<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/NCT02972710</url>
  </required_header>
  <id_info>
    <org_study_id>962801-1</org_study_id>
    <nct_id>NCT02972710</nct_id>
  </id_info>
  <brief_title>A 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 Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northern Arizona University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northern Arizona University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the short-term effects of two different thoracic&#xD;
      spine thrust manipulation techniques on neck range-of-motion, pain, and self-reported&#xD;
      disability in individuals experiencing neck pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted at the Musculoskeletal clinical facility in the Dept. of Physical&#xD;
      Therapy and Athletic Training, Northern Arizona University, Flagstaff AZ. The investigators&#xD;
      aim to test a maximum of 76 participants in this study. A phone screening will determine&#xD;
      initial eligibility. If the participant meets the inclusion criteria and is not excluded&#xD;
      after the phone screen, an appointment will be scheduled. Final eligibility will be&#xD;
      determined in the initial session after the participant completes the outcome measures and is&#xD;
      evaluated by a licensed physical therapist.&#xD;
&#xD;
      Participants will be involved in the study over a 4 week period. Each participant will be&#xD;
      asked to attend 4 sessions, with one week in between each session as follows: Week 0 =&#xD;
      baseline assessment and treatment 1; Week 1= treatment 2; Week 2 = treatment 3; and week 4 =&#xD;
      follow-up assessment.&#xD;
&#xD;
      After completion of the baseline assessment, qualified participants will be randomly assigned&#xD;
      to either a supine or prone thoracic spine thrust manipulation intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">November 2018</completion_date>
  <primary_completion_date type="Anticipated">November 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Numerical Pain Rating Scale (NPRS)</measure>
    <time_frame>Change in NPRS scores at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)</time_frame>
    <description>Each participant's neck pain intensity will be assessed by use of the Numeric Pain Rating Scale (NPRS of 0-10)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck Range of Motion</measure>
    <time_frame>Change in Neck ROM at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)</time_frame>
    <description>Cervical range of motion measured with the Goniometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck Disability Index (NDI)</measure>
    <time_frame>Change in NDI at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)</time_frame>
    <description>The Neck Disability Index (NDI) is a self-reported measure of disability consisting of a 0-50 point scale where higher scores indicate higher levels of disability</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shortened version of the Disabilities of the Arm, Shoulder, and Hand questionnaire (Quick DASH)</measure>
    <time_frame>Change in QuickDASH scores at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)</time_frame>
    <description>The shortened version of the Disabilities of the Arm, Shoulder, and Hand (Quick DASH) questionnaire is a self-report measure of function that can assess how neck pain may be impacting daily activities that require use of the upper limb</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">76</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 thoracic spine thrust manipulation (lying face-up on the treatment table) will be given 2 times at 3 treatment sessions (Weeks 0, 1, and 2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Seated thoracic spine manipulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Seated 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 thrust manipulation</intervention_name>
    <description>The participant will be positioned 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>Seated thoracic spine thrust manipulation</intervention_name>
    <description>The participant will be positioned 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>Seated thoracic spine manipulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between 20 and 50 years of age (inclusive)&#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;
             average of the participant's rating of current, least, and worst pain experienced over&#xD;
             the previous 24 hours on separate numeric pain rating scales where 0 corresponds to&#xD;
             &quot;no pain&quot; and 10 corresponds to &quot;worst possible pain&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 spinal stenosis (narrowing of the central canal that contains&#xD;
             the 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>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Heick, PT, PhD, DPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northern Arizona University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northern Arizona University</name>
      <address>
        <city>Flagstaff</city>
        <state>Arizona</state>
        <zip>86011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>March 9, 2018</last_update_submitted>
  <last_update_submitted_qc>March 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northern Arizona University</investigator_affiliation>
    <investigator_full_name>Tarang Jain</investigator_full_name>
    <investigator_title>Assistant Professor - Physical Therapy and Athletic Training</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>
  <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/NCT02972710
org study id: 962801-1
nct id: NCT02972710
lead sponsor: 
has dmc: No
The purpose of this study is 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 individuals experiencing neck pain.
The study will be conducted at the Musculoskeletal clinical facility in the Dept. of Physical
      Therapy and Athletic Training, Northern Arizona University, Flagstaff AZ. The investigators
      aim to test a maximum of 76 participants in this study. A phone screening will determine
      initial eligibility. If the participant meets the inclusion criteria and is not excluded
      after the phone screen, an appointment will be scheduled. Final eligibility will be
      determined in the initial session after the participant completes the outcome measures and is
      evaluated by a licensed physical therapist.

      Participants 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.

      After completion of the baseline assessment, qualified participants will be randomly assigned
      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: Numerical Pain Rating Scale (NPRS)
time frame: Change in NPRS scores at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)
description: Each participant's neck pain intensity will be assessed by use of the Numeric Pain Rating Scale (NPRS of 0-10)
measure: Neck Range of Motion
time frame: Change in Neck ROM at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)
description: Cervical range of motion measured with the Goniometer
measure: Neck Disability Index (NDI)
time frame: Change in NDI at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)
description: The Neck Disability Index (NDI) is a self-reported measure of disability consisting of a 0-50 point scale where higher scores indicate higher levels of disability
measure: Shortened version of the Disabilities of the Arm, Shoulder, and Hand questionnaire (Quick DASH)
time frame: Change in QuickDASH scores at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)
description: The shortened version of the Disabilities of the Arm, Shoulder, and Hand (Quick DASH) questionnaire is a self-report measure of function that can assess how neck pain may be impacting daily activities that require use of the upper limb
arm group label: Supine thoracic spine manipulation
arm group type: Active Comparator
description: Supine thoracic spine thrust manipulation (lying face-up on the treatment table) will be given 2 times at 3 treatment sessions (Weeks 0, 1, and 2)
arm group label: Seated thoracic spine manipulation
arm group type: Active Comparator
description: Seated 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 thrust manipulation
description: The participant will be positioned 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: Seated thoracic spine thrust manipulation
description: The participant will be positioned 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: Seated thoracic spine manipulation
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: No
last name: John Heick, PT, PhD, DPT
role: Principal Investigator
affiliation: Northern Arizona University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northern Arizona University
investigator full name: Tarang Jain
investigator title: Assistant Professor - Physical Therapy and Athletic Training
mesh term: Neck Pain
sharing ipd: No