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Developmental of Clinical Prediction Rule for Females Responding to Proximal Control Exercises

Primary Purpose

Patellofemoral Pain Syndrome Clinical Prediction Rule

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
proximal control exercises
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome Clinical Prediction Rule focused on measuring clinical predicton rule, proximal control exercises

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 to 35 years.
  • Anterior or retropatellar knee pain of non-traumatic origin that was greater than six weeks duration and provoked by at least two predefined activities (prolonged sitting or kneeling, squatting, jogging or running, hopping, jumping, or stair walking).
  • Pain on palpation of the patellar facets, or with step down from a 15 cm step, or double leg squat.

Exclusion Criteria:

  1. Concomitant injury or pathology of other knee structures.
  2. Previous knee surgery.
  3. patellofemoral instability (history of sublaxation or dislocation; positive apprehension test).
  4. knee joint effusion.
  5. Osgood-Schlatter's.
  6. hip or lumbar spine pain (local or referred).
  7. physiotherapy within previous year; prior foot orthoses treatment or use of anti inflammatories or corticosteroids.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    group will receive proximal control exercises

    Arm Description

    Outcomes

    Primary Outcome Measures

    level of pain
    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
    functional status
    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.
    Dynamic knee valgus 2d frontal plane projection angle
    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.

    Secondary Outcome Measures

    isometric muscle power of hip abductor and external rotation
    Hand held dynamometer will be used to asses isomteric hip abductor and isometric hip external rotator power

    Full Information

    First Posted
    July 17, 2020
    Last Updated
    September 1, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04481022
    Brief Title
    Developmental of Clinical Prediction Rule for Females Responding to Proximal Control Exercises
    Official Title
    Development of Clinical Prediction Rule for Classifying Females With Patellofemoral Pain Syndrome Who Respond to Proximal Control Exercises
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 3, 2020 (Anticipated)
    Primary Completion Date
    April 30, 2021 (Anticipated)
    Study Completion Date
    August 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Patellofemoral Pain Syndrome Clinical Prediction Rule
    Keywords
    clinical predicton rule, proximal control exercises

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group will receive proximal control exercises
    Arm Type
    Other
    Intervention Type
    Other
    Intervention Name(s)
    proximal control exercises
    Intervention 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).
    Primary Outcome Measure Information:
    Title
    level of pain
    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
    Time Frame
    baseline
    Title
    functional status
    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.
    Time Frame
    baseline
    Title
    Dynamic knee valgus 2d frontal plane projection angle
    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.
    Time Frame
    baseline
    Secondary Outcome Measure Information:
    Title
    isometric muscle power of hip abductor and external rotation
    Description
    Hand held dynamometer will be used to asses isomteric hip abductor and isometric hip external rotator power
    Time Frame
    baseline

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18 to 35 years. Anterior or retropatellar knee pain of non-traumatic origin that was greater than six weeks duration and provoked by at least two predefined activities (prolonged sitting or kneeling, squatting, jogging or running, hopping, jumping, or stair walking). Pain on palpation of the patellar facets, or with step down from a 15 cm step, or double leg squat. Exclusion Criteria: Concomitant injury or pathology of other knee structures. Previous knee surgery. patellofemoral instability (history of sublaxation or dislocation; positive apprehension test). knee joint effusion. Osgood-Schlatter's. hip or lumbar spine pain (local or referred). physiotherapy within previous year; prior foot orthoses treatment or use of anti inflammatories or corticosteroids.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    khaled AlaaEldin Fetouh, Master
    Phone
    01090737464
    Ext
    20
    Email
    drkhaled929292@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Mohamed El Melhat, dr
    Phone
    01112595022
    Ext
    20
    Email
    ahmed.elmelhat@cu.edu.eg

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17549951
    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.
    Results Reference
    background
    PubMed Identifier
    20929936
    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.
    Results Reference
    background
    PubMed Identifier
    17154139
    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.
    Results Reference
    background

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    Developmental of Clinical Prediction Rule for Females Responding to Proximal Control Exercises

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