<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/NCT03760887</url>
  </required_header>
  <id_info>
    <org_study_id>StAmbroseU sensory</org_study_id>
    <nct_id>NCT03760887</nct_id>
  </id_info>
  <brief_title>A Follow-up Comparison of Sensory Discrimination in Patients With Low Back Pain</brief_title>
  <official_title>A Follow-up Comparison of Sensory Discrimination in Patients With Low Back Pain: a Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Ambrose University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Ambrose University</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>
      To determine if there is any carry over difference with sensation training to the low back&#xD;
      for patients with low back pain with the addition of a training at home. This will be looked&#xD;
      at to see if there is a difference in pain or back / leg movement right after the training&#xD;
      and in a few days after doing some exercises at home.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In a previous case series patients with chronic Low Back Pain (LBP) who received tactile&#xD;
      acuity training to their lower back in the absence of movement, experienced immediate&#xD;
      positive changes in pain ratings and spinal movements. These changes, however, where only&#xD;
      measured immediate post-intervention. This study aims to use a similar design of sensory&#xD;
      discrimination for LBP, but will include a sensory discrimination home exercise program and&#xD;
      compare groups at a follow-up visit for any difference between groups (48-96 hours) of the&#xD;
      immediate changes. Changes will be assessed for pain and back and leg movement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">December 30, 2018</completion_date>
  <primary_completion_date type="Actual">December 30, 2018</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>
    <intervention_model_description>Randomized Control Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Patients were randomly assigned to one of two groups (control or experimental).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Low Back Pain Rating</measure>
    <time_frame>Change from baseline to following treatment immediately upon completion of initial session</time_frame>
    <description>Numeric Pain Rating Scale for Back pain (0 = no pain and 10 = worst pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Low Back Pain Rating</measure>
    <time_frame>Change from end of treatment initial session to 2-4 days</time_frame>
    <description>Numeric Pain Rating Scale for Back pain (0 = no pain and 10 = worst pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lumbar Flexion</measure>
    <time_frame>Change from baseline to treatment immediately upon completion of initial session</time_frame>
    <description>Active trunk forward flexion measured in cm (finger tips to floor)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lumbar Flexion</measure>
    <time_frame>Change from end of treatment initial session to 2-4 days</time_frame>
    <description>Active trunk forward flexion measured in cm (finger tips to floor)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Straight Leg Raise</measure>
    <time_frame>Change from baseline to treatment immediately upon completion of initial session</time_frame>
    <description>Neurodynamic measurement of leg raise (lower limb tension test)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Straight Leg Raise</measure>
    <time_frame>Change from end of treatment initial session to 2-4 days</time_frame>
    <description>Neurodynamic measurement of leg raise (lower limb tension test)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>No Home Sensory training</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients who perform a home exercise program only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Home sensory training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who perform home exercise and home sensory training</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home exercise program only</intervention_name>
    <description>After 5 minutes of sensory discrimination (using a 9 point grid) in the clinic patients will perform a home exercise program only</description>
    <arm_group_label>No Home Sensory training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home exercise program and home program of sensory discrimination</intervention_name>
    <description>After 5 minutes of sensory discrimination (using a 9 point grid) in the clinic patients will perform a home exercise program and two 5 minutes sessions of sensory training at home each day.</description>
    <arm_group_label>Home sensory training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults over the age of 18&#xD;
&#xD;
          -  patients presenting at PT with a primary complaint of LBP&#xD;
&#xD;
          -  LBP being present for 3 months or more&#xD;
&#xD;
          -  fluent in English&#xD;
&#xD;
          -  willing to participate in the study&#xD;
&#xD;
          -  They also will need someone who can assist with a sensory discrimination HEP.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  under age 18&#xD;
&#xD;
          -  not able to read/understand the English language&#xD;
&#xD;
          -  prisoners&#xD;
&#xD;
          -  no medical issues precluding physical therapy treatment (red flags)&#xD;
&#xD;
          -  if they had undergone spinal surgery&#xD;
&#xD;
          -  if they had any skin or medical condition preventing them from receiving tactile&#xD;
