Corticosteroid versus saline injections for thumb osteoarthritis
Comparison of the Efficacy of Intra-Articular Corticosteroid Injections Versus Saline Solution for Thumb Osteoarthritis: Double-Blind Pragmatic Randomized Pilot Study
This study will test whether saline injections work better than corticosteroid (triamcinolone) injections to reduce pain and improve hand function in adults with thumb (trapeziometacarpal) osteoarthritis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Université du Québec à Trois-Rivières Academic / other |
| Locations | 2 sites (Montreal, Quebec and 1 other locations) |
| Trial ID | NCT06401317 on ClinicalTrials.gov |
What this trial studies
This is a pragmatic, double-blind, randomized pilot trial that will enroll 40 adults with X-ray–confirmed trapeziometacarpal osteoarthritis to compare intra‑articular triamcinolone versus saline (0.9% NaCl) injections. Participants and the physicians performing injections will be blinded and randomized 1:1, with primary outcomes focused on pain reduction and hand function and secondary measures of feasibility. The pilot follows PRECIS-2 guidance and will collect data on recruitment, retention, and blinding success to inform a larger definitive trial. Study visits are conducted at CHUM sites in Montreal and materials are provided in French and English.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) with X-ray‑confirmed trapeziometacarpal osteoarthritis who have pain at the base of the thumb, for whom the treating physician would consider an intra‑articular corticosteroid injection, and who can read English or French.
Not a fit: Patients with traumatic thumb pain, inflammatory arthritis (such as rheumatoid arthritis), prior corticosteroid injections within 12 months, prior surgery on the affected thumb, pregnancy or breastfeeding, or known allergy to any injection components are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, saline injections could offer a cheaper and potentially safer alternative to corticosteroids for reducing pain and improving hand function in thumb osteoarthritis.
How similar studies have performed: Systematic reviews and prior randomized trials have shown mixed results but indicate that saline injections can sometimes relieve osteoarthritis pain and that corticosteroids do not consistently outperform placebo.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * aged ≥18 years; * diagnosis of TMO was confirmed by X-ray interpreted by a radiologist; * suffering from pain at the base of the thumb; * the attending physician deems that an intra-articular corticosteroid injection would be beneficial, rather than opting for other types of intervention such as surgery * can read, understand and answer in either French or English. Exclusion Criteria: * having received one or more corticosteroid injections in the last 12 months or surgery on the affected thumb; * suffering from painful thumb caused by a trauma (e.g., fracture, sprain), rheumatoid arthritis, or De Quervain's tendonitis; and * being pregnant or breastfeeding; and * known allergies to any components of the solutions (triamcinolone acetonide, benzyl alcohol, carboxymethylcellulose sodium, hydrochloric acid, polysorbate, sodium chloride, or sodium hydroxide) or to iodinated contrast media.
Where this trial is running
Montreal, Quebec and 1 other locations
- Centre Hospitalier de l'Université de Montréal - Physiatry — Montreal, Quebec, Canada (Recruiting)
- Centre Hospitalier de l'Université de Montréal - Chirurgie plastique — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Tokiko Hamasaki, PhD — Université du Québec à Trois-Rivières
- Study coordinator: Tokiko Hamasaki, PhD
- Email: tokiko.hamasaki@uqtr.ca
- Phone: 819-478-5011
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.