<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/NCT01727596</url>
  </required_header>
  <id_info>
    <org_study_id>200904034R</org_study_id>
    <nct_id>NCT01727596</nct_id>
  </id_info>
  <brief_title>The Effects and Predictors of Patella Taping in the Treatment of Patellafemoral Pain Syndrome</brief_title>
  <official_title>The Effects and Predictors of Patella Taping in the Treatment of Patellafemoral Pain Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Taping has been used for more than 20 years for patellofemoral pain syndrome&#xD;
      (PFPS) but the effectiveness is still controversial.&#xD;
&#xD;
      Purpose: This prospective study was conducted to investigate the effect and predictors of&#xD;
      effectiveness of taping in treating PFPS.&#xD;
&#xD;
      Study design: Prospective cohort study Methods: One hundred consecutive patients with the&#xD;
      diagnosis of PFPS were included in the study. Factors including sex, age, body mass index&#xD;
      (BMI), Q angle, lateral patella displacement (LPD), lateral patellofemoral angle (LPA) and&#xD;
      pre-taping pain score were measured. One well-trained therapist applied adhesive tape to each&#xD;
      patient by McConnell approach. Before and after taping, patients completed a visual analog&#xD;
      pain scale (VAS) after performing a step-down from an 8-inch platform. Paired-t test was used&#xD;
      for the difference of the VAS score measured before and after taping. Patients with&#xD;
      improvement of more than 1 point in VAS score after taping were considered responsible, and&#xD;
      others were non-responsible. The results were analyzed by logistic regression.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2009</start_date>
  <completion_date type="Actual">June 2009</completion_date>
  <primary_completion_date type="Actual">May 2009</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>Treatment</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VAS score</measure>
    <time_frame>two weeks</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Patellofemoral Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>taping</intervention_name>
    <description>Briefly, the patella was manually displaced medially, and maintained in the position by Tex Tape (Kinesio Holding Corporation, Albuquerque, NM)</description>
    <arm_group_label>1</arm_group_label>
    <other_name>McConnell taping, patella tapping</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (1) between the age of 20 to 60 years, (2) antero-, retro-, or peri-patellar pain from&#xD;
             at least two of the following: prolonged sitting, ascending or descending stairs,&#xD;
             prolonged walking, squatting, and (3) insidious onset of symptoms unrelated to a&#xD;
             traumatic incident.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1) symptoms or signs of any intrarticular derangement of the knee joint, such as&#xD;
             effusion, ligament laxity, and meniscal tear, (2) tenderness over the patella tendon,&#xD;
             iliotibial band, or pes anserinus tendons, (3) Osgood-Schlatter disease or&#xD;
             Sinding-Larsen-Joahanssen syndromes, (4) referral pain from hip or lumbar region, (5)&#xD;
             a history of patellar dislocation, previous knee surgery or infection, (6) malignancy,&#xD;
             (7) present pregnancy, (8) recent treatment for the PFPS, such as physiotherapy,&#xD;
             non-steroid anti-inflammatory or corticosteroid medication, (9) advanced&#xD;
             osteoarthritis of the knee joint.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ching-Chuan Jiang, M.D. PHD</last_name>
    <role>Study Chair</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NTUH</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>December 18, 2009</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>November 15, 2012</last_update_submitted>
  <last_update_submitted_qc>November 15, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 16, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Patellofemoral Pain Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Somatoform Disorders</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/NCT01727596
org study id: 200904034R
nct id: NCT01727596
lead sponsor: 
has dmc: No
Background: Taping has been used for more than 20 years for patellofemoral pain syndrome
      (PFPS) but the effectiveness is still controversial.

      Purpose: This prospective study was conducted to investigate the effect and predictors of
      effectiveness of taping in treating PFPS.

      Study design: Prospective cohort study Methods: One hundred consecutive patients with the
      diagnosis of PFPS were included in the study. Factors including sex, age, body mass index
      (BMI), Q angle, lateral patella displacement (LPD), lateral patellofemoral angle (LPA) and
      pre-taping pain score were measured. One well-trained therapist applied adhesive tape to each
      patient by McConnell approach. Before and after taping, patients completed a visual analog
      pain scale (VAS) after performing a step-down from an 8-inch platform. Paired-t test was used
      for the difference of the VAS score measured before and after taping. Patients with
      improvement of more than 1 point in VAS score after taping were considered responsible, and
      others were non-responsible. The results were analyzed by logistic regression.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: VAS score
time frame: two weeks
arm group label: 1
arm group type: Experimental
intervention type: Other
intervention name: taping
description: Briefly, the patella was manually displaced medially, and maintained in the position by Tex Tape (Kinesio Holding Corporation, Albuquerque, NM)
arm group label: 1
other name: McConnell taping, patella tapping
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Ching-Chuan Jiang, M.D. PHD
role: Study Chair
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Patellofemoral Pain Syndrome
mesh term: Syndrome
mesh term: Somatoform Disorders