<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/NCT03001037</url>
  </required_header>
  <id_info>
    <org_study_id>051626(27149)</org_study_id>
    <nct_id>NCT03001037</nct_id>
  </id_info>
  <brief_title>dorsaVi Back Pain and Movement Registry</brief_title>
  <acronym>BPAM</acronym>
  <official_title>dorsaVi Back Pain and Movement Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>dorsaVi Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>International Spine, Pain and Performance Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>dorsaVi Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will compare patients with low back pain (LBP) to age and gender matched controls&#xD;
      to determine if there are differences between the two groups related to: range of movement,&#xD;
      secondary outcomes (level of disability, quality of life, evidence of depression, anxiety or&#xD;
      stress), movement patterns and demographic characteristics. The first phase will include a&#xD;
      baseline and 3 month follow-up assessment of the LBP patients and controls, including&#xD;
      demographic characteristics, outcome measures, and a physical assessment. The second phase is&#xD;
      an ongoing phase with continued interim assessments of LBP patients only, at 6 and 12 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The first phase of the study will use a non-randomized two-group prospective longitudinal&#xD;
      study design (Group A subjects with LBP, Group B subjects without LBP). The second phase of&#xD;
      the study will use a single-group prospective longitudinal study design (Group A, subjects&#xD;
      with low back pain). A timeline and step-by-step detail of the study procedures for these&#xD;
      phases are also described in Appendix B.&#xD;
&#xD;
      Group A which will include subjects with LBP, members of the research team will screen and&#xD;
      attempt to consecutively enroll all patients who undergo assessment for low back pain at two&#xD;
      clinical locations (International Spine Pain &amp; Performance Center, and Synergy Manual&#xD;
      Physical Therapy). The enrollment and baseline visit can occur at the same time. During&#xD;
      enrollment each subject will privately be briefed on the purpose and involvement in the study&#xD;
      and be allowed to ask questions and opt out if not interested. Informed consent will be&#xD;
      reviewed and signed and each subject will be given a copy of the consent form (15 minutes).&#xD;
      Since collection of &quot;baseline data&quot; (outcome measures and ViMove Assessment) is already&#xD;
      considered standard clinical practice for subjects with low back pain at these clinical&#xD;
      settings, providing informed consent would allow the researchers to access this information&#xD;
      for purposes of the registry. A summary of the information collected at baseline will&#xD;
      include: patient demographics/medical history (age, gender, pain episode duration, BMI,&#xD;
      employment, marital status, comorbidities, co-interventions, ICD-10 LBP diagnosis), outcome&#xD;
      measures (LBP movement pattern classification, LBP Classifier Questionnaire, QVAS for back&#xD;
      and leg, Oswestry Disability index, START-Keele, Fear Avoidance Behavior Questionnaire,&#xD;
      EuroQol-5D, DASS-21, patient perception of movement contribution to pain) (20 minutes), and&#xD;
      an assessment (ViMove standard assessment, 30 sec chair test, 40m walk test) (25 minutes).&#xD;
      See Appendix C.&#xD;
&#xD;
      Group B which will include subjects without LBP, members of the research team will recruit&#xD;
      volunteers within the DC metro area using flyers posted on campus at the George Washington&#xD;
      University, local DC metro gymnasiums and recreational centers, word of mouth and email list&#xD;
      serves associated with educational programs within The George Washington University School of&#xD;
      Medicine and Health Sciences. Subjects will be screened by phone for the presence or history&#xD;
      of low back pain as well as other exclusion criteria. If the subject agrees to move forward&#xD;
      with participation they will be asked to come to The George Washington University Program in&#xD;
      Physical Therapy located at 2000 Pennsylvania Ave Suite 2000, NW Washington DC 20006, or&#xD;
      International Spine Pain &amp; Performance Center or Synergy Manual Physical Therapy. Enrollment&#xD;
      and baseline visits can occur at the same time. During enrollment each subject will privately&#xD;
      be briefed on the purpose and involvement in the study and be allowed to ask questions and&#xD;
      opt out if not interested. Informed consent will be reviewed and signed and each subject will&#xD;
      be given a copy of the consent form (15 minutes). Baseline data will then be collected which&#xD;
      will include: subject demographics/medical history (age, gender, BMI, employment, marital&#xD;
      status, comorbidities, co-interventions) and QVAS for back and leg, EQ-5D, DASS-21 (10&#xD;
      minutes) and ViMove standard assessment, 30 sec chair test, and 40m walk test (25 minutes).&#xD;
      See Appendix C.&#xD;
&#xD;
      ViMove Testing (Groups A &amp; B): The ViMove system (dorsaVi, Australia) which will be used to&#xD;
      assess movement patterns and lumbar muscle activity in both groups during the ViMove standard&#xD;
      assessment, 30 sec chair test, 40m walk test, is an inertial measurement system comprised of&#xD;
      two wireless motion sensors containing a triaxial accelerometer, a triaxial gyroscope and a&#xD;
      magnetometer, two wireless surface electromyography (EMG) sensors, and a small wireless&#xD;
      recording device (RFD) that can be worn by the subject. The manufacturer reports average&#xD;
      differences of &lt; 1 degree for single plane, through range movements when comparing matched&#xD;
      measurements from the ViMove and a Fastrak opto-electronic device (Charry, Umer et al. 2011).&#xD;
      The ViMove motion sensors collect data at approximately 20 Hz.&#xD;
&#xD;
      When ViMove testing is performed for both groups, 4 sensors will be adhered to the subject's&#xD;
      skin using customised biocompatible adhesives. The placement of the sensors is determined&#xD;
      through the use of templates which have been validated as part of the FDA 510K application.&#xD;
      During testing, the sensors communicate data wirelessly to the RFD which is connected to a&#xD;
      computer running dorsaVi (ViMove software). Customised algorithms convert data generated by&#xD;
      the software to meaningful biomechanical information, including measures such as range of&#xD;
      movement, peak angles, speed of movement and muscle activation.&#xD;
&#xD;
      Subjects in Group A will follow-up with their healthcare provider based on standard clinical&#xD;
      care practices. Enrolled subjects in Group A will undergo follow up at 3 months, 6 months and&#xD;
      12 months (45 minutes each session); these follow up visits may or may not coincide with a&#xD;
      regular clinical office visit with their healthcare provider. Subjects in Group B will follow&#xD;
      up at 3 months only (35 minutes).&#xD;
&#xD;
      Follow up will include completing outcome measures and an assessment as collected at baseline&#xD;
      as well as collection of patient status, events, and protocol deviations.&#xD;
&#xD;
      Subjects may exit from the research project under the following circumstances:&#xD;
&#xD;
        -  Subject chooses to withdraw (e.g. consent withdrawal)&#xD;
&#xD;
        -  At the end of their follow-up period&#xD;
&#xD;
        -  Investigator deems withdrawal is necessary (e.g. medically justified, failure of patient&#xD;
           to maintain adequate registry compliance)&#xD;
&#xD;
        -  Subject death&#xD;
&#xD;
        -  Subject is no longer available for follow-up&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Pending internal study review and potential protocol modification&#xD;
  </why_stopped>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">April 2020</completion_date>
  <primary_completion_date type="Anticipated">April 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Change in Range of Movement from baseline</measure>
    <time_frame>Baseline, 3 months, 6 months, and 12 months</time_frame>
    <description>Maximal range of low back movement in sagittal and coronal planes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Muscle Activity from baseline</measure>
    <time_frame>Baseline, 3 months, 6 months, and 12 months</time_frame>
    <description>Surface EMG measurement of erector spinae muscle activity at L3 vertebra level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pain from baseline</measure>
    <time_frame>Baseline, 3 months, 6 months, and 12 months</time_frame>
    <description>Pain Score out of 100 as measured on VAS scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Keele StarT Back Tool scores from baseline</measure>
    <time_frame>Baseline, 3 months, 6 months, and 12 months</time_frame>
    <description>Screening test for Classification of severity of low back pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fear Avoidance Beliefs Questionnaire responses from baseline</measure>
    <time_frame>Baseline, 3 months, 6 months, and 12 months</time_frame>
    <description>Measurement of fear and avoidance of physical activity and work related to low back pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Low Back Pain Classifier score from baseline</measure>
    <time_frame>Baseline, 3 months, 6 months, and 12 months</time_frame>
    <description>Questionnaire to classify low back pain into movement sub-categories based on movement related painful activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in EuroQol-5D scores from baseline</measure>
    <time_frame>Baseline, 3 months, 6 months, and 12 months</time_frame>
    <description>Quality of life measurement tool</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Oswestry Disability Index scores from baseline</measure>
    <time_frame>Baseline, 3 months, 6 months, and 12 months</time_frame>
    <description>Measurement of disability related to low back pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ViMove 40m Fast Paced Walk</measure>
    <time_frame>Baseline, 3 months, 6 months, and 12 months</time_frame>
    <description>Time taken to complete test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vimove 30 sec Sit to Stand Test</measure>
    <time_frame>Baseline, 3 months, 6 months, and 12 months</time_frame>
    <description>Count of repetitions of movement</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">350</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Group A - Low Back Pain</arm_group_label>
    <description>Group A:&#xD;
Subject provides written authorization and/or consent per institution and geographical requirements&#xD;
Subjects in Group A with a predominant complaint of Low back pain, with a minimum daily average VAS ≥ 30/100&#xD;
Subjects in Group A are intended to be assessed with ViMove based on standard of care&#xD;
Subject is willing to participate in follow-ups at 3, 6, 12 months post initial assessment&#xD;
Observational study, no intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B - Without Low Back Pain</arm_group_label>
    <description>Subject is without current low back pain&#xD;
Subject does not have a history of low back pain lasting longer than 3 months in the past 12 months&#xD;
Subject is willing to follow up 3 months post initial assessment&#xD;
Observational study, no intervention</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Group A:&#xD;
&#xD;
        • Subject present with a predominant complaint of Low Back Pain, with a minimum daily&#xD;
        average VAS ≥ 30/100&#xD;
&#xD;
        Group B:&#xD;
&#xD;
        • Subject is without current low back pain&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Group A:&#xD;
&#xD;
          -  Subject provides written authorization and/or consent per institution and geographical&#xD;
             requirements&#xD;
&#xD;
          -  Subjects in Group A with a predominant complaint of Low back pain, with a minimum&#xD;
             daily average VAS ≥ 30/100&#xD;
&#xD;
          -  Subjects in Group A are intended to be assessed with ViMove based on standard of care&#xD;
             - Subject is willing to participate in follow ups at 3, 6, 12 months post initial&#xD;
             assessment&#xD;
&#xD;
        Group B:&#xD;
&#xD;
          -  Subject is without current low back pain&#xD;
&#xD;
          -  Subject does not have a history of low back pain lasting longer than 3 months in the&#xD;
             past 12 months&#xD;
&#xD;
          -  Subject is willing to follow up 3 months post initial assessment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject who is, or is expected to be inaccessible for follow-up&#xD;
&#xD;
          -  Subject with exclusion criteria required by local law&#xD;
&#xD;
          -  Subject in whom movement assessment is contraindicated.&#xD;
&#xD;
          -  Subject is currently enrolled in or plans to enroll in any concurrent drug and/or&#xD;
             device study that may confound results&#xD;
&#xD;
          -  Body mass index ≥ 35 - In Group B only, subjects who had a history of low back pain in&#xD;
             the past 12 months which lasted &gt; 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mehul J Desai, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>International Spine, Pain and Performance Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The George Washington University</name>
      <address>
        <city>Washington DC</city>
        <state>Maryland</state>
        <zip>20006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>International Spine, Pain and Performance Center</name>
      <address>
        <city>Washington DC</city>
        <state>Maryland</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synergy Manual Physical Therapy LLC</name>
      <address>
        <city>Arlington</city>
        <state>Virginia</state>
        <zip>22209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>February 6, 2019</last_update_submitted>
  <last_update_submitted_qc>February 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Functional Outcome Measures</keyword>
  <keyword>Wearable Sensors</keyword>
  <keyword>ViMove</keyword>
  <keyword>Low Back Pain</keyword>
  <keyword>Range of Movement</keyword>
  <keyword>Muscle Activity</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>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03001037
org study id: 051626(27149)
nct id: NCT03001037
lead sponsor: 
collaborator: 
has dmc: Yes
This study will compare patients with low back pain (LBP) to age and gender matched controls
      to determine if there are differences between the two groups related to: range of movement,
      secondary outcomes (level of disability, quality of life, evidence of depression, anxiety or
      stress), movement patterns and demographic characteristics. The first phase will include a
      baseline and 3 month follow-up assessment of the LBP patients and controls, including
      demographic characteristics, outcome measures, and a physical assessment. The second phase is
      an ongoing phase with continued interim assessments of LBP patients only, at 6 and 12 months.
The first phase of the study will use a non-randomized two-group prospective longitudinal
      study design (Group A subjects with LBP, Group B subjects without LBP). The second phase of
      the study will use a single-group prospective longitudinal study design (Group A, subjects
      with low back pain). A timeline and step-by-step detail of the study procedures for these
      phases are also described in Appendix B.

      Group A which will include subjects with LBP, members of the research team will screen and
      attempt to consecutively enroll all patients who undergo assessment for low back pain at two
      clinical locations (International Spine Pain & Performance Center, and Synergy Manual
      Physical Therapy). The enrollment and baseline visit can occur at the same time. During
      enrollment each subject will privately be briefed on the purpose and involvement in the study
      and be allowed to ask questions and opt out if not interested. Informed consent will be
      reviewed and signed and each subject will be given a copy of the consent form (15 minutes).
      Since collection of "baseline data" (outcome measures and ViMove Assessment) is already
      considered standard clinical practice for subjects with low back pain at these clinical
      settings, providing informed consent would allow the researchers to access this information
      for purposes of the registry. A summary of the information collected at baseline will
      include: patient demographics/medical history (age, gender, pain episode duration, BMI,
      employment, marital status, comorbidities, co-interventions, ICD-10 LBP diagnosis), outcome
      measures (LBP movement pattern classification, LBP Classifier Questionnaire, QVAS for back
      and leg, Oswestry Disability index, START-Keele, Fear Avoidance Behavior Questionnaire,
      EuroQol-5D, DASS-21, patient perception of movement contribution to pain) (20 minutes), and
      an assessment (ViMove standard assessment, 30 sec chair test, 40m walk test) (25 minutes).
      See Appendix C.

      Group B which will include subjects without LBP, members of the research team will recruit
      volunteers within the DC metro area using flyers posted on campus at the George Washington
      University, local DC metro gymnasiums and recreational centers, word of mouth and email list
      serves associated with educational programs within The George Washington University School of
      Medicine and Health Sciences. Subjects will be screened by phone for the presence or history
      of low back pain as well as other exclusion criteria. If the subject agrees to move forward
      with participation they will be asked to come to The George Washington University Program in
      Physical Therapy located at 2000 Pennsylvania Ave Suite 2000, NW Washington DC 20006, or
      International Spine Pain & Performance Center or Synergy Manual Physical Therapy. Enrollment
      and baseline visits can occur at the same time. During enrollment each subject will privately
      be briefed on the purpose and involvement in the study and be allowed to ask questions and
      opt out if not interested. Informed consent will be reviewed and signed and each subject will
      be given a copy of the consent form (15 minutes). Baseline data will then be collected which
      will include: subject demographics/medical history (age, gender, BMI, employment, marital
      status, comorbidities, co-interventions) and QVAS for back and leg, EQ-5D, DASS-21 (10
      minutes) and ViMove standard assessment, 30 sec chair test, and 40m walk test (25 minutes).
      See Appendix C.

      ViMove Testing (Groups A & B): The ViMove system (dorsaVi, Australia) which will be used to
      assess movement patterns and lumbar muscle activity in both groups during the ViMove standard
      assessment, 30 sec chair test, 40m walk test, is an inertial measurement system comprised of
      two wireless motion sensors containing a triaxial accelerometer, a triaxial gyroscope and a
      magnetometer, two wireless surface electromyography (EMG) sensors, and a small wireless
      recording device (RFD) that can be worn by the subject. The manufacturer reports average
      differences of < 1 degree for single plane, through range movements when comparing matched
      measurements from the ViMove and a Fastrak opto-electronic device (Charry, Umer et al. 2011).
      The ViMove motion sensors collect data at approximately 20 Hz.

      When ViMove testing is performed for both groups, 4 sensors will be adhered to the subject's
      skin using customised biocompatible adhesives. The placement of the sensors is determined
      through the use of templates which have been validated as part of the FDA 510K application.
      During testing, the sensors communicate data wirelessly to the RFD which is connected to a
      computer running dorsaVi (ViMove software). Customised algorithms convert data generated by
      the software to meaningful biomechanical information, including measures such as range of
      movement, peak angles, speed of movement and muscle activation.

      Subjects in Group A will follow-up with their healthcare provider based on standard clinical
      care practices. Enrolled subjects in Group A will undergo follow up at 3 months, 6 months and
      12 months (45 minutes each session); these follow up visits may or may not coincide with a
      regular clinical office visit with their healthcare provider. Subjects in Group B will follow
      up at 3 months only (35 minutes).

      Follow up will include completing outcome measures and an assessment as collected at baseline
      as well as collection of patient status, events, and protocol deviations.

      Subjects may exit from the research project under the following circumstances:

        -  Subject chooses to withdraw (e.g. consent withdrawal)

        -  At the end of their follow-up period

        -  Investigator deems withdrawal is necessary (e.g. medically justified, failure of patient
           to maintain adequate registry compliance)

        -  Subject death

        -  Subject is no longer available for follow-up
observational model: Case-Control
time perspective: Prospective
measure: Change in Range of Movement from baseline
time frame: Baseline, 3 months, 6 months, and 12 months
description: Maximal range of low back movement in sagittal and coronal planes
measure: Change in Muscle Activity from baseline
time frame: Baseline, 3 months, 6 months, and 12 months
description: Surface EMG measurement of erector spinae muscle activity at L3 vertebra level
measure: Change in Pain from baseline
time frame: Baseline, 3 months, 6 months, and 12 months
description: Pain Score out of 100 as measured on VAS scale
measure: Change in Keele StarT Back Tool scores from baseline
time frame: Baseline, 3 months, 6 months, and 12 months
description: Screening test for Classification of severity of low back pain
measure: Change in Fear Avoidance Beliefs Questionnaire responses from baseline
time frame: Baseline, 3 months, 6 months, and 12 months
description: Measurement of fear and avoidance of physical activity and work related to low back pain
measure: Change in Low Back Pain Classifier score from baseline
time frame: Baseline, 3 months, 6 months, and 12 months
description: Questionnaire to classify low back pain into movement sub-categories based on movement related painful activities.
measure: Change in EuroQol-5D scores from baseline
time frame: Baseline, 3 months, 6 months, and 12 months
description: Quality of life measurement tool
measure: Change in Oswestry Disability Index scores from baseline
time frame: Baseline, 3 months, 6 months, and 12 months
description: Measurement of disability related to low back pain
measure: ViMove 40m Fast Paced Walk
time frame: Baseline, 3 months, 6 months, and 12 months
description: Time taken to complete test
measure: Vimove 30 sec Sit to Stand Test
time frame: Baseline, 3 months, 6 months, and 12 months
description: Count of repetitions of movement
arm group label: Group A - Low Back Pain
description: Group A:
Subject provides written authorization and/or consent per institution and geographical requirements
Subjects in Group A with a predominant complaint of Low back pain, with a minimum daily average VAS ≥ 30/100
Subjects in Group A are intended to be assessed with ViMove based on standard of care
Subject is willing to participate in follow-ups at 3, 6, 12 months post initial assessment
Observational study, no intervention
arm group label: Group B - Without Low Back Pain
description: Subject is without current low back pain
Subject does not have a history of low back pain lasting longer than 3 months in the past 12 months
Subject is willing to follow up 3 months post initial assessment
Observational study, no intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mehul J Desai, MD
role: Principal Investigator
affiliation: International Spine, Pain and Performance Center
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: Undecided