Clinical trial NCT02250144: Foot Orthoses in Patellofemoral Pain Syndrome: a Prospective Randomized Study of Morpho-specific Versus Placebo Orthoses
Official title: Foot Orthoses in Patellofemoral Pain Syndrome: a Prospective Randomized Study of Morpho-specific Versus Placebo Orthoses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Keywords: Patellofemoral pain syndrome
Feet orthoses
KOOS
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2014-09-26
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Item Pain of the KOOS Score
timeFrame: Twice : at inclusion and at 10 weeks follow-up with feet orthoses
Secondary outcomes:
measure: KOOS Score (items Symptoms, Activities of daily living, Sport and recreation function, Knee-related quality of life)
timeFrame: Twice : at inclusion and at 10 weeks follow-up with feet orthoses
measure: Kujala Score
timeFrame: Twice : at inclusion and at 10 weeks follow-up with feet orthoses
measure: Pain level
timeFrame: Twice : at inclusion and at 10 weeks follow-up with feet orthoses
Other outcomes:
Locations:
city: Haguenau
country: France
facility: Cabinet libéral - 12, rue du Puits
city: Illkirch Graffenstaden
country: France
facility: Service de Chirurgie Orthopédique - Hôpital CCOM - Hôpitaux Universitaires de Strasbourg
city: Strasbourg
country: France
facility: Cabinet libéral - 50, avenue des Vosges
Study officials:
References: