<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/NCT01680263</url>
  </required_header>
  <id_info>
    <org_study_id>K Homayouni</org_study_id>
    <nct_id>NCT01680263</nct_id>
  </id_info>
  <brief_title>Kinesiotaping in Treatment of Pes Anserinus Tendino-bursitis</brief_title>
  <official_title>Kinesiotaping in Treatment of Pes Anserinus Tendino-bursitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shiraz University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shiraz University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to determine the effects of kinesiotaping in comparison to NSAIDs&#xD;
      and physical therapy in treatment of pes anserinus tendino-bursitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The treatment of pes anserinus tendino-bursitis includes refraining from aggravating&#xD;
      activities, local modalities such as heat, ice, ultrasound (US), iontophoresis,&#xD;
      phonophoresis, electrical stimulation (ES), nonsteroidal anti-inflammatory drugs (NSAIDs) and&#xD;
      injections with either corticosteroids or local anesthetics. Another treatment that seems to&#xD;
      have a significant effect on the improvement of the disease is kinesiotaping. Kinesiotaping&#xD;
      is a cotton strip with an acrylic adhesive that is used for treating athletic injuries and a&#xD;
      variety of physical conditions. The therapeutic effects of the tape is to relax the overused&#xD;
      muscles and in rehabilitation to facilitate the underused muscles. Advocates claim that the&#xD;
      wave pattern found on the kinesiotaping has a lifting effect on the skin which can diminish&#xD;
      swelling and inflammation via improving circulation and reduce pain by removing pressure from&#xD;
      pain receptors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain (VAS)and swelling scores</measure>
    <time_frame>3 weeks</time_frame>
    <description>Visual analog scale for pain evaluation Assessment of the local swelling via palpation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The number of participants with adverse events</measure>
    <time_frame>3 weeks</time_frame>
    <description>The number of participants with adverse events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Pes Anserinus Tendinobursitis</condition>
  <arm_group>
    <arm_group_label>Kinesiotaping</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of kinesiotaping on the painful area in the form of &quot;space correction&quot;. Kinesiotaping was repeated for 3 weeks with 1 week interval</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NSAIDs/Physical therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>treatment was done with NSAIDs and 10 sessions of daily physical therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Kinesiotaping</intervention_name>
    <description>Use of kinesiotaping on the painful area in the form of &quot;space correction&quot;. Kinesiotaping was repeated for 3 weeks with 1week interval</description>
    <arm_group_label>Kinesiotaping</arm_group_label>
    <other_name>taping</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>NSAIDs/Physical therapy</intervention_name>
    <description>Use of non-steroidal anti-inflammatory drugs and 10 sessions of daily physical therapy.</description>
    <arm_group_label>NSAIDs/Physical therapy</arm_group_label>
    <other_name>non-steroidal anti-inflammatory drugs</other_name>
    <other_name>physical therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with clinical diagnosis of pes anserinus tendino-bursitis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous history of trauma or surgery on the knee joint,&#xD;
&#xD;
          -  History of NSAIDs induced acid-peptic disease&#xD;
&#xD;
          -  Systemic and rheumatic diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kaynoosh Homayouni, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Shiraz University of Medical Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shima Foruzi, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shiraz University of Medical Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fereshte Kalhori, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shiraz University of Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shiraz University of Medical Sciences</name>
      <address>
        <city>Shiraz</city>
        <state>Fars</state>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>July 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>September 3, 2012</last_update_submitted>
  <last_update_submitted_qc>September 3, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 7, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shiraz University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Kaynoosh Homayouni</investigator_full_name>
    <investigator_title>Assistant professor of Physical Medicine and Rehabilitation</investigator_title>
  </responsible_party>
  <keyword>Kinesiotaping</keyword>
  <keyword>pes anserinus tendino-bursitis</keyword>
  <keyword>nonsteroidal anti-inflammatory drugs</keyword>
  <keyword>physical therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bursitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Inflammatory Agents</mesh_term>
    <mesh_term>Anti-Inflammatory Agents, Non-Steroidal</mesh_term>
  </intervention_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/NCT01680263
org study id: K Homayouni
nct id: NCT01680263
lead sponsor: 
has dmc: No
The aim of this study was to determine the effects of kinesiotaping in comparison to NSAIDs
      and physical therapy in treatment of pes anserinus tendino-bursitis.
The treatment of pes anserinus tendino-bursitis includes refraining from aggravating
      activities, local modalities such as heat, ice, ultrasound (US), iontophoresis,
      phonophoresis, electrical stimulation (ES), nonsteroidal anti-inflammatory drugs (NSAIDs) and
      injections with either corticosteroids or local anesthetics. Another treatment that seems to
      have a significant effect on the improvement of the disease is kinesiotaping. Kinesiotaping
      is a cotton strip with an acrylic adhesive that is used for treating athletic injuries and a
      variety of physical conditions. The therapeutic effects of the tape is to relax the overused
      muscles and in rehabilitation to facilitate the underused muscles. Advocates claim that the
      wave pattern found on the kinesiotaping has a lifting effect on the skin which can diminish
      swelling and inflammation via improving circulation and reduce pain by removing pressure from
      pain receptors.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Pain (VAS)and swelling scores
time frame: 3 weeks
description: Visual analog scale for pain evaluation Assessment of the local swelling via palpation
measure: The number of participants with adverse events
time frame: 3 weeks
description: The number of participants with adverse events
arm group label: Kinesiotaping
arm group type: Experimental
description: Use of kinesiotaping on the painful area in the form of "space correction". Kinesiotaping was repeated for 3 weeks with 1 week interval
arm group label: NSAIDs/Physical therapy
arm group type: Active Comparator
description: treatment was done with NSAIDs and 10 sessions of daily physical therapy.
intervention type: Device
intervention name: Kinesiotaping
description: Use of kinesiotaping on the painful area in the form of "space correction". Kinesiotaping was repeated for 3 weeks with 1week interval
arm group label: Kinesiotaping
other name: taping
intervention type: Procedure
intervention name: NSAIDs/Physical therapy
description: Use of non-steroidal anti-inflammatory drugs and 10 sessions of daily physical therapy.
arm group label: NSAIDs/Physical therapy
other name: non-steroidal anti-inflammatory drugs
other name: physical therapy
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Kaynoosh Homayouni, M.D.
role: Study Chair
affiliation: Shiraz University of Medical Sciences
last name: Shima Foruzi, M.D.
role: Principal Investigator
affiliation: Shiraz University of Medical Sciences
last name: Fereshte Kalhori, M.D.
role: Principal Investigator
affiliation: Shiraz University of Medical Sciences
facility: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Shiraz University of Medical Sciences
investigator full name: Kaynoosh Homayouni
investigator title: Assistant professor of Physical Medicine and Rehabilitation
mesh term: Bursitis
mesh term: Anti-Inflammatory Agents
mesh term: Anti-Inflammatory Agents, Non-Steroidal