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

University Hospital, Strasbourg, France

Status: Unknown

Conditions: Patellofemoral Pain Syndrome

Treatments: Device: Foot orthoses

Study type: Interventional

Funder types: Other

Identifiers

NCT02250144

5832

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 12 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Morpho-specific foot orthoses

Experimental group

Description:

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.

Treatment:

Device: Foot orthoses

Placebo foot orthoses

Placebo Comparator group

Description:

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.

Treatment:

Device: Foot orthoses