<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/NCT02261233</url>
  </required_header>
  <id_info>
    <org_study_id>NCCAM U19 AT006057 Project 1</org_study_id>
    <secondary_id>5U19AT006057-02</secondary_id>
    <nct_id>NCT02261233</nct_id>
  </id_info>
  <brief_title>Osteopathic Manipulative Treatment and Postural Control: Systems Engineering Approach</brief_title>
  <official_title>Osteopathic Manipulative Treatment and Postural Control: Systems Engineering Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Michigan State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Michigan State University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall goal of this project is to develop sensitive and objective clinical research&#xD;
      tools for the assessment of postural control of the trunk. In order to accomplish this goal,&#xD;
      we aim to quantify balance performance in an unstable seated task. Specifically, the&#xD;
      investigators will quantify balance performance in low back pain participants before and&#xD;
      after osteopathic manipulative treatment. The investigators hypothesize that there will be a&#xD;
      significant improvement in balance performance after a single session of osteopathic&#xD;
      manipulative treatment as well as after 4 sessions of osteopathic manipulative treatment and&#xD;
      this improvement will be greater than any learning effect.&#xD;
&#xD;
      A secondary objective of this study is to quantify differences in patient-oriented outcome&#xD;
      measures (e.g., self-reported pain, disability) in low back pain participants before and&#xD;
      after osteopathic manipulative treatment. The investigators hypothesize that there will be a&#xD;
      significant improvement in these self-reported outcomes following osteopathic manipulative&#xD;
      treatment. The association between improvement in postural control parameters and&#xD;
      patient-oriented measures will also be explored.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Funding for this project ended as of August 31, 2018&#xD;
  </why_stopped>
  <start_date type="Actual">April 1, 2014</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in postural control</measure>
    <time_frame>Change from baseline to shortly after first treatment (1-2 days), from baseline to an expected average of week 4, and from week 4 to an expected average of week 8.</time_frame>
    <description>Postural control will be assessed in an unstable seated task, in which subjects will be asked to balance on a specially designed seat. The average deviations from the neutral seat position will be measured in degrees.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in trunk muscle reflex latency</measure>
    <time_frame>Change from baseline to shortly after first treatment (1-2 days), from baseline to an expected average of week 4, and from week 4 to an expected average of week 8.</time_frame>
    <description>Subjects will be pulling with their trunk on a cable held by an electromagnet. The electromagnet will be suddenly released. Trunk muscle response to sudden load release will be measured on electromyographical recordings in milliseconds.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Reported Outcomes Measurement Information System (PROMIS)</measure>
    <time_frame>The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).</time_frame>
    <description>Assesses weekly changes in physical function, anxiety, depression, fatigue, sleep, satisfaction with social role, and pain with PROMIS-29 questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in concomitant medication</measure>
    <time_frame>The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).tcome measure until the end, an expected average of 8 weeks.</time_frame>
    <description>Assesses weekly changes in the use of medication for treating low back pain, including the type of medication and the quantity of medication (i.e., number of pills) with a questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Oswestry Disability Index</measure>
    <time_frame>The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).</time_frame>
    <description>Assesses weekly changes in functional activities related to low back disability with the Oswestry Disability Index questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fear avoidance behavior</measure>
    <time_frame>The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).</time_frame>
    <description>Assesses weekly changes in fear avoidance behavior using the Fear Avoidance Beliefs questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Immediate treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm receives osteopathic manipulative treatment shortly after enrollment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm receives osteopathic manipulative treatment approximately 4 weeks after enrollment</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Osteopathic manipulative treatment</intervention_name>
    <description>Up to 4 sessions of osteopathic manipulative treatment (once per week)</description>
    <arm_group_label>Delayed treatment</arm_group_label>
    <arm_group_label>Immediate treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All participants must meet all of the inclusion criteria to participate in the study. Below&#xD;
        is a list of inclusion criteria for LBP participants:&#xD;
&#xD;
          -  Age 21-65 years&#xD;
&#xD;
          -  Independently ambulatory&#xD;
&#xD;
          -  Able to speak and read English&#xD;
&#xD;
          -  Able to understand study procedures and to comply with them for the entire length of&#xD;
             the study.&#xD;
&#xD;
          -  Willing to be randomized to either immediate or delayed treatment group.&#xD;
&#xD;
          -  Musculoskeletal pain - primarily in the low back region&#xD;
&#xD;
          -  Pain rating equal to or greater than 3 out of10 as indicated on the Numeric Rating&#xD;
             Scale for Pain&#xD;
&#xD;
          -  Disability equal to or greater than 26% as indicated on the Oswestry Disability&#xD;
             Questionnaire&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        All candidates meeting any of the exclusion criteria at baseline will be excluded from&#xD;
        study participation. Exclusion criteria will be self-reported. However, during each&#xD;
        treatment session, the physicians will be watching for clinical signs and symptoms not&#xD;
        consistent with physical findings that are suggestive of the presence of any of the&#xD;
        exclusion criteria. In such a case, further treatment will be discontinued and the subject&#xD;
        will be excluded.&#xD;
&#xD;
        Below is a list of exclusion criteria:&#xD;
&#xD;
          -  Inability or unwillingness of individual to give written informed consent.&#xD;
&#xD;
          -  Physical therapy or any other form of manual medicine (e.g., Osteopathic Manipulative&#xD;
             Medicine, Chiropractic Manipulation, etc.), acupuncture or spinal injections within&#xD;
             one month prior to study enrollment&#xD;
&#xD;
          -  Workers' compensation benefits in the past 3 months or ongoing medical legal issues&#xD;
&#xD;
          -  Possibly pregnant&#xD;
&#xD;
          -  Obesity (BMI&gt;32)&#xD;
&#xD;
          -  Currently using electrical implants (e.g., cardiac pacemakers, drug delivery pumps,&#xD;
             etc.)&#xD;
&#xD;
        History of:&#xD;
&#xD;
          -  Spinal surgery&#xD;
&#xD;
          -  Spinal fracture&#xD;
&#xD;
          -  Spinal infection (e.g., osteomyelitis)&#xD;
&#xD;
          -  Cancer&#xD;
&#xD;
        Unresolved symptoms from:&#xD;
&#xD;
          -  Head trauma&#xD;
&#xD;
          -  Inner ear infection with associated balance and coordination problems&#xD;
&#xD;
          -  Orthostatic hypotension&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Vestibular disorder (e.g. vertigo)&#xD;
&#xD;
        Current diagnosis of:&#xD;
&#xD;
          -  Significant spinal deformity (e.g., scoliosis &gt; 20 degrees, torticollis)&#xD;
&#xD;
          -  Ankylosing spondylitis&#xD;
&#xD;
          -  Spondylolisthesis grades III or IV&#xD;
&#xD;
          -  Cauda equine syndrome&#xD;
&#xD;
          -  Rheumatoid arthritis&#xD;
&#xD;
          -  Osteoporosis&#xD;
&#xD;
          -  Angina or congestive heart failure symptoms&#xD;
&#xD;
          -  Active bleeding or infection in the back&#xD;
&#xD;
          -  Blindness&#xD;
&#xD;
          -  Seizures&#xD;
&#xD;
          -  Neurologic disease (e.g., Parkinson's disease, multiple sclerosis, cerebral palsy,&#xD;
             Alzheimer's disease, amyotrophic lateral sclerosis, stroke or transient ischemic&#xD;
             attack in the past year, cervical dystonia)&#xD;
&#xD;
        Conditions recognized by a physician any time during the study:&#xD;
&#xD;
          -  Significant or worsening signs of neurologic deficit&#xD;
&#xD;
          -  Symptoms are not consistent with mechanical findings&#xD;
&#xD;
          -  Other conditions impeding protocol implementation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacek Cholewicki, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Michigan State University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Norman P Reeves, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Michigan State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MSU Osteopathic Manipulative Medicine</name>
      <address>
        <city>East Lansing</city>
        <state>Michigan</state>
        <zip>48823</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MSU Musculoskeletal Rehabilitation</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <zip>48891</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan State University Center for Orthopedic Research</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <zip>48910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://orthopedicresearch.msu.edu/</url>
    <description>Website for Michigan State University Center for Orthopedic Research</description>
  </link>
  <link>
    <url>http://nccam.nih.gov/</url>
    <description>Website for the National Center for Complementary and Alternative Medicine (Sponsor)</description>
  </link>
  <reference>
    <citation>Radebold A, Cholewicki J, Polzhofer GK, Greene HS. Impaired postural control of the lumbar spine is associated with delayed muscle response times in patients with chronic idiopathic low back pain. Spine (Phila Pa 1976). 2001 Apr 1;26(7):724-30. doi: 10.1097/00007632-200104010-00004.</citation>
    <PMID>11295888</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>January 2, 2019</last_update_submitted>
  <last_update_submitted_qc>January 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Michigan State University</investigator_affiliation>
    <investigator_full_name>Jacek Cholewicki</investigator_full_name>
    <investigator_title>Walter F. Patenge Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02261233
org study id: NCCAM U19 AT006057 Project 1
secondary id: 5U19AT006057-02
nct id: NCT02261233
lead sponsor: 
collaborator: 
has dmc: Yes
The overall goal of this project is to develop sensitive and objective clinical research
      tools for the assessment of postural control of the trunk. In order to accomplish this goal,
      we aim to quantify balance performance in an unstable seated task. Specifically, the
      investigators will quantify balance performance in low back pain participants before and
      after osteopathic manipulative treatment. The investigators hypothesize that there will be a
      significant improvement in balance performance after a single session of osteopathic
      manipulative treatment as well as after 4 sessions of osteopathic manipulative treatment and
      this improvement will be greater than any learning effect.

