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

Patellofemoral Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02250144
• Other study ID #: 5832
• Status: Recruiting
• Phase: N/A
• First received: September 16, 2014
• Last updated: August 6, 2015
• Start date: June 2015
• Est. completion date: August 2016

Study information

• Verified date: August 2015
• Source: University Hospital, Strasbourg, France
• Contact: Yann DIESINGER, MD
• Phone: 388552310
• Email: yann.diesinger[@]chru-strasbourg.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Patellofemoral Pain Syndrome
• Somatoform Disorders
• Syndrome

Intervention

Device:
• Foot orthoses

Locations

Country	Name	City	State
France	Cabinet libéral - 12, rue du Puits	Haguenau
France	Service de Chirurgie Orthopédique - Hôpital CCOM - Hôpitaux Universitaires de Strasbourg	Illkirch Graffenstaden
France	Cabinet libéral - 50, avenue des Vosges	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Item Pain of the KOOS Score		Twice : at inclusion and at 10 weeks follow-up with feet orthoses	No
Secondary	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	No
Secondary	Kujala Score		Twice : at inclusion and at 10 weeks follow-up with feet orthoses	No
Secondary	Pain level	Visual Analog Scale (VAS)	Twice : at inclusion and at 10 weeks follow-up with feet orthoses	No