<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/NCT03750253</url>
  </required_header>
  <id_info>
    <org_study_id>ESWT</org_study_id>
    <nct_id>NCT03750253</nct_id>
  </id_info>
  <brief_title>Extracorporeal Shock Wave Therapy for Pain-Relief After Arthroscopy for Osteochondral Lesions of the Talus</brief_title>
  <official_title>Extracorporeal Shock Wave Therapy for Pain-Relief After Arthroscopy for Osteochondral Lesions of the Talus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southwest Hospital, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Southwest Hospital, China</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Arthroscopic surgery is effective in treating osteochondral lesions of the talus. However,&#xD;
      there are still some patients with postoperative ankle pain. This study aims to investigate&#xD;
      the clinical efficacy of shock wave adjuvant therapy in the treatment of postoperative pain&#xD;
      caused by cartilage injury of talus after arthroscopy and to provide basis for further&#xD;
      popularization and application.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Arthroscopic surgery is effective in treating osteochondral lesions of the talus. However,&#xD;
      there are still some patients with postoperative ankle pain. This study was conducted to&#xD;
      investigate the clinical efficacy of shock wave therapy in the treatment of postoperative&#xD;
      pain caused by cartilage injury of talus after arthroscopy.&#xD;
&#xD;
      Patients with osteochondral lesions of the talus treated by arthroscopic microfracture&#xD;
      surgery and still complained ankle pain three months after surgery were enrolled. Radial&#xD;
      extracorporeal shock wave therapy was used to give energy to the injured region of the talus&#xD;
      and the adjacent area.Treatment was done once a week for 5 consecutive weeks. After shock&#xD;
      wave therapy,the patients were followed by Visual Analogue Scale (VAS), the American&#xD;
      Orthopaedic Foot and Ankle Society ankle-hindfoot scale(AOFAS-AHFS) , and followed finally by&#xD;
      Magnetic Resonance Imaging(MRI) of the ankle.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 1, 2013</start_date>
  <completion_date type="Anticipated">July 1, 2019</completion_date>
  <primary_completion_date type="Actual">February 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of VAS scores before and after shock wave therapy</measure>
    <time_frame>6 weeks, 12 weeks and last follow-up at an average of 2 years after shock wave therapy</time_frame>
    <description>The Visual Analogue Scale scores of the patients before and after the shock wave therapy are recorded. The scale ranges from 0-10 points, and decreases of the value represent a better outcome. The data analyses are performed with SPSS version 16.0 statistical software. Continuous variables are expressed as mean ± standard deviation, and 95% confidence intervals are determined. The data are compared by paired t test or rank-sum test. P value &lt; 0.05 is considered as statistically significant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of AOFAS scores before and after shock wave therapy</measure>
    <time_frame>6 weeks, 12 weeks and last follow-up last follow-up at an average of 2 years after shock wave therapy</time_frame>
    <description>The American Orthopaedic Foot &amp; Ankle Society scores of the patients before and after the shock wave therapy are recorded. The scale ranges from 0-100 points, and increases of the value represent a better outcome. The data analyses are performed with SPSS version 16.0 statistical software. Continuous variables are expressed as mean ± standard deviation, and 95% confidence intervals are determined. The data are compared by paired t test or rank-sum test. P value &lt; 0.05 is considered as statistically significant.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Osteochondral Lesion of Talus</condition>
  <arm_group>
    <arm_group_label>Extracorporeal Shock Wave Therapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Extracorporeal Shock Wave Therapy to relieve pain after arthroscopy for osteochondral lesions of talus</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Extracorporeal Shock Wave Therapy</intervention_name>
    <description>Extracorporeal Shock Wave Therapy will be used for pain-relief after arthroscopy for osteochondral lesions of the talus</description>
    <arm_group_label>Extracorporeal Shock Wave Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. For arthroscopy:&#xD;
&#xD;
               -  Ankle pain, aggravated after exercise or weight-bearing activity, accompanied by&#xD;
                  lameness, joint stiffness and dysfunction for at least 3 months&#xD;
&#xD;
               -  No talar collapse&#xD;
&#xD;
               -  Talar cartilage injury cases before stage Ⅳ of Hepple classification&#xD;
&#xD;
          2. For shock wave therapy:&#xD;
&#xD;
               -  Patients with micro-fractures treated with arthroscopic treatment of talar&#xD;
                  cartilage injury and were treated with routine rehabilitation training after&#xD;
                  arthroscopy&#xD;
&#xD;
               -  Patients who till complained obvious ankle pain 3 months after surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cardiovascular and cerebrovascular diseases&#xD;
