<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/NCT03274557</url>
  </required_header>
  <id_info>
    <org_study_id>2014/1277/REK sør-øst</org_study_id>
    <nct_id>NCT03274557</nct_id>
  </id_info>
  <brief_title>Radiofrequence Microtenotomy for Treatment of Achilles Tendinose</brief_title>
  <acronym>RFM</acronym>
  <official_title>Treatment of Achilles Tendinose</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital of North Norway</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital of North Norway</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>
      Prospective randomized controlled study using radio-frequency microtenotomy or physical&#xD;
      therapy (eccentric training) for treatment of Achilles tendinose&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Achilless tendinosis is a major clinical problem. There is a need for new studies to map the&#xD;
      effectiveness of treatment. This study will compare treatment effectiveness between&#xD;
      traditional physical therapy with surgical treatment using (RFM). The tendinosis grade will&#xD;
      be evaluated using MRI and /or ultrasound before and after intervention. The outcome&#xD;
      measurment include VAS and function using ( FAOS FOOT &amp; ANKLE SURVEY) at 6,12 weeks and 6, 12&#xD;
      months after intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2017</start_date>
  <completion_date type="Actual">December 30, 2018</completion_date>
  <primary_completion_date type="Actual">December 30, 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>
    <intervention_model_description>To evaluate improvement of VAS and functionality before and after treatment of Achilles tendinosis using radiofrequency-plasma based microtenotomy in comparison to traditional physical therapy.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain reduction</measure>
    <time_frame>6.12 weeks and 6,12 months</time_frame>
    <description>Pain reduction. Change of pain from baseline measured with VAS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Function</measure>
    <time_frame>6.12 weeks and 6,12 months</time_frame>
    <description>Change from baseline in functionality measured by (FAOS) FOOT &amp; ANKLE SURVEY</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Achilles Pain</condition>
  <arm_group>
    <arm_group_label>Radiofrequency microtenotomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment of Achilles tendinose with radio-frequency microtenotomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phusical therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Supervised eccentric training</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>RFM</intervention_name>
    <arm_group_label>Phusical therapy</arm_group_label>
    <arm_group_label>Radiofrequency microtenotomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with pain in Achilles tendon for at least 6 weeks.&#xD;
&#xD;
          -  MR / ultrasound confirms diagnosis tendinose.&#xD;
&#xD;
          -  Pain in sport and daily activities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Other co-morbidity that constitutes contraindication for surgery, serious illness, bad&#xD;
        compliance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital of North Norway</name>
      <address>
        <city>Tromsø</city>
        <zip>9038</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>February 25, 2019</last_update_submitted>
  <last_update_submitted_qc>February 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Achilles, tendinose, tendinopathy, pain</keyword>
  <!-- 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/NCT03274557
org study id: 2014/1277/REK sør-øst
nct id: NCT03274557
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective randomized controlled study using radio-frequency microtenotomy or physical
      therapy (eccentric training) for treatment of Achilles tendinose
Achilless tendinosis is a major clinical problem. There is a need for new studies to map the
      effectiveness of treatment. This study will compare treatment effectiveness between
      traditional physical therapy with surgical treatment using (RFM). The tendinosis grade will
      be evaluated using MRI and /or ultrasound before and after intervention. The outcome
      measurment include VAS and function using ( FAOS FOOT & ANKLE SURVEY) at 6,12 weeks and 6, 12
      months after intervention.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: To evaluate improvement of VAS and functionality before and after treatment of Achilles tendinosis using radiofrequency-plasma based microtenotomy in comparison to traditional physical therapy.
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Pain reduction
time frame: 6.12 weeks and 6,12 months
description: Pain reduction. Change of pain from baseline measured with VAS
measure: Function
time frame: 6.12 weeks and 6,12 months
description: Change from baseline in functionality measured by (FAOS) FOOT & ANKLE SURVEY
arm group label: Radiofrequency microtenotomy
arm group type: Active Comparator
description: Treatment of Achilles tendinose with radio-frequency microtenotomy
arm group label: Phusical therapy
arm group type: Active Comparator
description: Supervised eccentric training
intervention type: Procedure
intervention name: RFM
arm group label: Phusical therapy
arm group label: Radiofrequency microtenotomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
facility: 
country: Norway
responsible party type: Sponsor