Intra-articular Hyaluronic Acid Injection for Therapy-resistant Patellofemoral Pain Syndrome
- Conditions
- Patellofemoral Pain Syndrome
- Interventions
- Device: Hylan G-F 20
- Registration Number
- NCT02613247
- Lead Sponsor
- University of Calgary
- 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 Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- Adults aged 18-45
- Previously diagnosed with PFPS that failed to improve with at least 6 weeks of active rehabilitation, supervised by physiotherapist.
- Retropatellar or peripatellar knee pain for a minimum of 2 months
- Pain aggravated by at least two of the following patellofemoral joint loading activities: squatting, running, ascending or descending stairs, or sitting with prolonged knee flexion
- Pain with patellar grind test on clinical examination
- Visual Analog Scale (VAS) > 4/10 with patellofemoral joint loading activities
- Normal knee x-ray
- X-ray evidence of osteoarthritis or fracture
- Meniscal or ligamentous injury suspected clinical examination
- Previous knee surgery
- History of patellar instability or positive patellar apprehension test
- Any contraindication to knee injection (overlying skin or joint infection, joint effusion, coagulopathy, previous adverse reaction etc.)
- Known allergy to avian products
- Previous knee injection within the last 3 months
- Pregnant or breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Delayed-start group Hylan G-F 20 Washout control group which then becomes an experimental group (Hylan G-F 20 6 mL intra-articular knee injection) at 6 weeks post-enrolment Immediate-start group Hylan G-F 20 Hylan G-F 20 6 mL intra-articular knee injection
- Primary Outcome Measures
Name Time Method Pain measured using the visual analog scale (VAS) 6 weeks
- Secondary Outcome Measures
Name Time Method Function measured using the Anterior Knee Pain Scale (AKPS) 6 weeks and 12 weeks Kinetic and kinematic data 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
Pain measured using the visual analog scale (VAS) Weekly until 12 weeks post injection
Trial Locations
- Locations (1)
Calgary Running Injury Clinic
🇨🇦Calgary, Alberta, Canada