<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/NCT02198677</url>
  </required_header>
  <id_info>
    <org_study_id>AP vs LAT</org_study_id>
    <nct_id>NCT02198677</nct_id>
  </id_info>
  <brief_title>Cardiovascular Response to Two Manual Techniques for Neck Pain</brief_title>
  <official_title>Randomized Trial of Cardiovascular Response to Two Manual Techniques Non-thrust Joint Manipulation of the Cervical Spine in Patients With Non-traumatic Mechanical Neck Pain.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azusa Pacific University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azusa Pacific University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the investigators study is to investigate whether posteriorly directed (AP)&#xD;
      pressures and laterally directed (LAT) glides, cause blood pressure and heart rate elevation&#xD;
      or lowering in patients with neck pain. The answer will advance the investigators&#xD;
      understanding of why manual therapy works.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To be included in the study, these subjects with unilateral non-traumatic, non-chronic neck&#xD;
      pain (operationally defined as neck pain with mobility deficits lasting less than 3 months)&#xD;
      shall have numeric pain rating scale (NPRS) of between 0 and 5 out of 10 as the most painful&#xD;
      neck movement even with passive scapular elevation, neck disability index (NDI) of between 16&#xD;
      and 50 out of 100%, resting systolic and diastolic blood pressure between 90/60 and 138/88,&#xD;
      and resting heart rate between 60 and 90. Subjects are excluded if they are current smoker,&#xD;
      over 50 years of age, has a history of fainting spells or loss of consciousness, is on blood&#xD;
      thinners, is taking medications for or have a history of diabetes mellitus, neurologic or&#xD;
      cardiovascular disease, has a history of spinal surgeries, and has neck pain classified or&#xD;
      associated with headache, radiating pain, and movement coordination impairments. A&#xD;
      convenience sample of subjects will be randomly allocated to 1 of 2 groups. Both Group 1: AP&#xD;
      and Group 2: LAT will receive posterior pressures and lateral glides respectively to one&#xD;
      hypomobile segment. Baseline NPRS, and NDI will be collected at the initial visit. Systolic&#xD;
      blood pressure (SBP) and heart rate (HR) will be measured with a OMRON automatic monitor&#xD;
      recording time points: (1) 5 minutes, and (2) 7 minutes after lying supine; (3) during the&#xD;
      1st set, (4) 5th set of one of the glides, (5) 2 minutes after time point #4, and (6) 4&#xD;
      minutes after time point #4. After time point #6, a global rating of change (GROC) will&#xD;
      immediately be collected based on the most painful neck movement. A finger pulse oximeter&#xD;
      will be placed on the subjects' index finger to constantly monitor their pulse rate for&#xD;
      slowing heart rate or asystole. The primary author will perform one of the techniques on all&#xD;
      subjects. After one visit, a follow-up NPRS, and NDI will be collected again.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">July 2016</completion_date>
  <primary_completion_date type="Anticipated">July 2016</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in heart rate</measure>
    <time_frame>7 minutes before, 5 minutes before, During first set, During fifth set, 2 minutes after time point 4, 4 minutes after time point 4</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in blood pressure</measure>
    <time_frame>7 minutes before, 5 minutes before, During first set, During fifth set, 2 minutes after time point 4, 4 minutes after time point 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Numeric Pain Rating Scale</measure>
    <time_frame>Baseline and within 7 days after the intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Neck Disability Index</measure>
    <time_frame>Baseline and 7 days after the intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global rating of change</measure>
    <time_frame>Immediately after intervention</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">34</enrollment>
  <condition>Neck Pain</condition>
  <arm_group>
    <arm_group_label>AP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Anterior to posterior pressures 5x10 seconds per set with 10 seconds rest between each set</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lateral glides</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lateral glides 5x10 seconds per set with 10 seconds rest between each set</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Anterior to posterior pressures</intervention_name>
    <description>Anterior to posterior pressures</description>
    <arm_group_label>AP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lateral glide</intervention_name>
    <description>Lateral glide</description>
    <arm_group_label>Lateral glides</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unilateral, non-traumatic, non-chronic mechanical neck pain&#xD;
&#xD;
          -  Numeric pain rating scale between 0-5/10 as the most painful neck movement (with&#xD;
