<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/NCT02245425</url>
  </required_header>
  <id_info>
    <org_study_id>2014096</org_study_id>
    <nct_id>NCT02245425</nct_id>
  </id_info>
  <brief_title>Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain</brief_title>
  <official_title>A Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>A.T. Still University of Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>A.T. Still University of Health Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to compare the short-term effects of two different thoracic spine&#xD;
      thrust manipulation techniques on neck range-of-motion, pain, and self-reported disability in&#xD;
      people with neck pain.&#xD;
&#xD;
      The null hypothesis is that there will be no differences between the two manipulation&#xD;
      techniques for short-term effects on neck range-of-motion, pain, and self-reported disability&#xD;
      in people with neck pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be involved in the study over a 4 week period. Each participant will be asked&#xD;
      to attend 4 sessions, with one week in between each session as follows: Week 0 = baseline&#xD;
      assessment and treatment 1; Week 1= treatment 2; Week 2 = treatment 3; and week 4 = follow-up&#xD;
      assessment.&#xD;
&#xD;
      Patients who meet the inclusion/exclusion criteria will be randomized to either a supine or&#xD;
      prone thoracic spine thrust manipulation intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">July 8, 2015</completion_date>
  <primary_completion_date type="Actual">April 30, 2015</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Numeric Pain Rating Scale (NPRS)</measure>
    <time_frame>Baseline (Week 0)</time_frame>
    <description>Patient-rated assessment of pain on scale of 0-10</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NPRS</measure>
    <time_frame>Change from Week 0 to Week 1</time_frame>
    <description>Patient-rating of pain on a scale of 0-10</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NPRS</measure>
    <time_frame>Change from Baseline (Week 0) and Follow-up (Week 3) and From Week 1 and Week 3</time_frame>
    <description>Patient-rating of pain on a scale of 0-10</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck Disability Index (NDI)</measure>
    <time_frame>Baseline (Week 0)</time_frame>
    <description>10 Question patient-rated outcome measures specific to neck disability</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NDI</measure>
    <time_frame>Change from Baseline (Week 0) to Week 1</time_frame>
    <description>10 Question patient-rated outcome measures specific to neck disability</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NDI</measure>
    <time_frame>Change from Baseline (Week 0) to Follow-up (Week 3) and from Week 1 to Week 3</time_frame>
    <description>10 Question patient-rated outcome measures specific to neck disability</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shortened Version of Disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH)</measure>
    <time_frame>Baseline (Week 0)</time_frame>
    <description>11 item patient-rated outcome measure related to disability in the upper extremity with optional work and sport modules.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>QuickDASH</measure>
    <time_frame>Change from Week 0 to Week 1</time_frame>
    <description>11 item patient-rated outcome measure related to disability in the upper extremity with optional work and sport modules.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>QuickDASH</measure>
    <time_frame>Change from Baseline (Week 0) to Follow-up (Week 3) and from Week 1 to Week 3</time_frame>
    <description>11 item patient-rated outcome measure related to disability in the upper extremity with optional work and sport modules.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck Range of Motion (ROM)</measure>
    <time_frame>Baseline (Week 0)</time_frame>
    <description>Cervical rotation and lateral flexion measured with goniometer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck ROM</measure>
    <time_frame>Change from Baseline (Week 0) to Week 1</time_frame>
    <description>Cervical rotation and lateral flexion measured with goniometer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck ROM</measure>
    <time_frame>Change from Baseline (Week 0) to Follow-up (Week 3) and between Week 1 and Week 3</time_frame>
    <description>Cervical rotation and lateral flexion measured with goniometer.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Neck Pain</condition>
  <arm_group>
