NCT05906433 · Foundation for Orthopaedic Research and Education
Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis
(Injections)
What this study is about
To evaluate pain relief from corticosteroid injection with and without anesthetic as well as with variable volume of anesthetic. Pain relief will be measured using the VAS pain score at the time of the injection as well as several time points following the injection to capture pain relief longevity.
View original scientific description
To evaluate pain relief from corticosteroid injection with and without anesthetic as well as with variable volume of anesthetic. Pain relief will be measured using the VAS pain score at the time of the injection as well as several time points following the injection to capture pain relief longevity. The investigators intend to evaluate how well the patients tolerate corticosteroid mixtures without anesthetic as well as with different volumes of anesthetic. Primary measure will be the time from procedure when postoperative status is considered success (as measured by global perceived improvement score).
Interventions
DRUG
Kenalog with bupivacaine Injection
Indications, relevant for this study include Kenalog injection for knee pain from osteoarthritis or inflammatory arthritis. A single injection to a patient who has no known allergies to anesthetic or corticosteroids would be administered during a scheduled clinical visit.
Primary outcome measures
Injection for Knee Pain
Time frame: Prior to procedure (in office)
Visual Analogue Scale (VAS)
Injection for Knee Pain
Time frame: Immediate post procedure (in office)
Visual Analogue Scale (VAS)
Injection for Knee Pain
Time frame: 2 minutes post procedure (in office)
Visual Analogue Scale (VAS)
Injection for Knee Pain
Time frame: Day 1 post procedure (phone interview)
Visual Analogue Scale (VAS)
Injection for Knee Pain
Time frame: Day 14 post procedure (through EDC)
Visual Analogue Scale (VAS)
Injection for Knee Pain
Time frame: Day 42 post procedure (in office)
Visual Analogue Scale (VAS)
Injection for Knee Pain
Time frame: Day 84 post procedure (through EDC)
Visual Analogue Scale (VAS)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients must be 18 years of age and be able to consent for themselves.
- OA grade Kellgren Lawrence Stage II or III.
- Diagnosis of primary osteoarthritis.
Exclusion criteria
- Patients with other forms of arthritis such as inflammatory arthritis.
- History of narcotic use for the past 6 months.
- Kellgren Lawrence arthritis grade 1 or 4.
- Pregnant women and prisoners.
Where
- Tampa, Florida
Collaborators
Florida Orthopaedic Institute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 9, 2024 · Source of record for eligibility and locations