<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/NCT03749564</url>
  </required_header>
  <id_info>
    <org_study_id>59006084</org_study_id>
    <nct_id>NCT03749564</nct_id>
  </id_info>
  <brief_title>Influence of Opioid Use on the Effects of Spinal Manipulative Therapy for Low Back Pain</brief_title>
  <official_title>Examining the Influence of Opioid Use on the Effects of Spinal Manipulative Therapy for Low Back Pain: Administrative Supplement to UH3AT009293 - Optimization of Spinal Manipulative Therapy (SMT) Protocols</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This project is a supplement to the parent project (UH3AT009293) entitled &quot;Optimization of&#xD;
      Spinal Manipulative Therapy (SMT) Protocols&quot;. The goal of the parent project is to examine&#xD;
      strategies to optimize SMT treatment protocols for patients with low back pain (LBP). The&#xD;
      parent project is investigating mechanistic and clinical outcomes of SMT combined with&#xD;
      varying co-interventions. This supplemental project will examine the impact of opioid use on&#xD;
      these outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This supplement expands the parent research project to include three additional Aims and the&#xD;
      recruitment of the 70 additional participants. The additional participants will undergo the&#xD;
      same assessment and intervention procedures outlined in the parent project to permit&#xD;
      leveraging the full cohort to evaluate the supplemental Aims.&#xD;
&#xD;
      The overall objective is to examine the impact of opioid use on patient-centered and&#xD;
      mechanistic outcomes related to SMT and explore the impact on SMT followed by various&#xD;
      co-interventions. The goal of this research is to better tailor SMT protocols to optimize&#xD;
      outcomes for patients with LBP who are opioid users and facilitate efforts to reduce reliance&#xD;
      on opioid pain management among those with LBP. Accomplishing this goal will facilitate&#xD;
      future research evaluating the efficacy of non-pharmacologic alternative pain management&#xD;
      strategies for individuals with LBP.&#xD;
&#xD;
      Specific Aims to be addressed through this supplement are:&#xD;
&#xD;
        1. Compare baseline psychological, mechanistic and LBP-related characteristics between&#xD;
           sub-groups of participants with LBP based on opioid use.&#xD;
&#xD;
        2. Examine the association of opioid use with changes in mechanistic and patient-centered&#xD;
           outcomes between a baseline assessment and subsequent assessment after 1-week and&#xD;
           completion of a 2-session SMT intervention protocol.&#xD;
&#xD;
        3. Explore the moderating effects of opioid use on mechanistic and patient-centered&#xD;
           outcomes obtained 4 weeks following SMT intervention with varied co-intervention&#xD;
           components.&#xD;
&#xD;
      Examining these aims as a supplement to the parent project will allow evaluation of whether&#xD;
      or not opioid use impacts short-term mechanistic and patient-centered outcomes of SMT (Aim&#xD;
      2), and will explore if the longer-term effects of the three co-interventions differ between&#xD;
      opioid users and non-users. (Aim 3). This research will also compare baseline characteristics&#xD;
      between participants who are or are not opioid users (Aim 1).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    COVID-19 restrictions on research activities&#xD;
  </why_stopped>
  <start_date type="Actual">January 17, 2019</start_date>
  <completion_date type="Actual">March 3, 2020</completion_date>
  <primary_completion_date type="Actual">March 3, 2020</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>Factorial Assignment</intervention_model>
    <intervention_model_description>Factorial design examining the outcomes of SMT with varying combinations of co-interventions.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Design precludes blinding of patients or care providers. Research personnel conducting outcomes assessments and the principal investigator are blind to participants' group assignment throughout the study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Oswestry</measure>
    <time_frame>1 week</time_frame>
    <description>The Oswestry Index measures back pain-related disability. The scale contains 10 items with a final score ranging from 0-100. Higher numbers indicate more disability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain intensity: 0-10 numeric pain rating</measure>
    <time_frame>1 week</time_frame>
    <description>A 0-10 numeric pain rating is used to assess pain intensity. Higher numbers indicate greater pain intensity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Multifidus Activation</measure>
    <time_frame>Baseline, 1-week, 4-weeks, 3 months</time_frame>
