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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04481022
Recruitment Status : Not yet recruiting
First Posted : July 22, 2020
Last Update Posted : September 3, 2020
Information provided by (Responsible Party):
Khaled Alaa Eldin, Cairo University

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.

Condition or disease Intervention/treatment Phase
Patellofemoral Pain Syndrome Clinical Prediction Rule Other: proximal control exercises Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of Clinical Prediction Rule for Classifying Females With Patellofemoral Pain Syndrome Who Respond to Proximal Control Exercises
Estimated Study Start Date : September 3, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : August 30, 2021

Arm Intervention/treatment
group will receive proximal control exercises Other: proximal control exercises

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 Measures :
  1. level of pain [ Time Frame: baseline ]
    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

  2. functional status [ Time Frame: baseline ]
    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.

  3. Dynamic knee valgus 2d frontal plane projection angle [ Time Frame: baseline ]
    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 :
  1. isometric muscle power of hip abductor and external rotation [ Time Frame: baseline ]
    Hand held dynamometer will be used to asses isomteric hip abductor and isometric hip external rotator power

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04481022

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Contact: khaled AlaaEldin Fetouh, Master 01090737464 ext 20
Contact: Ahmed Mohamed El Melhat, dr 01112595022 ext 20

Sponsors and Collaborators
Cairo University
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Responsible Party: Khaled Alaa Eldin, Mr, Cairo University Identifier: NCT04481022    
Other Study ID Numbers: PFPS clinical prediction rule
First Posted: July 22, 2020    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Khaled Alaa Eldin, Cairo University:
clinical predicton rule
proximal control exercises
Additional relevant MeSH terms:
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Patellofemoral Pain Syndrome
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases