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Lidocaine for Osteoarthritis
Phase 4
Recruiting
Led By Patrick Corrigan, DPT, PhD
Research Sponsored by St. Louis University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to immediately after treatment
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial will study how knee pain affects walking, and how movement and loading changes in people with painful knee osteoarthritis. Participants will fill out surveys, have clinical exams, and walk on a treadmill.
Who is the study for?
This trial is for people over 45 with knee osteoarthritis causing pain in one knee during walking. They must have had symptoms most days for the past 3 months and no lower body pain or injury in the last 6 months. Excluded are those over 300 pounds, using anticoagulants or narcotics recently, with a history of hypersensitivity to local anesthetics, or conditions affecting walking mechanics other than osteoarthritis.
What is being tested?
The study tests how unilateral knee pain from osteoarthritis affects loading on the opposite knee during various types of treadmill walking. Participants will fill out surveys, undergo clinical exams, walk under different conditions on a treadmill, and receive two injections of Lidocaine Hydrochloride in their knees.
What are the potential side effects?
Possible side effects include reactions at the injection site such as redness and swelling, allergic reactions to Lidocaine (if sensitive), and general discomfort from prolonged walking tasks during testing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to immediately after treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to immediately after treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in lateral knee contact forces during walking
Change in medial knee contact forces during walking
Change in patellofemoral knee contact forces during walking
Secondary study objectives
Change in knee joint angles during walking
Change in knee joint moments during walking
Change in knee joint work during walking
Side effects data
From 2021 Phase 1 & 2 trial • 26 Patients • NCT0325439443%
Nausea
29%
Dizziness
21%
Headache
14%
Paresthesia
14%
Lightheadedness
7%
Somnolence
7%
Arrhythmia
7%
Blurred vision
7%
Itching
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + FOLFOX
Lidocaine + FOLFOX
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Knee OsteoarthritisExperimental Treatment1 Intervention
Individuals with clinically defined unilateral symptomatic knee osteoarthritis.
Group II: HealthyActive Control1 Intervention
Individuals who serve as healthy controls.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lidocaine Hydrochloride
2022
Completed Phase 4
~2260
Find a Location
Who is running the clinical trial?
St. Louis UniversityLead Sponsor
194 Previous Clinical Trials
40,963 Total Patients Enrolled
2 Trials studying Osteoarthritis
371 Patients Enrolled for Osteoarthritis
Patrick Corrigan, DPT, PhDPrincipal InvestigatorSt. Louis University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a knee injection in the last 3 months for my osteoarthritis.I have had knee replacement surgery.I cannot walk for 30 minutes without help like a cane or walker.I have had lower body pain or injury, not including knee osteoarthritis, in the last 6 months.I have had knee pain on one side for at least 3 months.My knee stiffens for less than 30 minutes after sitting or lying down.I haven't had lower body pain or injuries in the last 6 months.I have a condition that affects how I feel pain.I cannot walk for 30 minutes without help due to knee pain.I weigh more than 300 pounds and have knee osteoarthritis.I have used narcotics for my knee pain in the last 3 months.I have a condition affecting my walking, not just knee osteoarthritis.I have used opiates in the last 3 months for my knee osteoarthritis.I have knee osteoarthritis and have used blood thinners in the last 3 months.I am at least 45 years old.I am pregnant and have knee osteoarthritis.I am allergic to certain local anesthetics.I have had knee replacement surgery due to osteoarthritis.I am at high risk for a heart attack or stroke.I am 45 or older with knee osteoarthritis.I have knee osteoarthritis and am at high risk for heart problems.I have knee pain in one knee when walking, rating at least 3 out of 10.I have a condition that affects how I feel pain.I weigh more than 300 pounds.I have a condition that affects how I walk.I am allergic to adhesives and have knee osteoarthritis.My knee stiffens for less than 30 minutes after sitting or lying down.I have had symptoms on one side of my body for the last 3 months.I experience knee pain while walking that I would rate at least 3 out of 10.I am at least 45 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy
- Group 2: Knee Osteoarthritis
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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