Effectiveness of Cingal™ for Improving Pain Scores and Function in Anterior Knee Pain

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Cingal

About this trial

This is an interventional treatment trial for Anterior Knee Pain Syndrome

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Banff Sport Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cingal Injection

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Strength Testing

A crane scale (strain gauge) will assess isometric strength testing of the quadriceps and hamstring muscles.

Biomechanical Assessment

The Drop Vertical Jump test will be used to assess dynamic valgus collapse of the knee.

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".

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.

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.

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.

Full Information

NCT ID

NCT05714397

First Posted

January 17, 2023

Last Updated

January 26, 2023

Sponsor

Banff Sport Medicine Foundation

1. Study Identification

Unique Protocol Identification Number

NCT05714397

Brief Title

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

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

April 2023 (Anticipated)

Primary Completion Date

April 2024 (Anticipated)

Study Completion Date

November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Banff Sport Medicine Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anterior Knee Pain Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cingal Injection

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Cingal

Intervention Description

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.

Primary Outcome Measure Information:

Title

2D Kinematic Data

Description

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.

Time Frame

baseline, 6 weeks, 12 weeks

Secondary Outcome Measure Information:

Title

Strength Testing

Description

A crane scale (strain gauge) will assess isometric strength testing of the quadriceps and hamstring muscles.

Time Frame

baseline, 12 weeks

Title

Biomechanical Assessment

Description

The Drop Vertical Jump test will be used to assess dynamic valgus collapse of the knee.

Time Frame

baseline, 12 weeks

Title

Pain scores measured using a 100 mm Visual Analog Scale (VAS)

Description

The Pain VAS is anchored by 0, which corresponds to "no pain", and 10, which corresponds to the "worst possible pain".

Time Frame

baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks

Title

Anterior knee pain using the Anterior Knee Pain Scale (AKPS)

Description

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.

Time Frame

baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks

Title

Symptoms of knee injury using the Knee Injury and Osteoarthritis Outcomes Score (KOOS)

Description

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.

Time Frame

baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks

Title

General activity rating using the Marx Activity Score

Description

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.

Time Frame

baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

No

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Julie-Anne Fritz, PhD

Phone

4037602897

Ext

6

Email

BSMresearch@banffsportmed.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laurie Hiemstra, MD PhD FRCSC

Organizational Affiliation

Banff Sport Medicine Foundation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Banff Sport Medicine

City

Canmore

State/Province

Alberta

ZIP/Postal Code

T1W 0L5

Country

Canada

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laurie Hiemstra, MD PhD FRCSC

Phone

4037602897

12. IPD Sharing Statement

Plan to Share IPD

No

Anterior Knee Pain Syndrome

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial