<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/NCT02261259</url>
  </required_header>
  <id_info>
    <org_study_id>NCCAM U19 AT006057 Project 3</org_study_id>
    <secondary_id>5U19AT006057-02</secondary_id>
    <nct_id>NCT02261259</nct_id>
  </id_info>
  <brief_title>Effects of Osteopathic Manipulative Treatment on Neuromuscular Control of the Head-neck System</brief_title>
  <official_title>Effects of Osteopathic Manipulative Treatment on Neuromuscular Control of the Head-neck System</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 head-neck motor control. In order to accomplish this goal, the&#xD;
      investigators aim to quantify changes in head-neck motor control before and after osteopathic&#xD;
      manipulative treatment. The investigators hypothesize that head-neck motor control will&#xD;
      improve in neck pain participants after 4-weeks of treatment. Additionally, the investigators&#xD;
      will compare position and force head-neck motor control between healthy controls and neck&#xD;
      pain patients. The investigators hypothesize that baseline tests of position and force&#xD;
      head-neck motor control will be better in healthy individuals than neck pain patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2014</start_date>
  <completion_date type="Actual">November 13, 2017</completion_date>
  <primary_completion_date type="Actual">November 13, 2017</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 from baseline to week 4 and from week 4 to 8 in head position tracking accuracy</measure>
    <time_frame>Change from baseline to week 4 and from week 4 to 8</time_frame>
    <description>Participants will be seated in an upright position with their upper body secured to a backrest and will wear a head harness with an attached position sensor. The angular position of the head will be displayed on a monitor 1 meter in front of the participants and they will be asked to follow a moving target by moving their head. Accuracy will be determined by taking the difference between the target position signal and the actual head position (measured in degrees with string potentiometers).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline to week 4 and from week 4 to 8 in head force tracking accuracy</measure>
    <time_frame>Change from baseline to week 4 and from week 4 to 8</time_frame>
    <description>Participants will be seated in an upright position with their upper body secured to a backrest and will be asked to generate force with their head against a fixed pad. The pad will be attached to a load cell that monitors how much force is being generated by their head. The force level will be displayed on a monitor 1 meter in front of the participants and they will be asked to follow a moving target by generating force with their head. Accuracy will be determined by taking the difference between target force signal and the actual head force (measured in Newtons with the load cell).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline to week 4 and from week 4 to 8 in head position stabilization accuracy</measure>
    <time_frame>Change from baseline to week 4 and from week 4 to 8</time_frame>
    <description>Participants will be sitting upright in a seat mounted to a robotic platform (Mikrolar Hexapod Robot) with their upper body secured to a backrest and will wear a head harness with an attached position sensor. The robotic platform will provide an angular perturbation to the participant about the cervical spine in the sagittal plane while the participant is asked to maintain (stabilize) their head position in the upright posture. Accuracy will be determined by measuring the amount of head displacement (measured in degrees with string potentiometers) during the perturbation trial.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline to week 4 in neck force and muscle activation directionality</measure>
    <time_frame>Change from baseline to week 4</time_frame>
    <description>Participants will be seated in an upright position with their upper body secured to a backrest and will be asked to generate force with their head against a fixed pad. They will be asked to performed 6-seconds isometric exertions in different directions. Surface EMG will be recorded from the sternocliedomastoid, splenius capitis, and upper trapezius muscles. Muscle directionality will be determined by the EMG magnitude in each direction of exertion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from week 4 to 8 in neck force and muscle activation directionality</measure>
    <time_frame>Change from week 4 to 8</time_frame>
    <description>Participants will be seated in an upright position with their upper body secured to a backrest and will be asked to generate force with their head against a fixed pad. They will be asked to performed 6-seconds isometric exertions in different directions. Surface EMG will be recorded from the sternocliedomastoid, splenius capitis, and upper trapezius muscles. Muscle directionality will be determined by the EMG magnitude in each direction of exertion.</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).</time_frame>
    <description>Assesses weekly changes in the use of medication for treating neck 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 neck disability</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 neck disability with the Neck 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>3</number_of_arms>
  <enrollment type="Actual">154</enrollment>
  <condition>Neck 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>
  <arm_group>
    <arm_group_label>Healthy control (no neck pain)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In this arm, healthy controls are tested at baseline.</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 ALL 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;
        Below is an additional list of inclusion criteria for NECK PAIN participants:&#xD;
&#xD;
          -  Willing to be randomized to either immediate or delayed treatment group.&#xD;
&#xD;
          -  Musculoskeletal pain - primarily in the cervical region lasting longer than 3 months&#xD;
&#xD;
          -  Pain rating greater than or equal to 3 out of 10 as indicated on the Numeric Rating&#xD;
             Scale for Pain&#xD;
&#xD;
          -  Neck Disability greater than or equal to 30% as indicated on the Neck Disability Index&#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 for ALL participants:&#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;
          -  Extreme obesity (BMI&gt;36)&#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;
          -  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;
&#xD;
        Below is an additional exclusion criterion for healthy control participants:&#xD;
&#xD;
        • Based on the minimal clinically important difference of 2 points (Childs et al., 2005),&#xD;
        &quot;healthy controls&quot; with 2 points or greater pain on NRS will not be eligible to&#xD;
        participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</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 Manual 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>Reeves NP, Popovich JM Jr, Priess MC, Cholewicki J, Choi J, Radcliffe CJ. Reliability of assessing trunk motor control using position and force tracking and stabilization tasks. J Biomech. 2014 Jan 3;47(1):44-9. doi: 10.1016/j.jbiomech.2013.10.018. Epub 2013 Oct 22.</citation>
    <PMID>24262851</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>Neck 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/NCT02261259
org study id: NCCAM U19 AT006057 Project 3
secondary id: 5U19AT006057-02
nct id: NCT02261259
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 head-neck motor control. In order to accomplish this goal, the
      investigators aim to quantify changes in head-neck motor control before and after osteopathic
      manipulative treatment. The investigators hypothesize that head-neck motor control will
      improve in neck pain participants after 4-weeks of treatment. Additionally, the investigators
      will compare position and force head-neck motor control between healthy controls and neck
      pain patients. The investigators hypothesize that baseline tests of position and force
      head-neck motor control will be better in healthy individuals than neck pain patients.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline to week 4 and from week 4 to 8 in head position tracking accuracy
time frame: Change from baseline to week 4 and from week 4 to 8
description: Participants will be seated in an upright position with their upper body secured to a backrest and will wear a head harness with an attached position sensor. The angular position of the head will be displayed on a monitor 1 meter in front of the participants and they will be asked to follow a moving target by moving their head. Accuracy will be determined by taking the difference between the target position signal and the actual head position (measured in degrees with string potentiometers).
measure: Change from baseline to week 4 and from week 4 to 8 in head force tracking accuracy
time frame: Change from baseline to week 4 and from week 4 to 8
description: Participants will be seated in an upright position with their upper body secured to a backrest and will be asked to generate force with their head against a fixed pad. The pad will be attached to a load cell that monitors how much force is being generated by their head. The force level will be displayed on a monitor 1 meter in front of the participants and they will be asked to follow a moving target by generating force with their head. Accuracy will be determined by taking the difference between target force signal and the actual head force (measured in Newtons with the load cell).
measure: Change from baseline to week 4 and from week 4 to 8 in head position stabilization accuracy
time frame: Change from baseline to week 4 and from week 4 to 8
description: Participants will be sitting upright in a seat mounted to a robotic platform (Mikrolar Hexapod Robot) with their upper body secured to a backrest and will wear a head harness with an attached position sensor. The robotic platform will provide an angular perturbation to the participant about the cervical spine in the sagittal plane while the participant is asked to maintain (stabilize) their head position in the upright posture. Accuracy will be determined by measuring the amount of head displacement (measured in degrees with string potentiometers) during the perturbation trial.
measure: Change from baseline to week 4 in neck force and muscle activation directionality
time frame: Change from baseline to week 4
description: Participants will be seated in an upright position with their upper body secured to a backrest and will be asked to generate force with their head against a fixed pad. They will be asked to performed 6-seconds isometric exertions in different directions. Surface EMG will be recorded from the sternocliedomastoid, splenius capitis, and upper trapezius muscles. Muscle directionality will be determined by the EMG magnitude in each direction of exertion.
measure: Change from week 4 to 8 in neck force and muscle activation directionality
time frame: Change from week 4 to 8
description: Participants will be seated in an upright position with their upper body secured to a backrest and will be asked to generate force with their head against a fixed pad. They will be asked to performed 6-seconds isometric exertions in different directions. Surface EMG will be recorded from the sternocliedomastoid, splenius capitis, and upper trapezius muscles. Muscle directionality will be determined by the EMG magnitude in each direction of exertion.
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).
description: Assesses weekly changes in the use of medication for treating neck pain, including the type of medication and the quantity of medication (i.e., number of pills) with a questionnaire.
measure: Change in neck disability
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 neck disability with the Neck 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
arm group label: Healthy control (no neck pain)
arm group type: No Intervention
description: In this arm, healthy controls are tested at baseline.
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: Accepts Healthy Volunteers
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: Reeves NP, Popovich JM Jr, Priess MC, Cholewicki J, Choi J, Radcliffe CJ. Reliability of assessing trunk motor control using position and force tracking and stabilization tasks. J Biomech. 2014 Jan 3;47(1):44-9. doi: 10.1016/j.jbiomech.2013.10.018. Epub 2013 Oct 22.
PMID: 24262851
responsible party type: Principal Investigator
investigator affiliation: Michigan State University
investigator full name: Jacek Cholewicki
investigator title: Walter F. Patenge Professor
mesh term: Neck Pain