             passive scapular elevation)&#xD;
&#xD;
          -  Neck Disability Index between 16-50/100 percent&#xD;
&#xD;
          -  Resting blood pressure between 90/60 and 138/88 mmHg&#xD;
&#xD;
          -  Resting heart rate between 60 and 90 beats per minute&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current smoker&#xD;
&#xD;
          -  Under 18 years and over 50 years of age&#xD;
&#xD;
          -  History of fainting spells or loss of consciousness&#xD;
&#xD;
          -  Currently on blood thinners&#xD;
&#xD;
          -  Taking medications for or have a history of diabetes mellitus, neurologic or&#xD;
             cardiovascular disease&#xD;
&#xD;
          -  History of spinal surgery&#xD;
&#xD;
          -  Has neck pain classified or associated headache, arm pain, trauma/whiplash&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Wong, DPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azusa Pacific University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Emmanuel Yung, DPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sacred Heart University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michael Wong, DPT</last_name>
    <phone>909 379 5433</phone>
    <email>mswong@apu.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Physical Therapy Department</name>
      <address>
        <city>Azusa</city>
        <state>California</state>
        <zip>91784</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Wong, DPT</last_name>
    </contact>
    <investigator>
      <last_name>Michael Wong, DPT</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Childs JD, Cleland JA, Elliott JM, Teyhen DS, Wainner RS, Whitman JM, Sopky BJ, Godges JJ, Flynn TW; American Physical Therapy Association. Neck pain: Clinical practice guidelines linked to the International Classification of Functioning, Disability, and Health from the Orthopedic Section of the American Physical Therapy Association. J Orthop Sports Phys Ther. 2008 Sep;38(9):A1-A34. doi: 10.2519/jospt.2008.0303. Epub 2008 Sep 1. Erratum In: J Orthop Sports Phys Ther. 2009 Apr;39(4):297.</citation>
    <PMID>18758050</PMID>
  </reference>
  <reference>
    <citation>Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.</citation>
    <PMID>843571</PMID>
  </reference>
  <results_reference>
    <citation>Bruehl S, Dengler-Crish CM, Smith CA, Walker LS. Hypoalgesia related to elevated resting blood pressure is absent in adolescents and young adults with a history of functional abdominal pain. Pain. 2010 Apr;149(1):57-63. doi: 10.1016/j.pain.2010.01.009. Epub 2010 Feb 1.</citation>
    <PMID>20122805</PMID>
  </results_reference>
  <results_reference>
    <citation>Hurwitz EL, Morgenstern H, Vassilaki M, Chiang LM. Frequency and clinical predictors of adverse reactions to chiropractic care in the UCLA neck pain study. Spine (Phila Pa 1976). 2005 Jul 1;30(13):1477-84. doi: 10.1097/01.brs.0000167821.39373.c1.</citation>
    <PMID>15990659</PMID>
  </results_reference>
  <results_reference>
    <citation>Knutson GA. Significant changes in systolic blood pressure post vectored upper cervical adjustment vs resting control groups: a possible effect of the cervicosympathetic and/or pressor reflex. J Manipulative Physiol Ther. 2001 Feb;24(2):101-9. doi: 10.1067/mmt.2001.112564.</citation>
    <PMID>11208222</PMID>
  </results_reference>
  <results_reference>
    <citation>Krediet CT, Jardine DL, Wieling W. Dissection of carotid sinus hypersensitivity: the timing of vagal and vasodepressor effects and the effect of body position. Clin Sci (Lond). 2011 Nov;121(9):389-96. doi: 10.1042/CS20100607.</citation>
    <PMID>21595633</PMID>
  </results_reference>
  <results_reference>
    <citation>Lidegaard O, Lokkegaard E, Jensen A, Skovlund CW, Keiding N. Thrombotic stroke and myocardial infarction with hormonal contraception. N Engl J Med. 2012 Jun 14;366(24):2257-66. doi: 10.1056/NEJMoa1111840.</citation>
    <PMID>22693997</PMID>
  </results_reference>
  <results_reference>
    <citation>Lidegaard O, Nielsen LH, Skovlund CW, Skjeldestad FE, Lokkegaard E. Risk of venous thromboembolism from use of oral contraceptives containing different progestogens and oestrogen doses: Danish cohort study, 2001-9. BMJ. 2011 Oct 25;343:d6423. doi: 10.1136/bmj.d6423.</citation>
    <PMID>22027398</PMID>
  </results_reference>
  <results_reference>
    <citation>McGuiness J, Vicenzino B, Wright A. Influence of a cervical mobilization technique on respiratory and cardiovascular function. Man Ther. 1997 Nov;2(4):216-220. doi: 10.1054/math.1997.0302.</citation>
    <PMID>11440535</PMID>
  </results_reference>
  <results_reference>
    <citation>Puentedura EJ, Cleland JA, Landers MR, Mintken PE, Louw A, Fernandez-de-Las-Penas C. Development of a clinical prediction rule to identify patients with neck pain likely to benefit from thrust joint manipulation to the cervical spine. J Orthop Sports Phys Ther. 2012 Jul;42(7):577-92. doi: 10.2519/jospt.2012.4243. Epub 2012 May 14.</citation>
    <PMID>22585595</PMID>
  </results_reference>
  <results_reference>
