<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/NCT02197962</url>
  </required_header>
  <id_info>
    <org_study_id>Radial Shockwave</org_study_id>
    <nct_id>NCT02197962</nct_id>
  </id_info>
  <brief_title>Efficacy of Radial Shockwave Therapy for Treatment of Pain in Knee Osteoarthritis</brief_title>
  <official_title>Efficacy of Radial Shockwave Therapy for Treatment of Pain in Knee Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marta Imamura</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to compare the results of 2000 impulses of radius shockwaves&#xD;
      per week with 2000 placebo shockwaves on the treatment of pain and functional incapacity of&#xD;
      patients with severe primary knee osteoarthritis, who did not satisfactory respond to&#xD;
      previous conventional treatments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Prospective, placebo controlled randomized and double-blind study.&#xD;
&#xD;
        -  Treatment Method:&#xD;
&#xD;
      Radial extracorporeal shockwaves will be applied using the Swiss Dolorclast (EMS Electro&#xD;
      Medical Systems, Switzerland), generated by pneumatic waves.&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
        -  Group 1 - Intervention group Patients will receive 2,000 impulses of radial shockwave&#xD;
           per week, with pressure of 2.5bar to 4.0bar, at the frequency of 8Hz. The impulses will&#xD;
           be applied at the most painful site of the knee joint interface on manual palpation, for&#xD;
           three consecutive weeks.&#xD;
&#xD;
        -  Group 2 - Control Group:&#xD;
&#xD;
      Patients will receive 2,000 impulses of placebo radial shockwave per week, without any energy&#xD;
      flow intensity. Frequency of 8Hz will appear in the screen. The impulses will be applied at&#xD;
      the most painful site of the knee joint interface on manual palpation, for three consecutive&#xD;
      weeks.&#xD;
&#xD;
      Post application program for both groups: Three consecutive days of:&#xD;
&#xD;
        1. Hot packs (superficial heat) applied on the application site for 20 minutes;&#xD;
&#xD;
        2. Simple analgesics, when needed (Acetaminophen 500mg every 6 hours, or analogue in case&#xD;
           of allergy).&#xD;
&#xD;
      Outcome Evaluation:&#xD;
&#xD;
      The evaluation of pain intensity will be done according to the VAS (Visual Analog Scale) The&#xD;
      influence of pain on the functional capacity of patients will be measured with WOMAC (Western&#xD;
      Ontario and McMaster Osteoarthritis Index) for knee evaluation.&#xD;
&#xD;
      Another evaluation criteria will be the level of tolerance of pressure on several muscles and&#xD;
      other parts as the pes anserinus and patellar tendon, the knee joint interface, and the&#xD;
      supraspinal of L1 to S1 also on the dermatomal from T12 to S2. These measures will be done by&#xD;
      the Fisher algometry.&#xD;
&#xD;
      The evaluations will be carried out before the treatment, immediately after the treatment and&#xD;
      3 months after the end of the treatment.&#xD;
&#xD;
      Analgesia drut will be prescribed, if patients feel pain during the days after the&#xD;
      application.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2010</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>Phase 2</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale</measure>
    <time_frame>Before intervention and after 3 months of the end of intervention</time_frame>
    <description>The Visual Analog Scale consists of a straight line of 10cm length which presents the phrase &quot;absence of pain&quot; (0) at one extremity, and unbearable pain (10) at the other extremity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Level of tolerance of pain</measure>
    <time_frame>Immediately before the intervention, immediately after the intervention and 3 months after the intervention.</time_frame>
    <description>Measures will be taken with the Fisher algometry in the following muscles: vastus medialis, vastus lateralis, rectus femoris, gracilis, adductor longus, tibialis anterior, fibularis longus, quadratus lumborum, iliopsoas and popliteus; also at the pes anserinus and patellar tendon, the knee joint interface, the supraspinal of L1 to S1 and on the dermatomal from T12 to S2.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The influence of pain over the functional capacity of patients based on the WOMAC questionnaire</measure>
    <time_frame>Immediately before the intervention and 3 months after the intervention.</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Extracorporeal radial shockwaves</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive 2,000 impulses of extracorporeal radial shockwave per week, with pressure of 2.5bar to 4.0bar, at the frequency of 8Hz. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Radial Shockwaves</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will receive 2,000 impulses of placebo radial shockwave per week, without any energy flow intensity. Frequency of 8Hz will appear in the screen. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Extracorporeal Radial shockwaves</intervention_name>
    <description>Patients will receive 2,000 impulses of extracorporeal radial shockwaves or per week, with pressure of 2.5bar to 4.0bar, at the frequency of 8Hz. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.</description>
    <arm_group_label>Extracorporeal radial shockwaves</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo Radial Shockwaves</intervention_name>
    <description>Patients will receive 2,000 impulses of placebo extracorporeal radial shockwaves per week, without any pressure, therefore no energy will be applied, at the frequency of 8Hz. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.</description>
    <arm_group_label>Placebo Radial Shockwaves</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical and radiological diagnosis of primary knee diagnosis.&#xD;
&#xD;
          -  Pain intensity: Visual Analog Scale (VAS) ≥ 6;&#xD;
&#xD;
          -  One of more failures with conventional treatment (drugs, Non-Steroidal&#xD;
             Anti-inflammatory Drugs - NSAD, physiotherapy, stretching, acupuncture, orthosis and&#xD;
             others);&#xD;
&#xD;
          -  Age over 60 years;&#xD;
&#xD;
          -  No use of corticosteroids in the prior 48 hours;&#xD;
&#xD;
          -  No major osteoarthritis events in other joints of lower limbs (waist and ankle) and&#xD;
             lower back;&#xD;
&#xD;
          -  No clinical evidence of related neuropathy, including radiculopathy and peripheral&#xD;
             neuropathy;&#xD;
&#xD;
          -  Absence of systemic inflammatory disease (Rheumatoid arthritis, Reiter, ankylosing&#xD;
             spondylitis, generalized polyarthritis, cancer);&#xD;
&#xD;
          -  Absence of infection or cancer at the application site;&#xD;
&#xD;
          -  Absence of related endocrine and metabolic diseases;&#xD;
&#xD;
          -  Absence of fibromyalgia, diagnosed after the American College of Rheumatology, 1999;&#xD;
&#xD;
          -  Absence of severe blood dyscrasias;&#xD;
&#xD;
          -  Absence of severe psychiatric disturbances that requires psychiatric assessment;&#xD;
&#xD;
          -  Availability to comply with the clinic visits and follow up evaluations along the&#xD;
             treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who withdraw the informed consent form at any time&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marta Imamura, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto de Medicina Fisica e Reabilitacao HCFMUSP</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto de Ortopedia e Traumatologia HCFMUSP</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05403-010</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Medicina Fisica e Reabilitacao HCFMUSP</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05716-150</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>October 4, 2016</last_update_submitted>
  <last_update_submitted_qc>October 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Marta Imamura</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>Osteoarthritis</keyword>
  <keyword>Radial shockwaves</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</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/NCT02197962
org study id: Radial Shockwave
nct id: NCT02197962
lead sponsor: 
collaborator: 
has dmc: Yes
The objective of this study is to compare the results of 2000 impulses of radius shockwaves
      per week with 2000 placebo shockwaves on the treatment of pain and functional incapacity of
      patients with severe primary knee osteoarthritis, who did not satisfactory respond to
      previous conventional treatments.
-  Prospective, placebo controlled randomized and double-blind study.

