- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04481022
Developmental of Clinical Prediction Rule for Females Responding to Proximal Control Exercises
Development of Clinical Prediction Rule for Classifying Females With Patellofemoral Pain Syndrome Who Respond to Proximal Control Exercises
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: group will receive 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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
baseline
|
|
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.
|
baseline
|
|
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.
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PFPS clinical prediction rule
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Patellofemoral Pain Syndrome Clinical Prediction Rule
-
University of North Carolina, Chapel HillCanadian Institutes of Health Research (CIHR)CompletedPatellofemoral Pain Syndrome | Patellofemoral Pain (PFPS) | Patellofemoral Pain | Patellofemoral Pain, PFPUnited States
-
Lauren EricksonAmerican College of Sports MedicineCompleted
-
Beijing Sport UniversityCompletedPatellofemoral PainChina
-
Boston Children's HospitalEnrolling by invitationPatellofemoral PainUnited States
-
Pamukkale UniversityNot yet recruitingPatellofemoral Pain, PFPTurkey (Türkiye)
-
Ahram Canadian UniversityNot yet recruitingPatellofemoral Pain (PFPS)Egypt
-
Beijing Sport UniversityCompletedPatellofemoral Pain, PFPChina
-
Beijing Sport UniversityNot yet recruitingPatellofemoral Pain, PFP
-
Beijing Sport UniversityNot yet recruiting
-
Istanbul University - CerrahpasaRecruitingPatellofemoral Pain, PFPTurkey (Türkiye)
Clinical Trials on proximal control exercises
-
Ahram Canadian UniversityBenha UniversityRecruiting
-
National Yang Ming Chiao Tung UniversityCompletedPatellofemoral Pain Syndrome | Hallux ValgusTaiwan
-
University of OklahomaMemorial Sloan Kettering Cancer Center; Massachusetts General Hospital; Tufts...CompletedTobacco Smoking | Health BehaviorUnited States
-
Universidad Complutense de MadridCompleted
-
Emory UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedVestibular Schwannoma | Vestibular Neuronitis | Vestibular Neuronitis, BilateralUnited States
-
Riphah International UniversityCompleted
-
Uskudar UniversityCompleted
-
University of Sao PauloCompletedShoulder Impingement SyndromeBrazil
-
AO Clinical Investigation and Publishing DocumentationSynthes Inc.; AO Research FundCompleted
-
University of GreenwichCompletedInjury Prevention