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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: University Hospital, Strasbourg, France

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • KOOS Score (items Symptoms, Activities of daily living, Sport and recreation function, Knee-related quality of life) [ Time Frame: Twice : at inclusion and at 10 weeks follow-up with feet orthoses ]
  • Kujala Score [ Time Frame: Twice : at inclusion and at 10 weeks follow-up with feet orthoses ]
  • Pain level [ Time Frame: Twice : at inclusion and at 10 weeks follow-up with feet orthoses ]
    Visual Analog Scale (VAS)


Original Secondary Outcome: Same as current

Information By: University Hospital, Strasbourg, France

Dates:
Date Received: September 16, 2014
Date Started: June 2015
Date Completion: August 2016
Last Updated: August 6, 2015
Last Verified: August 2015