<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/NCT03762252</url>
  </required_header>
  <id_info>
    <org_study_id>URJC 2018-12-10</org_study_id>
    <nct_id>NCT03762252</nct_id>
  </id_info>
  <brief_title>Dry Needling of Scalene Muscle Trigger Points in Mechanical Neck Pain</brief_title>
  <official_title>Effects of Dry Needling of Active Trigger Points in the Scalene Muscles on Individuals 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 preliminary evidence suggesting that referred pain from active trigger points can&#xD;
      play a relevant role in individuals with mechanical neck pain. Some studies have investigated&#xD;
      the effectiveness of dry needling over the upper trapezius muscle in this population.&#xD;
      However, other muscles, such as the scalene muscles, can be also relevant for neck pain&#xD;
      symptoms. No study has investigated the effects of the application of dry needling over&#xD;
      active trigger points in the scalenes muscles in a sample of patients with mechanical neck&#xD;
      pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2018</start_date>
  <completion_date type="Actual">July 1, 2019</completion_date>
  <primary_completion_date type="Actual">May 15, 2019</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 neck pain intensity with a numerical pain rate scale before and after the intervention</measure>
    <time_frame>Baseline, one day (immediately post), 7 days (one week) and 30 days (one month) after the intervention</time_frame>
    <description>A Numerical Pain Rate Scale (NPRS, 0-10) will be used to assess spontaneous neck pain intensity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in oxigen saturation with a pulse oximeter before and after the intervention</measure>
    <time_frame>Baseline, one day (immediately post), 7 days (one week) and 30 days (one month) after the intervention</time_frame>
    <description>Oxygen saturation will be monitored with a handheld pulse oximeter with Masimo SET® measure-through Motion and Low Perfusion™ pulse oximeter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in inspiratory vital capacity with an incentive spirometer before and after the intervention</measure>
    <time_frame>Baseline, one day (immediately post), 7 days (one week) and 30 days (one month) after the intervention</time_frame>
    <description>Changes in inspiratory vital capacity will be assessed with the incentive spirometer DHD Coach 2®</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in neck-related disability with the Neck Disability Index before and after the intervention</measure>
    <time_frame>Baseline and 7 days (one week) and 30 days (one month) after the intervention</time_frame>
    <description>The Neck Disability Index (NDI, 0-50), a specific neck pain related disability questionaire, will be used for assessing neck pain related-disability</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</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 scalene muscles</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 scalene muscles</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dry needling</intervention_name>
    <description>A solid filiform needle will be inserted over active trigger points in the scalene muscles for 30 seconds. The aim will be to elicit local twitch responses or the referred pain pattern of the scalene muscles.</description>
    <arm_group_label>Dry needling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual Therapy</intervention_name>
    <description>The therapist will apply manual compression over active trigger points in the scalene muscles for 30 seconds</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 45 years of age&#xD;
&#xD;
          -  fear to needles&#xD;
&#xD;
          -  any respiratory disease, e.g., chronic brochitis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>César Fernández-de-las-Peñas</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad Rey Juan Carlos</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>César Fernández-de-las-Peñas</name>
      <address>
        <city>Alcorcón</city>
        <state>Madrid</state>
        <zip>28922</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>July 7, 2019</last_update_submitted>
  <last_update_submitted_qc>July 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2019</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>
  <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/NCT03762252
org study id: URJC 2018-12-10
nct id: NCT03762252
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
There is preliminary evidence suggesting that referred pain from active trigger points can
      play a relevant role in individuals with mechanical neck pain. Some studies have investigated
      the effectiveness of dry needling over the upper trapezius muscle in this population.
      However, other muscles, such as the scalene muscles, can be also relevant for neck pain
      symptoms. No study has investigated the effects of the application of dry needling over
      active trigger points in the scalenes muscles in a sample of patients with mechanical neck
      pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Changes in neck pain intensity with a numerical pain rate scale before and after the intervention
time frame: Baseline, one day (immediately post), 7 days (one week) and 30 days (one month) after the intervention
description: A Numerical Pain Rate Scale (NPRS, 0-10) will be used to assess spontaneous neck pain intensity
measure: Changes in oxigen saturation with a pulse oximeter before and after the intervention
time frame: Baseline, one day (immediately post), 7 days (one week) and 30 days (one month) after the intervention
description: Oxygen saturation will be monitored with a handheld pulse oximeter with Masimo SET® measure-through Motion and Low Perfusion™ pulse oximeter
measure: Changes in inspiratory vital capacity with an incentive spirometer before and after the intervention
time frame: Baseline, one day (immediately post), 7 days (one week) and 30 days (one month) after the intervention
description: Changes in inspiratory vital capacity will be assessed with the incentive spirometer DHD Coach 2®
measure: Changes in neck-related disability with the Neck Disability Index before and after the intervention
time frame: Baseline and 7 days (one week) and 30 days (one month) after the intervention
description: The Neck Disability Index (NDI, 0-50), a specific neck pain related disability questionaire, will be used for assessing neck pain related-disability
arm group label: Dry needling
arm group type: Experimental
description: Patients will receive dry needling over active trigger points in the scalene muscles
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 scalene muscles
intervention type: Other
intervention name: Dry needling
description: A solid filiform needle will be inserted over active trigger points in the scalene muscles for 30 seconds. The aim will be to elicit local twitch responses or the referred pain pattern of the scalene muscles.
arm group label: Dry needling
intervention type: Other
intervention name: Manual Therapy
description: The therapist will apply manual compression over active trigger points in the scalene muscles for 30 seconds
arm group label: Manual Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: César Fernández-de-las-Peñas
role: Principal Investigator
affiliation: Universidad Rey Juan Carlos
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