        -  Treatment Method:

      Radial extracorporeal shockwaves will be applied using the Swiss Dolorclast (EMS Electro
      Medical Systems, Switzerland), generated by pneumatic waves.

      Intervention:

        -  Group 1 - Intervention group Patients will receive 2,000 impulses of radial shockwave
           per week, with pressure of 2.5bar to 4.0bar, at the frequency of 8Hz. The impulses will
           be applied at the most painful site of the knee joint interface on manual palpation, for
           three consecutive weeks.

        -  Group 2 - Control Group:

      Patients will receive 2,000 impulses of placebo radial shockwave per week, without any energy
      flow intensity. Frequency of 8Hz will appear in the screen. The impulses will be applied at
      the most painful site of the knee joint interface on manual palpation, for three consecutive
      weeks.

      Post application program for both groups: Three consecutive days of:

        1. Hot packs (superficial heat) applied on the application site for 20 minutes;

        2. Simple analgesics, when needed (Acetaminophen 500mg every 6 hours, or analogue in case
           of allergy).

      Outcome Evaluation:

      The evaluation of pain intensity will be done according to the VAS (Visual Analog Scale) The
      influence of pain on the functional capacity of patients will be measured with WOMAC (Western
      Ontario and McMaster Osteoarthritis Index) for knee evaluation.

      Another evaluation criteria will be the level of tolerance of pressure on several muscles and
      other parts as the pes anserinus and patellar tendon, the knee joint interface, and the
      supraspinal of L1 to S1 also on the dermatomal from T12 to S2. These measures will be done by
      the Fisher algometry.

      The evaluations will be carried out before the treatment, immediately after the treatment and
      3 months after the end of the treatment.

      Analgesia drut will be prescribed, if patients feel pain during the days after the
      application.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Visual Analog Scale
time frame: Before intervention and after 3 months of the end of intervention
description: The Visual Analog Scale consists of a straight line of 10cm length which presents the phrase "absence of pain" (0) at one extremity, and unbearable pain (10) at the other extremity.
measure: Level of tolerance of pain
time frame: Immediately before the intervention, immediately after the intervention and 3 months after the intervention.
description: Measures will be taken with the Fisher algometry in the following muscles: vastus medialis, vastus lateralis, rectus femoris, gracilis, adductor longus, tibialis anterior, fibularis longus, quadratus lumborum, iliopsoas and popliteus; also at the pes anserinus and patellar tendon, the knee joint interface, the supraspinal of L1 to S1 and on the dermatomal from T12 to S2.
measure: The influence of pain over the functional capacity of patients based on the WOMAC questionnaire
time frame: Immediately before the intervention and 3 months after the intervention.
arm group label: Extracorporeal radial shockwaves
arm group type: Experimental
description: Patients will receive 2,000 impulses of extracorporeal radial shockwave per week, with pressure of 2.5bar to 4.0bar, at the frequency of 8Hz. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
arm group label: Placebo Radial Shockwaves
arm group type: Placebo Comparator
description: Patients will receive 2,000 impulses of placebo radial shockwave per week, without any energy flow intensity. Frequency of 8Hz will appear in the screen. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
intervention type: Device
intervention name: Extracorporeal Radial shockwaves
description: Patients will receive 2,000 impulses of extracorporeal radial shockwaves or per week, with pressure of 2.5bar to 4.0bar, at the frequency of 8Hz. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
arm group label: Extracorporeal radial shockwaves
intervention type: Device
intervention name: Placebo Radial Shockwaves
description: Patients will receive 2,000 impulses of placebo extracorporeal radial shockwaves per week, without any pressure, therefore no energy will be applied, at the frequency of 8Hz. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
arm group label: Placebo Radial Shockwaves
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Marta Imamura, MD
role: Principal Investigator
affiliation: Instituto de Medicina Fisica e Reabilitacao HCFMUSP
facility: 
facility: 
country: Brazil
responsible party type: Sponsor-Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Marta Imamura
investigator title: Medical Doctor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No