<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/NCT04481022</url>
  </required_header>
  <id_info>
    <org_study_id>PFPS clinical prediction rule</org_study_id>
    <nct_id>NCT04481022</nct_id>
  </id_info>
  <brief_title>Developmental of Clinical Prediction Rule for Females Responding to Proximal Control Exercises</brief_title>
  <official_title>Development of Clinical Prediction Rule for Classifying Females With Patellofemoral Pain Syndrome Who Respond to Proximal Control Exercises</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</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>
      the aim of study is to investigate the effect of body mass index (BMI), age, duration of&#xD;
      symptoms, pain severity and knee angle valgus on patient̕̕s response to proximal control&#xD;
      exercises.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patellofemoral pain syndrome (PFPS) is recognized as one of the most common lower-extremity&#xD;
      disorders encountered by orthopaedic physical therapists. Females were 2.23 times more likely&#xD;
      to develop PFPS than males. Various authors have suggested that hip weakness may be an&#xD;
      impairment associated with PFPS, because poor hip control may lead to abnormal lower&#xD;
      extremity or patellofemoral motions. Clinical prediction rules (CPRs) are tools designed to&#xD;
      improve decision making in clinical practice by assisting practitioners in making a&#xD;
      particular diagnosis, establishing a prognosis, or matching patients to optimal&#xD;
      interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 3, 2020</start_date>
  <completion_date type="Anticipated">August 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2021</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>level of pain</measure>
    <time_frame>baseline</time_frame>
    <description>visual analogue scale 100-mm horizontal line anchored by word descriptors at each end by no the left and worst imaginable pain on the right</description>
  </primary_outcome>
  <primary_outcome>
    <measure>functional status</measure>
    <time_frame>baseline</time_frame>
    <description>Kujala questionnaire is a 13-items knee specific self-report questionnaire. It documents response to six activities thought to be associated specifically with anterior knee pain syndrome (walking, running, jumping, climbing stairs, squatting, and sitting for prolonged periods with knees bent), as well as symptoms such as limp, inability to bear weight through the affected limb, swelling, abnormal patellar movement, muscle atrophy and limitation of knee flexion. This questionnaire was used to ssess the individual's functional status and PFPS experienced during specific functional tasks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dynamic knee valgus 2d frontal plane projection angle</measure>
    <time_frame>baseline</time_frame>
    <description>2D frontal plane projection angle (FPPA) analysis to measure dynamic knee valgus. for 2D FPPA analysis, the centers of each of hip, knee and ankle joints will be determined using a standard tape measure, markers will be placed at the midpoint of the ankle malleoli for the center of the ankle joint, midpoint of the femoral condyles to approximate the center of the knee joint, and on the proximal thigh at the midpoint of the line from the anterior superior iliac spine to the knee joint center.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>isometric muscle power of hip abductor and external rotation</measure>
    <time_frame>baseline</time_frame>
    <description>Hand held dynamometer will be used to asses isomteric hip abductor and isometric hip external rotator power</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Patellofemoral Pain Syndrome Clinical Prediction Rule</condition>
  <arm_group>
    <arm_group_label>group will receive proximal control exercises</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>proximal control exercises</intervention_name>
    <description>study investigates the effectiveness of proximal control exercises for patients with PFPS in improving pain and function. The findings of this systematic review are consistent with previous evidence reporting effectiveness of exercise for PFPS. In particular, there is consistent moderate to high quality evidence (three RCT, one CCT, three cohort studies, and one case series) that proximal interventions provide relief of pain and improved function in the short term, whereas the knee programs have variable effectiveness. Physical therapists should consider using proximal interventions for early stage treatment for PFPS (Peters et al., 2013).&#xD;
After 4 weeks of a combined knee and hip strengthening exercise program, sedentary females with PFPS had a greater reduction in pain during stair descent compared to the group who performed knee strengthening exercises only. Both groups also showed significant improvement in function and pain during stair ascent (Fakuda et al., 2010).</description>
    <arm_group_label>group will receive proximal control exercises</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 to 35 years.&#xD;
&#xD;
          -  Anterior or retropatellar knee pain of non-traumatic origin that was greater than six&#xD;
             weeks duration and provoked by at least two predefined activities (prolonged sitting&#xD;
             or kneeling, squatting, jogging or running, hopping, jumping, or stair walking).&#xD;
&#xD;
          -  Pain on palpation of the patellar facets, or with step down from a 15 cm step, or&#xD;
             double leg squat.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Concomitant injury or pathology of other knee structures.&#xD;
&#xD;
          2. Previous knee surgery.&#xD;
&#xD;
          3. patellofemoral instability (history of sublaxation or dislocation; positive&#xD;
             apprehension test).&#xD;
&#xD;
          4. knee joint effusion.&#xD;
&#xD;
          5. Osgood-Schlatter's.&#xD;
&#xD;
          6. hip or lumbar spine pain (local or referred).&#xD;
&#xD;
          7. physiotherapy within previous year; prior foot orthoses treatment or use of anti&#xD;
             inflammatories or corticosteroids.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>khaled AlaaEldin Fetouh, Master</last_name>
    <phone>01090737464</phone>
    <phone_ext>20</phone_ext>
    <email>drkhaled929292@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ahmed Mohamed El Melhat, dr</last_name>
    <phone>01112595022</phone>
    <phone_ext>20</phone_ext>
    <email>ahmed.elmelhat@cu.edu.eg</email>
  </overall_contact_backup>
  <reference>
    <citation>Robinson RL, Nee RJ. Analysis of hip strength in females seeking physical therapy treatment for unilateral patellofemoral pain syndrome. J Orthop Sports Phys Ther. 2007 May;37(5):232-8. doi: 10.2519/jospt.2007.2439.</citation>
    <PMID>17549951</PMID>
  </reference>
  <reference>
    <citation>Earl JE, Hoch AZ. A proximal strengthening program improves pain, function, and biomechanics in women with patellofemoral pain syndrome. Am J Sports Med. 2011 Jan;39(1):154-63. doi: 10.1177/0363546510379967. Epub 2010 Oct 7.</citation>
    <PMID>20929936</PMID>
  </reference>
  <reference>
    <citation>Lesher JD, Sutlive TG, Miller GA, Chine NJ, Garber MB, Wainner RS. Development of a clinical prediction rule for classifying patients with patellofemoral pain syndrome who respond to patellar taping. J Orthop Sports Phys Ther. 2006 Nov;36(11):854-66. doi: 10.2519/jospt.2006.2208.</citation>
    <PMID>17154139</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>September 1, 2020</last_update_submitted>
  <last_update_submitted_qc>September 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Khaled Alaa Eldin</investigator_full_name>
    <investigator_title>Mr</investigator_title>
  </responsible_party>
  <keyword>clinical predicton rule</keyword>
  <keyword>proximal control exercises</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>
  </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/NCT04481022
org study id: PFPS clinical prediction rule
nct id: NCT04481022
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
the aim of study is to investigate the effect of body mass index (BMI), age, duration of
      symptoms, pain severity and knee angle valgus on patient̕̕s response to proximal control
      exercises.
Patellofemoral pain syndrome (PFPS) is recognized as one of the most common lower-extremity
      disorders encountered by orthopaedic physical therapists. Females were 2.23 times more likely
      to develop PFPS than males. Various authors have suggested that hip weakness may be an
      impairment associated with PFPS, because poor hip control may lead to abnormal lower
      extremity or patellofemoral motions. Clinical prediction rules (CPRs) are tools designed to
      improve decision making in clinical practice by assisting practitioners in making a
      particular diagnosis, establishing a prognosis, or matching patients to optimal
      interventions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: level of pain
time frame: baseline
description: visual analogue scale 100-mm horizontal line anchored by word descriptors at each end by no the left and worst imaginable pain on the right
measure: functional status
time frame: baseline
description: Kujala questionnaire is a 13-items knee specific self-report questionnaire. It documents response to six activities thought to be associated specifically with anterior knee pain syndrome (walking, running, jumping, climbing stairs, squatting, and sitting for prolonged periods with knees bent), as well as symptoms such as limp, inability to bear weight through the affected limb, swelling, abnormal patellar movement, muscle atrophy and limitation of knee flexion. This questionnaire was used to ssess the individual's functional status and PFPS experienced during specific functional tasks.
measure: Dynamic knee valgus 2d frontal plane projection angle
time frame: baseline
description: 2D frontal plane projection angle (FPPA) analysis to measure dynamic knee valgus. for 2D FPPA analysis, the centers of each of hip, knee and ankle joints will be determined using a standard tape measure, markers will be placed at the midpoint of the ankle malleoli for the center of the ankle joint, midpoint of the femoral condyles to approximate the center of the knee joint, and on the proximal thigh at the midpoint of the line from the anterior superior iliac spine to the knee joint center.
measure: isometric muscle power of hip abductor and external rotation
time frame: baseline
description: Hand held dynamometer will be used to asses isomteric hip abductor and isometric hip external rotator power
arm group label: group will receive proximal control exercises
arm group type: Other
intervention type: Other
intervention name: proximal control exercises
description: study investigates the effectiveness of proximal control exercises for patients with PFPS in improving pain and function. The findings of this systematic review are consistent with previous evidence reporting effectiveness of exercise for PFPS. In particular, there is consistent moderate to high quality evidence (three RCT, one CCT, three cohort studies, and one case series) that proximal interventions provide relief of pain and improved function in the short term, whereas the knee programs have variable effectiveness. Physical therapists should consider using proximal interventions for early stage treatment for PFPS (Peters et al., 2013).
After 4 weeks of a combined knee and hip strengthening exercise program, sedentary females with PFPS had a greater reduction in pain during stair descent compared to the group who performed knee strengthening exercises only. Both groups also showed significant improvement in function and pain during stair ascent (Fakuda et al., 2010).
arm group label: group will receive proximal control exercises
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: khaled AlaaEldin Fetouh, Master
phone: 01090737464
phone ext: 20
email: drkhaled929292@yahoo.com
last name: Ahmed Mohamed El Melhat, dr
phone: 01112595022
phone ext: 20
email: ahmed.elmelhat@cu.edu.eg
citation: Robinson RL, Nee RJ. Analysis of hip strength in females seeking physical therapy treatment for unilateral patellofemoral pain syndrome. J Orthop Sports Phys Ther. 2007 May;37(5):232-8. doi: 10.2519/jospt.2007.2439.
PMID: 17549951
citation: Earl JE, Hoch AZ. A proximal strengthening program improves pain, function, and biomechanics in women with patellofemoral pain syndrome. Am J Sports Med. 2011 Jan;39(1):154-63. doi: 10.1177/0363546510379967. Epub 2010 Oct 7.
PMID: 20929936
citation: Lesher JD, Sutlive TG, Miller GA, Chine NJ, Garber MB, Wainner RS. Development of a clinical prediction rule for classifying patients with patellofemoral pain syndrome who respond to patellar taping. J Orthop Sports Phys Ther. 2006 Nov;36(11):854-66. doi: 10.2519/jospt.2006.2208.
PMID: 17154139
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Khaled Alaa Eldin
investigator title: Mr
mesh term: Patellofemoral Pain Syndrome
mesh term: Syndrome