<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/NCT03308279</url>
  </required_header>
  <id_info>
    <org_study_id>Pronator Teres Prediction</org_study_id>
    <nct_id>NCT03308279</nct_id>
  </id_info>
  <brief_title>Prediction Model for Minimizing the Risk of Median Nerve Puncture</brief_title>
  <official_title>Ultrasound and Anthropometric Prediction Model for Minimizing the Risk of Median Nerve Puncture With Dry Needling Approach Into the Pronator Teres Muscle</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Autonoma de Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Autonoma de Madrid</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>
      The main aim of this study was to correlate anthropometric measures of the forearm in healthy&#xD;
      subjects with the ultrasound pronator teres depth to determine the needle length in order to&#xD;
      avoid injury of the median nerve during pronator teres dry needle approach. A cross-sectional&#xD;
      study, was carried out in order to perform a predictive model for the median nerve depth into&#xD;
      the pronator teres muscle using a decision tree analysis algorithm.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2016</start_date>
  <completion_date type="Actual">August 15, 2017</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle thicknesses</measure>
    <time_frame>10 minutes</time_frame>
    <description>With ultrasound</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Median Nerve depth</measure>
    <time_frame>5 minutes</time_frame>
    <description>With ultrasound</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forearm Perimeter</measure>
    <time_frame>2 minutes</time_frame>
    <description>in cm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forearm Longitude</measure>
    <time_frame>2 minutes</time_frame>
    <description>in cm</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">65</enrollment>
  <condition>Pronator Teres Nerve Syndrome</condition>
  <arm_group>
    <arm_group_label>Asinthomatic</arm_group_label>
    <description>The only group evaluated</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <description>Ultrasound and Anthropometric meassures</description>
    <arm_group_label>Asinthomatic</arm_group_label>
    <other_name>Anthropometric meassures</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Asinthomatic subjets who respond to the researchers calls&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Asinthomatic subjets&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pain in the 3 moths before in the forearm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
  </eligibility>
  <reference>
    <citation>Gurses IA, Altinel L, Gayretli O, Akgul T, Uzun I, Dikici F. Morphology and morphometry of the ulnar head of the pronator teres muscle in relation to median nerve compression at the proximal forearm. Orthop Traumatol Surg Res. 2016 Dec;102(8):1005-1008. doi: 10.1016/j.otsr.2016.08.016. Epub 2016 Nov 11.</citation>
    <PMID>27843079</PMID>
  </reference>
  <reference>
    <citation>Dang AC, Rodner CM. Unusual compression neuropathies of the forearm, part II: median nerve. J Hand Surg Am. 2009 Dec;34(10):1915-20. doi: 10.1016/j.jhsa.2009.10.017.</citation>
    <PMID>19969200</PMID>
  </reference>
  <reference>
    <citation>Kowalska B, Sudol-Szopinska I. Ultrasound assessment on selected peripheral nerve pathologies. Part I: Entrapment neuropathies of the upper limb - excluding carpal tunnel syndrome. J Ultrason. 2012 Sep;12(50):307-18. doi: 10.15557/JoU.2012.0016. Epub 2012 Sep 30.</citation>
    <PMID>26674101</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 7, 2017</study_first_submitted>
  <study_first_submitted_qc>October 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>October 12, 2017</last_update_submitted>
  <last_update_submitted_qc>October 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Autonoma de Madrid</investigator_affiliation>
    <investigator_full_name>Raúl Ferrer-Peña</investigator_full_name>
    <investigator_title>Prof. Raúl Ferrer Peña</investigator_title>
  </responsible_party>
  <keyword>dry needling</keyword>
  <keyword>median nerve</keyword>
  <keyword>Pronator Teres</keyword>
  <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/NCT03308279
org study id: Pronator Teres Prediction
nct id: NCT03308279
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main aim of this study was to correlate anthropometric measures of the forearm in healthy
      subjects with the ultrasound pronator teres depth to determine the needle length in order to
      avoid injury of the median nerve during pronator teres dry needle approach. A cross-sectional
      study, was carried out in order to perform a predictive model for the median nerve depth into
      the pronator teres muscle using a decision tree analysis algorithm.
observational model: Other
time perspective: Cross-Sectional
measure: Muscle thicknesses
time frame: 10 minutes
description: With ultrasound
measure: Median Nerve depth
time frame: 5 minutes
description: With ultrasound
measure: Forearm Perimeter
time frame: 2 minutes
description: in cm
measure: Forearm Longitude
time frame: 2 minutes
description: in cm
arm group label: Asinthomatic
description: The only group evaluated
intervention type: Diagnostic Test
intervention name: Ultrasound
description: Ultrasound and Anthropometric meassures
arm group label: Asinthomatic
other name: Anthropometric meassures
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
citation: Gurses IA, Altinel L, Gayretli O, Akgul T, Uzun I, Dikici F. Morphology and morphometry of the ulnar head of the pronator teres muscle in relation to median nerve compression at the proximal forearm. Orthop Traumatol Surg Res. 2016 Dec;102(8):1005-1008. doi: 10.1016/j.otsr.2016.08.016. Epub 2016 Nov 11.
PMID: 27843079
citation: Dang AC, Rodner CM. Unusual compression neuropathies of the forearm, part II: median nerve. J Hand Surg Am. 2009 Dec;34(10):1915-20. doi: 10.1016/j.jhsa.2009.10.017.
PMID: 19969200
citation: Kowalska B, Sudol-Szopinska I. Ultrasound assessment on selected peripheral nerve pathologies. Part I: Entrapment neuropathies of the upper limb - excluding carpal tunnel syndrome. J Ultrason. 2012 Sep;12(50):307-18. doi: 10.15557/JoU.2012.0016. Epub 2012 Sep 30.
PMID: 26674101
responsible party type: Principal Investigator
investigator affiliation: Universidad Autonoma de Madrid
investigator full name: Raúl Ferrer-Peña
investigator title: Prof. Raúl Ferrer Peña
sharing ipd: No