    <description>Multifidus activation wis measured with brightness-mode ultrasound images using a 60mm, 2-5 MHz curvilinear array. The subject is prone. The ultrasound transducer is placed just lateral to midline and angled medially until a parasagittal view of the multifidus is obtained. Images are acquired at each level with the multifidus at rest and during submaximal contraction elicited by the subject lifting the contralateral arm about 2 inches while holding a weight proportional to body weight. Three images in each state are acquired and averaged. Offline multifidus thickness measures are obtained from the distance between the posterior-most aspect of the facet joint inferiorly and the plane between the multifidus and thoracolumbar fascia superior. Muscle activation is calculated as the change in thickness at rest and submaximal contraction and expressed in mm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spinal Stiffness</measure>
    <time_frame>Baseline, 1-week, 4-weeks, 3 months</time_frame>
    <description>Spinal stiffness is assessed with a mechanically-assisted indentation device over the spinous processes. Indentation involves advancement of the probe from a 5 N pre-load to 60 N final load maintained for 1 second, then the probe raises automatically. Three indentation trials are performed with mean values used for analysis. Indentation data (force and displacement) are used to calculate stiffness variables. Global stiffness (N) is calculated as the slope of the force displacement curve between 5 - 60 N, representing stiffness of underlying tissues during indentation.</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Low Back Pain</condition>
  <condition>Opioid Use</condition>
  <arm_group>
    <arm_group_label>SMT Only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients receive 2 SMT sessions in the first week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMT extended</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients receive 2 SMT sessions in the first week. This arm also involves 6 additional SMT sessions. Each SMT session is conducted as described previously.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMT with Activation Exercises</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients receive 2 SMT sessions in the first week.&#xD;
This arm receives 6 additional sessions of activation exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMT with Mobilizing Exercises</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients receive 2 SMT sessions in the first week.&#xD;
This arm involves 6 additional sessions of mobilizing exercise.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMT with Mobilizing and Activation Exercises</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients receive 2 SMT sessions in the first week.&#xD;
This arm involves 6 additions sessions including both activation and mobilizing exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMT extended with Mobilizing Exercises</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients receive 2 SMT sessions in the first week.&#xD;
This arm includes 6 additional sessions including both SMT and mobilizing exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMT extended with Activation Exercises</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients receive 2 SMT sessions in the first week.&#xD;
This arm includes 6 additional sessions including both SMT and activation exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMT extended with Mobilizing and Activation Exercises</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients receive 2 SMT sessions in the first week.&#xD;
This arm includes 6 additional sessions including SMT, activation and mobilizing exercises.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SMT</intervention_name>
    <description>The subject is supine. The clinician stands opposite the side to be manipulated and side-bends the subject away from the side to manipulate. The side to be manipulated is the more painful. If the subject cannot identify a more painful side the clinician selects a side. The clinician rotates the subject, and delivers a high-velocity, low-amplitude (HVLA) thrust to the pelvis in a posterior/inferior direction. The clinician notes if a cavitation (ie, a &quot;pop&quot;) occurred. If it does, SMT treatment is complete. If no cavitation occurs, the subject is repositioned and SMT is performed again. If no cavitation occurs on the second attempt, the clinician manipulates the opposite side. A maximum of 2 attempts per side is permitted. If no cavitation is noted by that time, SMT treatment is complete. Substitution with a side-posture HVLA technique is allowed if the preferred technique is not possible due to subject preference or comfort.</description>
    <arm_group_label>SMT Only</arm_group_label>
    <arm_group_label>SMT extended</arm_group_label>
    <arm_group_label>SMT extended with Activation Exercises</arm_group_label>
    <arm_group_label>SMT extended with Mobilizing Exercises</arm_group_label>
    <arm_group_label>SMT extended with Mobilizing and Activation Exercises</arm_group_label>
    <arm_group_label>SMT with Activation Exercises</arm_group_label>
    <arm_group_label>SMT with Mobilizing Exercises</arm_group_label>
    <arm_group_label>SMT with Mobilizing and Activation Exercises</arm_group_label>