    <citation>Van Dillen LR, McDonnell MK, Susco TM, Sahrmann SA. The immediate effect of passive scapular elevation on symptoms with active neck rotation in patients with neck pain. Clin J Pain. 2007 Oct;23(8):641-7. doi: 10.1097/AJP.0b013e318125c5b6.</citation>
    <PMID>17885341</PMID>
  </results_reference>
  <results_reference>
    <citation>Egwu MO. Relative therapeutic efficacy of some vertebral mobilization techniques in the management of unilateral cervical spondylosis: a comparative study. Journal of Physical Therapy and Science. 2008;20:103-8.</citation>
  </results_reference>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>January 5, 2016</last_update_submitted>
  <last_update_submitted_qc>January 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT02198677
org study id: AP vs LAT
nct id: NCT02198677
lead sponsor: 
has dmc: No
The aim of the investigators study is to investigate whether posteriorly directed (AP)
      pressures and laterally directed (LAT) glides, cause blood pressure and heart rate elevation
      or lowering in patients with neck pain. The answer will advance the investigators
      understanding of why manual therapy works.
To be included in the study, these subjects with unilateral non-traumatic, non-chronic neck
      pain (operationally defined as neck pain with mobility deficits lasting less than 3 months)
      shall have numeric pain rating scale (NPRS) of between 0 and 5 out of 10 as the most painful
      neck movement even with passive scapular elevation, neck disability index (NDI) of between 16
      and 50 out of 100%, resting systolic and diastolic blood pressure between 90/60 and 138/88,
      and resting heart rate between 60 and 90. Subjects are excluded if they are current smoker,
      over 50 years of age, has a history of fainting spells or loss of consciousness, is on blood
      thinners, is taking medications for or have a history of diabetes mellitus, neurologic or
      cardiovascular disease, has a history of spinal surgeries, and has neck pain classified or
      associated with headache, radiating pain, and movement coordination impairments. A
      convenience sample of subjects will be randomly allocated to 1 of 2 groups. Both Group 1: AP
      and Group 2: LAT will receive posterior pressures and lateral glides respectively to one
      hypomobile segment. Baseline NPRS, and NDI will be collected at the initial visit. Systolic
      blood pressure (SBP) and heart rate (HR) will be measured with a OMRON automatic monitor
      recording time points: (1) 5 minutes, and (2) 7 minutes after lying supine; (3) during the
      1st set, (4) 5th set of one of the glides, (5) 2 minutes after time point #4, and (6) 4
      minutes after time point #4. After time point #6, a global rating of change (GROC) will
      immediately be collected based on the most painful neck movement. A finger pulse oximeter
      will be placed on the subjects' index finger to constantly monitor their pulse rate for
      slowing heart rate or asystole. The primary author will perform one of the techniques on all
      subjects. After one visit, a follow-up NPRS, and NDI will be collected again.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in heart rate
time frame: 7 minutes before, 5 minutes before, During first set, During fifth set, 2 minutes after time point 4, 4 minutes after time point 4
measure: Change in blood pressure
time frame: 7 minutes before, 5 minutes before, During first set, During fifth set, 2 minutes after time point 4, 4 minutes after time point 4
measure: Change in Numeric Pain Rating Scale
time frame: Baseline and within 7 days after the intervention
measure: Change in Neck Disability Index
time frame: Baseline and 7 days after the intervention
measure: Global rating of change
time frame: Immediately after intervention
arm group label: AP
arm group type: Experimental
description: Anterior to posterior pressures 5x10 seconds per set with 10 seconds rest between each set
arm group label: Lateral glides
arm group type: Experimental
description: Lateral glides 5x10 seconds per set with 10 seconds rest between each set
intervention type: Procedure
intervention name: Anterior to posterior pressures
description: Anterior to posterior pressures
arm group label: AP
intervention type: Procedure
intervention name: Lateral glide
description: Lateral glide
arm group label: Lateral glides
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Michael Wong, DPT
role: Principal Investigator
affiliation: Azusa Pacific University
last name: Emmanuel Yung, DPT
role: Principal Investigator
affiliation: Sacred Heart University
last name: Michael Wong, DPT
phone: 909 379 5433
email: mswong@apu.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
citation: Childs JD, Cleland JA, Elliott JM, Teyhen DS, Wainner RS, Whitman JM, Sopky BJ, Godges JJ, Flynn TW; American Physical Therapy Association. Neck pain: Clinical practice guidelines linked to the International Classification of Functioning, Disability, and Health from the Orthopedic Section of the American Physical Therapy Association. J Orthop Sports Phys Ther. 2008 Sep;38(9):A1-A34. doi: 10.2519/jospt.2008.0303. Epub 2008 Sep 1. Erratum In: J Orthop Sports Phys Ther. 2009 Apr;39(4):297.
