Corticosteroid Against Saline Injections for Thumb Osteoarthritis (CASITOA) (CASITOA)

January 20, 2026 updated by: Tokiko Hamasaki, Université du Québec à Trois-Rivières

Comparison of the Efficacy of Intra-Articular Corticosteroid Injections Versus Saline Solution for Thumb Osteoarthritis: Double-Blind Pragmatic Randomized Pilot Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2W 1T6
      • Montreal, Quebec, Canada, H2X 0C1
        • Recruiting
        • Centre Hospitalier de l'Université de Montréal - Chirurgie plastique
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Saline Injection
A single injection of saline solution
Drug: Saline Solution (NaCl 0,9%)
Ultrasound/fluoroscopy-guided intra-articular injection of 0.25ml of 0.9% saline solution.
Other Names:
  • Saline solution
Active Comparator: Corticosteroid Injection
Usual care, consisting on a single injection of corticosteroids
Drug: Triamcinolone Acetonide
Ultrasound-guided intra-articular injection 0.25ml (10 mg) of triamcinolone.
Other Names:
  • Corticosteroid

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trapeziometacarpal pain intensity
Time Frame: Baseline, 1, 3, and 6 months after injection
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)
Baseline, 1, 3, and 6 months after injection
QuickDASH questionnaire (short version of the 30-item Disabilities of the Arm, Shoulder and Hand).
Time Frame: Baseline, 1, 3, and 6 months after injection
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.
Baseline, 1, 3, and 6 months after injection
Adverse events
Time Frame: 24 hours after the injection and at 1-month, 3-month- and 6-month post-injection.
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.
24 hours after the injection and at 1-month, 3-month- and 6-month post-injection.
Concomitant analgesic use
Time Frame: Baseline, 1, 3, and 6 months after injection
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.
Baseline, 1, 3, and 6 months after injection

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Second injection
Time Frame: 1, 3, and 6 months after 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)
1, 3, and 6 months after injection
Arthroplasty
Time Frame: 1, 3, and 6 months after injection
The number of participants undergoing arthroplasty during the study period will also be compared between groups..
1, 3, and 6 months after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université du Québec à Trois-Rivières

Collaborators

McGill University
Centre hospitalier de l'Université de Montréal (CHUM)
Université de Montréal
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Investigators

  • Principal Investigator: Tokiko Hamasaki, PhD, Université du Québec à Trois-Rivières

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

April 30, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 6, 2024

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASITOA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be shared by the investigators upon reasonable request

IPD Sharing Time Frame

Undecided yet

IPD Sharing Access Criteria

IPD will be shared by the investigators upon reasonable request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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