    <other_name>spinal manipulative therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Activation Exercises</intervention_name>
    <description>Activation exercises are designed to facilitate use of the lumbar multifidus muscle. Exercises will begin with isometric multifidus contractions in different positions with clinician feedback and exercises to isometrically co-contract the multifidus and deep abdominal muscles. Subjects will also perform lumbar extensor strengthening exercises shown to produce 20%-50% of multifidus maximum voluntary contraction. Subjects will continue to perform isometric exercises throughout treatment. Subjects will perform their prescribed exercises at treatment sessions and will be instructed to perform the exercises daily on other days.</description>
    <arm_group_label>SMT extended with Activation Exercises</arm_group_label>
    <arm_group_label>SMT extended with Mobilizing and Activation Exercises</arm_group_label>
    <arm_group_label>SMT with Activation Exercises</arm_group_label>
    <arm_group_label>SMT with Mobilizing and Activation Exercises</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mobilizing Exercises</intervention_name>
    <description>Mobilizing exercises include a program of repeated movements progressing into end-ranges of spinal flexion and/or extension shown in past studies to improve ROM and reduce spinal stiffness. Patients will be instructed in mid-range exercises and will be further assessed for a directional preference. A directional preference is present if movement in a particular direction decreases LBP intensity or causes symptoms to centralize towards the midline. If a subject has a directional preference he or she will be prescribed exercises specifically in that direction along with mid-range exercise. Otherwise the subject will be assigned exercises moving into either flexion or extension based on the clinician's discretion. Subjects will perform their prescribed exercises at treatment sessions and will be instructed to perform the exercises daily on other days.</description>
    <arm_group_label>SMT extended with Mobilizing Exercises</arm_group_label>
    <arm_group_label>SMT extended with Mobilizing and Activation Exercises</arm_group_label>
    <arm_group_label>SMT with Mobilizing Exercises</arm_group_label>
    <arm_group_label>SMT with Mobilizing and Activation Exercises</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Extended SMT</intervention_name>
    <description>Additional 6 SMT sessions provided</description>
    <arm_group_label>SMT extended</arm_group_label>
    <arm_group_label>SMT extended with Activation Exercises</arm_group_label>
    <arm_group_label>SMT extended with Mobilizing Exercises</arm_group_label>
    <arm_group_label>SMT extended with Mobilizing and Activation Exercises</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pain between the 12th rib and buttocks with or without symptoms into one or both legs,&#xD;
             which, in the opinion of the examiner, originate from the lumbar region.&#xD;
&#xD;
          -  Age 18 - 60 years&#xD;
&#xD;
          -  Oswestry disability score &gt; 20%&#xD;
&#xD;
          -  Self-reported&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior surgery to the lumbosacral spine&#xD;
&#xD;
          -  Currently pregnant&#xD;
&#xD;
          -  Currently receiving mind-body or exercise treatment for LBP from a healthcare provider&#xD;
             (e.g., chiropractic, physical therapy, massage therapy, etc.)&#xD;
&#xD;
          -  Neurogenic signs including any of the following: positive ipsi- or contra-lateral&#xD;
             straight leg raise test; reflex, sensory, or strength deficit in a pattern consistent&#xD;
             with lumbar nerve root compression&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Utah, Department of Physical Therapy</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>September 20, 2022</last_update_submitted>
  <last_update_submitted_qc>September 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Julie Fritz</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Spinal Manipulative Therapy</keyword>
  <keyword>Optimization</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/NCT03749564
org study id: 59006084
nct id: NCT03749564
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This project is a supplement to the parent project (UH3AT009293) entitled "Optimization of
      Spinal Manipulative Therapy (SMT) Protocols". The goal of the parent project is to examine
      strategies to optimize SMT treatment protocols for patients with low back pain (LBP). The
      parent project is investigating mechanistic and clinical outcomes of SMT combined with
      varying co-interventions. This supplemental project will examine the impact of opioid use on
      these outcomes.
This supplement expands the parent research project to include three additional Aims and the
      recruitment of the 70 additional participants. The additional participants will undergo the
      same assessment and intervention procedures outlined in the parent project to permit
      leveraging the full cohort to evaluate the supplemental Aims.

