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

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.

Study Overview

• Status: Unknown
• Conditions: Patellofemoral Pain Syndrome
• Intervention / Treatment: Device: Foot orthoses

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Haguenau, France, 67500
    • Recruiting
    • Cabinet libéral - 12, rue du Puits
    • Contact: Joseph ARNDT, MD; Email: joseph.arndt@hotmail.fr
    • Principal Investigator: Joseph ARNDT, MD
  • Illkirch Graffenstaden, France, 67400
    • Recruiting
    • Service de Chirurgie Orthopédique - Hôpital CCOM - Hôpitaux Universitaires de Strasbourg
    • Contact: Yann DIESINGER, MD; Phone Number: 0033 388552310; Email: yann.diesinger@chru-strasbourg.fr
    • Principal Investigator: Yann DIESINGER, MD
  • Strasbourg, France, 67000
    • Recruiting
    • Cabinet libéral - 50, avenue des Vosges
    • Contact: Christian LUTZ, MD; Email: lutzortho@wanadoo.fr
    • Principal Investigator: Christian LUTZ, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Item Pain of the KOOS Score	Twice : at inclusion and at 10 weeks follow-up with feet orthoses

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Visual Analog Scale (VAS)	Twice : at inclusion and at 10 weeks follow-up with feet orthoses

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: September 16, 2014
• First Submitted That Met QC Criteria: September 23, 2014
• First Posted (Estimate): September 26, 2014

Study Record Updates

• Last Update Posted (Estimate): August 7, 2015
• Last Update Submitted That Met QC Criteria: August 6, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: KOOS; Patellofemoral pain syndrome; Feet orthoses
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Joint Diseases; Musculoskeletal Diseases; Syndrome; Somatoform Disorders; Patellofemoral Pain Syndrome
• Other Study ID Numbers: 5832