    <arm_group_label>Supine Thoracic Spine Manipulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Supine (lying face-up on the treatment table) thoracic spine thrust manipulation will be given 2 times at 3 treatment sessions (Weeks 0, 1, and 2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prone Thoracic Spine Manipulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Prone (lying face down on the treatment table) thoracic spine thrust manipulation will be given 2 times at 3 treatment sessions (Weeks 0, 1, and 2).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Supine Thoracic Spine Manipulation</intervention_name>
    <description>Position patient so that small amplitude quick stretch can be applied to the least mobile area of the thoracic spine that is identified during the spinal segmental mobility testing. The thoracic spine thrust manipulation will be applied at an appropriate range of motion as identified by the clinician.</description>
    <arm_group_label>Supine Thoracic Spine Manipulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Prone Thoracic Spine Manipulation</intervention_name>
    <description>Position patient so that small amplitude quick stretch can be applied to the least mobile area of the thoracic spine that is identified during the spinal segmental mobility testing. The thoracic spine thrust manipulation will be applied at an appropriate range of motion as identified by the clinician.</description>
    <arm_group_label>Prone Thoracic Spine Manipulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between 22 and 50 years of age&#xD;
&#xD;
          -  Primary complaint of neck pain with or without symptoms that spread down into one arm&#xD;
&#xD;
          -  Overall rating of neck pain intensity is at least 3/10; the overall rating is the&#xD;
             overall average of the participant's rating of current, least, and worst pain&#xD;
             experienced over the previous 24 hours on separate numeric pain rating scales where 0&#xD;
             corresponds to &quot;no pain&quot; and 10 corresponds to &quot;worst pain possible&quot;.&#xD;
&#xD;
          -  Neck Disability Index (NDI) score &gt; 10 points (measure of self-reported disability&#xD;
             with a 0 to 50 point scale where higher scores indicate higher levels of disability).&#xD;
&#xD;
          -  Proficient in speaking and reading English to complete outcome questionnaires&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neck pain related to a motor vehicle accident or other trauma within the previous 6&#xD;
             weeks&#xD;
&#xD;
          -  Neck pain that spreads down into both arms&#xD;
&#xD;
          -  Low back pain or thoracic origin of pain&#xD;
&#xD;
          -  Nerve root involvement; defined as the presence of two or more neurological findings&#xD;
             (e.g. decreased strength, diminished deep tendon reflex, or decreased sensation) at&#xD;
             the same nerve root level&#xD;
&#xD;
          -  Diagnosis of cervical spine stenosis (narrowing of the central canal that contains the&#xD;
             spinal cord)&#xD;
&#xD;
          -  History of spinal tumors, spinal infection, cervical spine fracture, or previous neck&#xD;
             surgery&#xD;
&#xD;
          -  Pending legal action related to current episode of neck pain&#xD;
&#xD;
          -  Contraindications to thoracic spine thrust manipulation&#xD;
&#xD;
               1. serious pathologies or conditions (tumor, fracture, metabolic diseases,&#xD;
                  rheumatoid arthritis, osteoporosis, history of prolonged steroid use)&#xD;
&#xD;
               2. hyperreflexia&#xD;
&#xD;
               3. unsteadiness during gait&#xD;
&#xD;
               4. Nystagmus&#xD;
&#xD;
               5. Loss of visual acuity&#xD;
&#xD;
               6. Impaired sensation of the face&#xD;
&#xD;
               7. Altered taste&#xD;
&#xD;
               8. The presence of pathological reflexes&#xD;
&#xD;
               9. pregnancy or considering pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Heick, PT, DPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>A.T. Still University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>A.T. Still University</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>November 7, 2018</last_update_submitted>
  <last_update_submitted_qc>November 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neck pain</keyword>
  <keyword>Thoracic spine manipulation</keyword>
  <keyword>Range of Motion</keyword>
  <keyword>Disability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neck 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/NCT02245425
org study id: 2014096
nct id: NCT02245425
lead sponsor: 
has dmc: No
This study is designed to compare the short-term effects of two different thoracic spine
      thrust manipulation techniques on neck range-of-motion, pain, and self-reported disability in
      people with neck pain.

