Clinical trial NCT05714397: Effectiveness of Cingal™ for Improving Pain Scores and Function in Anterior Knee Pain
Official title: Effectiveness of Cingal™ for Improving Pain Scores and Function in Anterior Knee Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anterior Knee Pain Syndrome
Lead sponsor: Banff Sport Medicine Foundation
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Anterior Knee Pain (AKP) is a common condition that can be challenging to treat effectively. The main goal of treatment regimens is to improve the function of the knee. However, treatment can be challenging due to the knee pain experience. Cingal™ contains hyaluronic acid (HA), which acts as a joint lubricant, and the corticosteroid triamcinolone hexacetonide (TH). Some studies have shown that Cingal™ can improve joint function and provide short-term pain relief.


Eligibility criteria: Inclusion Criteria:

* Age 18 - 35 years
* Standard weight-bearing AP and skyline view knee x-rays
* Retropatellar or peripatellar knee pain for a minimum of 2 months
* Confirmed diagnosis of AKP that has failed to improve with a minimum of 6 weeks of conservative treatment (activity modification, supervised physiotherapy, exercise therapy, taping or bracing, NSAIDS)
* 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.

Exclusion Criteria:

* X-ray evidence of knee osteoarthritis or fracture
* Meniscal or ligamentous injury assessed or suspected on clinical examination
* Previous knee surgery
* History of patellar instability
* Any contraindication to knee injection (overlying skin condition, joint infection, significant joint effusion, coagulopathy, previous adverse reaction, etc.)
* Known allergy to Cingal™ or its constituents
* Previous knee injection within the last 3 months
* BMI greater than 30 kg/m2
* Diabetes, inflammatory conditions (rheumatologic disease, ankylosing spondylitis), or concurrent medical conditions which may result in chronic pain or altered pain sensation
* Pregnant or breastfeeding
* Workers Compensation Board case
* Patient involved in litigation

Primary outcomes:
measure: 2D Kinematic Data
timeFrame: baseline, 6 weeks, 12 weeks
Secondary outcomes:
measure: Strength Testing
timeFrame: baseline, 12 weeks
measure: Biomechanical Assessment
timeFrame: baseline, 12 weeks
measure: Pain scores measured using a 100 mm Visual Analog Scale (VAS)
timeFrame: baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks
measure: Anterior knee pain using the Anterior Knee Pain Scale (AKPS)
timeFrame: baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks
measure: Symptoms of knee injury using the Knee Injury and Osteoarthritis Outcomes Score (KOOS)
timeFrame: baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks
measure: General activity rating using the Marx Activity Score
timeFrame: baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks
Other outcomes:
Locations:
city: Canmore
country: Canada
facility: Banff Sport Medicine
state: Alberta
Study officials:
affiliation: Banff Sport Medicine Foundation
name: Laurie Hiemstra, MD PhD FRCSC
role: PRINCIPAL_INVESTIGATOR
References: