<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/NCT02190890</url>
  </required_header>
  <id_info>
    <org_study_id>16/2013</org_study_id>
    <nct_id>NCT02190890</nct_id>
  </id_info>
  <brief_title>Dry Needling Dosage in the Treatment of Myofascial Neck Pain</brief_title>
  <official_title>Effects of Different Deep Dry Needling Dosages on Pain and Postneedling Soreness in the Treatment of Patients With Cervical Myofascial 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>
  <brief_summary>
    <textblock>
      The purpose of this study are (1) to determine the effectiveness of different dry needling&#xD;
      dosages in the treatment of myofascial trigger points in the upper trapezius muscle in&#xD;
      patients with myofascial neck pain, (2) to assess postneedling soreness and tenderness and&#xD;
      (3) evaluate the influence of psychological factors on the perception of postneedling&#xD;
      soreness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">May 2014</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</measure>
    <time_frame>1 week</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>Postneedling soreness</measure>
    <time_frame>1 week</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>1 week</time_frame>
    <description>Three consecutive trials of pressure pain threshold on the active trigger point at a rate of 1 kg/sec at intervals of 30 seconds were conducted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cervical range of motion</measure>
    <time_frame>1 week</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>
  <secondary_outcome>
    <measure>Neck disability</measure>
    <time_frame>1 week</time_frame>
    <description>Neck Disability Index questionnarie was completed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain in cervical range of motion</measure>
    <time_frame>1 week</time_frame>
    <description>Pain in a numerical pain rating scale during all cervical movements was recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological factors</measure>
    <time_frame>Pre-intervention</time_frame>
    <description>State Trait Anxiety Inventory (STAI-T)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological factors</measure>
    <time_frame>Pre-intervention</time_frame>
    <description>Beck Depression Inventory (BDI-II)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological factors</measure>
    <time_frame>Pre-intervention</time_frame>
    <description>Tampa Scale for Kinesiophobia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological factors</measure>
    <time_frame>Pre-intervention</time_frame>
    <description>Pain Catastrophizing Scale</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">94</enrollment>
  <condition>Neck Pain</condition>
  <arm_group>
    <arm_group_label>Dry needling: 4 local twitch responses</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Deep dry needling in the active myofascial trigger point in the upper trapezius muscle. The muscle fibers were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the MTrP until 4 local twitch responses were elicited.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dry needling: 6 local twitch responses</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Deep dry needling in the active myofascial trigger point in the upper trapezius muscle. The muscle fibers were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the MTrP until 6 local twitch responses were elicited.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dry needling: Until no more local twitch responses elicited</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Deep dry needling in the active myofascial trigger point in the upper trapezius muscle. The muscle fibers were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the MTrP until no more local twitch responses were elicited.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The needle was inserted 1.5 cm away from the trigger point in the trapezius muscle and withdrawn without any consecutive insertion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Dry needling</intervention_name>
    <arm_group_label>Dry needling: 4 local twitch responses</arm_group_label>
    <arm_group_label>Dry needling: 6 local twitch responses</arm_group_label>
    <arm_group_label>Dry needling: Until no more local twitch responses elicited</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Control</intervention_name>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of an active myofascial trigger point. Neck pain: Superior to 3 cm in VAS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neck area: Fracture, radiculopathy, previous surgery, previous needling treatment in&#xD;
             the last 6 months, previous analgesic medication (24 hours), psychiatric disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>53 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>December 5, 2017</last_update_submitted>
  <last_update_submitted_qc>December 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2017</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>PhD</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/NCT02190890
org study id: 16/2013
nct id: NCT02190890
lead sponsor: 
The purpose of this study are (1) to determine the effectiveness of different dry needling
      dosages in the treatment of myofascial trigger points in the upper trapezius muscle in
      patients with myofascial neck pain, (2) to assess postneedling soreness and tenderness and
      (3) evaluate the influence of psychological factors on the perception of postneedling
      soreness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Pain
time frame: 1 week
description: Visual analog scale. A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain).
measure: Postneedling soreness
time frame: 1 week
description: Visual analog scale. A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain).
measure: Pressure pain threshold
time frame: 1 week
description: Three consecutive trials of pressure pain threshold on the active trigger point at a rate of 1 kg/sec at intervals of 30 seconds were conducted.
measure: Cervical range of motion
time frame: 1 week
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.
measure: Neck disability
time frame: 1 week
description: Neck Disability Index questionnarie was completed.
measure: Pain in cervical range of motion
time frame: 1 week
description: Pain in a numerical pain rating scale during all cervical movements was recorded.
measure: Psychological factors
time frame: Pre-intervention
description: State Trait Anxiety Inventory (STAI-T)
measure: Psychological factors
time frame: Pre-intervention
description: Beck Depression Inventory (BDI-II)
measure: Psychological factors
time frame: Pre-intervention
description: Tampa Scale for Kinesiophobia
measure: Psychological factors
time frame: Pre-intervention
description: Pain Catastrophizing Scale
arm group label: Dry needling: 4 local twitch responses
arm group type: Experimental
description: Deep dry needling in the active myofascial trigger point in the upper trapezius muscle. The muscle fibers were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the MTrP until 4 local twitch responses were elicited.
arm group label: Dry needling: 6 local twitch responses
arm group type: Experimental
description: Deep dry needling in the active myofascial trigger point in the upper trapezius muscle. The muscle fibers were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the MTrP until 6 local twitch responses were elicited.
arm group label: Dry needling: Until no more local twitch responses elicited
arm group type: Experimental
description: Deep dry needling in the active myofascial trigger point in the upper trapezius muscle. The muscle fibers were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the MTrP until no more local twitch responses were elicited.
arm group label: Control
arm group type: Active Comparator
description: The needle was inserted 1.5 cm away from the trigger point in the trapezius muscle and withdrawn without any consecutive insertion.
intervention type: Procedure
intervention name: Dry needling
arm group label: Dry needling: 4 local twitch responses
arm group label: Dry needling: 6 local twitch responses
arm group label: Dry needling: Until no more local twitch responses elicited
intervention type: Procedure
intervention name: Control
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 53 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Universidad Rey Juan Carlos
investigator full name: Josue Fernandez Carnero
investigator title: PhD
mesh term: Neck Pain