<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/NCT03756428</url>
  </required_header>
  <id_info>
    <org_study_id>CEU UCH 210</org_study_id>
    <nct_id>NCT03756428</nct_id>
  </id_info>
  <brief_title>Effects on Plantar Support After Deep Dry Needling in Posterior Tibial Muscle</brief_title>
  <official_title>Effects on Plantar Support After Deep Dry Needling in Posterior Tibial Muscle: Baropodometric Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardenal Herrera University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cardenal Herrera University</source>
  <oversight_info>
    <has_dmc>No</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>
      This study aims to analyze the changes in plantar support after the technique of deep dry&#xD;
      puncture in the posterior tibial. The data will be analyzed by a baropodometer which will&#xD;
      record the possible changes in the footprint. The investigator will perform a&#xD;
      pre-intervention measurement and 3 post-intervention measurements (immediately after the&#xD;
      intervention, at 24 hours and at 72 hours)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">December 11, 2018</completion_date>
  <primary_completion_date type="Actual">December 5, 2018</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain pressure threshold</measure>
    <time_frame>72 hours</time_frame>
    <description>Amount of pressure (Kg/cm2) applied at the tibialis posterior myofascial trigger point site that elicit pain for the patient will be reported</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>baropodometric measurements: footprint</measure>
    <time_frame>72 hours</time_frame>
    <description>The investigator will be collected maximum pressure point in the footprint (g / cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>baropodometric measurements: Average footprint pressure</measure>
    <time_frame>72 hours</time_frame>
    <description>The investigator will be collected the average footprint pressure (g/cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>baropodometric measurements: forefoot area</measure>
    <time_frame>72 hours</time_frame>
    <description>The investigator will be collected the forefoot area (cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>baropodometric measurements:forefoot load</measure>
    <time_frame>72 hours</time_frame>
    <description>The investigator will be collected the forefoot load (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>baropodometric measurements: forefoot pressure variation</measure>
    <time_frame>72 hours</time_frame>
    <description>The investigator will be collected the forefoot pressure variation (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>baropodometric measurements: rearfoot support surface</measure>
    <time_frame>72 hours</time_frame>
    <description>The investigator will be collected the rearfoot support surface (cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>baropodometric measurements: hindfoot load</measure>
    <time_frame>72 hours</time_frame>
    <description>The investigator will be collected the hindfoot load ( %)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>baropodometric measurements: areas of maximum pressure between the foot lines</measure>
    <time_frame>72 hours</time_frame>
    <description>The investigator will be collected the areas of maximum pressure between the foot lines (g/cm)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Movement Disorders</condition>
  <arm_group>
    <arm_group_label>Deep dry needling in tibialis posterior</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Deep dry needling will be applied in the tibialis posterior myofascial trigger point</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham technique in tibialis posterior</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo tibialis dry needling</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Deep dry needling in tibialis posterior</intervention_name>
    <description>The inspector, with gloves, disinfects the area to be treated with 70º alcohol. Once the alcohol is applied, the intervenor locates and takes the myofascial trigger point and places the needle with the guide tube resting on the skin of the patient. The inspector holds the guide tube between the index and middle fingers lightly touch the needle with the index finger of the other hand to insert the needle perpendicularly into the skin, directing it towards the inspector's thumb. Once the needle is inserted subcutaneously, the guide tube is removed. The controller deepens the needle to myofascial trigger point, and makes fast inputs and outputs into it. The rapid exit is made to the subcutaneous cellular tissue, outside the muscle, but not outside the skin. Next, hemostasis is performed in the area. Once this hemostasis is completed, the patient is incorporated and dressed.</description>
    <arm_group_label>Deep dry needling in tibialis posterior</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sham technique in tibialis posterior</intervention_name>
    <description>The patient lies on the stretcher without the trousers. The interventor, with the guide tube, simulates the technique of puncture in the right twin of the subject. The comptroller cleans the area with 70º alcohol. Once the alcohol is applied, he performs the simulated dry needling technique in a plane with his index and middle fingers with the guide tube. It is important that the subject has his head stuck in the hollow of the head of the stretcher throughout the technique to make a correct masking.</description>
    <arm_group_label>Sham technique in tibialis posterior</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  presence of myofascial trigger point in the posterior tibialis&#xD;
&#xD;
          -  Accept participation in the study (signature of informed consent)&#xD;
&#xD;
          -  Do not present any exclusion criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Do not present myofascial trigger point in the tibialis posterior.&#xD;
&#xD;
          -  Suffering and / or having suffered from lower limb pathologies, deformities or&#xD;
             orthopedic injuries that could alter the static and biomechanics.&#xD;
&#xD;
          -  Not clearly identify the Myofascial trigger point in the tibialis posterior.&#xD;
&#xD;
          -  Have been diagnosed with fibromyalgia, myelopathy or radiculopathy.&#xD;
&#xD;
          -  Having contraindicated the technique of dry needling for suffering, for example,&#xD;
             coagulation problems.&#xD;
&#xD;
          -  Be pregnant.&#xD;
&#xD;
          -  Have used analgesics 24 hours before participating in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universidad CEU Cardenal Herrera</name>
      <address>
        <city>Valencia</city>
        <state>Moncada</state>
        <zip>46113</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://www.uchceu.es</url>
    <description>The University CEU-Cardenal Herrera is th first private university in the Valencian Community. It belongs to the Foundation San Pablo - CEU and is the leading educational organization in Spain with three Universities all over Spain</description>
  </link>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>December 12, 2018</last_update_submitted>
  <last_update_submitted_qc>December 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cardenal Herrera University</investigator_affiliation>
    <investigator_full_name>SERGIO MONTERO NAVARRO</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Movement Disorders</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 18, 2013</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03756428/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03756428
org study id: CEU UCH 210
nct id: NCT03756428
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to analyze the changes in plantar support after the technique of deep dry
      puncture in the posterior tibial. The data will be analyzed by a baropodometer which will
      record the possible changes in the footprint. The investigator will perform a
      pre-intervention measurement and 3 post-intervention measurements (immediately after the
      intervention, at 24 hours and at 72 hours)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Pain pressure threshold
time frame: 72 hours
description: Amount of pressure (Kg/cm2) applied at the tibialis posterior myofascial trigger point site that elicit pain for the patient will be reported
measure: baropodometric measurements: footprint
time frame: 72 hours
description: The investigator will be collected maximum pressure point in the footprint (g / cm)
measure: baropodometric measurements: Average footprint pressure
time frame: 72 hours
description: The investigator will be collected the average footprint pressure (g/cm)
measure: baropodometric measurements: forefoot area
time frame: 72 hours
description: The investigator will be collected the forefoot area (cm)
measure: baropodometric measurements:forefoot load
time frame: 72 hours
description: The investigator will be collected the forefoot load (%)
measure: baropodometric measurements: forefoot pressure variation
time frame: 72 hours
description: The investigator will be collected the forefoot pressure variation (%)
measure: baropodometric measurements: rearfoot support surface
time frame: 72 hours
description: The investigator will be collected the rearfoot support surface (cm)
measure: baropodometric measurements: hindfoot load
time frame: 72 hours
description: The investigator will be collected the hindfoot load ( %)
measure: baropodometric measurements: areas of maximum pressure between the foot lines
time frame: 72 hours
description: The investigator will be collected the areas of maximum pressure between the foot lines (g/cm)
arm group label: Deep dry needling in tibialis posterior
arm group type: Experimental
description: Deep dry needling will be applied in the tibialis posterior myofascial trigger point
arm group label: Sham technique in tibialis posterior
arm group type: Placebo Comparator
description: Placebo tibialis dry needling
intervention type: Procedure
intervention name: Deep dry needling in tibialis posterior
description: The inspector, with gloves, disinfects the area to be treated with 70º alcohol. Once the alcohol is applied, the intervenor locates and takes the myofascial trigger point and places the needle with the guide tube resting on the skin of the patient. The inspector holds the guide tube between the index and middle fingers lightly touch the needle with the index finger of the other hand to insert the needle perpendicularly into the skin, directing it towards the inspector's thumb. Once the needle is inserted subcutaneously, the guide tube is removed. The controller deepens the needle to myofascial trigger point, and makes fast inputs and outputs into it. The rapid exit is made to the subcutaneous cellular tissue, outside the muscle, but not outside the skin. Next, hemostasis is performed in the area. Once this hemostasis is completed, the patient is incorporated and dressed.
arm group label: Deep dry needling in tibialis posterior
intervention type: Procedure
intervention name: Sham technique in tibialis posterior
description: The patient lies on the stretcher without the trousers. The interventor, with the guide tube, simulates the technique of puncture in the right twin of the subject. The comptroller cleans the area with 70º alcohol. Once the alcohol is applied, he performs the simulated dry needling technique in a plane with his index and middle fingers with the guide tube. It is important that the subject has his head stuck in the hollow of the head of the stretcher throughout the technique to make a correct masking.
arm group label: Sham technique in tibialis posterior
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
url: http://www.uchceu.es
description: The University CEU-Cardenal Herrera is th first private university in the Valencian Community. It belongs to the Foundation San Pablo - CEU and is the leading educational organization in Spain with three Universities all over Spain
responsible party type: Principal Investigator
investigator affiliation: Cardenal Herrera University
investigator full name: SERGIO MONTERO NAVARRO
investigator title: Principal Investigator
mesh term: Movement Disorders
provided document: 