Foot Orthoses in Patellofemoral Pain Syndrome: a Prospective Randomized Study of Morpho-specific Versus Placebo Orthoses
- Conditions
- Patellofemoral Pain Syndrome
- Interventions
- Device: Foot orthoses
- Registration Number
- NCT02250144
- Lead Sponsor
- University Hospital, Strasbourg, France
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Morpho-specific foot orthoses Foot orthoses 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. Placebo foot orthoses Foot orthoses 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.
- Primary Outcome Measures
Name Time Method Item Pain of the KOOS Score Twice : at inclusion and at 10 weeks follow-up with feet orthoses
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (3)
Service de Chirurgie Orthopédique - Hôpital CCOM - Hôpitaux Universitaires de Strasbourg
🇫🇷Illkirch Graffenstaden, France
Cabinet libéral - 12, rue du Puits
🇫🇷Haguenau, France
Cabinet libéral - 50, avenue des Vosges
🇫🇷Strasbourg, France