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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-08-31

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.

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Detailed Description

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Conditions

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Patellofemoral Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Morpho-specific 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.

Group Type EXPERIMENTAL

Foot orthoses

Intervention Type DEVICE

Placebo 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.

Group Type PLACEBO_COMPARATOR

Foot orthoses

Intervention Type DEVICE

Interventions

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Foot orthoses

Intervention Type DEVICE

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

Minimum Eligible Age

12 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No