      The overall objective is to examine the impact of opioid use on patient-centered and
      mechanistic outcomes related to SMT and explore the impact on SMT followed by various
      co-interventions. The goal of this research is to better tailor SMT protocols to optimize
      outcomes for patients with LBP who are opioid users and facilitate efforts to reduce reliance
      on opioid pain management among those with LBP. Accomplishing this goal will facilitate
      future research evaluating the efficacy of non-pharmacologic alternative pain management
      strategies for individuals with LBP.

      Specific Aims to be addressed through this supplement are:

        1. Compare baseline psychological, mechanistic and LBP-related characteristics between
           sub-groups of participants with LBP based on opioid use.

        2. Examine the association of opioid use with changes in mechanistic and patient-centered
           outcomes between a baseline assessment and subsequent assessment after 1-week and
           completion of a 2-session SMT intervention protocol.

        3. Explore the moderating effects of opioid use on mechanistic and patient-centered
           outcomes obtained 4 weeks following SMT intervention with varied co-intervention
           components.

      Examining these aims as a supplement to the parent project will allow evaluation of whether
      or not opioid use impacts short-term mechanistic and patient-centered outcomes of SMT (Aim
      2), and will explore if the longer-term effects of the three co-interventions differ between
      opioid users and non-users. (Aim 3). This research will also compare baseline characteristics
      between participants who are or are not opioid users (Aim 1).
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Factorial design examining the outcomes of SMT with varying combinations of co-interventions.
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: Design precludes blinding of patients or care providers. Research personnel conducting outcomes assessments and the principal investigator are blind to participants' group assignment throughout the study.
measure: Oswestry
time frame: 1 week
description: The Oswestry Index measures back pain-related disability. The scale contains 10 items with a final score ranging from 0-100. Higher numbers indicate more disability.
measure: Pain intensity: 0-10 numeric pain rating
time frame: 1 week
description: A 0-10 numeric pain rating is used to assess pain intensity. Higher numbers indicate greater pain intensity.
measure: Multifidus Activation
time frame: Baseline, 1-week, 4-weeks, 3 months
description: Multifidus activation wis measured with brightness-mode ultrasound images using a 60mm, 2-5 MHz curvilinear array. The subject is prone. The ultrasound transducer is placed just lateral to midline and angled medially until a parasagittal view of the multifidus is obtained. Images are acquired at each level with the multifidus at rest and during submaximal contraction elicited by the subject lifting the contralateral arm about 2 inches while holding a weight proportional to body weight. Three images in each state are acquired and averaged. Offline multifidus thickness measures are obtained from the distance between the posterior-most aspect of the facet joint inferiorly and the plane between the multifidus and thoracolumbar fascia superior. Muscle activation is calculated as the change in thickness at rest and submaximal contraction and expressed in mm.
measure: Spinal Stiffness
time frame: Baseline, 1-week, 4-weeks, 3 months
description: Spinal stiffness is assessed with a mechanically-assisted indentation device over the spinous processes. Indentation involves advancement of the probe from a 5 N pre-load to 60 N final load maintained for 1 second, then the probe raises automatically. Three indentation trials are performed with mean values used for analysis. Indentation data (force and displacement) are used to calculate stiffness variables. Global stiffness (N) is calculated as the slope of the force displacement curve between 5 - 60 N, representing stiffness of underlying tissues during indentation.
arm group label: SMT Only
arm group type: Experimental
description: All patients receive 2 SMT sessions in the first week.
arm group label: SMT extended
arm group type: Experimental
description: All patients receive 2 SMT sessions in the first week. This arm also involves 6 additional SMT sessions. Each SMT session is conducted as described previously.
arm group label: SMT with Activation Exercises
arm group type: Experimental
description: All patients receive 2 SMT sessions in the first week.
This arm receives 6 additional sessions of activation exercises.
arm group label: SMT with Mobilizing Exercises
arm group type: Experimental
description: All patients receive 2 SMT sessions in the first week.
This arm involves 6 additional sessions of mobilizing exercise.
arm group label: SMT with Mobilizing and Activation Exercises
arm group type: Experimental
description: All patients receive 2 SMT sessions in the first week.
This arm involves 6 additions sessions including both activation and mobilizing exercises.
arm group label: SMT extended with Mobilizing Exercises
arm group type: Experimental
description: All patients receive 2 SMT sessions in the first week.
This arm includes 6 additional sessions including both SMT and mobilizing exercises.
arm group label: SMT extended with Activation Exercises
arm group type: Experimental
description: All patients receive 2 SMT sessions in the first week.
This arm includes 6 additional sessions including both SMT and activation exercises.
arm group label: SMT extended with Mobilizing and Activation Exercises
arm group type: Experimental
description: All patients receive 2 SMT sessions in the first week.
This arm includes 6 additional sessions including SMT, activation and mobilizing exercises.
intervention type: Behavioral
intervention name: SMT
description: The subject is supine. The clinician stands opposite the side to be manipulated and side-bends the subject away from the side to manipulate. The side to be manipulated is the more painful. If the subject cannot identify a more painful side the clinician selects a side. The clinician rotates the subject, and delivers a high-velocity, low-amplitude (HVLA) thrust to the pelvis in a posterior/inferior direction. The clinician notes if a cavitation (ie, a "pop") occurred. If it does, SMT treatment is complete. If no cavitation occurs, the subject is repositioned and SMT is performed again. If no cavitation occurs on the second attempt, the clinician manipulates the opposite side. A maximum of 2 attempts per side is permitted. If no cavitation is noted by that time, SMT treatment is complete. Substitution with a side-posture HVLA technique is allowed if the preferred technique is not possible due to subject preference or comfort.
arm group label: SMT Only
arm group label: SMT extended
arm group label: SMT extended with Activation Exercises
arm group label: SMT extended with Mobilizing Exercises
arm group label: SMT extended with Mobilizing and Activation Exercises
arm group label: SMT with Activation Exercises
arm group label: SMT with Mobilizing Exercises
arm group label: SMT with Mobilizing and Activation Exercises
other name: spinal manipulative therapy
intervention type: Behavioral
intervention name: Activation Exercises
description: Activation exercises are designed to facilitate use of the lumbar multifidus muscle. Exercises will begin with isometric multifidus contractions in different positions with clinician feedback and exercises to isometrically co-contract the multifidus and deep abdominal muscles. Subjects will also perform lumbar extensor strengthening exercises shown to produce 20%-50% of multifidus maximum voluntary contraction. Subjects will continue to perform isometric exercises throughout treatment. Subjects will perform their prescribed exercises at treatment sessions and will be instructed to perform the exercises daily on other days.
arm group label: SMT extended with Activation Exercises
arm group label: SMT extended with Mobilizing and Activation Exercises
arm group label: SMT with Activation Exercises
arm group label: SMT with Mobilizing and Activation Exercises
intervention type: Behavioral
intervention name: Mobilizing Exercises
description: Mobilizing exercises include a program of repeated movements progressing into end-ranges of spinal flexion and/or extension shown in past studies to improve ROM and reduce spinal stiffness. Patients will be instructed in mid-range exercises and will be further assessed for a directional preference. A directional preference is present if movement in a particular direction decreases LBP intensity or causes symptoms to centralize towards the midline. If a subject has a directional preference he or she will be prescribed exercises specifically in that direction along with mid-range exercise. Otherwise the subject will be assigned exercises moving into either flexion or extension based on the clinician's discretion. Subjects will perform their prescribed exercises at treatment sessions and will be instructed to perform the exercises daily on other days.
arm group label: SMT extended with Mobilizing Exercises
arm group label: SMT extended with Mobilizing and Activation Exercises
arm group label: SMT with Mobilizing Exercises
arm group label: SMT with Mobilizing and Activation Exercises
intervention type: Behavioral
intervention name: Extended SMT
description: Additional 6 SMT sessions provided
arm group label: SMT extended
arm group label: SMT extended with Activation Exercises
arm group label: SMT extended with Mobilizing Exercises
arm group label: SMT extended with Mobilizing and Activation Exercises
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Julie Fritz
investigator title: Professor
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No