<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/NCT03813485</url>
  </required_header>
  <id_info>
    <org_study_id>5/2018</org_study_id>
    <nct_id>NCT03813485</nct_id>
  </id_info>
  <brief_title>Electromyographic´s Differences Between Dry Needling in Tonic or Phasic Skeletal Muscle Fibers.</brief_title>
  <official_title>Electromyographic´s Differences Between Dry Needling in Latent Myofascial Trigger Point in Tonic or Phasic Skeletal Muscle Fibers of Trapezius</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Francisco de Vitoria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Francisco de Vitoria</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>
      The aim of this study is to compare the surface electromyography (EGM) changes between dry&#xD;
      needling in the upper trapezius, is a prevalence tonic fiber or lower trapezius is a&#xD;
      prevalence phasic fiber.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several studies already found a disturbed surface electromyography activity in myalgic muscle&#xD;
      tissue and in the vicinity of myofascial trigger points, however studies about the effect of&#xD;
      dry needling in this fibers type on these disturbances in EMG activity are scarce.&#xD;
&#xD;
      The surface electromyography of upper trapezius is related with a tonic muscle dysfunction,&#xD;
      for example muscle contracture; and the lower fiber of trapezius is related with atrophy&#xD;
      muscle.&#xD;
&#xD;
      Dry needling is an effective method for the treatment of myofascial trigger points for&#xD;
      immediate reduction of pain. There are some studies about latent myofascial trigger point and&#xD;
      motor activity, but we don't know any research about the effect of dry needling in the&#xD;
      differences fibers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 11, 2019</start_date>
  <completion_date type="Anticipated">June 10, 2019</completion_date>
  <primary_completion_date type="Actual">April 10, 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 surface electromyographic before and after the intervention.</measure>
    <time_frame>Baseline and 10 minutes after the intervention</time_frame>
    <description>Root mean square values (RMS)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Muscle Disorder</condition>
  <condition>Trigger Point Pain, Myofascial</condition>
  <arm_group>
    <arm_group_label>Dry needling in upper trapezius</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive dry needling in latent myofascial trigger point in upper trapezius. The needle was penetrated into the muscle fibers of the taut band and was moved upward and downward (&quot;fast in, fast out&quot;) in different directions with the aim to elicit LTRs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dry needling in lower trapezius</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive dry needling in latent myofascial trigger point in lower trapezius. The needle was penetrated into the muscle fibers of the taut band and was moved upward and downward (&quot;fast in, fast out&quot;) in different directions with the aim to elicit LTRs</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dry Needling in upper trapezius</intervention_name>
    <description>The following criteria are required for a patient to have latent TrPs: the presence of a palpable taut band in the upper trapezius muscle, the presence of a hypersensitive spot in the taut band, a palpable or visible local twitch on snapping palpation, and a no familiar reproduction of referred pain elicited by palpation of the sensitive spot.&#xD;
Dry needling is performed with solid filiform needles (0.30x30 mm), these needles are sterile and separately packaged. Needles are not reused and are immediately deposited in a needle container after usage. Patients receive dry needling in latent myofascial trigger point (LTRs) in upper trapezius. The needle is penetrated into the muscle fibers of the taut band and was moved upward and downward (&quot;fast in, fast out&quot;) in different directions with the aim to elicit LTRs</description>
    <arm_group_label>Dry needling in upper trapezius</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dry Needling in lower trapezius</intervention_name>
    <description>The following criteria are required for a patient to have latent TrPs: the presence of a palpable taut band in the lower trapezius muscle, the presence of a hypersensitive spot in the taut band, a palpable or visible local twitch on snapping palpation, and a no familiar reproduction of referred pain elicited by palpation of the sensitive spot.&#xD;
Dry needling is performed with solid filiform needles (0.30x 30 mm), these needles are sterile and separately packaged. Needles are not reused and are immediately deposited in a needle container after usage. Patients receive dry needling in latent myofascial trigger point (LTRs) in lower trapezius. The needle is penetrated into the muscle fibers of the taut band and was moved upward and downward (&quot;fast in, fast out&quot;) in different directions with the aim to elicit LTRs</description>
    <arm_group_label>Dry needling in lower trapezius</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence latent myofascial trigger point in the upper/lower trapezius asymptomatic&#xD;
             subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  neck or shoulder pain at the moment or 6 month ago. whiplash injury previous spine or&#xD;
             shoulder surgery pregnancy diagnosis of radiculopathy or myelopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sandra Sánchez Jorge, Pt, PhD</last_name>
    <phone>+34 91 7091887</phone>
    <email>s.sjorge.prof@ufv.es</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jaime Salom Moreno, Pt, PhD</last_name>
    <phone>+34 91 7091905</phone>
    <email>jaime.salom@ufv.es</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Universidad Francisco de Vitoria</name>
      <address>
        <city>Madrid</city>
        <state>Pozuelo De Alarcón</state>
        <zip>28223</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sandra Sancjez, PhD</last_name>
      <email>s.sjorge.prof@ufv.es</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>April 12, 2019</last_update_submitted>
  <last_update_submitted_qc>April 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Francisco de Vitoria</investigator_affiliation>
    <investigator_full_name>Jaime Salom</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>surface electromyographic</keyword>
  <keyword>dry needling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
    <mesh_term>Muscular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03813485
org study id: 5/2018
nct id: NCT03813485
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to compare the surface electromyography (EGM) changes between dry
      needling in the upper trapezius, is a prevalence tonic fiber or lower trapezius is a
      prevalence phasic fiber.
Several studies already found a disturbed surface electromyography activity in myalgic muscle
      tissue and in the vicinity of myofascial trigger points, however studies about the effect of
      dry needling in this fibers type on these disturbances in EMG activity are scarce.

      The surface electromyography of upper trapezius is related with a tonic muscle dysfunction,
      for example muscle contracture; and the lower fiber of trapezius is related with atrophy
      muscle.

      Dry needling is an effective method for the treatment of myofascial trigger points for
      immediate reduction of pain. There are some studies about latent myofascial trigger point and
      motor activity, but we don't know any research about the effect of dry needling in the
      differences fibers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Changes in surface electromyographic before and after the intervention.
time frame: Baseline and 10 minutes after the intervention
description: Root mean square values (RMS)
arm group label: Dry needling in upper trapezius
arm group type: Active Comparator
description: Patients receive dry needling in latent myofascial trigger point in upper trapezius. The needle was penetrated into the muscle fibers of the taut band and was moved upward and downward ("fast in, fast out") in different directions with the aim to elicit LTRs
arm group label: Dry needling in lower trapezius
arm group type: Experimental
description: Patients receive dry needling in latent myofascial trigger point in lower trapezius. The needle was penetrated into the muscle fibers of the taut band and was moved upward and downward ("fast in, fast out") in different directions with the aim to elicit LTRs
intervention type: Other
intervention name: Dry Needling in upper trapezius
description: The following criteria are required for a patient to have latent TrPs: the presence of a palpable taut band in the upper trapezius muscle, the presence of a hypersensitive spot in the taut band, a palpable or visible local twitch on snapping palpation, and a no familiar reproduction of referred pain elicited by palpation of the sensitive spot.
Dry needling is performed with solid filiform needles (0.30x30 mm), these needles are sterile and separately packaged. Needles are not reused and are immediately deposited in a needle container after usage. Patients receive dry needling in latent myofascial trigger point (LTRs) in upper trapezius. The needle is penetrated into the muscle fibers of the taut band and was moved upward and downward ("fast in, fast out") in different directions with the aim to elicit LTRs
arm group label: Dry needling in upper trapezius
intervention type: Other
intervention name: Dry Needling in lower trapezius
description: The following criteria are required for a patient to have latent TrPs: the presence of a palpable taut band in the lower trapezius muscle, the presence of a hypersensitive spot in the taut band, a palpable or visible local twitch on snapping palpation, and a no familiar reproduction of referred pain elicited by palpation of the sensitive spot.
Dry needling is performed with solid filiform needles (0.30x 30 mm), these needles are sterile and separately packaged. Needles are not reused and are immediately deposited in a needle container after usage. Patients receive dry needling in latent myofascial trigger point (LTRs) in lower trapezius. The needle is penetrated into the muscle fibers of the taut band and was moved upward and downward ("fast in, fast out") in different directions with the aim to elicit LTRs
arm group label: Dry needling in lower trapezius
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sandra Sánchez Jorge, Pt, PhD
phone: +34 91 7091887
email: s.sjorge.prof@ufv.es
last name: Jaime Salom Moreno, Pt, PhD
phone: +34 91 7091905
email: jaime.salom@ufv.es
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Francisco de Vitoria
investigator full name: Jaime Salom
investigator title: Principal Investigator
mesh term: Myofascial Pain Syndromes
mesh term: Muscular Diseases
sharing ipd: No