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The goal of this study is to determine if pain in one knee influences loading of the other knee during different types of walking. The main questions it aims to answer are:
Participants will:
This study will evaluate the effects of unilateral knee pain on contralateral knee joint loading during different types of walking. Thirty adults with unilateral symptomatic knee osteoarthritis will complete four, 1.5-hour study visits. The first and third visits will include level, inclined, and declined walking at comfortable, fast, and slow speeds. The second and fourth visits will include a 30-minute walk. There will be at least two days between visits. The only difference between each pair of visits is that one visit will involve walking with unilateral knee pain (painful walking) and the other visit will involve walking without unilateral knee pain (nonpainful walking). Individuals will be recruited based on the presence of unilateral knee pain so the painful walking will be representative of their typical walking. For the visits with nonpainful walking, the third and fourth visits, pain will be alleviated by performing an intraarticular injection with a local anesthetic (lidocaine hydrochloride). All walking will be performed in a three-dimensional motion capture environment on a split-belt treadmill that is instrumented with force plates.
A cohort of 30 healthy individuals will complete the same walking conditions at two, 1.5-hour study visits. The healthy control group will not receive intraarticular knee injections. The purpose of this cohort is to better understand how walking mechanics in individuals with unilateral knee osteoarthritis compare to similar individuals without knee osteoarthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Knee Osteoarthritis | Experimental | Individuals with clinically defined unilateral symptomatic knee osteoarthritis. |
|
| Healthy | No Intervention | Individuals who serve as healthy controls. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine Hydrochloride | Drug | 10 mL of 1% lidocaine hydrochloride for each intraarticular knee injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Medial Knee Contact Forces During Walking | Contact forces estimated with musculoskeletal modeling | Change from before treatment (approximately 1 week prior to the injection visit) to 30 minutes after treatment (the injection). |
| Change in Lateral Knee Contact Forces During Walking | Contact forces estimated with musculoskeletal modeling | Change from before treatment (approximately 1 week prior to the injection visit) to 30 minutes after treatment (the injection). |
| Change in Patellofemoral Knee Contact Forces During Walking | Contact forces estimated with musculoskeletal modeling | Change from before treatment (approximately 1 week prior to the injection visit) to 30 minutes after treatment (the injection). |
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Inclusion Criteria for Knee Osteoarthritis Arm:
Exclusion Criteria for Knee Osteoarthritis Arm:
Inclusion Criteria for Healthy Arm:
Exclusion Criteria for Healthy Arm:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Corrigan, DPT, PhD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Knee Osteoarthritis | Individuals with clinically defined unilateral symptomatic knee osteoarthritis. Lidocaine Hydrochloride: 10 mL of 1% lidocaine hydrochloride for each intraarticular knee injection |
| FG001 | Healthy | Individuals who serve as healthy controls. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Knee Osteoarthritis | Individuals with clinically defined unilateral symptomatic knee osteoarthritis. Lidocaine Hydrochloride: 10 mL of 1% lidocaine hydrochloride for each intraarticular knee injection |
| BG001 | Healthy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Medial Knee Contact Forces During Walking | Contact forces estimated with musculoskeletal modeling | The healthy control group did not receive a treatment. Therefore, no change was expected or measured. | Posted | Mean | Standard Deviation | bodyweights | Change from before treatment (approximately 1 week prior to the injection visit) to 30 minutes after treatment (the injection). |
|
Adverse event data were collected at each study visit. All study visits occurred within a one-month period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Knee Osteoarthritis | Individuals with clinically defined unilateral symptomatic knee osteoarthritis. Lidocaine Hydrochloride: 10 mL of 1% lidocaine hydrochloride for each intraarticular knee injection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Patrick Corrigan | Cleveland Clinic Foundation | 216-618-9932 | corrigd4@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 9, 2024 | Sep 2, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 29, 2022 | Sep 2, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010146 | Pain |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Arm 1: Clinically defined unilateral symptomatic knee osteoarthritis;
Arm 2: Healthy Controls
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Individuals who serve as healthy controls.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
|
|
| Primary | Change in Lateral Knee Contact Forces During Walking | Contact forces estimated with musculoskeletal modeling | The healthy control group did not receive a treatment. Therefore, no change was expected or measured. | Posted | Mean | Standard Deviation | bodyweights | Change from before treatment (approximately 1 week prior to the injection visit) to 30 minutes after treatment (the injection). |
|
|
|
| Primary | Change in Patellofemoral Knee Contact Forces During Walking | Contact forces estimated with musculoskeletal modeling | The healthy control group did not receive a treatment. Therefore, no change was expected or measured. | Posted | Mean | Standard Deviation | bodyweights | Change from before treatment (approximately 1 week prior to the injection visit) to 30 minutes after treatment (the injection). |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Healthy | Individuals who serve as healthy controls. | 0 | 25 | 0 | 25 | 0 | 25 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |