Recruiting
Phase 2

Saline vs. Corticosteroids

Sponsor:

Université du Québec à Trois-Rivières

Code:

NCT06401317

Conditions

Trapeziometacarpal Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Saline Solution (NaCl 0,9%)

Triamcinolone Acetonide

Study Details

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.

Conditions

Trapeziometacarpal Osteoarthritis

Study ID

NCT06401317

Start date

Nov 4, 2025

Status verified date

Aug, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Saline Injection

A single injection of saline solution

active comparator: Corticosteroid Injection

Usual care, consisting on a single injection of corticosteroids

Interventions

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.

Primary outcome measure

  • Rate of participant recruitment [ Time Frame: Through study completion (estimated time, 1 year) ]
  • Rate of participants completing the follow-ups [ Time Frame: Through study completion (estimated time, 1 year) ]
  • Success of blinded procedures for clinicians [ Time Frame: Up to 24 hours after each injection ]
  • Success of blinded procedures for patients [ Time Frame: 1, 3, and 6 months after receiving the injection ]

Central Contacts and Locations

Central contacts

Tokiko Hamasaki, PhD

819-478-5011tokiko.hamasaki@uqtr.ca

Carlos Gevers-Montoro, PhD

819-979-0448carlos.geversmontoro@mcgill.ca

Locations

Centre Hospitalier de l'Université de Montréal - Physiatry

Recruiting

Montreal, Quebec, Canada, H2W 1T6

Contacts

Dr Luong

514-890-8000dien-hung.luong.med@ssss.gouv.qc.ca

Centre Hospitalier de l'Université de Montréal - Chirurgie plastique

Recruiting

Montreal, Quebec, Canada, H2X 0C1

Contacts

Dr Harris

514-890-8000patrick.harris.med@ssss.gouv.qc.ca

More Information

Sponsor

Université du Québec à Trois-Rivières

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • Corticosteroids
  • Feasibility
  • Blinding
  • Randomized controlled trial
  • Saline
  • Trapeziometacarpal osteoarthritis
  • Intra-articular injection
  • Pragmatic trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université du Québec à Trois-Rivières on 2026-08-18.