<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/NCT03758807</url>
  </required_header>
  <id_info>
    <org_study_id>StAmbroseUactive passive</org_study_id>
    <nct_id>NCT03758807</nct_id>
  </id_info>
  <brief_title>A Follow-up Comparison of Active Versus Passive Manual Therapy in Patients With Low Back Pain</brief_title>
  <official_title>A Follow-up Comparison of Active Versus Passive Manual Therapy 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 between the type of education provided&#xD;
      about common treatment techniques for patients with low back pain. This will be looked at&#xD;
      right after treatment and when patients return on their second visit after they do a common&#xD;
      exercise program for a few days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prior clinical trials have shown that patients respond differently to different explanations&#xD;
      about interventions performed. A recent randomized clinical trial demonstrated that a&#xD;
      10-minute manual therapy treatment (prone lumbar Posterior to Anterior mobilization (PA's)&#xD;
      with a neuroplasticity vs. traditional biomechanical explanation) produced an immediate,&#xD;
      significant improvement in straight leg raise (SLR) and pain for patients with chronic low&#xD;
      back pain. However, there is a need to examine whether there is any carry over (48-96 hours)&#xD;
      or if utilizing a home exercise program (HEP), aimed at increasing the various sensory&#xD;
      process applied in the clinic, produces any carry over. This will be looked at in patients&#xD;
      with who are provided different explanations about common back treatment techniques to see if&#xD;
      there will be any change in pain rating or 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 treatment groups</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Low Back Pain Rating</measure>
    <time_frame>Change from baseline to initial treatment</time_frame>
    <description>Numeric Pain Rating Scale for Back Pain (0 = no pain and 10 = worst pain). The minimal detectable change (MDC) for the NPRS for low back pain is reported to be 2.0.&#xD;
LBP is reported to be 2.0.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Low Back Pain Rating</measure>
    <time_frame>Change from initial treatment to 2-4 days</time_frame>
    <description>Numeric Pain Rating Scale for Back Pain (0 = no pain and 10 = worst pain). The minimal detectable change (MDC) for the NPRS for low back pain is reported to be 2.0.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lumbar flexion</measure>
    <time_frame>Change from baseline to initial treatment</time_frame>
    <description>Active trunk forward flexion in cm (distance finger tips to floor)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lumbar flexion</measure>
    <time_frame>Change from initial treatment to 2-4 days</time_frame>
    <description>Active trunk forward flexion in cm (distance finger tips to floor)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Straight Leg Raise</measure>
    <time_frame>Change from baseline to initial treatment</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 initial treatment 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>
  <condition>Manual Therapy</condition>
  <condition>Education</condition>
  <arm_group>
    <arm_group_label>Passive treatment</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Passive treatment will consist of Manual Therapy with biomechanical explanation of the technique.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active treatment will consist of Manual Therapy with a neuroplasticity explanation of the technique.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual Therapy with Traditional Biomechanical Explanation</intervention_name>
    <description>Patients will lie prone and receive lumbar Posterior to Anterior (AP) Pressure with a traditional biomechanical or anatomic explanation of the technique..</description>
    <arm_group_label>Passive treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual Therapy with Neuroplastiicity Explanation</intervention_name>
    <description>Patients will lie prone and receive lumbar Posterior to Anterior (PA) Pressure with a neuroplastic explanation of the technique.</description>
    <arm_group_label>Active Treatment</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 6 months or more&#xD;
&#xD;
          -  fluent in English&#xD;
&#xD;
          -  willing to participate in the study.&#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;
          -  no medical precautions to the use of manual therapy (metal, skin lesions, etc.)&#xD;
&#xD;
          -  prior spine surgery&#xD;
&#xD;
          -  unable to lay prone for the treatment&#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>Kevin Farrell</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>
  <results_reference>
    <citation>Louw A, Farrell K, Wettach L, Uhl J, Majkowski K, Wedling M. Immediate effects of sensory discrimination for chronic low back pain: a case series. New Zealand Journal of Physiotherapy. 2015;43(2):58-63.</citation>
  </results_reference>
  <results_reference>
    <citation>Louw A, Farrell K, Landers M, Barclay M, Goodman E, Gillund J, McCaffrey S, Timmerman L. The effect of manual therapy and neuroplasticity education on chronic low back pain: a randomized clinical trial. J Man Manip Ther. 2017 Dec;25(5):227-234. doi: 10.1080/10669817.2016.1231860. Epub 2016 Sep 22.</citation>
    <PMID>29449764</PMID>
  </results_reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 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>Manual Therapy</keyword>
  <keyword>Education</keyword>
  <keyword>Neuroplasticiy</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/NCT03758807
org study id: StAmbroseUactive passive
nct id: NCT03758807
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To determine if there is any carry over difference between the type of education provided
      about common treatment techniques for patients with low back pain. This will be looked at
      right after treatment and when patients return on their second visit after they do a common
      exercise program for a few days.
