Osteoarthritis, Knee
Conditions
Keywords
Gait, Pain, Osteoarthritis, Biomechanics
Brief summary
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: * How does unilateral knee pain affect contralateral knee joint loading during different types of walking? * Does movement and loading change at the hips, knees, and ankles during prolonged walking in persons with painful knee osteoarthritis? Participants will: * Fill out questionnaires/surveys * Complete clinical examinations * Walking on a treadmill under different types of walking conditions * Receive two knee injections For comparison purposes, researchers will also enroll healthy participants.
Detailed description
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.
Interventions
DRUGLidocaine Hydrochloride
10 mL of 1% lidocaine hydrochloride for each intraarticular knee injection
Sponsors
The Cleveland Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Arm 1: Clinically defined unilateral symptomatic knee osteoarthritis; Arm 2: Healthy Controls
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for Knee Osteoarthritis Arm: * At least 45 years old * Unilateral knee pain with walking that averages at least 3 out of 10 on a numeric pain rating scale * Unilateral knee stiffness that lasts less than 30 minutes after periods of inactivity * Unilateral symptoms on most days for at least the past 3 months
Exclusion criteria
for Knee Osteoarthritis Arm: * History of knee replacement surgery * Opiate use within the past 3 months * Narcotic use within the past 3 months * Known medical condition that affects walking mechanics, besides knee osteoarthritis * Known medical condition that affects pain perception * Inability to walk for 30 minutes without using an assistive device * Body weight greater than 300 pounds * Known allergy to adhesives * High risk for a cardiovascular event * Currently pregnant * Anticoagulant use within the past 3 months * Intraarticular knee injection within the past 3 months * Known history of hypersensitivity to local anesthetics of the amide type * History of lower body pain or injury, besides knee osteoarthritis, within the past 6 months Inclusion Criteria for Healthy Arm: * At least 45 years old * No lower body pain or injury within the past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Medial Knee Contact Forces During Walking | Change from before treatment (approximately 1 week prior to the injection visit) to 30 minutes after treatment (the injection). | Contact forces estimated with musculoskeletal modeling |
| Change in Lateral Knee Contact Forces During Walking | Change from before treatment (approximately 1 week prior to the injection visit) to 30 minutes after treatment (the injection). | Contact forces estimated with musculoskeletal modeling |
| Change in Patellofemoral Knee Contact Forces During Walking | Change from before treatment (approximately 1 week prior to the injection visit) to 30 minutes after treatment (the injection). | Contact forces estimated with musculoskeletal modeling |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Knee Osteoarthritis Individuals with clinically defined unilateral symptomatic knee osteoarthritis.
Lidocaine Hydrochloride: 10 mL of 1% lidocaine hydrochloride for each intraarticular knee injection | 30 |
| Healthy Individuals who serve as healthy controls. | 25 |
| Total | 55 |
Baseline characteristics
| Characteristic | Total | Healthy | Knee Osteoarthritis |
|---|---|---|---|
| Age, Continuous | 60.3 years STANDARD_DEVIATION 8.4 | 57.9 years STANDARD_DEVIATION 7.8 | 62.3 years STANDARD_DEVIATION 8.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 25 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 170.1 cm STANDARD_DEVIATION 9.1 | 171.1 cm STANDARD_DEVIATION 8 | 169.2 cm STANDARD_DEVIATION 10 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 44 Participants | 20 Participants | 24 Participants |
| Region of Enrollment United States | 55 participants | 25 participants | 30 participants |
| Sex: Female, Male Female | 37 Participants | 17 Participants | 20 Participants |
| Sex: Female, Male Male | 18 Participants | 8 Participants | 10 Participants |
| Weight | 79.8 kg STANDARD_DEVIATION 19.4 | 77.5 kg STANDARD_DEVIATION 17.7 | 81.7 kg STANDARD_DEVIATION 20.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 25 |
| other Total, other adverse events | 0 / 30 | 0 / 25 |
| serious Total, serious adverse events | 0 / 30 | 0 / 25 |
Outcome results
Primary
Change in Lateral Knee Contact Forces During Walking
Contact forces estimated with musculoskeletal modeling
Time frame: Change from before treatment (approximately 1 week prior to the injection visit) to 30 minutes after treatment (the injection).
Population: The healthy control group did not receive a treatment. Therefore, no change was expected or measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Knee Osteoarthritis | Change in Lateral Knee Contact Forces During Walking | 0.02 bodyweights | Standard Deviation 0.03 |
Primary
Change in Medial Knee Contact Forces During Walking
Contact forces estimated with musculoskeletal modeling
Time frame: Change from before treatment (approximately 1 week prior to the injection visit) to 30 minutes after treatment (the injection).
Population: The healthy control group did not receive a treatment. Therefore, no change was expected or measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Knee Osteoarthritis | Change in Medial Knee Contact Forces During Walking | -0.04 bodyweights | Standard Deviation 0.02 |
Primary
Change in Patellofemoral Knee Contact Forces During Walking
Contact forces estimated with musculoskeletal modeling
Time frame: Change from before treatment (approximately 1 week prior to the injection visit) to 30 minutes after treatment (the injection).
Population: The healthy control group did not receive a treatment. Therefore, no change was expected or measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Knee Osteoarthritis | Change in Patellofemoral Knee Contact Forces During Walking | -0.01 bodyweights | Standard Deviation 0.01 |