<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/NCT03785457</url>
  </required_header>
  <id_info>
    <org_study_id>L19-024</org_study_id>
    <nct_id>NCT03785457</nct_id>
  </id_info>
  <brief_title>Standing Trunk Extension and Spinal Height in Low Back Pain</brief_title>
  <official_title>Immediate Effect Of Standing Trunk Extension Postures On Spinal Height And Clinical Outcome Measures In Low Back Pain: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas Tech University Health Sciences Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Texas Tech University Health Sciences Center</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>
      Background: Standing trunk extension postures have been used for many years as a mechanical&#xD;
      approach to low back pain (LBP), sometimes directed by therapeutic intervention, sometimes&#xD;
      subconsciously performed by patientsto relieve LBP. However, no study to date has&#xD;
      investigated the effect of standing trunk extension postures on spinal height and clinical&#xD;
      outcome measures.&#xD;
&#xD;
      Objective: The purpose of this study will be to evaluate in subjects with LBP following a&#xD;
      period of trunk loading, how spinal height and/or pain, symptoms' centralization, and&#xD;
      function outcome measures respond to:(1) standing repetitive trunk extension posture; and (2)&#xD;
      standing sustained trunk extension posture. Lumbar range of motion (ROM) achieved during&#xD;
      these two trunk extension postures will be compared to spinal height and outcome measures.&#xD;
&#xD;
      Methods:A pre-test, post-test comparison group design (randomized clinical trial) will be&#xD;
      used to determine how spinal height changes in response to sustained and repetitive standing&#xD;
      trunk extension after a period of spinal loading. The study will evaluate the effects of&#xD;
      sustained and repetitive trunk extension in standing on spinal height, pain, symptoms'&#xD;
      centralization and function.&#xD;
&#xD;
      Statistical Analysis: A mixed ANOVA will be used to statistically identify significant&#xD;
      interactions and main effects for spinal height, pain and functionoutcome measures. Post-hoc&#xD;
      pairwise comparisons will be used to locate significant differences between the different&#xD;
      conditions. Significance will be set at α = 0.05. The Kruskal-Wallis 1-factor ANOVA for&#xD;
      difference scores will used to determine changes of intensity and location of symptoms&#xD;
      following sustained versus repetitive standing trunk extension. Spearman Rank correlation&#xD;
      will be used to evaluate the relationship between spinal height changes and changes of pain&#xD;
      and location of symptoms for each group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Standing trunk extension postures have been used for many years as a mechanical approach to&#xD;
      low back pain (LBP), sometimes directed by therapeutic intervention, sometimes subconsciously&#xD;
      performed by patients to relieve LBP. However, no study to date has investigated the effects&#xD;
      of standing extension postures on spinal height, pain, centralization and function.&#xD;
      Therefore, the purposes of this study will be to evaluate in a sample of LBP patients the&#xD;
      effect of standing trunk extension, both sustained and repetitive, following a period of&#xD;
      spinal loading, on (1) spinal height; (2) pain; (3) symptoms centralization and (4)&#xD;
      functional measures.&#xD;
&#xD;
      Research Design(s) A pre-test, post-test comparison group design (randomized clinical trial)&#xD;
      will be used to determine how spinal height changes in response to sustained and repetitive&#xD;
      standing trunk extension after a period of spinal loading. The study will use a 2 (between&#xD;
      subjects - type of trunk extension: sustained vs. repetitive) x 3 (within subjects - time:&#xD;
      before vs. after vs. 2 weeks after) mixed design to evaluate the effects of sustained and&#xD;
      repetitive trunk extension in standing on spinal height, pain, centralization and function&#xD;
      outcome measures.&#xD;
&#xD;
      Subjects / Specimens Systematic consecutive sampling of up to 100 subjects with LBP (40&#xD;
      subjects completing both days of data collection) attending &quot;Sports medicine and Physical&#xD;
      therapy clinic&quot; in Fredericksburg (Texas) as patients or for the purpose of health and&#xD;
      wellness will be recruited. Flyers will also be posted at physician offices and the general&#xD;
      Fredericksburg community and surrounding areas to inform subjects about the study.&#xD;
&#xD;
      Testing Sequence Subjects will be asked to attend two physical therapy sessions over&#xD;
      approximately a 60-minute period each to complete the study.&#xD;
&#xD;
      SESSION 1&#xD;
&#xD;
      Participants will complete a pre-screening questionnaire regarding inclusion. Each subject&#xD;
      will watch an audio-visual power point presentation explaining the study, test procedures and&#xD;
      describing the interventions (standing repetitive trunk extension and standing sustained&#xD;
      trunk extension). Written informed consent will be obtained. To determine directional&#xD;
      preference, the investigator (JH) will use the guidelines set forth in the directional&#xD;
      preference definition and based off of standards set forth in randomized clinical trials.&#xD;
      Directional preference has been defined as either (1) a specific direction of trunk movement&#xD;
      or posture noted during the physical examination or (2) a specific easing factor reported by&#xD;
      the patient during the subjective history that alleviates or decreases the patient's pain,&#xD;
      with or without the pain having changed location and/or increased the patient's lumbar range&#xD;
      of motion. A questionnaire including pertinent medical history will be completed. Subjects&#xD;
      will complete (1) a Numerical Pain Rating Scale (NPRS) to rate their current, minimum,&#xD;
      maximum and average LBP over the last two days as well as paresthesia signs/symptoms&#xD;
      intensity; (2) Body Diagram for indicating location of symptoms; (3) Modified Oswestry low&#xD;
      back pain questionnaire; (4) Fear Avoidance Belief Questionnaire. A researcher will record&#xD;
      subject's height and weight.&#xD;
&#xD;
      If the subject meets criteria for inclusion in the study, the subject will complete a&#xD;
      familiarization procedure to determine the consistency to reposition themselves in the&#xD;
      stadiometer. Subjects able to reposition themselves in the stadiometer with a SD of 1.3mm or&#xD;
      less for five consecutive measurements will be included in the study. The digital display&#xD;
      will be covered to blind the researcher performing the measurements. The data will be&#xD;
      automatically recorded by the stadiometer and manually downloaded to a laptop computer.&#xD;
&#xD;
      At the beginning of data collection, a randomization plan generator&#xD;
      (http://www.randomization.com ) will assign each subject to one of two interventions: (1)&#xD;
      standing repetitive trunk extension at a rate of 10 per 45 seconds, repeated five times with&#xD;
      15-second rest breaks; or (2) standing sustained trunk extension for 5 x 45 seconds with&#xD;
      15-second rest breaks. Each subject will complete one intervention. The intervention number&#xD;
      assigned will be recorded by the subject next to their name to allow blinding of the&#xD;
      investigator as to which intervention the subject is assigned to. The subject will undergo&#xD;
      the test sequence after a 10-minute period of trunk unloading in a supine posture to ensure&#xD;
      spinal height is normalized, head in neutral posture, knees supported over a small bolster&#xD;
      pillow, hands placed on the abdomen. The subject will reposition on the stadiometer and&#xD;
      spinal height will be measured after a relaxed exhalation. The subject then will undergo a&#xD;
      five-minute period of loaded upright sitting with a 4.5kg bag secured on each shoulder and&#xD;
      spinal height will be measured (Measurement 2). As continued spinal height reduction has been&#xD;
      demonstrated following loaded sitting, the subject will undergo an additional five minutes&#xD;
      sitting without load and spinal height will be measured (Measurement 3). Inclinometers will&#xD;
      be used to take an initial measure of each subject trunk extension prior to intervention. The&#xD;
      subject will then undergo one intervention for 5 minutes as previously described, according&#xD;
      to the randomization assignment. In order to determine how sustained and repetitive&#xD;
      interventions related in terms of change in spinal height, the time to perform the sustained&#xD;
      lumbar posture matches the time necessary to perform the repetitive lumbar extension&#xD;
      postures.&#xD;
&#xD;
      The subject will reposition on the stadiometer and spinal height will be measured&#xD;
      (Measurement 4). Trunk extension will be measured to determine the strength of correlations&#xD;
      between the degree of trunk extension during standing trunk extension posture and spinal&#xD;
      height, pain and centralization testing outcomes changes. The subject will score their low&#xD;
      back and lower extremity symptoms using NPRS, and map their pain on a body pain diagram prior&#xD;
      to intervention, immediately after and 2-week following the intervention to determine pain&#xD;
      rating and centralization of symptoms. The principal investigator will apply a numeric&#xD;
      overlay template to the patient's body diagrams to document the most distal pain location&#xD;
      scores between 1 and 6. Higher score will indicate a more distal symptoms' location.&#xD;
&#xD;
      Home instructions Subjects will be instructed to continue to use their medications, including&#xD;
      medications aimed at decreasing their pain, as prescribed by their primary healthcare&#xD;
      provider and not to change them during the follow-up two-week period. A sheet including home&#xD;
      exercise instructions will be provided to each patient. Instructions will include repetitive&#xD;
      or sustained trunk extension based on random group assignment, performed approximately 5&#xD;
      times per day. Each subject will complete a sheet recording home exercise compliance upon&#xD;
      arrival in session 2.&#xD;
&#xD;
      SESSION 2&#xD;
&#xD;
      Subjects will complete: (1) a NPRS to rate their current, minimum, maximum and average LBP&#xD;
      over the last two days as well as paresthesia signs/symptoms intensity; (2) Body Diagram for&#xD;
      indicating location of symptoms; (3) Modified Oswestry low back pain questionnaire; (4) Fear&#xD;
      Avoidance Belief Questionnaire. Each subject will then complete a familiarization procedure&#xD;
      to determine the consistency to reposition themselves in the stadiometer as described in&#xD;
      session 1. The subject will undergo a 10-minute period of trunk unloading in a supine posture&#xD;
      to ensure spinal height is normalized as described in session 1. The subject will reposition&#xD;
      on the stadiometer and spinal height will be measured after a relaxed exhalation (Measurement&#xD;
      1). The subject then will undergo a five-minute period of loaded upright sitting with a 4.5kg&#xD;
      bag secured on each shoulder and spinal height will be measured. The subject will then&#xD;
      undergo an additional five minutes sitting without load and spinal height will be measured&#xD;
      (Measurement 3). Inclinometers will be used to take an initial measure of each subject trunk&#xD;
      extension prior to intervention. The subject will then undergo the same intervention as in&#xD;
      session 1 for 5 minutes as previously described (standing repetitive trunk extension or&#xD;
      standing sustained trunk extension). The subject will reposition on the stadiometer and&#xD;
      spinal height will be measured (Measurement 4). Trunk extension will be measured to determine&#xD;
      the strength of correlations between the degree of trunk extension during standing trunk&#xD;
      extension posture and spinal height, pain and centralization testing outcomes changes. The&#xD;
      subjects will then score their low back and lower extremity symptoms using NPRS, and map&#xD;
      their pain on a body pain diagram.&#xD;
&#xD;
      Investigator Blinding Two investigators will be involved with data collection and will carry&#xD;
      out inclinometer measurements of lumbar and sacral posture, supervised positioning in the&#xD;
      stadiometer and stadiometric measurements. The measuring investigator will be blinded to the&#xD;
      intervention (each subject will receive a hidden random number and will perform independently&#xD;
      the intervention in a treatment room) and the stadiometric measurements during the&#xD;
      experiment. He will also be responsible for assigning subjects to their initial groups,&#xD;
      supervising the subjects' positioning in the different standing postures and confirming that&#xD;
      a stadiometer reading is recorded on an Excel spreadsheet.&#xD;
&#xD;
      Subjects Charges There will be no charge for the two physical therapy sessions, including&#xD;
      examination and intervention. Following the two intervention sessions, subjects referred by&#xD;
      primary care providers (physicians, chiropractors, nurse practitioners, physician assistants)&#xD;
      to physical therapy for LBP will have the choice to receive standard care and be charged for&#xD;
      physical therapy intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 15, 2019</start_date>
  <completion_date type="Actual">March 6, 2022</completion_date>
  <primary_completion_date type="Actual">March 6, 2022</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>Treatment</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The primary investigator will be blinded to the measurements of spinal height using stadiometry, and to the group assignment of each participant (sustained versus repetitive extension postures)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Spinal Height (Stadiometry)</measure>
    <time_frame>Before intervention at first visit</time_frame>
    <description>Spinal height of subjects measured in stadiometer (mm) from 100 to 2000 mm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Spinal Height (Stadiometry)</measure>
    <time_frame>Immediately after intervention at first visit</time_frame>
    <description>Spinal height of subjects measured in stadiometer (mm) from 100 to 2000 mm. Height will be compared to height at initial measure. Greater height than at initial measure will indicate height gain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Spinal Height (Stadiometry)</measure>
    <time_frame>2-week following initial visit</time_frame>
    <description>Spinal height of subjects measured in stadiometer (mm) from 100 to 2000 mm. Height will be compared to height at initial measure. Greater height than at initial measure will indicate height gain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lumbar Extension range of motion (Inclinometer)</measure>
    <time_frame>Before intervention at first visit</time_frame>
    <description>Lumbar extension range of motion measured using bubble inclinometers (degrees) from 0 to 180 degrees. Greater numbers indicate greater trunk extension range of motion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lumbar Extension range of motion (Inclinometer)</measure>
    <time_frame>Immediately after intervention at first visit</time_frame>
    <description>Lumbar extension range of motion measured using bubble inclinometers (degrees) from 0 to 180 degrees. Greater numbers indicate greater trunk extension range of motion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lumbar Extension range of motion (Inclinometer)</measure>
    <time_frame>2-week following initial visit</time_frame>
    <description>Lumbar extension range of motion measured using bubble inclinometers (degrees) from 0 to 180 degrees. Greater numbers indicate greater trunk extension range of motion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain (Numerical pain rating scale - NPRS)</measure>
    <time_frame>Before intervention at first visit</time_frame>
    <description>Pain (Numerical Pain Rating Scale - NPRS) from 0 (no pain) to 10 (most severe pain requiring emergency room consultation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain (Numerical pain rating scale - NPRS)</measure>
    <time_frame>After intervention at first visit</time_frame>
    <description>Pain (Numerical Pain Rating Scale - NPRS) from 0 (no pain) to 10 (most severe pain requiring emergency room consultation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain (Numerical pain rating scale - NPRS)</measure>
    <time_frame>2-week following initial visit</time_frame>
    <description>Pain (Numerical Pain Rating Scale - NPRS) from 0 (no pain) to 10 (most severe pain requiring emergency room consultation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Centralization (Dallas Pain Diagram)</measure>
    <time_frame>Before intervention at first visit</time_frame>
    <description>Centralization of symptoms will be assessed using Dallas Pain diagram. A numeric overlay template will be applied to the patient's body diagram to document the most distal pain location scores between 1 and 6. Higher score will indicate a more distal symptoms' location.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Centralization (Dallas Pain Diagram)</measure>
    <time_frame>After intervention at first visit</time_frame>
    <description>Centralization of symptoms will be assessed using Dallas Pain diagram. A numeric overlay template will be applied to the patient's body diagram to document the most distal pain location scores between 1 and 6. Higher score will indicate a more distal symptoms' location.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Centralization (Dallas Pain Diagram)</measure>
    <time_frame>2-week following initial visit</time_frame>
    <description>Centralization of symptoms will be assessed using Dallas Pain diagram. A numeric overlay template will be applied to the patient's body diagram to document the most distal pain location scores between 1 and 6. Higher score will indicate a more distal symptoms' location.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Oswestry low back pain questionnaire</measure>
    <time_frame>Before intervention at first visit</time_frame>
    <description>The questionnaire measures how well patient function in life with scale from 0 (normal-no disability) to 100 (crippled with severe disability).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Oswestry low back pain questionnaire</measure>
    <time_frame>2-week following initial visit</time_frame>
    <description>The questionnaire measures how well patient function in life with scale from 0 (normal-no disability) to 100 (crippled with severe disability).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Repetitive Trunk Extension</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with low back pain will be asked to perform standing repetitive trunk extension at a rate of 10 per 45 seconds, repeated five times with 15-second rest breaks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sustained Trunk Extension</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with low back pain will be asked to perform standing sustained trunk extension for 5 x 45 seconds with 15-second rest breaks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Repetitive Trunk Extension</intervention_name>
    <description>Subjects will be asked to perform standing repetitive trunk extension at a rate of 10 per 45 seconds (Figure 2), repeated five times with 15-second rest breaks.</description>
    <arm_group_label>Repetitive Trunk Extension</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sustained Trunk Extension</intervention_name>
    <description>Subjects will be asked to perform standing sustained trunk extension for 5 x 45 seconds with 15-second rest breaks.</description>
    <arm_group_label>Sustained Trunk Extension</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability and willingness to come twice to the clinic for approximately 60 minutes each&#xD;
&#xD;
          -  Subjects with LBP and directional preference in back extension&#xD;
&#xD;
          -  Age 18-80&#xD;
&#xD;
          -  Ability to stand for 5 minutes&#xD;
&#xD;
          -  Ability to sit for 10 minutes&#xD;
&#xD;
          -  Low back pain on Numerical Pain Rating scale (NPRS) of at least 2/10 and less or equal&#xD;
             to 9/10&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy by subject report&#xD;
&#xD;
          -  history of back surgery or spinal fractures within the last six months&#xD;
&#xD;
          -  history of spinal fusion or physician's diagnosis of spinal instability&#xD;
&#xD;
          -  current history of acute systemic infection, active inflammatory disease, or&#xD;
             malignancy&#xD;
&#xD;
          -  subjects engaged in legal/compensation claims for their back symptoms&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sports Medicine &amp; Physical Therapy</name>
      <address>
        <city>Fredericksburg</city>
        <state>Texas</state>
        <zip>78624</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>March 17, 2022</last_update_submitted>
  <last_update_submitted_qc>March 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Low Back Pain</keyword>
  <keyword>Extension</keyword>
  <keyword>Posture</keyword>
  <keyword>Physical Therapy</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 28, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/57/NCT03785457/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 15, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/57/NCT03785457/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>December 8, 2022</submitted>
  </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/NCT03785457
org study id: L19-024
nct id: NCT03785457
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Standing trunk extension postures have been used for many years as a mechanical
      approach to low back pain (LBP), sometimes directed by therapeutic intervention, sometimes
      subconsciously performed by patientsto relieve LBP. However, no study to date has
      investigated the effect of standing trunk extension postures on spinal height and clinical
      outcome measures.

      Objective: The purpose of this study will be to evaluate in subjects with LBP following a
      period of trunk loading, how spinal height and/or pain, symptoms' centralization, and
      function outcome measures respond to:(1) standing repetitive trunk extension posture; and (2)
      standing sustained trunk extension posture. Lumbar range of motion (ROM) achieved during
      these two trunk extension postures will be compared to spinal height and outcome measures.

      Methods:A pre-test, post-test comparison group design (randomized clinical trial) will be
      used to determine how spinal height changes in response to sustained and repetitive standing
      trunk extension after a period of spinal loading. The study will evaluate the effects of
      sustained and repetitive trunk extension in standing on spinal height, pain, symptoms'
      centralization and function.

      Statistical Analysis: A mixed ANOVA will be used to statistically identify significant
      interactions and main effects for spinal height, pain and functionoutcome measures. Post-hoc
      pairwise comparisons will be used to locate significant differences between the different
      conditions. Significance will be set at α = 0.05. The Kruskal-Wallis 1-factor ANOVA for
      difference scores will used to determine changes of intensity and location of symptoms
      following sustained versus repetitive standing trunk extension. Spearman Rank correlation
      will be used to evaluate the relationship between spinal height changes and changes of pain
      and location of symptoms for each group.
Standing trunk extension postures have been used for many years as a mechanical approach to
      low back pain (LBP), sometimes directed by therapeutic intervention, sometimes subconsciously
      performed by patients to relieve LBP. However, no study to date has investigated the effects
      of standing extension postures on spinal height, pain, centralization and function.
      Therefore, the purposes of this study will be to evaluate in a sample of LBP patients the
      effect of standing trunk extension, both sustained and repetitive, following a period of
      spinal loading, on (1) spinal height; (2) pain; (3) symptoms centralization and (4)
      functional measures.

      Research Design(s) A pre-test, post-test comparison group design (randomized clinical trial)
      will be used to determine how spinal height changes in response to sustained and repetitive
      standing trunk extension after a period of spinal loading. The study will use a 2 (between
      subjects - type of trunk extension: sustained vs. repetitive) x 3 (within subjects - time:
      before vs. after vs. 2 weeks after) mixed design to evaluate the effects of sustained and
      repetitive trunk extension in standing on spinal height, pain, centralization and function
      outcome measures.

      Subjects / Specimens Systematic consecutive sampling of up to 100 subjects with LBP (40
      subjects completing both days of data collection) attending "Sports medicine and Physical
      therapy clinic" in Fredericksburg (Texas) as patients or for the purpose of health and
      wellness will be recruited. Flyers will also be posted at physician offices and the general
      Fredericksburg community and surrounding areas to inform subjects about the study.

      Testing Sequence Subjects will be asked to attend two physical therapy sessions over
      approximately a 60-minute period each to complete the study.

      SESSION 1

      Participants will complete a pre-screening questionnaire regarding inclusion. Each subject
      will watch an audio-visual power point presentation explaining the study, test procedures and
      describing the interventions (standing repetitive trunk extension and standing sustained
      trunk extension). Written informed consent will be obtained. To determine directional
      preference, the investigator (JH) will use the guidelines set forth in the directional
      preference definition and based off of standards set forth in randomized clinical trials.
      Directional preference has been defined as either (1) a specific direction of trunk movement
      or posture noted during the physical examination or (2) a specific easing factor reported by
      the patient during the subjective history that alleviates or decreases the patient's pain,
      with or without the pain having changed location and/or increased the patient's lumbar range
      of motion. A questionnaire including pertinent medical history will be completed. Subjects
      will complete (1) a Numerical Pain Rating Scale (NPRS) to rate their current, minimum,
      maximum and average LBP over the last two days as well as paresthesia signs/symptoms
      intensity; (2) Body Diagram for indicating location of symptoms; (3) Modified Oswestry low
      back pain questionnaire; (4) Fear Avoidance Belief Questionnaire. A researcher will record
      subject's height and weight.

      If the subject meets criteria for inclusion in the study, the subject will complete a
      familiarization procedure to determine the consistency to reposition themselves in the
      stadiometer. Subjects able to reposition themselves in the stadiometer with a SD of 1.3mm or
      less for five consecutive measurements will be included in the study. The digital display
      will be covered to blind the researcher performing the measurements. The data will be
      automatically recorded by the stadiometer and manually downloaded to a laptop computer.

      At the beginning of data collection, a randomization plan generator
      (http://www.randomization.com ) will assign each subject to one of two interventions: (1)
      standing repetitive trunk extension at a rate of 10 per 45 seconds, repeated five times with
      15-second rest breaks; or (2) standing sustained trunk extension for 5 x 45 seconds with
      15-second rest breaks. Each subject will complete one intervention. The intervention number
      assigned will be recorded by the subject next to their name to allow blinding of the
      investigator as to which intervention the subject is assigned to. The subject will undergo
      the test sequence after a 10-minute period of trunk unloading in a supine posture to ensure
      spinal height is normalized, head in neutral posture, knees supported over a small bolster
      pillow, hands placed on the abdomen. The subject will reposition on the stadiometer and
      spinal height will be measured after a relaxed exhalation. The subject then will undergo a
      five-minute period of loaded upright sitting with a 4.5kg bag secured on each shoulder and
      spinal height will be measured (Measurement 2). As continued spinal height reduction has been
      demonstrated following loaded sitting, the subject will undergo an additional five minutes
      sitting without load and spinal height will be measured (Measurement 3). Inclinometers will
      be used to take an initial measure of each subject trunk extension prior to intervention. The
      subject will then undergo one intervention for 5 minutes as previously described, according
      to the randomization assignment. In order to determine how sustained and repetitive
      interventions related in terms of change in spinal height, the time to perform the sustained
      lumbar posture matches the time necessary to perform the repetitive lumbar extension
      postures.