      The null hypothesis is that there will be no differences between the two manipulation
      techniques for short-term effects on neck range-of-motion, pain, and self-reported disability
      in people with neck pain.
Patients will be involved in the study over a 4 week period. Each participant will be asked
      to attend 4 sessions, with one week in between each session as follows: Week 0 = baseline
      assessment and treatment 1; Week 1= treatment 2; Week 2 = treatment 3; and week 4 = follow-up
      assessment.

      Patients who meet the inclusion/exclusion criteria will be randomized to either a supine or
      prone thoracic spine thrust manipulation intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Numeric Pain Rating Scale (NPRS)
time frame: Baseline (Week 0)
description: Patient-rated assessment of pain on scale of 0-10
measure: NPRS
time frame: Change from Week 0 to Week 1
description: Patient-rating of pain on a scale of 0-10
measure: NPRS
time frame: Change from Baseline (Week 0) and Follow-up (Week 3) and From Week 1 and Week 3
description: Patient-rating of pain on a scale of 0-10
measure: Neck Disability Index (NDI)
time frame: Baseline (Week 0)
description: 10 Question patient-rated outcome measures specific to neck disability
measure: NDI
time frame: Change from Baseline (Week 0) to Week 1
description: 10 Question patient-rated outcome measures specific to neck disability
measure: NDI
time frame: Change from Baseline (Week 0) to Follow-up (Week 3) and from Week 1 to Week 3
description: 10 Question patient-rated outcome measures specific to neck disability
measure: Shortened Version of Disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH)
time frame: Baseline (Week 0)
description: 11 item patient-rated outcome measure related to disability in the upper extremity with optional work and sport modules.
measure: QuickDASH
time frame: Change from Week 0 to Week 1
description: 11 item patient-rated outcome measure related to disability in the upper extremity with optional work and sport modules.
measure: QuickDASH
time frame: Change from Baseline (Week 0) to Follow-up (Week 3) and from Week 1 to Week 3
description: 11 item patient-rated outcome measure related to disability in the upper extremity with optional work and sport modules.
measure: Neck Range of Motion (ROM)
time frame: Baseline (Week 0)
description: Cervical rotation and lateral flexion measured with goniometer.
measure: Neck ROM
time frame: Change from Baseline (Week 0) to Week 1
description: Cervical rotation and lateral flexion measured with goniometer.
measure: Neck ROM
time frame: Change from Baseline (Week 0) to Follow-up (Week 3) and between Week 1 and Week 3
description: Cervical rotation and lateral flexion measured with goniometer.
arm group label: Supine Thoracic Spine Manipulation
arm group type: Active Comparator
description: Supine (lying face-up on the treatment table) thoracic spine thrust manipulation will be given 2 times at 3 treatment sessions (Weeks 0, 1, and 2)
arm group label: Prone Thoracic Spine Manipulation
arm group type: Active Comparator
description: Prone (lying face down on the treatment table) thoracic spine thrust manipulation will be given 2 times at 3 treatment sessions (Weeks 0, 1, and 2).
intervention type: Other
intervention name: Supine Thoracic Spine Manipulation
description: Position patient so that small amplitude quick stretch can be applied to the least mobile area of the thoracic spine that is identified during the spinal segmental mobility testing. The thoracic spine thrust manipulation will be applied at an appropriate range of motion as identified by the clinician.
arm group label: Supine Thoracic Spine Manipulation
intervention type: Other
intervention name: Prone Thoracic Spine Manipulation
description: Position patient so that small amplitude quick stretch can be applied to the least mobile area of the thoracic spine that is identified during the spinal segmental mobility testing. The thoracic spine thrust manipulation will be applied at an appropriate range of motion as identified by the clinician.
arm group label: Prone Thoracic Spine Manipulation
criteria: 
gender: All
minimum age: 22 Years
maximum age: 50 Years
healthy volunteers: No
last name: John Heick, PT, DPT
role: Principal Investigator
affiliation: A.T. Still University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neck Pain
sharing ipd: No