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

Patellofemoral Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02613247
• Other study ID #: VIP-123
• Status: Recruiting
• Phase: Phase 2
• First received: November 20, 2015
• Last updated: November 6, 2016
• Start date: March 2016
• Est. completion date: December 2017

Study information

• Verified date: November 2016
• Source: University of Calgary
• Contact: Jordan Raugust
• Phone: 403-251-1165
• Email: info[@]kinesis.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Adults aged 18-45

2. Previously diagnosed with PFPS that failed to improve with at least 6 weeks of active rehabilitation, supervised by physiotherapist.

3. Retropatellar or peripatellar knee pain for a minimum of 2 months

4. 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

5. Pain with patellar grind test on clinical examination

6. Visual Analog Scale (VAS) > 4/10 with patellofemoral joint loading activities

7. Normal knee x-ray

Exclusion Criteria:

1. X-ray evidence of osteoarthritis or fracture

2. Meniscal or ligamentous injury suspected clinical examination

3. Previous knee surgery

4. History of patellar instability or positive patellar apprehension test

5. Any contraindication to knee injection (overlying skin or joint infection, joint effusion, coagulopathy, previous adverse reaction etc.)

6. Known allergy to avian products

7. Previous knee injection within the last 3 months

8. Pregnant or breastfeeding

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Patellofemoral Pain Syndrome
• Somatoform Disorders
• Syndrome

Intervention

Device:
• Hylan G-F 20
Intra-articular injection of 6 mL Hylan G-F 20

Locations

Country	Name	City	State
Canada	Calgary Running Injury Clinic	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain measured using the visual analog scale (VAS)		6 weeks	No
Secondary	Function measured using the Anterior Knee Pain Scale (AKPS)		6 weeks and 12 weeks	No
Secondary	Pain measured using the visual analog scale (VAS)		Weekly until 12 weeks post injection	No
Secondary	Kinetic and kinematic data	Data will be collected using a 3-D motion analysis system with 8 cameras and an instrumented treadmill	Baseline compared to 6 weeks post injection	No