&#xD;
          -  Hemorrhagic diseases, coagulation disorders&#xD;
&#xD;
          -  Bone immaturity&#xD;
&#xD;
          -  Thrombosis&#xD;
&#xD;
          -  Use of anti-immune agents&#xD;
&#xD;
          -  Various types of tumor patients&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  History of mental illness&#xD;
&#xD;
          -  Patients who could not be followed&#xD;
&#xD;
          -  Patients with other lower extremity injuries after surgery and were unwilling to&#xD;
             participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaojun Duan, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Southwest Hospital, China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southwest Hospital</name>
      <address>
        <city>Chongqing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>November 18, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>March 20, 2019</last_update_submitted>
  <last_update_submitted_qc>March 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southwest Hospital, China</investigator_affiliation>
    <investigator_full_name>Xiaojun Duan</investigator_full_name>
    <investigator_title>Deputy Director of the Center for Joint Surgery</investigator_title>
  </responsible_party>
  <keyword>Extracorporeal Shock Wave Therapy</keyword>
  <keyword>Osteochondral Lesions of Talus</keyword>
  <keyword>Arthroscopy</keyword>
  <keyword>Pain-relief</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock</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/NCT03750253
org study id: ESWT
nct id: NCT03750253
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Arthroscopic surgery is effective in treating osteochondral lesions of the talus. However,
      there are still some patients with postoperative ankle pain. This study aims to investigate
      the clinical efficacy of shock wave adjuvant therapy in the treatment of postoperative pain
      caused by cartilage injury of talus after arthroscopy and to provide basis for further
      popularization and application.
Arthroscopic surgery is effective in treating osteochondral lesions of the talus. However,
      there are still some patients with postoperative ankle pain. This study was conducted to
      investigate the clinical efficacy of shock wave therapy in the treatment of postoperative
      pain caused by cartilage injury of talus after arthroscopy.

      Patients with osteochondral lesions of the talus treated by arthroscopic microfracture
      surgery and still complained ankle pain three months after surgery were enrolled. Radial
      extracorporeal shock wave therapy was used to give energy to the injured region of the talus
      and the adjacent area.Treatment was done once a week for 5 consecutive weeks. After shock
      wave therapy,the patients were followed by Visual Analogue Scale (VAS), the American
      Orthopaedic Foot and Ankle Society ankle-hindfoot scale(AOFAS-AHFS) , and followed finally by
      Magnetic Resonance Imaging(MRI) of the ankle.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change of VAS scores before and after shock wave therapy
time frame: 6 weeks, 12 weeks and last follow-up at an average of 2 years after shock wave therapy
description: The Visual Analogue Scale scores of the patients before and after the shock wave therapy are recorded. The scale ranges from 0-10 points, and decreases of the value represent a better outcome. The data analyses are performed with SPSS version 16.0 statistical software. Continuous variables are expressed as mean ± standard deviation, and 95% confidence intervals are determined. The data are compared by paired t test or rank-sum test. P value < 0.05 is considered as statistically significant.
measure: Change of AOFAS scores before and after shock wave therapy
time frame: 6 weeks, 12 weeks and last follow-up last follow-up at an average of 2 years after shock wave therapy
description: The American Orthopaedic Foot & Ankle Society scores of the patients before and after the shock wave therapy are recorded. The scale ranges from 0-100 points, and increases of the value represent a better outcome. The data analyses are performed with SPSS version 16.0 statistical software. Continuous variables are expressed as mean ± standard deviation, and 95% confidence intervals are determined. The data are compared by paired t test or rank-sum test. P value < 0.05 is considered as statistically significant.
arm group label: Extracorporeal Shock Wave Therapy
arm group type: Other
description: Extracorporeal Shock Wave Therapy to relieve pain after arthroscopy for osteochondral lesions of talus
intervention type: Other
intervention name: Extracorporeal Shock Wave Therapy
description: Extracorporeal Shock Wave Therapy will be used for pain-relief after arthroscopy for osteochondral lesions of the talus
arm group label: Extracorporeal Shock Wave Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Xiaojun Duan, M.D.
role: Principal Investigator
affiliation: Southwest Hospital, China
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Southwest Hospital, China
investigator full name: Xiaojun Duan
investigator title: Deputy Director of the Center for Joint Surgery
mesh term: Shock
sharing ipd: No