Anterior Knee Pain SyndromeNCT05714397
Effectiveness of Cingal™ for Improving Pain Scores and Function in Anterior Knee Pain
A study testing Cingal in people with Anterior Knee Pain Syndrome, run by Banff Sport Medicine Foundation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Anterior Knee Pain Syndrome
- What is being tested?
- Cingal
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Banff Sport Medicine
Canmore, Alberta, T1W 0L5
Laurie Hiemstra, MD PhD FRCSC, 4037602897
About this study
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.
- Conditions
- Anterior Knee Pain Syndrome
- Being tested
- Cingal
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CingalDevice
A single Cingal injection will be administered by fellowship-trained physicians through ultrasound-guided injection using a 20-gauge needle into the joint space of the knee under sterile conditions. The needle track will be anesthetized with local anesthetic.
| Study group | Role | What they receive |
|---|---|---|
| Cingal Injection | Experimental | Cingal will be administered by fellowship-trained physicians through ultrasound-guided injection using a 20-gauge needle into the joint space of the knee under sterile conditions. The needle track will be anesthetized with local anesthetic. Receives: Device: Cingal |
What is being measured
The primary outcome is the main question the study is designed to answer.
2D Kinematic Data
Kinematic data will be collected at baseline and 6 and 12 weeks after administration of the Cingal™ injection. Outcome measures include ankle dorsiflexion at contact, maximum rear foot eversion, knee flexion at contact, knee adduction in late stance, and hip joint angle. In addition, the mean of three angle measurements for each parameter will be recorded.
Measured: baseline, 6 weeks, 12 weeks
Secondary outcomes (6)
Strength Testing
A crane scale (strain gauge) will assess isometric strength testing of the quadriceps and hamstring muscles.
Measured: baseline, 12 weeks
Biomechanical Assessment
The Drop Vertical Jump test will be used to assess dynamic valgus collapse of the knee.
Measured: baseline, 12 weeks
Pain scores measured using a 100 mm Visual Analog Scale (VAS)
The Pain VAS is anchored by 0, which corresponds to "no pain", and 10, which corresponds to the "worst possible pain".
Measured: baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks
Anterior knee pain using the Anterior Knee Pain Scale (AKPS)
The AKPS is a 13-item knee-specific self-report questionnaire. It documents responses to six activities thought to be explicitly associated with anterior knee pain syndrome (walking, running, jumping, climbing stairs, squatting, and sitting for prolonged periods with knees bent), as well as symptoms such as limp, inability to weight bear through the affected limb, swelling, abnormal patellar movement, muscle atrophy and limitation of knee flexion. In addition, the AKPS asks about the duration of symptoms and the limb(s) affected. The maximum score is 100, and lower scores indicate greater pain/disability.
Measured: baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks
Symptoms of knee injury using the Knee Injury and Osteoarthritis Outcomes Score (KOOS)
The KOOS is a knee-specific instrument developed to assess patients' opinions about their knee and associated problems.The KOOS assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. The KOOS is a patient reported joint-specific score, which may be useful for assessing changes in knee pathology over time, with or without treatment.
Measured: baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks
General activity rating using the Marx Activity Score
The MARX Activity Rating Scale is a four-item activity rating scale where the patient is asked to rate how often they were able to perform each activity (e.g., running, cutting, decelerating, and pivoting) in their most healthy and active state. The four knee functions are rated on a 5-point scale of frequency (from 0 - 5) and scores are added up to a maximum of sixteen points, with a higher score indicating more frequent participation.
Measured: baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study startApr 2026 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Knee Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Banff Sport Medicine Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurie Hiemstra, MD PhD FRCSC, Principal investigator, Banff Sport Medicine Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714397
- Sponsor's protocol ID
- REB21-0205
- Status last verified
- Feb 2025
- First submitted
- 17 Jan 2023
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cingal™ for Improving Pain Scores and Function in Anterior Knee Pain
- ClinicalTrials.gov ID
- NCT05714397
- Acronym / sponsor ID
- REB21-0205
- Conditions
- Anterior Knee Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Banff Sport Medicine FoundationUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cingal Injection | Experimental | Device: CingalCingal will be administered by fellowship-trained physicians through ultrasound-guided injection using a 20-gauge needle into the joint space of the knee under sterile conditions. The needle track will be anesthetized with local anesthetic. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CingalA single Cingal injection will be administered by fellowship-trained physicians through ultrasound-guided injection using a 20-gauge needle into the joint space of the knee under sterile conditions. The needle track will be anesthetized with local anesthetic. | Device | Cingal Injection |
Primary outcome
2D Kinematic Data
Time frame: baseline, 6 weeks, 12 weeks
Kinematic data will be collected at baseline and 6 and 12 weeks after administration of the Cingal™ injection. Outcome measures include ankle dorsiflexion at contact, maximum rear foot eversion, knee flexion at contact, knee adduction in late stance, and hip joint angle. In addition, the mean of three angle measurements for each parameter will be recorded.
6 secondary outcomes
Strength Testing
Time frame: baseline, 12 weeks
Biomechanical Assessment
Time frame: baseline, 12 weeks
Pain scores measured using a 100 mm Visual Analog Scale (VAS)
Time frame: baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks
Anterior knee pain using the Anterior Knee Pain Scale (AKPS)
Time frame: baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks
Symptoms of knee injury using the Knee Injury and Osteoarthritis Outcomes Score (KOOS)
Time frame: baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks
General activity rating using the Marx Activity Score
Time frame: baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laurie Hiemstra, MD PhD FRCSC principal investigator
Banff Sport Medicine Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cingal in people with Anterior Knee Pain Syndrome, run by Banff Sport Medicine Foundation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie-Anne Fritz, PhD (4037602897 ext. 6, BSMresearch@banffsportmed.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2D Kinematic Data (time frame: baseline, 6 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.