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.
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
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.
Parallel
Saline Solution (NaCl 0,9%)
DrugUltrasound/fluoroscopy-guided intra-articular injection of 0.25ml of 0.9% saline solution.
Triamcinolone Acetonide
DrugUltrasound-guided intra-articular injection 0.25ml (10 mg) of triamcinolone.
Rate of participant recruitment
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
The number of participants completing the follow-ups at 1, 3, and 6 months, divided by those recruited
Success of blinded procedures for clinicians
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
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).
Trapeziometacarpal pain intensity
Three types of pain intensity (current, on the average in the last 7 days, at its worst in the last 7 days) will be measured using a 0-10 rating scale (0 = no pain and 10 = worst pain possible)
QuickDASH questionnaire (short version of the 30-item Disabilities of the Arm, Shoulder and Hand).
11-item questionnaire assesses the level of physical function and symptoms among patients with upper limb musculoskeletal condition. The total score ranges from 0 to 100 and the higher it is, the more disabled is the patient.
Concomitant analgesic use
This will be captured using the Cumulative Analgesic Consumption Score (CACS), a tool that combines a qualitative assessment based on the World Health Organization analgesic ladder with a quantitative evaluation based on a score computed from the number of analgesics taken from each of three different categories: acetaminophen/NSAIDs, weak opioids, and strong opioids.
Adverse events
Side effects will be reported systematically by using a questionnaire with 5 items assessing the presence, type, frequency, severity and duration of injection-related adverse events.
Second injection
The number of participants requesting a second injection with a different solution due to a perceived lack of efficacy, as well as the number of participants requesting a second injection with the same solution due to pain relapse will be compared between groups will be compared between groups (saline vs. cortisone)
Arthroplasty
The number of participants undergoing arthroplasty during the study period will also be compared between groups..
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Université du Québec à Trois-Rivières
Lead sponsor
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Collaborator
McGill University
Collaborator
Université de Montréal
Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborator
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Collaborator
