Patellofemoral Pain Syndrome
Conditions
Keywords
Patellofemoral pain syndrome, Feet orthoses, KOOS
Brief summary
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.
Interventions
DEVICEFoot orthoses
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Item Pain of the KOOS Score | Twice : at inclusion and at 10 weeks follow-up with feet orthoses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Twice : at inclusion and at 10 weeks follow-up with feet orthoses | Visual Analog Scale (VAS) |
Countries
France
Contacts
Primary ContactYann DIESINGER, MD
Outcome results
None listed