<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/NCT03769246</url>
  </required_header>
  <id_info>
    <org_study_id>AAAR4123</org_study_id>
    <nct_id>NCT03769246</nct_id>
  </id_info>
  <brief_title>Upright Back Posture Device Study</brief_title>
  <official_title>Upright Back Posture Device Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Upright Technologies Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized controlled study to determine if patients between the ages of 18-50&#xD;
      years, with posture related low back pain, who use the Upright device demonstrate improved&#xD;
      pain control and self perception of posture compared to those given standard ergonomic&#xD;
      instruction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Back pain is a common complaint among students. For many, back pain is directly related to&#xD;
      poor posture while sitting and standing. Those who spend prolonged time sitting in poor&#xD;
      posture often develop muscular imbalances leading to tight chest muscles and weakness in back&#xD;
      muscles. The Upright system is a device which helps provide a sensory reminder to alert users&#xD;
      when their posture is poor. The purpose of this study is to determine if patients who use the&#xD;
      upright posture device demonstrate improved pain control and self perception of posture when&#xD;
      compared to those given standard ergonomic instruction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 8, 2018</start_date>
  <completion_date type="Actual">August 29, 2019</completion_date>
  <primary_completion_date type="Actual">August 29, 2019</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Score on Numeric Pain Rating Scale (NPRS)</measure>
    <time_frame>4 weeks</time_frame>
    <description>The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. &quot;no pain&quot;) to '10' representing the other pain extreme (e.g. &quot;pain as bad as you can imagine&quot; or &quot;worst pain imaginable&quot;).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Score on the PROMIS Pain Interference Short Form 6b</measure>
    <time_frame>4 weeks</time_frame>
    <description>The Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Short Form utilizes a 7-day recall period (items include the phrase &quot;the past 7 days&quot;). Individuals are to score pain interference for each of the 6 questions from a scale of 1 indicating 'not at all' to 5 indicating 'very much'.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Back Pain</condition>
  <condition>Postural Low Back Pain</condition>
  <condition>Lower Back Pain</condition>
  <arm_group>
    <arm_group_label>Upright Go Device Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receiving the Upright device will have a brief training on the use of the device and proper posture. They will be asked to download the Upright app on their phone from the Playstore.&#xD;
Patients will wear the device once daily for training. They will attach the device applying an adhesive on their upper back, as instructed, and the device will be attached to the adhesive by velcro. Once completed they should remove adhesive.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will receive a 15-20 minute instruction on proper posture by the physician and will receive an ergonomic handout.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Upright Go Device</intervention_name>
    <description>Participants will be asked to use the Upright device everyday for four (4) weeks. After four (4) weeks, the participants will be asked to complete a couple of questionnaires regarding their pain scale and back posture.</description>
    <arm_group_label>Upright Go Device Group</arm_group_label>
    <other_name>Upright Technologies</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ergonomic Handout</intervention_name>
    <description>Participants will be asked to use the ergonomic handout everyday for four (4) weeks. After four (4) weeks, the participants will be asked to complete a couple of questionnaires regarding their pain scale and back posture.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postural-related back pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A diagnosis of significant scoliosis, herniated/bulging disc, lumbar spondylolysis,&#xD;
             radiculitis, facet arthrosis, fibromyalgia, rheumatoid arthritis, seronegative&#xD;
             spondyloarthropathy.&#xD;
&#xD;
          -  Neurologic deficits on exam&#xD;
&#xD;
          -  Currently in physical therapy (PT)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anna-Christina Bevelaqua, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University Irving Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>November 2, 2019</last_update_submitted>
  <last_update_submitted_qc>November 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Anna-Christina Bevelaqua</investigator_full_name>
    <investigator_title>Assistant Professor of Rehabilitation and Regenerative Medicine</investigator_title>
  </responsible_party>
  <keyword>Upright</keyword>
  <keyword>Back</keyword>
  <keyword>Posture</keyword>
  <keyword>Back pain</keyword>
  <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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 21, 2020</submitted>
    <returned>September 11, 2020</returned>
    <submitted>September 18, 2020</submitted>
    <returned>October 12, 2020</returned>
  </pending_results>
  <!-- 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/NCT03769246
org study id: AAAR4123
nct id: NCT03769246
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
This is a randomized controlled study to determine if patients between the ages of 18-50
      years, with posture related low back pain, who use the Upright device demonstrate improved
      pain control and self perception of posture compared to those given standard ergonomic
      instruction.
Back pain is a common complaint among students. For many, back pain is directly related to
      poor posture while sitting and standing. Those who spend prolonged time sitting in poor
      posture often develop muscular imbalances leading to tight chest muscles and weakness in back
      muscles. The Upright system is a device which helps provide a sensory reminder to alert users
      when their posture is poor. The purpose of this study is to determine if patients who use the
      upright posture device demonstrate improved pain control and self perception of posture when
      compared to those given standard ergonomic instruction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Score on Numeric Pain Rating Scale (NPRS)
time frame: 4 weeks
description: The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
measure: Score on the PROMIS Pain Interference Short Form 6b
time frame: 4 weeks
description: The Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Short Form utilizes a 7-day recall period (items include the phrase "the past 7 days"). Individuals are to score pain interference for each of the 6 questions from a scale of 1 indicating 'not at all' to 5 indicating 'very much'.
arm group label: Upright Go Device Group
arm group type: Experimental
description: Patients receiving the Upright device will have a brief training on the use of the device and proper posture. They will be asked to download the Upright app on their phone from the Playstore.
Patients will wear the device once daily for training. They will attach the device applying an adhesive on their upper back, as instructed, and the device will be attached to the adhesive by velcro. Once completed they should remove adhesive.
arm group label: Control Group
arm group type: Active Comparator
description: The control group will receive a 15-20 minute instruction on proper posture by the physician and will receive an ergonomic handout.
intervention type: Device
intervention name: Upright Go Device
description: Participants will be asked to use the Upright device everyday for four (4) weeks. After four (4) weeks, the participants will be asked to complete a couple of questionnaires regarding their pain scale and back posture.
arm group label: Upright Go Device Group
other name: Upright Technologies
intervention type: Other
intervention name: Ergonomic Handout
description: Participants will be asked to use the ergonomic handout everyday for four (4) weeks. After four (4) weeks, the participants will be asked to complete a couple of questionnaires regarding their pain scale and back posture.
arm group label: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Anna-Christina Bevelaqua, M.D
role: Principal Investigator
affiliation: Columbia University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Anna-Christina Bevelaqua
investigator title: Assistant Professor of Rehabilitation and Regenerative Medicine
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No
submitted: August 21, 2020
returned: September 11, 2020
submitted: September 18, 2020
returned: October 12, 2020