Comparing different doses of triamcinolone for knee osteoarthritis pain relief
The Efficacy of Intra-articular Triamcinolone Acetonide 5mg vs. 10 mg vs. 40 mg in Patients With Knee Osteoarthritis: a Non-inferiority Randomized Controlled Double-blind Study
This study is testing different doses of a knee injection to see which one helps people with knee osteoarthritis pain the most while causing the least side effects.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 327 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT05806021 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy of three different doses of intra-articular triamcinolone acetonide (5mg, 10mg, and 40mg) in patients suffering from knee osteoarthritis. The study aims to determine the optimal dose that provides effective pain relief while minimizing potential side effects associated with corticosteroid injections. Participants will be assessed based on their knee pain levels and the severity of their osteoarthritis, following established criteria. The trial is designed to provide clearer guidance on corticosteroid dosing for knee osteoarthritis management.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 60 and older with symptomatic primary gonarthrosis lasting over six months and moderate knee pain.
Not a fit: Patients with advanced osteoarthritis (Grade 4) or those who have received recent corticosteroid injections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and safer treatment options for patients with knee osteoarthritis.
How similar studies have performed: Previous studies have shown varying success with corticosteroid injections for knee osteoarthritis, but this specific dose comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Symptomatic primary gonarthrosis of over 6 months duration (gonarthrosis according to the American College of Rheumatology criteria) * Grade 1 to 3 Kellgren-Lawrence femorotibial osteoarthritis * Knee pain provoked by activity over 4 and under 8 on 10 (Visual Analog Scale) Exclusion Criteria: * Bilateral symptomatic primary gonarthrosis * Grade 4 Kellgren-Lawrence femorotibial osteoarthritis * Isolated patellofemoral osteoarthritis * Intra-articular corticosteroid infiltration to the knee within the past 3 months or chronic use of per os corticosteroid * Intra-articular hyaluronic acid infiltration within the past 12 months. * Intra-articular infiltration of platelet-rich plasma within the past 12 months. * Disease affecting the study joint (systemic inflammatory disease, history of septic arthritis, osteonecrosis, etc.). * Suspicion or presence of active local infectious process. * Presence or suspicion of local neoplasia or metastasis * Recent severe trauma to the knee (≤ 3 months) * Significant cognitive impairment or inadequate language proficiency not allowing adequate response to study questionnaires * Any other serious medical condition that does not allow participation in the study or may be a contraindication to cortisone injection
Where this trial is running
Montreal, Quebec
- Centre Hospitalier Universitaire de Montréal - Hôtel-Dieu — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Dien Hung Luong, MD — Centre hospitalier de l'Université de Montréal (CHUM)
- Study coordinator: Dien Hung Luong, MD
- Email: dh.luong79@gmail.com
- Phone: 5148908000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.