<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/NCT03029910</url>
  </required_header>
  <id_info>
    <org_study_id>UEMadrid-Tendon01</org_study_id>
    <nct_id>NCT03029910</nct_id>
  </id_info>
  <brief_title>Eccentric Training and Cryotherapy Vs Eccentric Training and Whole Body Vibration in Achilles Tendinopathy</brief_title>
  <official_title>Eccentric Training and Cryotherapy Vs Eccentric Training and Whole Body Vibration in Achilles Tendinopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Europea de Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Europea 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 purpose of this study is to determine the effectiveness of eccentric exercise combined&#xD;
      with vibration or cryotherapy in Achilles tendon pathology.&#xD;
&#xD;
      The investigators hypothesis is that the combined eccentric exercise is better than the&#xD;
      results presented by the exclusive eccentric exercise.&#xD;
&#xD;
      This intervention differs from the classic studies in that we maintain the intensity&#xD;
      throughout the treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2017</start_date>
  <completion_date type="Actual">January 15, 2018</completion_date>
  <primary_completion_date type="Actual">December 15, 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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change at Achilles Tendon Cross Sectional Area</measure>
    <time_frame>3 months</time_frame>
    <description>Ultrasound diagnosis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change at Achilles Tendon Thickness</measure>
    <time_frame>3 months</time_frame>
    <description>Ultrasound diagnosis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Differences between healthy volunteers and volunteers with Achilles tendinopathy</measure>
    <time_frame>2 weeks</time_frame>
    <description>Ultrasound diagnosis</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">132</enrollment>
  <condition>Achilles Tendon</condition>
  <condition>Tendinopathy</condition>
  <arm_group>
    <arm_group_label>Cryotherapy and eccentric exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Vibration and eccentric exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cryotherapy and eccentric exercise</intervention_name>
    <description>12 weeks, 5 days/week, once a day, 2 exercises, 3 sets/exercise, 15 repetition/set. Of excentric exercise of foot plantar flexors. First exercise with knee in extension. Second exercise with knee in flexion. Previously subjects should cool their leg in ice water during sixteen minutes at a temperature of 8ºC (+/-2ºC)</description>
    <arm_group_label>Cryotherapy and eccentric exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vibration and eccentric exercise</intervention_name>
    <description>12 weeks, 5 days/week, once a day, 2 exercises, 3 sets/exercise, 15 repetition/set. Of excentric exercise of foot plantar flexors. First exercise with knee in extension. Second exercise with knee in flexion. During the exercise subjects will be subjected to vibration. Vibration parameters: Frequency: 35Hz, Amplitude: 4 millimeters, Force: 3,9G</description>
    <arm_group_label>Vibration and eccentric exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sports people&#xD;
&#xD;
          -  Positive initial ultrasound diagnosis&#xD;
&#xD;
          -  Presence of degenerative changes at achilles mid portion&#xD;
&#xD;
          -  Chronic Achilles tendon pain, (3/10 VAS)&#xD;
&#xD;
          -  Pain when walking or running of Achilles tendon, (3/10 VAS)&#xD;
&#xD;
          -  Pain in load in plantar flexion of Achilles tendon, 3/10 VAS)&#xD;
&#xD;
          -  Pain in palpation of Achilles, (3/10 VAS)&#xD;
&#xD;
          -  Morning Stiffness&#xD;
&#xD;
        Inclusion Criteria Healthy pople:&#xD;
&#xD;
          -  Sports people&#xD;
&#xD;
          -  Negative initial ultrasound diagnosis&#xD;
&#xD;
          -  No syntomp of achilles tendinophaty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receive physical, orthotic or physiotherapeutic treatment&#xD;
&#xD;
          -  Asociated low back pain, ankle/knee/hip injury that may affect the study&#xD;
&#xD;
          -  Previous injury or surgery of Achilles tendon.&#xD;
&#xD;
          -  Pathologies that may limit the joint of ankle&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Obesity&#xD;
&#xD;
          -  Patients with diabetes and/or other endocrine or metabolic pathologies or neurologic&#xD;
             pathologies&#xD;
&#xD;
          -  Patients diagnosed with cardiovascular disease&#xD;
&#xD;
          -  Subjets diagnosed with familiar hypercholesterolemia and/or presence of xanthomas or&#xD;
             with hyperuricemia&#xD;
&#xD;
          -  Patients who have received renal transplantation&#xD;
&#xD;
          -  Subjects who have suffered retinal detachment&#xD;
&#xD;
          -  Subjects who have received oral contraceptives, statins, corticoids or hormone&#xD;
             replacement therapy in the last six months&#xD;
&#xD;
          -  Subjects who have received treatment wiht fluoroquinolones in the last two years&#xD;
&#xD;
          -  Subjects who have received treatment with AINE's in the last four weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universidad Europea</name>
      <address>
        <city>Madrid</city>
        <zip>28022</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>February 15, 2018</last_update_submitted>
  <last_update_submitted_qc>February 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Europea de Madrid</investigator_affiliation>
    <investigator_full_name>Pedro Javier Martin</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Eccentric exercise</keyword>
  <keyword>Whole body vibration</keyword>
  <keyword>Cryotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tendinopathy</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/NCT03029910
org study id: UEMadrid-Tendon01
nct id: NCT03029910
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine the effectiveness of eccentric exercise combined
      with vibration or cryotherapy in Achilles tendon pathology.

      The investigators hypothesis is that the combined eccentric exercise is better than the
      results presented by the exclusive eccentric exercise.

      This intervention differs from the classic studies in that we maintain the intensity
      throughout the treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Change at Achilles Tendon Cross Sectional Area
time frame: 3 months
description: Ultrasound diagnosis.
measure: Change at Achilles Tendon Thickness
time frame: 3 months
description: Ultrasound diagnosis.
measure: Differences between healthy volunteers and volunteers with Achilles tendinopathy
time frame: 2 weeks
description: Ultrasound diagnosis
arm group label: Cryotherapy and eccentric exercise
arm group type: Experimental
arm group label: Vibration and eccentric exercise
arm group type: Experimental
arm group label: Control
arm group type: No Intervention
intervention type: Other
intervention name: Cryotherapy and eccentric exercise
description: 12 weeks, 5 days/week, once a day, 2 exercises, 3 sets/exercise, 15 repetition/set. Of excentric exercise of foot plantar flexors. First exercise with knee in extension. Second exercise with knee in flexion. Previously subjects should cool their leg in ice water during sixteen minutes at a temperature of 8ºC (+/-2ºC)
arm group label: Cryotherapy and eccentric exercise
intervention type: Other
intervention name: Vibration and eccentric exercise
description: 12 weeks, 5 days/week, once a day, 2 exercises, 3 sets/exercise, 15 repetition/set. Of excentric exercise of foot plantar flexors. First exercise with knee in extension. Second exercise with knee in flexion. During the exercise subjects will be subjected to vibration. Vibration parameters: Frequency: 35Hz, Amplitude: 4 millimeters, Force: 3,9G
arm group label: Vibration and eccentric exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Europea de Madrid
investigator full name: Pedro Javier Martin
investigator title: Principal Investigator
mesh term: Tendinopathy
sharing ipd: No