Clinical Trial: Intra-articular Hyaluronic Acid Injection for Therapy-resistant Patellofemoral Pain Syndrome

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

Official Title: Intra-articular Hyaluronic Acid Injection for Therapy-resistant Patellofemoral Pain Syndrome: an Open-label, Randomized, Delayed-start Clinical Trial

Brief Summary:

Patellofemoral pain syndrome (PFPS) is the most common overuse injury seen in the athletic population, particularly amongst runners. The standard of care treatment for PFPS is a comprehensive active rehabilitation program. Eighty percent of patients with PFPS report improvement in their symptoms with such a program. Unfortunately, the remaining twenty percent fail to achieve adequate symptom relief with rehabilitation alone. Considering the enormous number of individuals running for fitness, PFPS represents a significant challenge to public health as the investigators strive to encourage active living in our society.

A relationship between PFPS and the development of patellofemoral osteoarthritis (PFOA) has been suggested in scientific literature. Given that intra-articular viscosupplementation (hyaluronic acid) injections have shown clinically significant symptom improvement in knee osteoarthritis, and PFPS is likely on the same spectrum, the investigators propose a trial for therapy-resistant PFPS.

Hyaluronic acid is a naturally occurring molecule found in the synovial fluid of freely movable joints (such as the knee). It is believed to contribute to lubrication and cushioning in these joints. The composition of synovial fluid within arthritic joints is altered, resulting in reduced fluid viscosity and elasticity. One modern formulation of hyaluronic acid is Hylan G-F 20 (Synvisc-One, Sanofi Canada). This treatment is offered as a single injection and will be utilized in this clinical trial.


Detailed Summary:
Sponsor: University of Calgary

Current Primary Outcome: Pain measured using the visual analog scale (VAS) [ Time Frame: 6 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Function measured using the Anterior Knee Pain Scale (AKPS) [ Time Frame: 6 weeks and 12 weeks ]
  • Pain measured using the visual analog scale (VAS) [ Time Frame: Weekly until 12 weeks post injection ]
  • Kinetic and kinematic data [ Time Frame: Baseline compared to 6 weeks post injection ]
    Data will be collected using a 3-D motion analysis system with 8 cameras and an instrumented treadmill


Original Secondary Outcome: Same as current

Information By: University of Calgary

Dates:
Date Received: November 20, 2015
Date Started: March 2016
Date Completion: December 2017
Last Updated: November 6, 2016
Last Verified: November 2016