<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/NCT01691170</url>
  </required_header>
  <id_info>
    <org_study_id>USP01</org_study_id>
    <nct_id>NCT01691170</nct_id>
  </id_info>
  <brief_title>Comparison of Two Protocols for Patellofemoral Pain Syndrome</brief_title>
  <acronym>PFPS</acronym>
  <official_title>Quadriceps Femoris Strengthening Versus Hamstring Stretching for Patellofemoral Pain Syndrome: A Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <brief_summary>
    <textblock>
      The patellofemoral pain syndrome (PFPS) is defined as a painful complaint in the anterior&#xD;
      aspect of the knee, although peripatellar pain and / or retropatellar are also common. In&#xD;
      general, conservative treatment is the initial option of choice for patients with PFPS,&#xD;
      however, the lack of a specific causal factor makes it difficult to choose the best treatment&#xD;
      so early. This way, the purpose of this study is investigate the effects of the quadriceps&#xD;
      femoris strengthening versus hamstring stretching in patients with pattellofemoral pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2008</start_date>
  <completion_date type="Actual">September 2011</completion_date>
  <primary_completion_date type="Actual">February 2011</primary_completion_date>
  <phase>Phase 1/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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Numeric Pain Rating Scale</measure>
    <time_frame>Participants will be followed for the duration of 8 weeks.</time_frame>
    <description>Pain was assessed using an 11-point numeric pain rating scale (NPRS), on which 0 denoted an absence of pain and 10 denoted unbearable pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lysholm Scale</measure>
    <time_frame>Participants will be followed for the duration of 8 weeks.</time_frame>
    <description>This questionnaire is made up of eight items with objective response options. The final score is expressed in nominal and ordinal form, as follows: 95 to 100 points - excellent; 84 to 94 points - good; 65 to 83 points - fair; and 64 or fewer points - poor.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Patellofemoral Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>Quadriceps Strengthening</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Stretching Hamstring</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stretching Hamstring</intervention_name>
    <arm_group_label>Stretching Hamstring</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quadriceps Strengthening</intervention_name>
    <arm_group_label>Quadriceps Strengthening</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Symptoms of anterior knee pain for at least 1 moth;&#xD;
&#xD;
          -  Average pain level of 3 or more on a 10-cm visual analogue scale during stepping up&#xD;
             and down a 25-cm height;&#xD;
&#xD;
          -  Anterior or retropatellar knee pain on at least 2 of the following activities:&#xD;
             prolonged sitting, climbing stairs, squatting, running, kneeling, and hopping/jumping;&#xD;
&#xD;
          -  Presence of 2 of the following clinical criteria on assessment: pain during&#xD;
             apprehension test, pain during the patellar compression test, and crepitation during&#xD;
             the compression test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous knee surgery or arthritis;&#xD;
&#xD;
          -  History of patellar dislocation or subluxation, malalignment, or ligament laxity;&#xD;
&#xD;
          -  Patellar tendon pathology or chondral damage;&#xD;
&#xD;
          -  Spinal referred pain;&#xD;
&#xD;
          -  History of other abnormalities such as leg length inequalities (&gt;2 cm);&#xD;
&#xD;
          -  Medication as a part of the treatment;&#xD;
&#xD;
          -  Previous physical therapy or acupuncture treatment for the knee within the previous 30&#xD;
             days.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Physical Therapy, Speech and Occupational Therapy Department, University of São Paulo.</name>
      <address>
        <city>São Paulo</city>
        <zip>05360-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 16, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>September 21, 2012</last_update_submitted>
  <last_update_submitted_qc>September 21, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Gabriel Peixoto Leão Almeida, PT</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Pattelofemoral pain syndrome</keyword>
  <keyword>Stretching</keyword>
  <keyword>Strengthening</keyword>
  <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/NCT01691170
org study id: USP01
nct id: NCT01691170
lead sponsor: 
The patellofemoral pain syndrome (PFPS) is defined as a painful complaint in the anterior
      aspect of the knee, although peripatellar pain and / or retropatellar are also common. In
      general, conservative treatment is the initial option of choice for patients with PFPS,
      however, the lack of a specific causal factor makes it difficult to choose the best treatment
      so early. This way, the purpose of this study is investigate the effects of the quadriceps
      femoris strengthening versus hamstring stretching in patients with pattellofemoral pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Numeric Pain Rating Scale
time frame: Participants will be followed for the duration of 8 weeks.
description: Pain was assessed using an 11-point numeric pain rating scale (NPRS), on which 0 denoted an absence of pain and 10 denoted unbearable pain.
measure: Lysholm Scale
time frame: Participants will be followed for the duration of 8 weeks.
description: This questionnaire is made up of eight items with objective response options. The final score is expressed in nominal and ordinal form, as follows: 95 to 100 points - excellent; 84 to 94 points - good; 65 to 83 points - fair; and 64 or fewer points - poor.
arm group label: Quadriceps Strengthening
arm group type: Active Comparator
arm group label: Stretching Hamstring
arm group type: Active Comparator
intervention type: Other
intervention name: Stretching Hamstring
arm group label: Stretching Hamstring
intervention type: Other
intervention name: Quadriceps Strengthening
arm group label: Quadriceps Strengthening
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Gabriel Peixoto Leão Almeida, PT
investigator title: Principal Investigator
mesh term: Patellofemoral Pain Syndrome
mesh term: Syndrome
mesh term: Somatoform Disorders