PMID: 18758050
citation: Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.
PMID: 843571
citation: Bruehl S, Dengler-Crish CM, Smith CA, Walker LS. Hypoalgesia related to elevated resting blood pressure is absent in adolescents and young adults with a history of functional abdominal pain. Pain. 2010 Apr;149(1):57-63. doi: 10.1016/j.pain.2010.01.009. Epub 2010 Feb 1.
PMID: 20122805
citation: Hurwitz EL, Morgenstern H, Vassilaki M, Chiang LM. Frequency and clinical predictors of adverse reactions to chiropractic care in the UCLA neck pain study. Spine (Phila Pa 1976). 2005 Jul 1;30(13):1477-84. doi: 10.1097/01.brs.0000167821.39373.c1.
PMID: 15990659
citation: Knutson GA. Significant changes in systolic blood pressure post vectored upper cervical adjustment vs resting control groups: a possible effect of the cervicosympathetic and/or pressor reflex. J Manipulative Physiol Ther. 2001 Feb;24(2):101-9. doi: 10.1067/mmt.2001.112564.
PMID: 11208222
citation: Krediet CT, Jardine DL, Wieling W. Dissection of carotid sinus hypersensitivity: the timing of vagal and vasodepressor effects and the effect of body position. Clin Sci (Lond). 2011 Nov;121(9):389-96. doi: 10.1042/CS20100607.
PMID: 21595633
citation: Lidegaard O, Lokkegaard E, Jensen A, Skovlund CW, Keiding N. Thrombotic stroke and myocardial infarction with hormonal contraception. N Engl J Med. 2012 Jun 14;366(24):2257-66. doi: 10.1056/NEJMoa1111840.
PMID: 22693997
citation: Lidegaard O, Nielsen LH, Skovlund CW, Skjeldestad FE, Lokkegaard E. Risk of venous thromboembolism from use of oral contraceptives containing different progestogens and oestrogen doses: Danish cohort study, 2001-9. BMJ. 2011 Oct 25;343:d6423. doi: 10.1136/bmj.d6423.
PMID: 22027398
citation: McGuiness J, Vicenzino B, Wright A. Influence of a cervical mobilization technique on respiratory and cardiovascular function. Man Ther. 1997 Nov;2(4):216-220. doi: 10.1054/math.1997.0302.
PMID: 11440535
citation: Puentedura EJ, Cleland JA, Landers MR, Mintken PE, Louw A, Fernandez-de-Las-Penas C. Development of a clinical prediction rule to identify patients with neck pain likely to benefit from thrust joint manipulation to the cervical spine. J Orthop Sports Phys Ther. 2012 Jul;42(7):577-92. doi: 10.2519/jospt.2012.4243. Epub 2012 May 14.
PMID: 22585595
citation: Van Dillen LR, McDonnell MK, Susco TM, Sahrmann SA. The immediate effect of passive scapular elevation on symptoms with active neck rotation in patients with neck pain. Clin J Pain. 2007 Oct;23(8):641-7. doi: 10.1097/AJP.0b013e318125c5b6.
PMID: 17885341
citation: Egwu MO. Relative therapeutic efficacy of some vertebral mobilization techniques in the management of unilateral cervical spondylosis: a comparative study. Journal of Physical Therapy and Science. 2008;20:103-8.
responsible party type: Sponsor
mesh term: Neck Pain