Saline Solution (NaCl 0,9%): Ultrasound/fluoroscopy-guided intra-articular injection of 0.25ml of 0.9% saline solution.
Triamcinolone Acetonide: Ultrasound-guided intra-articular injection 0.25ml (10 mg) of triamcinolone.
Study summary
Thumb osteoarthritis or trapeziometacarpal osteoarthritis (TMO) is a common and painful form of hand arthritis that limits thumb mobility and hand function, affecting patients' quality of life. Although corticosteroids injections are a typical treatment, their effectiveness has been challenged, and side effects have been reported. Recent studies suggest that saline injections, usually considered inactive, might be a viable treatment option. The primary goal of this study is to compare the effectiveness of saline injections versus corticosteroids injections in reducing TMO-related pain and improving hand function. In this study, 40 people with TMO will be randomly assigned to receive either a corticosteroids or a saline injection, without them or the doctors performing the injection knowing which one was administered (double blind). If saline injections prove more effective, they could provide a less harmful and cheaper therapeutic alternative for TMO patients.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 3 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.
Primary outcome measure(s)
Rate of participant recruitment — Through study completion (estimated time, 1 year) The number of participants recruited per week, raw and divided by those screened for eligibility and those deemed eligible
Rate of participants completing the follow-ups — Through study completion (estimated time, 1 year) The number of participants completing the follow-ups at 1, 3, and 6 months, divided by those recruited
Success of blinded procedures for clinicians — Up to 24 hours after each injection Success of blinded procedures for physicians will be by asking them by email after the injection to guess which treatment they administered. Three response categories for treatment guess: 'corticosteroid injection', 'saline injection', or 'I don't know'.
Success of blinded procedures for patients — 1, 3, and 6 months after receiving the injection Success of blinded procedures for patients will be investigated by asking them to guess which treatment they will have received via the post-injection questionnaire. Three response categories for treatment guess are 'corticosteroid injection', 'saline injection', or 'I don't know', after the last follow-up).
Trial sites (2)
Facility
City
Region
Status
Centre Hospitalier de l'Université de Montréal - Physiatry
Montreal
Quebec
Recruiting
Centre Hospitalier de l'Université de Montréal - Chirurgie plastique
Montreal
Quebec
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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