<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/NCT03273985</url>
  </required_header>
  <id_info>
    <org_study_id>DN-TS-UCM</org_study_id>
    <nct_id>NCT03273985</nct_id>
  </id_info>
  <brief_title>Effectiveness of Dry Needling in Shortened Triceps Surae Muscle</brief_title>
  <acronym>DN-TS</acronym>
  <official_title>Effectiveness of Deep Dry Needling in Subjects With Shortened Triceps Surae Originated by Myofascial Pain Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de León</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidad Complutense de Madrid</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad de León</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>
      To date, there are not studies about the effectiveness of dry needling versus ischemic&#xD;
      compression in the triceps surae trigger points. A randomized clinical trial is carried out.&#xD;
      A sample of 30 subjects are recruited and allocated into dry needling (n = 15) and ischemic&#xD;
      compression (n = 15). Outcome measurements such as dorsal flexion range of motion, plantar&#xD;
      pressures, temperature, superficial muscle activity and trigger points pressure pain&#xD;
      threshold are measured immediately before and after treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2017</start_date>
  <completion_date type="Actual">December 6, 2017</completion_date>
  <primary_completion_date type="Actual">December 6, 2017</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Range of motion</measure>
    <time_frame>Change from Baseline Range of motion at 25 minutes</time_frame>
    <description>Ankle dorsal flexion by means of the goniometer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plantar pressures</measure>
    <time_frame>Change from Baseline Plantar pressures at 25 minutes</time_frame>
    <description>Plantar pressures platform</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temperature</measure>
    <time_frame>Change from Baseline Temperature at 25 minutes</time_frame>
    <description>Thermal imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Superficial muscle activity</measure>
    <time_frame>Change from Baseline Superficial muscle activity at 25 minutes</time_frame>
    <description>Electromyography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pressure pain threshold</measure>
    <time_frame>Change from Baseline Pressure pain threshold at 25 minutes</time_frame>
    <description>Algometer</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Trigger Point Pain, Myofascial</condition>
  <condition>Myofascial Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>Dry needling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Ischemic compression</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dry needling</intervention_name>
    <description>Trigger point deep dry needling</description>
    <arm_group_label>Dry needling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ischemic compression</intervention_name>
    <description>Trigger point ischemic compression</description>
    <arm_group_label>Ischemic compression</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Myofascial pain syndrome in the triceps surae muscle, limitation of ankle dorsal&#xD;
             flexion range of motion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neurologic disorders, pharmacologic treatment (within the previous 3 months),&#xD;
             cognitive impairment, prosthesis in the lower limb, systemic or infectious diseases,&#xD;
             autoimmune diseases, fibromyalgia, hypothyroidism, anticoagulants or antiplatelet&#xD;
             agents, and fear of needles.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fisiofuenla</name>
      <address>
        <city>Fuenlabrada</city>
        <state>Madrid</state>
        <zip>28943</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>December 6, 2017</last_update_submitted>
  <last_update_submitted_qc>December 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de León</investigator_affiliation>
    <investigator_full_name>César Calvo Lobo</investigator_full_name>
    <investigator_title>Professor, PhD, MSc, PT</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Syndrome</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/NCT03273985
org study id: DN-TS-UCM
nct id: NCT03273985
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To date, there are not studies about the effectiveness of dry needling versus ischemic
      compression in the triceps surae trigger points. A randomized clinical trial is carried out.
      A sample of 30 subjects are recruited and allocated into dry needling (n = 15) and ischemic
      compression (n = 15). Outcome measurements such as dorsal flexion range of motion, plantar
      pressures, temperature, superficial muscle activity and trigger points pressure pain
      threshold are measured immediately before and after treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Range of motion
time frame: Change from Baseline Range of motion at 25 minutes
description: Ankle dorsal flexion by means of the goniometer
measure: Plantar pressures
time frame: Change from Baseline Plantar pressures at 25 minutes
description: Plantar pressures platform
measure: Temperature
time frame: Change from Baseline Temperature at 25 minutes
description: Thermal imaging
measure: Superficial muscle activity
time frame: Change from Baseline Superficial muscle activity at 25 minutes
description: Electromyography
measure: Pressure pain threshold
time frame: Change from Baseline Pressure pain threshold at 25 minutes
description: Algometer
arm group label: Dry needling
arm group type: Experimental
arm group label: Ischemic compression
arm group type: Experimental
intervention type: Other
intervention name: Dry needling
description: Trigger point deep dry needling
arm group label: Dry needling
intervention type: Other
intervention name: Ischemic compression
description: Trigger point ischemic compression
arm group label: Ischemic compression
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad de León
investigator full name: César Calvo Lobo
investigator title: Professor, PhD, MSc, PT
mesh term: Myofascial Pain Syndromes
mesh term: Fibromyalgia
mesh term: Syndrome
sharing ipd: No