             stimuli on the lower back or had specific movement-based precautions, i.e., no active&#xD;
             spinal flexion. - Patients presenting with leg pain only&#xD;
&#xD;
          -  Patients with neurological deficit only in the lower extremity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kevin Farrell</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Ambrose University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Ambrose university</name>
      <address>
        <city>Davenport</city>
        <state>Iowa</state>
        <zip>52803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Louw A, Farrell K, Wettach L, Uhl J, Majkowski K, Welding M (2015) Immediate effects of sensory discrimination for chronic low back pain: a case series. New Zealand Journal of Physiotherapy 43(2)</citation>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>April 22, 2019</last_update_submitted>
  <last_update_submitted_qc>April 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Ambrose University</investigator_affiliation>
    <investigator_full_name>Kevin Farrell</investigator_full_name>
    <investigator_title>Professor, Chair of Clinical Residency Program in Orthopaedic Physical Therapy</investigator_title>
  </responsible_party>
  <keyword>Low back pain</keyword>
  <keyword>Sensory</keyword>
  <keyword>Tactile</keyword>
  <keyword>Education</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>
  <!-- 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/NCT03760887
org study id: StAmbroseU sensory
nct id: NCT03760887
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To determine if there is any carry over difference with sensation training to the low back
      for patients with low back pain with the addition of a training at home. This will be looked
      at to see if there is a difference in pain or back / leg movement right after the training
      and in a few days after doing some exercises at home.
In a previous case series patients with chronic Low Back Pain (LBP) who received tactile
      acuity training to their lower back in the absence of movement, experienced immediate
      positive changes in pain ratings and spinal movements. These changes, however, where only
      measured immediate post-intervention. This study aims to use a similar design of sensory
      discrimination for LBP, but will include a sensory discrimination home exercise program and
      compare groups at a follow-up visit for any difference between groups (48-96 hours) of the
      immediate changes. Changes will be assessed for pain and back and leg movement.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Control Trial
primary purpose: Treatment
masking: Single (Participant)
masking description: Patients were randomly assigned to one of two groups (control or experimental).
measure: Low Back Pain Rating
time frame: Change from baseline to following treatment immediately upon completion of initial session
description: Numeric Pain Rating Scale for Back pain (0 = no pain and 10 = worst pain)
measure: Low Back Pain Rating
time frame: Change from end of treatment initial session to 2-4 days
description: Numeric Pain Rating Scale for Back pain (0 = no pain and 10 = worst pain)
measure: Lumbar Flexion
time frame: Change from baseline to treatment immediately upon completion of initial session
description: Active trunk forward flexion measured in cm (finger tips to floor)
measure: Lumbar Flexion
time frame: Change from end of treatment initial session to 2-4 days
description: Active trunk forward flexion measured in cm (finger tips to floor)
measure: Straight Leg Raise
time frame: Change from baseline to treatment immediately upon completion of initial session
description: Neurodynamic measurement of leg raise (lower limb tension test)
measure: Straight Leg Raise
time frame: Change from end of treatment initial session to 2-4 days
description: Neurodynamic measurement of leg raise (lower limb tension test)
arm group label: No Home Sensory training
arm group type: Sham Comparator
description: Patients who perform a home exercise program only
arm group label: Home sensory training
arm group type: Experimental
description: Patients who perform home exercise and home sensory training
intervention type: Other
intervention name: Home exercise program only
description: After 5 minutes of sensory discrimination (using a 9 point grid) in the clinic patients will perform a home exercise program only
arm group label: No Home Sensory training
intervention type: Other
intervention name: Home exercise program and home program of sensory discrimination
description: After 5 minutes of sensory discrimination (using a 9 point grid) in the clinic patients will perform a home exercise program and two 5 minutes sessions of sensory training at home each day.
arm group label: Home sensory training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kevin Farrell
role: Principal Investigator
affiliation: St. Ambrose University
facility: 
country: United States
citation: Louw A, Farrell K, Wettach L, Uhl J, Majkowski K, Welding M (2015) Immediate effects of sensory discrimination for chronic low back pain: a case series. New Zealand Journal of Physiotherapy 43(2)
responsible party type: Principal Investigator
investigator affiliation: St. Ambrose University
investigator full name: Kevin Farrell
investigator title: Professor, Chair of Clinical Residency Program in Orthopaedic Physical Therapy
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No