<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/NCT03040310</url>
  </required_header>
  <id_info>
    <org_study_id>2016-020</org_study_id>
    <nct_id>NCT03040310</nct_id>
  </id_info>
  <brief_title>Personalized Back Rx Exercise Program as a Treatment for Discogenic Low Back Pain</brief_title>
  <official_title>Personalized Back Rx Exercise Program With Coaching, Social Support, and Sensor-assisted Assessments as a Treatment for Discogenic Low Back Pain: A Prospective Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital for Special Surgery, New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cornell Tech</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>UnitedHealth Group</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital for Special Surgery, New York</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 prevalence and disability associated with discogenic low back pain are significant, and&#xD;
      there is a general lack of widely accepted conservative treatments for the condition. A&#xD;
      majority of previous studies that have assessed the efficacy of self-directed exercise-based&#xD;
      rehabilitation programs did not include comprehensive metrics to confirm whether participants&#xD;
      actually participated in the exercises prescribed. In this pilot study, the investigators&#xD;
      hope to determine whether proxies of compliance with a daily, self-directed rehabilitation&#xD;
      program for discogenic low back pain are correlated with participant-reported improvements in&#xD;
      pain and function. The feasibility of a mobile interface designed to help patients with&#xD;
      chronic low back pain track the daily management of their conditions will also be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</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>Oswestry Disability Index</measure>
    <time_frame>Up to 12 months post-program start</time_frame>
    <description>The Oswestry Disability Index is scored on a scale of 0-100, with a higher number representing more severe disability.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compliance with app/program</measure>
    <time_frame>Up to 12 months post-program start</time_frame>
    <description>Measured via usage analytics by a composite index based on % of videos viewed and % of videos completed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with program</measure>
    <time_frame>Up to 12 months post-program start</time_frame>
    <description>Participants will be asked whether they would recommend the app to a friend.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication utilization</measure>
    <time_frame>Up to 3 months post-program start</time_frame>
    <description>Usage of medications will be documented</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain score</measure>
    <time_frame>Up to 12 months post-program start</time_frame>
    <description>Pain will be assessed via the visual analog scale</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">98</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Back Rx program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study patients will use their smartphone apps to view their Back Rx program content, exercises, and videos.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Back Rx program</intervention_name>
    <description>The Back Rx program can be viewed via a smartphone app.</description>
    <arm_group_label>Back Rx program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Low back pain with predominantly axial symptoms (axial pain &gt; leg pain) that are&#xD;
             exacerbated with sitting and alleviated with walking&#xD;
&#xD;
          -  Persistence of symptoms for at least 3 months&#xD;
&#xD;
          -  Lumbar intervertebral disc pathology evident on magnetic resonance imaging&#xD;
&#xD;
          -  18 to 65 years old&#xD;
&#xD;
          -  Computer literate; have smartphone (iPhone 5S or up, Android 2.3 or up)&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concurrent pathology that may contribute to patients' axial low back symptoms (e.g.,&#xD;
             spondylolysis, spondylolisthesis, facet arthropathy)&#xD;
&#xD;
          -  Severe lumbar disc degeneration prior to beginning Back Rx exercise program&#xD;
&#xD;
          -  History of lumbar spine surgery or other interventions prior to beginning Back Rx&#xD;
             exercise program&#xD;
&#xD;
          -  History of trauma&#xD;
&#xD;
          -  Cases involving workers' compensation or other legal claims&#xD;
&#xD;
          -  Non-English speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>February 7, 2018</last_update_submitted>
  <last_update_submitted_qc>February 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2018</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>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03040310
org study id: 2016-020
nct id: NCT03040310
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The prevalence and disability associated with discogenic low back pain are significant, and
      there is a general lack of widely accepted conservative treatments for the condition. A
      majority of previous studies that have assessed the efficacy of self-directed exercise-based
      rehabilitation programs did not include comprehensive metrics to confirm whether participants
      actually participated in the exercises prescribed. In this pilot study, the investigators
      hope to determine whether proxies of compliance with a daily, self-directed rehabilitation
      program for discogenic low back pain are correlated with participant-reported improvements in
      pain and function. The feasibility of a mobile interface designed to help patients with
      chronic low back pain track the daily management of their conditions will also be evaluated.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Oswestry Disability Index
time frame: Up to 12 months post-program start
description: The Oswestry Disability Index is scored on a scale of 0-100, with a higher number representing more severe disability.
measure: Compliance with app/program
time frame: Up to 12 months post-program start
description: Measured via usage analytics by a composite index based on % of videos viewed and % of videos completed
measure: Satisfaction with program
time frame: Up to 12 months post-program start
description: Participants will be asked whether they would recommend the app to a friend.
measure: Medication utilization
time frame: Up to 3 months post-program start
description: Usage of medications will be documented
measure: Pain score
time frame: Up to 12 months post-program start
description: Pain will be assessed via the visual analog scale
arm group label: Back Rx program
arm group type: Experimental
description: Study patients will use their smartphone apps to view their Back Rx program content, exercises, and videos.
intervention type: Other
intervention name: Back Rx program
description: The Back Rx program can be viewed via a smartphone app.
arm group label: Back Rx program
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain