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Clinical Trials/NCT02250144
NCT02250144
Unknown
N/A

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

University Hospital, Strasbourg, France3 sites in 1 country80 target enrollmentJune 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Patellofemoral Pain Syndrome
Sponsor
University Hospital, Strasbourg, France
Enrollment
80
Locations
3
Primary Endpoint
Item Pain of the KOOS Score
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
August 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Strasbourg, France
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Item Pain of the KOOS Score

Time Frame: Twice : at inclusion and at 10 weeks follow-up with feet orthoses

Secondary Outcomes

  • 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)

Study Sites (3)

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