Trial Outcomes & Findings for Effect of Knee Pain on Walking Biomechanics (NCT NCT05670236)
NCT ID: NCT05670236
Last Updated: 2025-10-29
Results Overview
Contact forces estimated with musculoskeletal modeling
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
55 participants
Primary outcome timeframe
Change from before treatment (approximately 1 week prior to the injection visit) to 30 minutes after treatment (the injection).
Results posted on
2025-10-29
Participant Flow
Participant milestones
| Measure |
Knee Osteoarthritis
Individuals with clinically defined unilateral symptomatic knee osteoarthritis.
Lidocaine Hydrochloride: 10 mL of 1% lidocaine hydrochloride for each intraarticular knee injection
|
Healthy
Individuals who serve as healthy controls.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
25
|
|
Overall Study
COMPLETED
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Knee Pain on Walking Biomechanics
Baseline characteristics by cohort
| Measure |
Knee Osteoarthritis
n=30 Participants
Individuals with clinically defined unilateral symptomatic knee osteoarthritis.
Lidocaine Hydrochloride: 10 mL of 1% lidocaine hydrochloride for each intraarticular knee injection
|
Healthy
n=25 Participants
Individuals who serve as healthy controls.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
57.9 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
60.3 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
25 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Height
|
169.2 cm
STANDARD_DEVIATION 10.0 • n=5 Participants
|
171.1 cm
STANDARD_DEVIATION 8.0 • n=7 Participants
|
170.1 cm
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Weight
|
81.7 kg
STANDARD_DEVIATION 20.7 • n=5 Participants
|
77.5 kg
STANDARD_DEVIATION 17.7 • n=7 Participants
|
79.8 kg
STANDARD_DEVIATION 19.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Contact forces estimated with musculoskeletal modeling
Outcome measures
| Measure |
Knee Osteoarthritis
n=24 Participants
Individuals with clinically defined unilateral symptomatic knee osteoarthritis.
Lidocaine Hydrochloride: 10 mL of 1% lidocaine hydrochloride for each intraarticular knee injection
|
Healthy
Individuals who serve as healthy controls.
|
|---|---|---|
|
Change in Medial Knee Contact Forces During Walking
|
-0.04 bodyweights
Standard Deviation 0.02
|
—
|
PRIMARY outcome
Timeframe: 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.
Contact forces estimated with musculoskeletal modeling
Outcome measures
| Measure |
Knee Osteoarthritis
n=24 Participants
Individuals with clinically defined unilateral symptomatic knee osteoarthritis.
Lidocaine Hydrochloride: 10 mL of 1% lidocaine hydrochloride for each intraarticular knee injection
|
Healthy
Individuals who serve as healthy controls.
|
|---|---|---|
|
Change in Lateral Knee Contact Forces During Walking
|
0.02 bodyweights
Standard Deviation 0.03
|
—
|
PRIMARY outcome
Timeframe: 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.
Contact forces estimated with musculoskeletal modeling
Outcome measures
| Measure |
Knee Osteoarthritis
n=24 Participants
Individuals with clinically defined unilateral symptomatic knee osteoarthritis.
Lidocaine Hydrochloride: 10 mL of 1% lidocaine hydrochloride for each intraarticular knee injection
|
Healthy
Individuals who serve as healthy controls.
|
|---|---|---|
|
Change in Patellofemoral Knee Contact Forces During Walking
|
-0.01 bodyweights
Standard Deviation 0.01
|
—
|
Adverse Events
Knee Osteoarthritis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place