      The subject will reposition on the stadiometer and spinal height will be measured
      (Measurement 4). Trunk extension will be measured to determine the strength of correlations
      between the degree of trunk extension during standing trunk extension posture and spinal
      height, pain and centralization testing outcomes changes. The subject will score their low
      back and lower extremity symptoms using NPRS, and map their pain on a body pain diagram prior
      to intervention, immediately after and 2-week following the intervention to determine pain
      rating and centralization of symptoms. The principal investigator will apply a numeric
      overlay template to the patient's body diagrams to document the most distal pain location
      scores between 1 and 6. Higher score will indicate a more distal symptoms' location.

      Home instructions Subjects will be instructed to continue to use their medications, including
      medications aimed at decreasing their pain, as prescribed by their primary healthcare
      provider and not to change them during the follow-up two-week period. A sheet including home
      exercise instructions will be provided to each patient. Instructions will include repetitive
      or sustained trunk extension based on random group assignment, performed approximately 5
      times per day. Each subject will complete a sheet recording home exercise compliance upon
      arrival in session 2.

      SESSION 2

      Subjects will complete: (1) a NPRS to rate their current, minimum, maximum and average LBP
      over the last two days as well as paresthesia signs/symptoms intensity; (2) Body Diagram for
      indicating location of symptoms; (3) Modified Oswestry low back pain questionnaire; (4) Fear
      Avoidance Belief Questionnaire. Each subject will then complete a familiarization procedure
      to determine the consistency to reposition themselves in the stadiometer as described in
      session 1. The subject will undergo a 10-minute period of trunk unloading in a supine posture
      to ensure spinal height is normalized as described in session 1. The subject will reposition
      on the stadiometer and spinal height will be measured after a relaxed exhalation (Measurement
      1). The subject then will undergo a five-minute period of loaded upright sitting with a 4.5kg
      bag secured on each shoulder and spinal height will be measured. The subject will then
      undergo an additional five minutes sitting without load and spinal height will be measured
      (Measurement 3). Inclinometers will be used to take an initial measure of each subject trunk
      extension prior to intervention. The subject will then undergo the same intervention as in
      session 1 for 5 minutes as previously described (standing repetitive trunk extension or
      standing sustained trunk extension). The subject will reposition on the stadiometer and
      spinal height will be measured (Measurement 4). Trunk extension will be measured to determine
      the strength of correlations between the degree of trunk extension during standing trunk
      extension posture and spinal height, pain and centralization testing outcomes changes. The
      subjects will then score their low back and lower extremity symptoms using NPRS, and map
      their pain on a body pain diagram.

      Investigator Blinding Two investigators will be involved with data collection and will carry
      out inclinometer measurements of lumbar and sacral posture, supervised positioning in the
      stadiometer and stadiometric measurements. The measuring investigator will be blinded to the
      intervention (each subject will receive a hidden random number and will perform independently
      the intervention in a treatment room) and the stadiometric measurements during the
      experiment. He will also be responsible for assigning subjects to their initial groups,
      supervising the subjects' positioning in the different standing postures and confirming that
      a stadiometer reading is recorded on an Excel spreadsheet.

      Subjects Charges There will be no charge for the two physical therapy sessions, including
      examination and intervention. Following the two intervention sessions, subjects referred by
      primary care providers (physicians, chiropractors, nurse practitioners, physician assistants)
      to physical therapy for LBP will have the choice to receive standard care and be charged for
      physical therapy intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
masking description: The primary investigator will be blinded to the measurements of spinal height using stadiometry, and to the group assignment of each participant (sustained versus repetitive extension postures)
measure: Spinal Height (Stadiometry)
time frame: Before intervention at first visit
description: Spinal height of subjects measured in stadiometer (mm) from 100 to 2000 mm.
measure: Spinal Height (Stadiometry)
time frame: Immediately after intervention at first visit
description: Spinal height of subjects measured in stadiometer (mm) from 100 to 2000 mm. Height will be compared to height at initial measure. Greater height than at initial measure will indicate height gain.
measure: Spinal Height (Stadiometry)
time frame: 2-week following initial visit
description: Spinal height of subjects measured in stadiometer (mm) from 100 to 2000 mm. Height will be compared to height at initial measure. Greater height than at initial measure will indicate height gain.
measure: Lumbar Extension range of motion (Inclinometer)
time frame: Before intervention at first visit
description: Lumbar extension range of motion measured using bubble inclinometers (degrees) from 0 to 180 degrees. Greater numbers indicate greater trunk extension range of motion.
measure: Lumbar Extension range of motion (Inclinometer)
time frame: Immediately after intervention at first visit
description: Lumbar extension range of motion measured using bubble inclinometers (degrees) from 0 to 180 degrees. Greater numbers indicate greater trunk extension range of motion.
measure: Lumbar Extension range of motion (Inclinometer)
time frame: 2-week following initial visit
description: Lumbar extension range of motion measured using bubble inclinometers (degrees) from 0 to 180 degrees. Greater numbers indicate greater trunk extension range of motion.
measure: Pain (Numerical pain rating scale - NPRS)
time frame: Before intervention at first visit
description: Pain (Numerical Pain Rating Scale - NPRS) from 0 (no pain) to 10 (most severe pain requiring emergency room consultation)
measure: Pain (Numerical pain rating scale - NPRS)
time frame: After intervention at first visit
description: Pain (Numerical Pain Rating Scale - NPRS) from 0 (no pain) to 10 (most severe pain requiring emergency room consultation)
measure: Pain (Numerical pain rating scale - NPRS)
time frame: 2-week following initial visit
description: Pain (Numerical Pain Rating Scale - NPRS) from 0 (no pain) to 10 (most severe pain requiring emergency room consultation)
measure: Centralization (Dallas Pain Diagram)
time frame: Before intervention at first visit
description: Centralization of symptoms will be assessed using Dallas Pain diagram. A numeric overlay template will be applied to the patient's body diagram to document the most distal pain location scores between 1 and 6. Higher score will indicate a more distal symptoms' location.
measure: Centralization (Dallas Pain Diagram)
time frame: After intervention at first visit
description: Centralization of symptoms will be assessed using Dallas Pain diagram. A numeric overlay template will be applied to the patient's body diagram to document the most distal pain location scores between 1 and 6. Higher score will indicate a more distal symptoms' location.
measure: Centralization (Dallas Pain Diagram)
time frame: 2-week following initial visit
description: Centralization of symptoms will be assessed using Dallas Pain diagram. A numeric overlay template will be applied to the patient's body diagram to document the most distal pain location scores between 1 and 6. Higher score will indicate a more distal symptoms' location.
measure: Modified Oswestry low back pain questionnaire
time frame: Before intervention at first visit
description: The questionnaire measures how well patient function in life with scale from 0 (normal-no disability) to 100 (crippled with severe disability).
measure: Modified Oswestry low back pain questionnaire
time frame: 2-week following initial visit
description: The questionnaire measures how well patient function in life with scale from 0 (normal-no disability) to 100 (crippled with severe disability).
arm group label: Repetitive Trunk Extension
arm group type: Experimental
description: Participants with low back pain will be asked to perform standing repetitive trunk extension at a rate of 10 per 45 seconds, repeated five times with 15-second rest breaks
arm group label: Sustained Trunk Extension
arm group type: Experimental
description: Participants with low back pain will be asked to perform standing sustained trunk extension for 5 x 45 seconds with 15-second rest breaks
intervention type: Other
intervention name: Repetitive Trunk Extension
description: Subjects will be asked to perform standing repetitive trunk extension at a rate of 10 per 45 seconds (Figure 2), repeated five times with 15-second rest breaks.
arm group label: Repetitive Trunk Extension
intervention type: Other
intervention name: Sustained Trunk Extension
description: Subjects will be asked to perform standing sustained trunk extension for 5 x 45 seconds with 15-second rest breaks.
arm group label: Sustained Trunk Extension
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: Undecided
provided document: 
provided document: 
submitted: December 8, 2022