<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/NCT01704807</url>
  </required_header>
  <id_info>
    <org_study_id>LCC-12-RD0519110317</org_study_id>
    <nct_id>NCT01704807</nct_id>
  </id_info>
  <brief_title>Duration of Spinal Manipulation Effects as Influenced by Orthotics</brief_title>
  <official_title>Duration of Spinal Manipulation Effects as Influenced by Orthotics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Logan College of Chiropractic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Logan College of Chiropractic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose of study: To assess the effects of wearing custom orthotics as opposed to placebo&#xD;
      foot inserts on the duration of chiropractic correction of spinal fixations and muscle&#xD;
      imbalances using applied kinesiology techniques.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants with chronic lower back pain of greater than one month duration will be&#xD;
      randomized to receive custom foot orthotics or placebo flat inserts. Both groups will receive&#xD;
      chiropractic treatment 5 times over the course of 4 weeks following receipt of orthotics.&#xD;
      Subjects and treating doctor will be blind to the insert type. Patients will report present,&#xD;
      average, best and worst pain at each visit, and complete a Roland-Morris questionnaire.&#xD;
      Secondary outcome measures will be number of fixated vertebral levels identified by motion&#xD;
      palpation and challenge and number of muscles testing grade 4 and below from a list of 5&#xD;
      muscles to be tested bilaterally before and after each treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">March 2012</primary_completion_date>
  <phase>Phase 1/Phase 2</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 (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quadruple Visual Analog Pain Scale</measure>
    <time_frame>Six weeks</time_frame>
    <description>Pain present, best worst and average on a scale of 0 to 10, with 10 being the worst imaginable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Roland-Morris Questionnaire</measure>
    <time_frame>Six weeks</time_frame>
    <description>Questionnaire listing activities of daily living, impacted by low back pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of fixated vertebral levels</measure>
    <time_frame>Six weeks</time_frame>
    <description>Number of vertebral levels found to be fixated as determined by motion palpation and vertebral challenge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of tested muscles grade 4 and below</measure>
    <time_frame>Six weeks</time_frame>
    <description>Number of five muscles tested bilaterally, which tested grade 4 or below in manual muscle testing.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Intervention, Custom Orthotics</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Wearing custom foot orthotics</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Foot Orthotic</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Wearing sham or flat shoe insoles</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>foot orthotics</intervention_name>
    <description>Experimental wore experimental orthotics throughout the study period as much of the day as possible.</description>
    <arm_group_label>Intervention, Custom Orthotics</arm_group_label>
    <other_name>Foot Levelers, Full length ultra step foot orthotics</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham foot orthotic</intervention_name>
    <description>Control group wore sham insoles as much of the time as possible for the duration of the study period.</description>
    <arm_group_label>Sham Foot Orthotic</arm_group_label>
    <other_name>Foot Levelers flat insoles similar to Full Length Ultra Step</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current low back pain episode present for one month or more&#xD;
&#xD;
          -  No change in the past month in prescription medications affecting musculoskeletal pain&#xD;
&#xD;
          -  Able to speak and understand English adequately to complete study forms&#xD;
&#xD;
          -  Score on Roland-Morris questionnaire of 7.5 or higher or&#xD;
&#xD;
          -  Average score on Chiropractic pain Index (Now, Average, and Worst scales from the&#xD;
             Quadruple VAS pain scale) of 4 or higher.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of foot orthotics within the past 12 months&#xD;
&#xD;
          -  Previous lumbar spine surgery&#xD;
&#xD;
          -  Ongoing treatment for lower back pain by other health care providers other than stable&#xD;
             prescription medications affecting musculoskeletal pain.&#xD;
&#xD;
          -  Clinically significant chronic inflammatory spinal arthritis&#xD;
&#xD;
          -  Severe osteoporosis for which spinal manipulation is contraindicated&#xD;
