
        as stretching, strengthening and yoga, for patients undergoing PSF. There are multiple
        studies discussing core stabilization used for helping AIS patients non-operatively. There is
        no literature discussing the use of nonpharmacologic pain management methods for improved
        pain control (including decreased use of pharmacologic agents) and quicker return to
        activities.
  
        The aim of this study is to determine if patients with AIS undergoing PSF require fewer pain
        medications and have an earlier return to activities if completing a yoga program six weeks
        prior to their surgery.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Morphine Equivalent Units
  time frame: 7 weeks
  description: Number of narcotics taken after surgery
  measure: Time to first ambulation
  time frame: 1 week
  description: How long it takes patient to walk after surgery
  measure: Length of hospital stay
  time frame: 1 week
  description: How long before the patient was discharged after surgery
  measure: Return to school/activities
  time frame: 7 weeks
  description: How long before the patient returned to school/activities after surgery
  measure: Pain scores
  time frame: 14 weeks
  description: Pain scores before and various times after surgery using Faces Pain Scale-Revised. Range is from 0-10. 10 being most severe pain.
  measure: Compliance with yoga videos
  time frame: 14 weeks
  description: How often patients did yoga videos via patient recorded log and YouTube Analytics
  arm group label: Study group
  arm group type: No Intervention
  description: This group will be given standard pre- and post-surgery movement instructions.
  arm group label: Yoga group
  arm group type: Experimental
  description: This group will be asked to do a 6 week series of yoga videos at home pre- and post-surgery.
  intervention type: Behavioral
  intervention name: Yoga
  description: 6 yoga videos to be done 2-3x a week for 6 weeks before and after surgery.
  arm group label: Yoga group
  criteria: 
  gender: All
  minimum age: 10 Years
  maximum age: 18 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Scoliosis
  sharing ipd: No
  ipd description: All participants will be assigned a study number. Any identifiable information will be stored separately from study data and will only be accessed by authorized team members.