<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/NCT04466813</url>
  </required_header>
  <id_info>
    <org_study_id>DNMYOTMG</org_study_id>
    <nct_id>NCT04466813</nct_id>
  </id_info>
  <brief_title>Effect of Dry Needling on Muscle Mechanical Properties and Muscle Contractility in Latent Trigger Points</brief_title>
  <official_title>Effects of Dry Needling on Stiffness in Latent Trigger Points a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Castilla-La Mancha</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Castilla-La Mancha</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 purpose of this study is to determine whether application of Dry Needling (DN) is&#xD;
      effective for improved Muscle Mechanical Properties and Muscle Contractility in Latent&#xD;
      Trigger Points point (LTrP) of upper trapezius. Randomized controlled trial, in parallel with&#xD;
      cross-control design. Two groups with LTrP in upper trapezius, and will be randomly selected&#xD;
      to DN group or Sham-Dn group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Actual">October 20, 2020</completion_date>
  <primary_completion_date type="Actual">September 20, 2020</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>Change in Stiffness</measure>
    <time_frame>Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment</time_frame>
    <description>This outcome measure is obtained by a device named MyotonPro. Stiffness reflects the resistance of the muscle to the force deforming the muscle.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Maximal Radial Displacement (Dm)</measure>
    <time_frame>Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment</time_frame>
    <description>This outcome measure is obtained by a device named Tensiomiography. The variable Dm is given by the radial displacement of the muscular belly in a transverse plane, expressed in millimeters (mm) and depends on muscle tone or stiffness. A low Dm is related to a high muscle tone or an excess of stiffness, while a high Dm value indicates a lack of muscle tone or stiffness defect.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Oscillation Frequency</measure>
    <time_frame>Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment</time_frame>
    <description>This outcome measure is obtained by a device named MyotonPro. The frequency of the damped oscillations characterizes the muscle tone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Decrement (elasticity)</measure>
    <time_frame>Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment</time_frame>
    <description>This outcome measure is obtained by a device named MyotonPro.The logarithmic decrement of the damping oscillations characterizes muscle elasticity which is the ability of the muscle to restore its initial shape after contraction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mechanical Stress Relaxation Time [ms]</measure>
    <time_frame>Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment</time_frame>
    <description>This outcome measure is obtained by a device named MyotonPro. Mechanical Stress Relaxation Time [ms] is the time for a muscle to recover tis shape from deformation after a voluntary contraction or a removal of an external force.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Ratio of deformation and Relaxation time, characterising Creep (Deborah number)</measure>
    <time_frame>Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment</time_frame>
    <description>This outcome measure is obtained by a device named MyotonPro. Ratio of deformation and Relaxation time, characterising Creep (Deborah number) is the gradual elongation of a tissue over time when placed under a constant tensile stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Contraction time (Tc)</measure>
    <time_frame>Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment</time_frame>
    <description>This outcome measure is obtained by a device named Tensiomiography. Contraction time (Tc) as a time between 10% and 90% of the contraction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Delay time (Td)</measure>
    <time_frame>Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment</time_frame>
    <description>This outcome measure is obtained by a device named Tensiomiography. Delay time (Td) as a time between the electrical impulse and 10% of the contraction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sustain time (Ts)</measure>
    <time_frame>Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment</time_frame>
    <description>This outcome measure is obtained by a device named Tensiomiography. Sustain time (Ts) as a time between 50% of the contraction and 50% of the relaxation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Relaxation time (Tr)</measure>
    <time_frame>Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment</time_frame>
    <description>This outcome measure is obtained by a device named Tensiomiography. Relaxation time (Tr) as a time between 90% and 50% of the relaxation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pressure Pain Perception (PPP)</measure>
    <time_frame>Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment</time_frame>
    <description>Change in Pain Pressure Threshold (PPT) as assessed using an manual mechanical algometer. The procedure performed was the same as the prior described, but pressure was kept until 2.5 kg/cm2 and maintained for 5 seconds, whereas the subject had to characterize the level of pain using a 10-mm visual analog scale (VAS)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Trigger Point Pain, Myofascial</condition>
  <arm_group>
    <arm_group_label>Deep Dry Needling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention-Dry Needling: Deep Dry Needing into the latent trigger point of the upper trapezius muscle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Dry Needling</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Control-Dry Needling: Sham Dry Needling into the latent trigger point of the upper trapezius muscle</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intervention-Dry Needling</intervention_name>
    <description>Deep Dry Needling into the site of the latent Trigger Point of the upper trapezius muscle.&#xD;
1 session in upper trapezius muscle moving the needle up and down ten times.</description>
    <arm_group_label>Deep Dry Needling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control-Dry Needling</intervention_name>
    <description>Sham Dry Needling into the site of the latent Trigger Point of the upper trapezius muscle with non-penetrating needles</description>
    <arm_group_label>Sham Dry Needling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 30 years&#xD;
&#xD;
