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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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
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
~2200
Find a Location
Who is running the clinical trial?
St. Louis UniversityLead Sponsor
194 Previous Clinical Trials
43,595 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate amount of people participating in this experiment?
"Affirmative. As per clinicaltrials.gov, this medical inquiry is in the process of recruiting participants. It was first shared on January 15th 2023, and has been revised most recently on December 20th 2022. For now, 60 volunteers are required from one location to take part in the study."
Answered by AI
Has the FDA conferred approval for Knee Osteoarthritis treatments?
"The safety of Knee osteoarthritis has been established in a Phase 4 trial, so our team at Power gave it the highest rating possible: 3."
Answered by AI
Are there still available openings for individuals to partake in this investigation?
"Indeed, the information stored on clinicaltrials.gov verifies that this study is actively enrolling participants. The trial originally went online on January 15th 2023 and has been updated as recently as December 20th 2022. The aim of the experiment is to recruit 60 individuals from a single site."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
What site did they apply to?
Saint Louis University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I have been diagnosed with osteoarthritis and have psoriasis. Currently on Celebrix and its not helping much.
PatientReceived 2+ prior treatments
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