<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/NCT02982369</url>
  </required_header>
  <id_info>
    <org_study_id>MBracht</org_study_id>
    <secondary_id>U1111-1190-4280</secondary_id>
    <nct_id>NCT02982369</nct_id>
  </id_info>
  <brief_title>The Effects of Vertebral Manipulation and Pain Education in Chronic Neck Pain</brief_title>
  <official_title>The Effects of Vertebral Manipulation and Pain Education in Chronic Neck Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Santa Catarina Federal University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Santa Catarina Federal University</source>
  <brief_summary>
    <textblock>
      This study aims to investigate the effects of vertebral manipulation and pain education on&#xD;
      subjects with neck pain. For this purpose, 90 subjects who present chronic neck pain will be&#xD;
      selected and allocated randomly into 2 groups: vertebral manipulation group and pain&#xD;
      education group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Actual">April 18, 2018</completion_date>
  <primary_completion_date type="Actual">March 1, 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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Intensity</measure>
    <time_frame>4 weeks after randomization</time_frame>
    <description>Intensity of pain will be measured by the numeric pain rating scale (NPRS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cytokines</measure>
    <time_frame>4 weeks after randomization</time_frame>
    <description>Level of concentration of pro and anti-inflammatory cytokines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pressure Pain Threshold</measure>
    <time_frame>4 weeks and 3 months after randomization</time_frame>
    <description>Pressure pain Threshold will be measured with a digital algometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability</measure>
    <time_frame>4 weeks and 3 months after randomization</time_frame>
    <description>Disability will be measured by the Neck Disability Index (NDI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear Avoidance Beliefs</measure>
    <time_frame>4 weeks and 3 months after randomization</time_frame>
    <description>Fear Avoidance will be measured by the Fear Avoidance Beliefs Questionnaire (FABQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related Quality of Life</measure>
    <time_frame>4 weeks and 3 months after randomization</time_frame>
    <description>Quality of Life will be measured by the 12-Item Health Survey (SF-12)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kinesiophobia</measure>
    <time_frame>4 weeks and 3 months after randomization</time_frame>
    <description>Kinesiophobia will be measured byTampa Scale for Kinesiophobia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Intensity</measure>
    <time_frame>3 months after randomization</time_frame>
    <description>Intensity of pain will be measured by the numeric pain rating scale (NPRS)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Neck Pain</condition>
  <arm_group>
    <arm_group_label>Spinal Manipulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High-velocity and low-amplitude (HVLA) manipulation techniques to the cervical and thoracic region and pain education.&#xD;
The subjects will receive the treatment twice a week, for four weeks, totaling eight sessions, with an average duration of 30 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pain Education</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Pain education and a simulation of spinal manipulation (sham), involving manual contact over the cervical and thoracic region totaling 10 minutes.&#xD;
The subjects will receive the treatment twice a week, for four weeks, totaling eight sessions, with an average duration of 30 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Spinal Manipulation</intervention_name>
    <description>High-velocity and low-amplitude (HVLA) manipulation techniques to the cervical and thoracic region</description>
    <arm_group_label>Spinal Manipulation</arm_group_label>
    <other_name>Vertebral Manipulation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pain Education</intervention_name>
    <description>Subjects will receive pain education based in biopsychosocial approach</description>
    <arm_group_label>Pain Education</arm_group_label>
    <arm_group_label>Spinal Manipulation</arm_group_label>
    <other_name>Pain Neuroscience Education</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham</intervention_name>
    <description>A simulation of spinal manipulation (sham), involving manual contact over the cervical and thoracic region totaling 10 minutes.</description>
    <arm_group_label>Pain Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Main complaint of Neck Pain for at least six (6) months;&#xD;
&#xD;
          -  Score of at least 10 points in NDI (Neck Disability Index);&#xD;
&#xD;
          -  Pain and / or restriction of cervical movements;&#xD;
&#xD;
          -  Pain reported at least 3 points on the NPRS (Numeric Pain Rating Scale);&#xD;
&#xD;
          -  The definition of the term Neck Pain follows the classification of TFNP.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous history of rheumatic disease, cervical myelopathy, tumors, vertebrobasilar&#xD;
             insufficiency, central or peripheral neurological disorders;&#xD;
&#xD;
          -  History of major trauma, fracture or surgery in the neck, shoulder and/or upper limb;&#xD;
&#xD;
          -  Signs of nerve root compression as important muscle weakness affecting the upper&#xD;
             limbs, reduction, loss or increase of biceps and triceps reflexes, decreased sensation&#xD;
             in the dermatomes of the upper limb;&#xD;
&#xD;
          -  Red flags contraindicating spinal manipulation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adair R Soares dos Santos, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Santa Catarina Federal University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Santa Catarina Federal University</name>
      <address>
        <city>Florianopolis</city>
        <state>Santa Catarina</state>
        <zip>88040-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>August 25, 2018</last_update_submitted>
  <last_update_submitted_qc>August 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Santa Catarina Federal University</investigator_affiliation>
    <investigator_full_name>Marcelo Anderson Bracht</investigator_full_name>
    <investigator_title>Principal Investigator</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/NCT02982369
org study id: MBracht
secondary id: U1111-1190-4280
nct id: NCT02982369
lead sponsor: 
This study aims to investigate the effects of vertebral manipulation and pain education on
      subjects with neck pain. For this purpose, 90 subjects who present chronic neck pain will be
      selected and allocated randomly into 2 groups: vertebral manipulation group and pain
      education group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Pain Intensity
time frame: 4 weeks after randomization
description: Intensity of pain will be measured by the numeric pain rating scale (NPRS)
measure: Cytokines
time frame: 4 weeks after randomization
description: Level of concentration of pro and anti-inflammatory cytokines
measure: Pressure Pain Threshold
time frame: 4 weeks and 3 months after randomization
description: Pressure pain Threshold will be measured with a digital algometer
measure: Disability
time frame: 4 weeks and 3 months after randomization
description: Disability will be measured by the Neck Disability Index (NDI)
measure: Fear Avoidance Beliefs
time frame: 4 weeks and 3 months after randomization
description: Fear Avoidance will be measured by the Fear Avoidance Beliefs Questionnaire (FABQ)
measure: Health-related Quality of Life
time frame: 4 weeks and 3 months after randomization
description: Quality of Life will be measured by the 12-Item Health Survey (SF-12)
measure: Kinesiophobia
time frame: 4 weeks and 3 months after randomization
description: Kinesiophobia will be measured byTampa Scale for Kinesiophobia
measure: Pain Intensity
time frame: 3 months after randomization
description: Intensity of pain will be measured by the numeric pain rating scale (NPRS)
arm group label: Spinal Manipulation
arm group type: Experimental
description: High-velocity and low-amplitude (HVLA) manipulation techniques to the cervical and thoracic region and pain education.
The subjects will receive the treatment twice a week, for four weeks, totaling eight sessions, with an average duration of 30 minutes.
arm group label: Pain Education
arm group type: Sham Comparator
description: Pain education and a simulation of spinal manipulation (sham), involving manual contact over the cervical and thoracic region totaling 10 minutes.
The subjects will receive the treatment twice a week, for four weeks, totaling eight sessions, with an average duration of 30 minutes.
intervention type: Other
intervention name: Spinal Manipulation
description: High-velocity and low-amplitude (HVLA) manipulation techniques to the cervical and thoracic region
arm group label: Spinal Manipulation
other name: Vertebral Manipulation
intervention type: Other
intervention name: Pain Education
description: Subjects will receive pain education based in biopsychosocial approach
arm group label: Pain Education
arm group label: Spinal Manipulation
other name: Pain Neuroscience Education
intervention type: Other
intervention name: Sham
description: A simulation of spinal manipulation (sham), involving manual contact over the cervical and thoracic region totaling 10 minutes.
arm group label: Pain Education
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Adair R Soares dos Santos, PhD
role: Study Director
affiliation: Santa Catarina Federal University
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Santa Catarina Federal University
investigator full name: Marcelo Anderson Bracht
investigator title: Principal Investigator
mesh term: Neck Pain