Trapeziometacarpal OsteoarthritisPhase 2CASITOANCT06401317
Corticosteroid Against Saline Injections for Thumb Osteoarthritis (CASITOA)
A Phase 2 study testing Saline Solution (NaCl 0,9%) and Triamcinolone Acetonide in people with Trapeziometacarpal Osteoarthritis, run by Université du Québec à Trois-Rivières at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trapeziometacarpal Osteoarthritis
- What is being tested?
- Saline Solution (NaCl 0,9%) and Triamcinolone Acetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesCanada
- Study dates
- 4 Nov 2025to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Centre Hospitalier de l'Université de Montréal - Physiatry
Montreal, Quebec, H2W 1T6
Dr Luong, 514-890-8000, dien-hung.luong.med@ssss.gouv.qc.ca
- Recruiting
Centre Hospitalier de l'Université de Montréal - Chirurgie plastique
Montreal, Quebec, H2X 0C1
Dr Harris, 514-890-8000, patrick.harris.med@ssss.gouv.qc.ca
About this study
Official title: 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.
Read the 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, retention, 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
- Being tested
- Saline Solution (NaCl 0,9%), Triamcinolone Acetonide
- Keywords
- Corticosteroids, Feasibility, Blinding, Randomized controlled trial, Saline, Trapeziometacarpal osteoarthritis, Intra-articular injection, Pragmatic trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline Solution (NaCl 0,9%)Drug
Also called Saline solution
Ultrasound/fluoroscopy-guided intra-articular injection of 0.25ml of 0.9% saline solution.
Triamcinolone AcetonideDrug
Also called Corticosteroid
Ultrasound-guided intra-articular injection 0.25ml (10 mg) of triamcinolone.
| Study group | Role | What they receive |
|---|---|---|
| Saline Injection | Experimental | A single injection of saline solution Receives: Drug: Saline Solution (NaCl 0,9%) |
| Corticosteroid Injection | Active comparator | Usual care, consisting on a single injection of corticosteroids Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of participant recruitment
The number of participants recruited per week, raw and divided by those screened for eligibility and those deemed eligible
Measured: 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
Measured: 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'.
Measured: 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).
Measured: 1, 3, and 6 months after receiving the injection
Secondary outcomes (4)
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)
Measured: Baseline, 1, 3, and 6 months after injection
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.
Measured: Baseline, 1, 3, and 6 months after injection
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.
Measured: Baseline, 1, 3, and 6 months after injection
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.
Measured: 24 hours after the injection and at 1-month, 3-month- and 6-month post-injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start4 Nov 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Trapeziometacarpal OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-arm pragmatic randomized controlled pilot trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université du Québec à Trois-Rivières
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal, McGill University, Université de Montréal, Centre hospitalier de l'Université de Montréal (CHUM), Centre de Recherche du Centre Hospitalier de l'Université de Montréal
- Responsible party
- Principal investigator, Tokiko Hamasaki, Université du Québec à Trois-Rivières
- Investigators
- Tokiko Hamasaki, PhD, Principal investigator, Université du Québec à Trois-Rivières
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401317
- Sponsor's protocol ID
- CASITOA
- Acronym
- CASITOA
- Status last verified
- Aug 2026
- First submitted
- 30 Apr 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared by the investigators upon reasonable request
Publications
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.
PubMed 15374852Hamasaki 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.
PubMed 31600038Hamasaki 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.
PubMed 36918308Altman 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.
PubMed 27238876Ayub 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.
PubMed 33432345Saltzman 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.
PubMed 28027657Loudon 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.
PubMed 25956159Meenagh 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.
PubMed 15361383Gevers-Montoro C, Freire V, Harris PG, Ruel M, Luong DH, Bureau NJ, Bois MC, Aribert M, Efanov JI, Filali-Mouhim A, Piche M, Hamasaki T. Non-inferiority of saline versus corticosteroid injections for trapeziometacarpal osteoarthritis: a protocol for a pilot and feasibility randomised controlled trial. BMJ Open. 2026 May 26;16(5):e111844. doi: 10.1136/bmjopen-2025-111844.
PubMed 42191192
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Intra-Articular Corticosteroid Injections Versus Saline Solution for Thumb Osteoarthritis: Double-Blind Pragmatic Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT06401317
- Acronym / sponsor ID
- CASITOA / CASITOA
- Conditions
- Trapeziometacarpal Osteoarthritis
- Keywords
- Corticosteroids, Feasibility, Blinding, Randomized controlled trial, Saline, Trapeziometacarpal osteoarthritis, Intra-articular injection, Pragmatic trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Université du Québec à Trois-RivièresUniversity, hospital or other
- Collaborators
- