<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/NCT01691716</url>
  </required_header>
  <id_info>
    <org_study_id>PRJ-00014</org_study_id>
    <nct_id>NCT01691716</nct_id>
  </id_info>
  <brief_title>The Efficacy of Tendoactive, Eccentric Training, and the Combination of Both as a Treatment of Achilles Tendinopathy</brief_title>
  <acronym>Tendoactive</acronym>
  <official_title>A Prospective Randomized Study Comparing the Therapeutic Effect of Tendoactive®, Eccentric Training, and a Combination of Both as a Treatment of Achilles Tendinopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bioiberica</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bioiberica</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether Tendoactive, eccentric training, or the&#xD;
      combination or both could be effective in the treatment of Achilles tendinopathy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in VISA-A score at 12 weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>Functional impairment of the Achilles tendon is measured using VISA-A score. Score of patient-related outcome measure: Achilles tendon: VISA-A [0=worse, 100=perfect] derived from eight validated questions on pain and function during activities of daily living</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain level at rest [VAS 0-10]</measure>
    <time_frame>0, 6, 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain level at exertion [VAS 0-10]</measure>
    <time_frame>0, 6, 12weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Achilles transverse thickness by ultrasound</measure>
    <time_frame>0, 6, 12 weeks</time_frame>
    <description>Ultrasound evaluation of Achilles tendon. Maximum thickness will be recorded in the midportion of the affected Achilles tendon</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36 v2 quality of life survey</measure>
    <time_frame>0, 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>6, 12 weeks</time_frame>
    <description>Patient satisfaction will be evaluated using a subjective questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Achilles Tendinopathy</condition>
  <arm_group>
    <arm_group_label>Tendoactive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tendoactive dosage: 3 capsules per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Eccentric training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Protocol published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tendoactive and eccentric training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tendoactive dosage: 3 capsules per day. Eccentric training: protocol described by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tendoactive</intervention_name>
    <description>Food supplement containing mucopolysaccharides, type I collagen and vitamin C</description>
    <arm_group_label>Tendoactive</arm_group_label>
    <arm_group_label>Tendoactive and eccentric training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Eccentric training</intervention_name>
    <description>Eccentric training program published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)</description>
    <arm_group_label>Eccentric training</arm_group_label>
    <arm_group_label>Tendoactive and eccentric training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients suffering from a gradually evolving painful condition in the Achilles tendon&#xD;
             located at the midportion for at least 3 months (Diagnosis based on clinical&#xD;
             examination showing a painful thickening of the Achilles tendon located at a level of&#xD;
             2 to 6cm above the tendon insertion, and confirmed by ultrasonography: local&#xD;
             thickening of the tendon, irregular tendon structure with hypoechoic areas and&#xD;
             irregular fiber orientation).&#xD;
&#xD;
          -  Men and non-pregnant women aged 18-70 years&#xD;
&#xD;
          -  Be informed of the nature of the study and provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical suspicion of insertional disorders (pain at the site of the insertion of the&#xD;
             Achilles tendon on the calcaneum)&#xD;
&#xD;
          -  Clinical suspicion of an Achilles tendon rupture (Thompson test abnormal and palpable&#xD;
             &quot;gap&quot;)&#xD;
&#xD;
          -  Clinical suspicion of plantar flexor tenosynovitis (posteromedial pain when the toes&#xD;
             are plantar flexed against resistance)&#xD;
&#xD;
          -  Clinical suspicion of n.suralis pathology (sensitive disorder in the area of the sural&#xD;
             nerve)&#xD;
&#xD;
          -  Clinical suspicion of peroneal subluxation&#xD;
&#xD;
          -  Suspicion of internal disorders: spondylarthropathy, gout, hyperlipidemia, Rheumatoid&#xD;
             Arthritis and sarcoidosis.&#xD;
&#xD;
          -  Condition that prevents the patients from executing an active exercise programme&#xD;
&#xD;
          -  Patient has already performed eccentric exercises, according to the schedule of&#xD;
             Alfredson et al (12 weeks)&#xD;
&#xD;
          -  Patient has already received an injection of PRP for this injury&#xD;
&#xD;
          -  Patient does not wish, for whatever reason, to undergo one of the two treatments&#xD;
&#xD;
          -  Known presence of a pregnancy&#xD;
&#xD;
          -  Condition of the Achilles tendon caused by medications (arising in relation to moment&#xD;
             of intake), such as quinolones and statins&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CEARE</name>
      <address>
        <city>Esplugues de Llobregat</city>
        <state>Barcelona</state>
        <zip>08950</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CMI</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clínica CEMTRO</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AMS - Centro de Ejercicio</name>
      <address>
        <city>Malaga</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Medicina y Deporte</name>
      <address>
        <city>Toledo</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clínica Traumatológica</name>
      <address>
        <city>Valladolid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Alfredson H, Pietila T, Jonsson P, Lorentzon R. Heavy-load eccentric calf muscle training for the treatment of chronic Achilles tendinosis. Am J Sports Med. 1998 May-Jun;26(3):360-6. doi: 10.1177/03635465980260030301.</citation>
    <PMID>9617396</PMID>
  </reference>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>February 25, 2014</last_update_submitted>
  <last_update_submitted_qc>February 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Achilles tendinopathy</keyword>
  <keyword>Tendoactive</keyword>
  <keyword>Eccentric training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tendinopathy</mesh_term>
  </condition_browse>
  <!-- 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/NCT01691716
org study id: PRJ-00014
nct id: NCT01691716
lead sponsor: 
The purpose of this study is to determine whether Tendoactive, eccentric training, or the
      combination or both could be effective in the treatment of Achilles tendinopathy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Baseline in VISA-A score at 12 weeks
time frame: 12 weeks
description: Functional impairment of the Achilles tendon is measured using VISA-A score. Score of patient-related outcome measure: Achilles tendon: VISA-A [0=worse, 100=perfect] derived from eight validated questions on pain and function during activities of daily living
measure: Pain level at rest [VAS 0-10]
time frame: 0, 6, 12 weeks
measure: Pain level at exertion [VAS 0-10]
time frame: 0, 6, 12weeks
measure: Achilles transverse thickness by ultrasound
time frame: 0, 6, 12 weeks
description: Ultrasound evaluation of Achilles tendon. Maximum thickness will be recorded in the midportion of the affected Achilles tendon
measure: SF-36 v2 quality of life survey
time frame: 0, 12 weeks
measure: Patient satisfaction
time frame: 6, 12 weeks
description: Patient satisfaction will be evaluated using a subjective questionnaire.
arm group label: Tendoactive
arm group type: Experimental
description: Tendoactive dosage: 3 capsules per day
arm group label: Eccentric training
arm group type: Active Comparator
description: Protocol published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)
arm group label: Tendoactive and eccentric training
arm group type: Active Comparator
description: Tendoactive dosage: 3 capsules per day. Eccentric training: protocol described by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)
intervention type: Drug
intervention name: Tendoactive
description: Food supplement containing mucopolysaccharides, type I collagen and vitamin C
arm group label: Tendoactive
arm group label: Tendoactive and eccentric training
intervention type: Behavioral
intervention name: Eccentric training
description: Eccentric training program published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)
arm group label: Eccentric training
arm group label: Tendoactive and eccentric training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Spain
citation: Alfredson H, Pietila T, Jonsson P, Lorentzon R. Heavy-load eccentric calf muscle training for the treatment of chronic Achilles tendinosis. Am J Sports Med. 1998 May-Jun;26(3):360-6. doi: 10.1177/03635465980260030301.
PMID: 9617396
responsible party type: Sponsor
mesh term: Tendinopathy