Foot Orthoses in Patellofemoral Pain Syndrome: a Prospective Randomized Study of Morpho-specific Versus Placebo Orthoses

Study Overview
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Brief Summary
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Patellofemoral pain syndrome is one of the most common musculoskeletal disorders. It is defined as an anterior knee pain. Its origin is a conflict during patellar tracking, due to patellofemoral malalignment and soft tissue overload. A few recent studies seem to show a benefit of prefabricated feet orthoses in patellofemoral pain syndrome, alone or in association with rehabilitation. However, no one has analyzed the outcome of morpho-specific foot orthoses in a prospective randomized study. The purpose of this prospective randomized study is to compare clinical outcomes in daily living and in sports activities, between morpho-specific and placebo foot orthoses. Morpho-specific foot orthoses are designed according to the patient's morphotype. They are intended to correct structural defects of the hindfoot, midfoot and forefoot, in the aim to correct abnormal overload during patellofemoral tracking.

Official Title
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Foot Orthoses in Patellofemoral Pain Syndrome: a Prospective Randomized Study of Morpho-specific Versus Placebo Orthoses

Conditions
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Patellofemoral Pain Syndrome

Intervention / Treatment
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* Device: Foot orthoses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 12-40 years Patellofemoral pain syndrome Patient affiliated to a social protection regime Patient who signed an informed consent For teenagers with no complete growth and muscular maturation, failure of appropriate rehabilitation during minimum 2 months Patient informed of the results of the prior medical examination Normality (no sign of osteoarthritis) of the knee radiographs Ability to read and understand French Exclusion Criteria: Knee osteoarthritis Systemic disease Inflammatory rheumatism disease Unstable knee Prior patellofemoral dislocation Osteochondrosis Referred pain from a hip or spine disease (particularly proximal femoral epiphysiolysis in the teenagers) A history of patellar trauma A history of knee surgery Meniscus, ligament or osteochondral pathology Knee tendinitis or bursitis Neurologic disease Pregnancy Antidepressant therapy or behavioral disorder Patient unable to comply the required maximum observance Impossibility to give enlightened information to the patient Patient under guardianship

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Morpho-specific foot orthoses<br>Morpho-specific thermo-molded foot orthoses are designed according to the patient's morphotype. Orthoses are custom-molded from different materials such as BIOFLUX resin, Covercuir MF, EVA300/60, EVA400/70, PE255/55, ABSORB Dur and CAPITON PU. | Device: Foot orthoses<br> <br> |
| Placebo Comparator: Placebo foot orthoses<br>The placebo foot orthoses will be made with the same principle of molding and with the same materials as for the experimental group. The only difference is that they involve no active corrective insert element : they will be made without morphotype correction. | Device: Foot orthoses<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Item Pain of the KOOS Score |  | Twice : at inclusion and at 10 weeks follow-up with feet orthoses | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS Score (items Symptoms, Activities of daily living, Sport and recreation function, Knee-related quality of life) |  | Twice : at inclusion and at 10 weeks follow-up with feet orthoses | 
| Kujala Score |  | Twice : at inclusion and at 10 weeks follow-up with feet orthoses | 
| Pain level | Visual Analog Scale (VAS) | Twice : at inclusion and at 10 weeks follow-up with feet orthoses | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patellofemoral pain syndrome, Feet orthoses, KOOS