Corticosteroid Against Saline Injections for Thumb Osteoarthritis (CASITOA)

NCT ID: NCT06401317

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-04
• Study Completion Date: 2028-12-31

Brief 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.

Detailed Description

Trapeziometacarpal osteoarthritis (TMO) is one of the most painful, disabling and prevalent hand osteoarthritis. One of the most common treatments for TMO is an intra-articular corticosteroids injection. However, non-superiority of corticosteroids injection over placebo to reduce pain has also been reported for TMO and other types of osteoarthritis (knee, hip, or shoulder). Furthermore, adverse effects of corticosteroids injection such as subcutaneous atrophy, tendon ruptures, and articular cartilage damage have been reported. Given the uncertain relevance of corticosteroids injection as a therapeutic agent, it becomes imperative to consider alternative options. In fact, three systematic reviews suggest that saline injections may be a viable option for TMO or knee pain.

To investigate the hypothesis that saline injection is a more effective modality than corticosteroids injection for the treatment of TMO in terms of reducing TMO pain and improving hand function, we must undertake a large, randomized trial in real clinical settings to ensure the acquisition of high-quality evidence. This pilot project is a preparatory phase for a larger study aimed at comparing the effectiveness of saline and corticosteroids injections in treating TMO, focusing on pain reduction and functional improvements. The study design is a pragmatic, double-blind randomized trial, adhering to PRECIS-2 guidelines.

The pilot randomized controlled trial will assess the feasibility of a study by evaluating aspects such as recruitment capabilities, treatment adherence, and the success of blinding techniques for participants and clinicians. It will also identify potential challenges and gather preliminary data to support a funding application for the full-scale study. Recruitment and data collection are planned over a 12-month period, targeting 40 participants initially to refine procedures and validate the study's feasibility. Participants will be randomly assigned to treatment, and the clinicians delivering the intervention will be blinded to the content of the injections. The study's primary outcome will measure pain intensity using a numeric scale at multiple time points, while secondary outcomes include upper limb functional limitations using the QuickDASH scale. These will be measured at baseline, before treatment, and at follow-up, 1, 3, and 6 months after treatment.

Conditions

Trapeziometacarpal Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Saline Injection

A single injection of saline solution

Group Type: EXPERIMENTAL

Saline Solution (NaCl 0,9%)

Intervention Type: DRUG

Ultrasound/fluoroscopy-guided intra-articular injection of 0.25ml of 0.9% saline solution.

Corticosteroid Injection

Usual care, consisting on a single injection of corticosteroids

Group Type: ACTIVE_COMPARATOR

Triamcinolone Acetonide

Intervention Type: DRUG

Ultrasound-guided intra-articular injection 0.25ml (10 mg) of triamcinolone.

Interventions

Saline Solution (NaCl 0,9%)

Ultrasound/fluoroscopy-guided intra-articular injection of 0.25ml of 0.9% saline solution.

Intervention Type: DRUG

Triamcinolone Acetonide

Ultrasound-guided intra-articular injection 0.25ml (10 mg) of triamcinolone.

Intervention Type: DRUG

Other Intervention Names

Saline solution; Corticosteroid

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

OTHER

Sponsor Role: collaborator

McGill University

OTHER

Sponsor Role: collaborator

Université de Montréal

OTHER

Sponsor Role: collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: collaborator

Centre de Recherche du Centre Hospitalier de l'Université de Montréal

OTHER

Sponsor Role: collaborator

Université du Québec à Trois-Rivières

OTHER

Sponsor Role: lead

Responsible Party

Tokiko Hamasaki

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tokiko Hamasaki, PhD

Role: PRINCIPAL_INVESTIGATOR

Université du Québec à Trois-Rivières

Locations

Centre Hospitalier de l'Université de Montréal - Physiatry

Montreal, Quebec, Canada

Site Status: RECRUITING

Centre Hospitalier de l'Université de Montréal - Chirurgie plastique

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Tokiko Hamasaki, PhD

Role: CONTACT

tokiko.hamasaki@uqtr.ca

819-478-5011 ext. 2903

Carlos Gevers-Montoro, PhD

Role: CONTACT

carlos.geversmontoro@mcgill.ca

819-979-0448

Facility Contacts

Dr Luong

Role: primary

dien-hung.luong.med@ssss.gouv.qc.ca

514-890-8000

Dr Harris

Role: primary

patrick.harris.med@ssss.gouv.qc.ca

514-890-8000

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Reference Type: BACKGROUND

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Other Identifiers

CASITOA

Identifier Type: -

Identifier Source: org_study_id