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

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Unknown status

CT.gov ID

NCT02250144

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

26.7

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patellofemoral Pain Syndrome	Device: Foot orthoses	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jun 1, 2015

Anticipated Primary Completion Date :

Aug 1, 2016

Anticipated Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: Foot orthoses
Placebo Comparator: 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.	Device: Foot orthoses

Arm

Intervention/Treatment

Experimental: 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.

Device: Foot orthoses

Placebo Comparator: 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.

Device: Foot orthoses

Outcome Measures

Primary Outcome Measures

Item Pain of the KOOS Score [Twice : at inclusion and at 10 weeks follow-up with feet orthoses]

Secondary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 40 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Cabinet libéral - 12, rue du Puits	Haguenau	France	67500
2	Service de Chirurgie Orthopédique - Hôpital CCOM - Hôpitaux Universitaires de Strasbourg	Illkirch Graffenstaden	France	67400
3	Cabinet libéral - 50, avenue des Vosges	Strasbourg	France	67000