&#xD;
          -  Spinal pathology or fracture&#xD;
&#xD;
          -  Progressive neurologic deficits due to nerve root or spinal cord compression,&#xD;
             including symptoms/signs of cauda equina syndrome&#xD;
&#xD;
          -  History of bleeding disorder&#xD;
&#xD;
          -  Known arterial aneurysm&#xD;
&#xD;
          -  Pending/current litigation pertaining to back pain, including workers compensation&#xD;
             claims&#xD;
&#xD;
          -  Current pregnancy&#xD;
&#xD;
          -  Lack of means of contacting which might preclude successful completion of study&#xD;
             requirements&#xD;
&#xD;
          -  Does not speak , read or understand English to an extent which would affect the&#xD;
             subject's capacity to participate in informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katharine Conable, DC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Logan College of Chiropractic/University Programs</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anthony Rosner, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>International College of Applied Kinesiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Logan College of Chiropractic/University Programs</name>
      <address>
        <city>Chesterfield</city>
        <state>Missouri</state>
        <zip>63017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>October 10, 2012</last_update_submitted>
  <last_update_submitted_qc>October 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 11, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Low Back Pain</keyword>
  <keyword>Chronic</keyword>
  <keyword>Orthotic Device</keyword>
  <keyword>Applied Kinesiology</keyword>
  <keyword>Manual Muscle Testing</keyword>
  <keyword>Chiropractic</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>
  <!-- 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/NCT01704807
org study id: LCC-12-RD0519110317
nct id: NCT01704807
lead sponsor: 
has dmc: No
Purpose of study: To assess the effects of wearing custom orthotics as opposed to placebo
      foot inserts on the duration of chiropractic correction of spinal fixations and muscle
      imbalances using applied kinesiology techniques.
Participants with chronic lower back pain of greater than one month duration will be
      randomized to receive custom foot orthotics or placebo flat inserts. Both groups will receive
      chiropractic treatment 5 times over the course of 4 weeks following receipt of orthotics.
      Subjects and treating doctor will be blind to the insert type. Patients will report present,
      average, best and worst pain at each visit, and complete a Roland-Morris questionnaire.
      Secondary outcome measures will be number of fixated vertebral levels identified by motion
      palpation and challenge and number of muscles testing grade 4 and below from a list of 5
      muscles to be tested bilaterally before and after each treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Quadruple Visual Analog Pain Scale
time frame: Six weeks
description: Pain present, best worst and average on a scale of 0 to 10, with 10 being the worst imaginable.
measure: Roland-Morris Questionnaire
time frame: Six weeks
description: Questionnaire listing activities of daily living, impacted by low back pain.
measure: Number of fixated vertebral levels
time frame: Six weeks
description: Number of vertebral levels found to be fixated as determined by motion palpation and vertebral challenge.
measure: Number of tested muscles grade 4 and below
time frame: Six weeks
description: Number of five muscles tested bilaterally, which tested grade 4 or below in manual muscle testing.
arm group label: Intervention, Custom Orthotics
arm group type: Active Comparator
description: Wearing custom foot orthotics
arm group label: Sham Foot Orthotic
arm group type: Sham Comparator
description: Wearing sham or flat shoe insoles
intervention type: Device
intervention name: foot orthotics
description: Experimental wore experimental orthotics throughout the study period as much of the day as possible.
arm group label: Intervention, Custom Orthotics
other name: Foot Levelers, Full length ultra step foot orthotics
intervention type: Device
intervention name: Sham foot orthotic
description: Control group wore sham insoles as much of the time as possible for the duration of the study period.
arm group label: Sham Foot Orthotic
other name: Foot Levelers flat insoles similar to Full Length Ultra Step
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Katharine Conable, DC
role: Principal Investigator
affiliation: Logan College of Chiropractic/University Programs
last name: Anthony Rosner, PhD
role: Principal Investigator
affiliation: International College of Applied Kinesiology
facility: 
country: United States
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain