<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/NCT02230709</url>
  </required_header>
  <id_info>
    <org_study_id>50/2012</org_study_id>
    <nct_id>NCT02230709</nct_id>
  </id_info>
  <brief_title>Immediate Effects of Dry Needling and Tens in Chronic Neck Pain</brief_title>
  <official_title>IMMEDIATE EFFECTS OF DRY NEEDLING VERSUS DRY NEEDLING AND TENS ON PAIN IN PATIENTS WITH CHRONIC MIOFASCIAL 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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to determinate the effects of percutaneous electrical nerve&#xD;
      stimulation in the short-term for pain in patients with myofascial chronic neck pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <phase>Phase 2</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, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neck Pain</measure>
    <time_frame>4 days</time_frame>
    <description>Visual analog scale. A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-needling pain</measure>
    <time_frame>4 days</time_frame>
    <description>Visual analog scale. A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pressure Pain threshold</measure>
    <time_frame>4 days</time_frame>
    <description>Pressure needed to evoke pain recognized by patient. Measured using an algometer in Kg/cm2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Motion</measure>
    <time_frame>4 days</time_frame>
    <description>The subjects sat in a chair and a CROM goniometer was placed over the head. They were asked to perform active neck movements to the fullest extent of their mobility. Each movement was recorded three times and the average value was calculated.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Myofascial Neck Pain</condition>
  <arm_group>
    <arm_group_label>Dry needling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dry needling treatment on the trigger point number 2 of the trapezius muscle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>&quot;TENS&quot; and &quot;dry needling&quot;</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Application of TENS current after dry needling treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dry Needling</intervention_name>
    <description>Needling with acupuncture needle in a myofascial trigger point.</description>
    <arm_group_label>Dry needling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>&quot;TENS&quot; and &quot;dry needling&quot;</intervention_name>
    <description>Application of TENS current after dry needling technique</description>
    <arm_group_label>&quot;TENS&quot; and &quot;dry needling&quot;</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Neck pain for more than six months of evolution.&#xD;
&#xD;
          -  Active Myofascial Trigger Point number 2 on Trapezius muscle.&#xD;
&#xD;
          -  Score of more than 2 points in a Visual Analog Scale.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neck pain specific.&#xD;
&#xD;
          -  Radiculopathies.&#xD;
&#xD;
          -  Whiplash.&#xD;
&#xD;
          -  Dizziness and migraines&#xD;
&#xD;
          -  Cervical surgical intervention&#xD;
&#xD;
          -  Previous treatment of Dry Needling&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>48 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CSEU La Salle</name>
      <address>
        <city>Aravaca</city>
        <state>Madrid</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>September 20, 2016</last_update_submitted>
  <last_update_submitted_qc>September 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Rey Juan Carlos</investigator_affiliation>
    <investigator_full_name>Josue Fernandez Carnero</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <keyword>Neck pain</keyword>
  <keyword>Myofascial pain syndrome</keyword>
  <keyword>Soreness</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/NCT02230709
org study id: 50/2012
nct id: NCT02230709
lead sponsor: 
has dmc: No
The aim of this study is to determinate the effects of percutaneous electrical nerve
      stimulation in the short-term for pain in patients with myofascial chronic neck pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Neck Pain
time frame: 4 days
description: Visual analog scale. A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain).
measure: Post-needling pain
time frame: 4 days
description: Visual analog scale. A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain).
measure: Pressure Pain threshold
time frame: 4 days
description: Pressure needed to evoke pain recognized by patient. Measured using an algometer in Kg/cm2
measure: Range of Motion
time frame: 4 days
description: The subjects sat in a chair and a CROM goniometer was placed over the head. They were asked to perform active neck movements to the fullest extent of their mobility. Each movement was recorded three times and the average value was calculated.
arm group label: Dry needling
arm group type: Experimental
description: Dry needling treatment on the trigger point number 2 of the trapezius muscle.
arm group label: "TENS" and "dry needling"
arm group type: Active Comparator
description: Application of TENS current after dry needling treatment.
intervention type: Other
intervention name: Dry Needling
description: Needling with acupuncture needle in a myofascial trigger point.
arm group label: Dry needling
intervention type: Other
intervention name: "TENS" and "dry needling"
description: Application of TENS current after dry needling technique
arm group label: "TENS" and "dry needling"
criteria: 
gender: All
minimum age: 18 Years
maximum age: 48 Years
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Rey Juan Carlos
investigator full name: Josue Fernandez Carnero
investigator title: associate professor
mesh term: Neck Pain