      A secondary objective of this study is to quantify differences in patient-oriented outcome
      measures (e.g., self-reported pain, disability) in low back pain participants before and
      after osteopathic manipulative treatment. The investigators hypothesize that there will be a
      significant improvement in these self-reported outcomes following osteopathic manipulative
      treatment. The association between improvement in postural control parameters and
      patient-oriented measures will also be explored.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Change in postural control
time frame: Change from baseline to shortly after first treatment (1-2 days), from baseline to an expected average of week 4, and from week 4 to an expected average of week 8.
description: Postural control will be assessed in an unstable seated task, in which subjects will be asked to balance on a specially designed seat. The average deviations from the neutral seat position will be measured in degrees.
measure: Change in trunk muscle reflex latency
time frame: Change from baseline to shortly after first treatment (1-2 days), from baseline to an expected average of week 4, and from week 4 to an expected average of week 8.
description: Subjects will be pulling with their trunk on a cable held by an electromagnet. The electromagnet will be suddenly released. Trunk muscle response to sudden load release will be measured on electromyographical recordings in milliseconds.
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS)
time frame: The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).
description: Assesses weekly changes in physical function, anxiety, depression, fatigue, sleep, satisfaction with social role, and pain with PROMIS-29 questionnaire.
measure: Change in concomitant medication
time frame: The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).tcome measure until the end, an expected average of 8 weeks.
description: Assesses weekly changes in the use of medication for treating low back pain, including the type of medication and the quantity of medication (i.e., number of pills) with a questionnaire.
measure: Change in Oswestry Disability Index
time frame: The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).
description: Assesses weekly changes in functional activities related to low back disability with the Oswestry Disability Index questionnaire.
measure: Change in fear avoidance behavior
time frame: The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).
description: Assesses weekly changes in fear avoidance behavior using the Fear Avoidance Beliefs questionnaire.
arm group label: Immediate treatment
arm group type: Experimental
description: This arm receives osteopathic manipulative treatment shortly after enrollment
arm group label: Delayed treatment
arm group type: Experimental
description: This arm receives osteopathic manipulative treatment approximately 4 weeks after enrollment
intervention type: Procedure
intervention name: Osteopathic manipulative treatment
description: Up to 4 sessions of osteopathic manipulative treatment (once per week)
arm group label: Delayed treatment
arm group label: Immediate treatment
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jacek Cholewicki, PhD
role: Principal Investigator
affiliation: Michigan State University
last name: Norman P Reeves, PhD
role: Principal Investigator
affiliation: Michigan State University
facility: 
facility: 
facility: 
country: United States
url: http://orthopedicresearch.msu.edu/
description: Website for Michigan State University Center for Orthopedic Research
url: http://nccam.nih.gov/
description: Website for the National Center for Complementary and Alternative Medicine (Sponsor)
citation: Radebold A, Cholewicki J, Polzhofer GK, Greene HS. Impaired postural control of the lumbar spine is associated with delayed muscle response times in patients with chronic idiopathic low back pain. Spine (Phila Pa 1976). 2001 Apr 1;26(7):724-30. doi: 10.1097/00007632-200104010-00004.
PMID: 11295888
responsible party type: Principal Investigator
investigator affiliation: Michigan State University
investigator full name: Jacek Cholewicki
investigator title: Walter F. Patenge Professor
mesh term: Low Back Pain