Prior clinical trials have shown that patients respond differently to different explanations
      about interventions performed. A recent randomized clinical trial demonstrated that a
      10-minute manual therapy treatment (prone lumbar Posterior to Anterior mobilization (PA's)
      with a neuroplasticity vs. traditional biomechanical explanation) produced an immediate,
      significant improvement in straight leg raise (SLR) and pain for patients with chronic low
      back pain. However, there is a need to examine whether there is any carry over (48-96 hours)
      or if utilizing a home exercise program (HEP), aimed at increasing the various sensory
      process applied in the clinic, produces any carry over. This will be looked at in patients
      with who are provided different explanations about common back treatment techniques to see if
      there will be any change in pain rating or 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 treatment groups
measure: Low Back Pain Rating
time frame: Change from baseline to initial treatment
description: Numeric Pain Rating Scale for Back Pain (0 = no pain and 10 = worst pain). The minimal detectable change (MDC) for the NPRS for low back pain is reported to be 2.0.
LBP is reported to be 2.0.
measure: Low Back Pain Rating
time frame: Change from initial treatment to 2-4 days
description: Numeric Pain Rating Scale for Back Pain (0 = no pain and 10 = worst pain). The minimal detectable change (MDC) for the NPRS for low back pain is reported to be 2.0.
measure: Lumbar flexion
time frame: Change from baseline to initial treatment
description: Active trunk forward flexion in cm (distance finger tips to floor)
measure: Lumbar flexion
time frame: Change from initial treatment to 2-4 days
description: Active trunk forward flexion in cm (distance finger tips to floor)
measure: Straight Leg Raise
time frame: Change from baseline to initial treatment
description: Neurodynamic Measurement of Leg Raise (lower limb tension test)
measure: Straight Leg Raise
time frame: Change from initial treatment to 2-4 days
description: Neurodynamic Measurement of Leg Raise (lower limb tension test)
arm group label: Passive treatment
arm group type: Sham Comparator
description: Passive treatment will consist of Manual Therapy with biomechanical explanation of the technique.
arm group label: Active Treatment
arm group type: Experimental
description: Active treatment will consist of Manual Therapy with a neuroplasticity explanation of the technique.
intervention type: Other
intervention name: Manual Therapy with Traditional Biomechanical Explanation
description: Patients will lie prone and receive lumbar Posterior to Anterior (AP) Pressure with a traditional biomechanical or anatomic explanation of the technique..
arm group label: Passive treatment
intervention type: Other
intervention name: Manual Therapy with Neuroplastiicity Explanation
description: Patients will lie prone and receive lumbar Posterior to Anterior (PA) Pressure with a neuroplastic explanation of the technique.
arm group label: Active Treatment
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, Wedling M. Immediate effects of sensory discrimination for chronic low back pain: a case series. New Zealand Journal of Physiotherapy. 2015;43(2):58-63.
citation: Louw A, Farrell K, Landers M, Barclay M, Goodman E, Gillund J, McCaffrey S, Timmerman L. The effect of manual therapy and neuroplasticity education on chronic low back pain: a randomized clinical trial. J Man Manip Ther. 2017 Dec;25(5):227-234. doi: 10.1080/10669817.2016.1231860. Epub 2016 Sep 22.
PMID: 29449764
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