<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/NCT03787706</url>
  </required_header>
  <id_info>
    <org_study_id>URJC3010201812618</org_study_id>
    <nct_id>NCT03787706</nct_id>
  </id_info>
  <brief_title>Dry Needling and Electromyographic Changes in Neck Pain</brief_title>
  <official_title>Electromyographic Changes in the Cranio-Cervical Flexion Test After Dry Needling of the Upper Trapezius Muscle in Patients With Mechanical Neck Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Rey Juan Carlos</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Rey Juan Carlos</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is evidence suggesting that patients with mechanical neck pain exhibit higher activity&#xD;
      of the superficial neck flexor muscles during the execution of the cranio-cervical flexion&#xD;
      test. In addition, some studies have reported the presence of active trigger points in the&#xD;
      neck flexor and extensor muscles. Since preliminary evidence suggests that trigger points can&#xD;
      affect motor control behaviour, it is possible that management of these trigger points with&#xD;
      dry needling could be effective for improving muscle activity during low-load activities,&#xD;
      such as the cranio-cervical flexion test. Therefore, the aim of this study will be to&#xD;
      investigate the effects on electromyographical activity, pressure pain thresholds and&#xD;
      cervical range of motion after the application of dry needling over active TrPs in the upper&#xD;
      trapezius muscle in patients with mechanical neck pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Actual">September 1, 2021</completion_date>
  <primary_completion_date type="Actual">June 15, 2021</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 (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in electromyographic activity of the neck superficial flexor muscles before and after the intervention</measure>
    <time_frame>Baseline and 5 minutes after treatment</time_frame>
    <description>Bipolar surface EMG will be recorded with pairs of electrodes positioned 20mm apart and fixed firmly with an adhesive tape bilaterally over the sternocleidomastoid, the anterior scalene, the upper trapezius and the splenius capitis muscles.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in neck pain intensity with a numerical pain rate scale before and after the intervention</measure>
    <time_frame>Baseline and 5 minutes after treatment</time_frame>
    <description>A Numerical Pain Rate Scale (NPRS, 0-10) will be used to assess spontaneous neck pain intensity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in widespread pressure pain sensitivity before and after the intervention</measure>
    <time_frame>Baseline and 5 minutes after treatment</time_frame>
    <description>Pressure pain thresholds will be assessed over C5/C6 zygapophyseal joints, second metacarpal, and tibialis anterior muscle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in cervical range of motion before and after the intervention</measure>
    <time_frame>Baseline and 5 minutes after treatment</time_frame>
    <description>Active cervical range of motion will be assessed with a Cervical Range of Motion (CROM) device in all cervical motions</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Neck Pain</condition>
  <arm_group>
    <arm_group_label>Dry needling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive dry needling over active trigger points in the upper trapezius muscle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Manual Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive a manual compression for 30seconds over active trigger points in the upper trapezius muscle</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dry Needling</intervention_name>
    <description>Patients will receive dry needling over active trigger points in the upper trapezius muscle</description>
    <arm_group_label>Dry needling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual Therapy</intervention_name>
    <description>Patients will receive a manual compression for 30seconds over active trigger points in the upper trapezius muscle</description>
    <arm_group_label>Manual Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Generalized neck-shoulder pain with symptoms provoked by neck postures, neck movement, or&#xD;
        palpation of the cervical musculature.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  whiplash injury;&#xD;
&#xD;
          -  previous cervical or thoracic surgery;&#xD;
&#xD;
          -  cervical radiculopathy or myelopathy;&#xD;
&#xD;
          -  diagnosis of fibromyalgia syndrome;&#xD;
&#xD;
          -  having undergone physical therapy in the previous 6 months;&#xD;
&#xD;
          -  less than 18 or greater than 55 years of age&#xD;
&#xD;
          -  fear to needles&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cesar Fernandez-de-Las-Peñas</name>
      <address>
        <city>Alcorcon</city>
        <state>Madrid</state>
        <zip>28921</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 22, 2018</study_first_submitted>
  <study_first_submitted_qc>December 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Rey Juan Carlos</investigator_affiliation>
    <investigator_full_name>César Fernández-de-las-Peñas</investigator_full_name>
    <investigator_title>Director of Department</investigator_title>
  </responsible_party>
  <keyword>Neck Pain</keyword>
  <keyword>Trigger points</keyword>
  <keyword>Dry needling</keyword>
  <keyword>Cranio-cervical flexion test</keyword>
  <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/NCT03787706
org study id: URJC3010201812618
nct id: NCT03787706
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
There is evidence suggesting that patients with mechanical neck pain exhibit higher activity
      of the superficial neck flexor muscles during the execution of the cranio-cervical flexion
      test. In addition, some studies have reported the presence of active trigger points in the
      neck flexor and extensor muscles. Since preliminary evidence suggests that trigger points can
      affect motor control behaviour, it is possible that management of these trigger points with
      dry needling could be effective for improving muscle activity during low-load activities,
      such as the cranio-cervical flexion test. Therefore, the aim of this study will be to
      investigate the effects on electromyographical activity, pressure pain thresholds and
      cervical range of motion after the application of dry needling over active TrPs in the upper
      trapezius muscle in patients with mechanical neck pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Changes in electromyographic activity of the neck superficial flexor muscles before and after the intervention
time frame: Baseline and 5 minutes after treatment
description: Bipolar surface EMG will be recorded with pairs of electrodes positioned 20mm apart and fixed firmly with an adhesive tape bilaterally over the sternocleidomastoid, the anterior scalene, the upper trapezius and the splenius capitis muscles.
measure: Changes in neck pain intensity with a numerical pain rate scale before and after the intervention
time frame: Baseline and 5 minutes after treatment
description: A Numerical Pain Rate Scale (NPRS, 0-10) will be used to assess spontaneous neck pain intensity
measure: Changes in widespread pressure pain sensitivity before and after the intervention
time frame: Baseline and 5 minutes after treatment
description: Pressure pain thresholds will be assessed over C5/C6 zygapophyseal joints, second metacarpal, and tibialis anterior muscle
measure: Changes in cervical range of motion before and after the intervention
time frame: Baseline and 5 minutes after treatment
description: Active cervical range of motion will be assessed with a Cervical Range of Motion (CROM) device in all cervical motions
arm group label: Dry needling
arm group type: Experimental
description: Patients will receive dry needling over active trigger points in the upper trapezius muscle
arm group label: Manual Therapy
arm group type: Active Comparator
description: Patients will receive a manual compression for 30seconds over active trigger points in the upper trapezius muscle
intervention type: Other
intervention name: Dry Needling
description: Patients will receive dry needling over active trigger points in the upper trapezius muscle
arm group label: Dry needling
intervention type: Other
intervention name: Manual Therapy
description: Patients will receive a manual compression for 30seconds over active trigger points in the upper trapezius muscle
arm group label: Manual Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Rey Juan Carlos
investigator full name: César Fernández-de-las-Peñas
investigator title: Director of Department
mesh term: Neck Pain