Corticosteroid Against Saline Injections for Thumb Osteoarthritis (CASITOA)

NCT06401317 | Recruiting Phase 2

• 1 other identifier: CASITOA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Rate of participant recruitment

  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)

• 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

  Through study completion (estimated time, 1 year)

• 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'.

  Up to 24 hours after each injection

• 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).

  1, 3, and 6 months after receiving the injection

Secondary Outcomes (4)

• Trapeziometacarpal pain intensity

  Baseline, 1, 3, and 6 months after injection

• QuickDASH questionnaire (short version of the 30-item Disabilities of the Arm, Shoulder and Hand).

  Baseline, 1, 3, and 6 months after injection

• Concomitant analgesic use

  Baseline, 1, 3, and 6 months after injection

• Adverse events

  24 hours after the injection and at 1-month, 3-month- and 6-month post-injection.

Other Outcomes (2)

• Second injection

  1, 3, and 6 months after injection

• Arthroplasty

  1, 3, and 6 months after injection

Study Arms (2)

Saline Injection

EXPERIMENTAL

A single injection of saline solution

Drug: Saline Solution (NaCl 0,9%)

Corticosteroid Injection

ACTIVE COMPARATOR

Usual care, consisting on a single injection of corticosteroids

Drug: Triamcinolone Acetonide

Interventions

Triamcinolone Acetonide DRUG

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

Also known as: Corticosteroid

Corticosteroid Injection

Saline Solution (NaCl 0,9%) DRUG

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

Also known as: Saline solution

Saline Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université du Québec à Trois-Rivières: lead
• 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

Study Sites (2)

Centre Hospitalier de l'Université de Montréal - Physiatry

Montreal, Quebec, H2W 1T6, Canada

RECRUITING

Centre Hospitalier de l'Université de Montréal - Chirurgie plastique

Montreal, Quebec, H2X 0C1, Canada

RECRUITING

Related Publications (8)

• Dahaghin S, Bierma-Zeinstra SM, Ginai AZ, Pols HA, Hazes JM, Koes BW. Prevalence and pattern of radiographic hand osteoarthritis and association with pain and disability (the Rotterdam study). Ann Rheum Dis. 2005 May;64(5):682-7. doi: 10.1136/ard.2004.023564. Epub 2004 Sep 16.

  PMID: 15374852 BACKGROUND

• Hamasaki T, Laprise S, Harris PG, Bureau NJ, Gaudreault N, Ziegler D, Choiniere M. Efficacy of Nonsurgical Interventions for Trapeziometacarpal (Thumb Base) Osteoarthritis: A Systematic Review. Arthritis Care Res (Hoboken). 2020 Dec;72(12):1719-1735. doi: 10.1002/acr.24084. Epub 2020 Nov 7.

  PMID: 31600038 BACKGROUND

• Hamasaki T, Choiniere M, Harris PG, Bureau NJ, Gaudreault N, Patenaude N. Biopsychosocial factors associated with pain severity and hand disability in trapeziometacarpal osteoarthritis and non-surgical management. J Hand Ther. 2023 Jul-Sep;36(3):647-657. doi: 10.1016/j.jht.2022.10.001. Epub 2023 Mar 12.

  PMID: 36918308 BACKGROUND

• Altman RD, Devji T, Bhandari M, Fierlinger A, Niazi F, Christensen R. Clinical benefit of intra-articular saline as a comparator in clinical trials of knee osteoarthritis treatments: A systematic review and meta-analysis of randomized trials. Semin Arthritis Rheum. 2016 Oct;46(2):151-159. doi: 10.1016/j.semarthrit.2016.04.003. Epub 2016 Apr 27.

  PMID: 27238876 BACKGROUND

• Ayub S, Kaur J, Hui M, Espahbodi S, Hall M, Doherty M, Zhang W. Efficacy and safety of multiple intra-articular corticosteroid injections for osteoarthritis-a systematic review and meta-analysis of randomized controlled trials and observational studies. Rheumatology (Oxford). 2021 Apr 6;60(4):1629-1639. doi: 10.1093/rheumatology/keaa808.

  PMID: 33432345 BACKGROUND

• Saltzman BM, Leroux T, Meyer MA, Basques BA, Chahal J, Bach BR Jr, Yanke AB, Cole BJ. The Therapeutic Effect of Intra-articular Normal Saline Injections for Knee Osteoarthritis: A Meta-analysis of Evidence Level 1 Studies. Am J Sports Med. 2017 Sep;45(11):2647-2653. doi: 10.1177/0363546516680607. Epub 2016 Dec 27.

  PMID: 28027657 BACKGROUND

• Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015 May 8;350:h2147. doi: 10.1136/bmj.h2147. No abstract available.

  PMID: 25956159 BACKGROUND

• Meenagh GK, Patton J, Kynes C, Wright GD. A randomised controlled trial of intra-articular corticosteroid injection of the carpometacarpal joint of the thumb in osteoarthritis. Ann Rheum Dis. 2004 Oct;63(10):1260-3. doi: 10.1136/ard.2003.015438.

  PMID: 15361383 BACKGROUND

MeSH Terms

Interventions

Saline Solution; Triamcinolone Acetonide; Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Tokiko Hamasaki, PhD

  Université du Québec à Trois-Rivières

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tokiko Hamasaki, PhD

CONTACT

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

Carlos Gevers-Montoro, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants will be randomly assigned in a 1:1 ratio to receive either the saline injection or the corticosteroid injection. Opaque syringes will be used to mask the content to both participants and clinicians. The study will use computer-generated randomization to prepare and distribute sealed, opaque envelopes. These envelopes, indicating whether saline or corticosteroids should be injected, will be randomly sent to the healthcare facilities of the doctors involved in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 2-arm pragmatic randomized controlled pilot trial

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 6, 2024
• Study Start: November 4, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Undecided yet
• Access Criteria: IPD will be shared by the investigators upon reasonable request

Locations

CA (2)