          -  The presence of LTrP in the middle third of the upper trapezius muscle on the dominant&#xD;
             side&#xD;
&#xD;
          -  Being able to provide written informed consent&#xD;
&#xD;
          -  Being able to follow instructions and realize clinical tests&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any pharmacological therapeutic&#xD;
&#xD;
          -  Any medical treatment or physical therapies at cervical region during the 6-month&#xD;
             before this study - Any diagnosed health problem&#xD;
&#xD;
          -  Any history of head and upper extremity surgery or trauma&#xD;
&#xD;
          -  Any red flags to DN, (ie: metabolic diseases, pregnancy, kinesiophobia, Infection,&#xD;
             cancer)&#xD;
&#xD;
          -  Absence of recurrent history of neck pain&#xD;
&#xD;
          -  No neck pain symptomatology the previous 6 months&#xD;
&#xD;
          -  Cervical disk herniation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Javier Abián-Vicén, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Castilla-La Mancha University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Performance and Sport Rehabilitation Laboratory</name>
      <address>
        <city>Toledo</city>
        <zip>45071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>October 22, 2020</last_update_submitted>
  <last_update_submitted_qc>October 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Latent trigger point</keyword>
  <keyword>Dry needling</keyword>
  <keyword>Myotonometer</keyword>
  <keyword>Tensiomyography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myofascial Pain Syndromes</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/NCT04466813
org study id: DNMYOTMG
nct id: NCT04466813
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether application of Dry Needling (DN) is
      effective for improved Muscle Mechanical Properties and Muscle Contractility in Latent
      Trigger Points point (LTrP) of upper trapezius. Randomized controlled trial, in parallel with
      cross-control design. Two groups with LTrP in upper trapezius, and will be randomly selected
      to DN group or Sham-Dn group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change in Stiffness
time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
description: This outcome measure is obtained by a device named MyotonPro. Stiffness reflects the resistance of the muscle to the force deforming the muscle.
measure: Change in Maximal Radial Displacement (Dm)
time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
description: This outcome measure is obtained by a device named Tensiomiography. The variable Dm is given by the radial displacement of the muscular belly in a transverse plane, expressed in millimeters (mm) and depends on muscle tone or stiffness. A low Dm is related to a high muscle tone or an excess of stiffness, while a high Dm value indicates a lack of muscle tone or stiffness defect.
measure: Change in Oscillation Frequency
time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
description: This outcome measure is obtained by a device named MyotonPro. The frequency of the damped oscillations characterizes the muscle tone.
measure: Change in Decrement (elasticity)
time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
description: This outcome measure is obtained by a device named MyotonPro.The logarithmic decrement of the damping oscillations characterizes muscle elasticity which is the ability of the muscle to restore its initial shape after contraction
measure: Change in Mechanical Stress Relaxation Time [ms]
time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
description: This outcome measure is obtained by a device named MyotonPro. Mechanical Stress Relaxation Time [ms] is the time for a muscle to recover tis shape from deformation after a voluntary contraction or a removal of an external force.
measure: Change in Ratio of deformation and Relaxation time, characterising Creep (Deborah number)
time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
description: This outcome measure is obtained by a device named MyotonPro. Ratio of deformation and Relaxation time, characterising Creep (Deborah number) is the gradual elongation of a tissue over time when placed under a constant tensile stress.
measure: Change in Contraction time (Tc)
time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
description: This outcome measure is obtained by a device named Tensiomiography. Contraction time (Tc) as a time between 10% and 90% of the contraction
measure: Change in Delay time (Td)
time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
description: This outcome measure is obtained by a device named Tensiomiography. Delay time (Td) as a time between the electrical impulse and 10% of the contraction
measure: Change in Sustain time (Ts)
time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
description: This outcome measure is obtained by a device named Tensiomiography. Sustain time (Ts) as a time between 50% of the contraction and 50% of the relaxation
measure: Change in Relaxation time (Tr)
time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
description: This outcome measure is obtained by a device named Tensiomiography. Relaxation time (Tr) as a time between 90% and 50% of the relaxation
measure: Change in Pressure Pain Perception (PPP)
time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
description: Change in Pain Pressure Threshold (PPT) as assessed using an manual mechanical algometer. The procedure performed was the same as the prior described, but pressure was kept until 2.5 kg/cm2 and maintained for 5 seconds, whereas the subject had to characterize the level of pain using a 10-mm visual analog scale (VAS)
arm group label: Deep Dry Needling
arm group type: Experimental
description: Intervention-Dry Needling: Deep Dry Needing into the latent trigger point of the upper trapezius muscle
arm group label: Sham Dry Needling
arm group type: Sham Comparator
description: Control-Dry Needling: Sham Dry Needling into the latent trigger point of the upper trapezius muscle
intervention type: Device
intervention name: Intervention-Dry Needling
description: Deep Dry Needling into the site of the latent Trigger Point of the upper trapezius muscle.
1 session in upper trapezius muscle moving the needle up and down ten times.
arm group label: Deep Dry Needling
intervention type: Device
intervention name: Control-Dry Needling
description: Sham Dry Needling into the site of the latent Trigger Point of the upper trapezius muscle with non-penetrating needles
arm group label: Sham Dry Needling
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Javier Abián-Vicén, PhD
role: Study Director
affiliation: Castilla-La Mancha University
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Myofascial Pain Syndromes
sharing ipd: No