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
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
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.
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
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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