<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/NCT01710735</url>
  </required_header>
  <id_info>
    <org_study_id>Muscle and needling</org_study_id>
    <nct_id>NCT01710735</nct_id>
  </id_info>
  <brief_title>Skeletal Muscle Contractility, Self-reported Pain and Tissue Sensitivity in Females With Neck/Shoulder Pain and Trapezius MFTrPs</brief_title>
  <official_title>Skeletal Muscle Contractility, Self-reported Pain and Tissue Sensitivity in Females With Neck/Shoulder Pain and Upper Trapezius Myofascial Trigger Points- a Randomized Intervention Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lundbeck Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dansk Kiropraktor Fond</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>IMK Almene Fond</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In relation to Myofascial Triggerpoints (MFTrPs) of the upper Trapezius, this study will&#xD;
      explore muscle contractility characteristics, the occurrence of post-intervention muscle&#xD;
      soreness and the effect of dry needling on muscle contractile characteristics and clinical&#xD;
      outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">May 2012</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>muscle contractility</measure>
    <time_frame>30 minutes</time_frame>
    <description>Measurements of maximal isometric muscle force (Fmax), and rate of force development (RDF)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pressure-pain threshold</measure>
    <time_frame>60 seconds</time_frame>
    <description>Algometer measurement of pressure-pain perception</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS-101</measure>
    <time_frame>60 seconds</time_frame>
    <description>Self-reported pain</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Myofascial Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>Dry needling (deep)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects receive dry needle insertion deeper than 1,5cm below the skin of the Trapezius.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dry needling (superficial)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Insertion of dry needle less than 1cm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Dry needling</intervention_name>
    <description>Insertion of acupuncture needle into a myofascial trigger point.</description>
    <arm_group_label>Dry needling (deep)</arm_group_label>
    <arm_group_label>Dry needling (superficial)</arm_group_label>
    <other_name>Acupuncture</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A clinically relevant MFTrP of the upper Trapezius musculature&#xD;
&#xD;
          -  Self-reported pain of ≥3 on an eleven-point numerical pain rating scale (NRS-101).&#xD;
&#xD;
          -  BMI less than 31&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a history of chronic, systemic pathology (e.g. hemophilia)&#xD;
&#xD;
          -  pre-existing neck/shoulder pathology/surgical procedures,&#xD;
&#xD;
          -  clinical depression&#xD;
&#xD;
          -  health-related legal action&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  anti-inflammatory and/or chronic pain medication&#xD;
&#xD;
          -  had received dry needling for a shoulder/neck disorder within 6 months prior to the&#xD;
             study (to raise the level of patient naiveté) suffered from needle phobia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>46 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Hartvigsen Hartvigsen, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Univ. of Southern Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Per Aagaard, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Univ. of Southern Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Univ. of Southern Denmark</name>
      <address>
        <city>Odense</city>
        <state>Funen</state>
        <zip>5230</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>October 18, 2012</last_update_submitted>
  <last_update_submitted_qc>October 18, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern Denmark</investigator_affiliation>
    <investigator_full_name>Corrie Myburgh</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>TP</keyword>
  <keyword>Myofascial pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
    <mesh_term>Fibromyalgia</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/NCT01710735
org study id: Muscle and needling
nct id: NCT01710735
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
In relation to Myofascial Triggerpoints (MFTrPs) of the upper Trapezius, this study will
      explore muscle contractility characteristics, the occurrence of post-intervention muscle
      soreness and the effect of dry needling on muscle contractile characteristics and clinical
      outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Outcomes Assessor)
measure: muscle contractility
time frame: 30 minutes
description: Measurements of maximal isometric muscle force (Fmax), and rate of force development (RDF)
measure: pressure-pain threshold
time frame: 60 seconds
description: Algometer measurement of pressure-pain perception
measure: NRS-101
time frame: 60 seconds
description: Self-reported pain
arm group label: Dry needling (deep)
arm group type: Experimental
description: Subjects receive dry needle insertion deeper than 1,5cm below the skin of the Trapezius.
arm group label: Dry needling (superficial)
arm group type: Active Comparator
description: Insertion of dry needle less than 1cm.
intervention type: Procedure
intervention name: Dry needling
description: Insertion of acupuncture needle into a myofascial trigger point.
arm group label: Dry needling (deep)
arm group label: Dry needling (superficial)
other name: Acupuncture
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 46 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jan Hartvigsen Hartvigsen, PhD
role: Study Director
affiliation: Univ. of Southern Denmark
last name: Per Aagaard, PhD
role: Study Director
affiliation: Univ. of Southern Denmark
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Southern Denmark
investigator full name: Corrie Myburgh
investigator title: Dr
mesh term: Shoulder Pain
mesh term: Myofascial Pain Syndromes
mesh term: Fibromyalgia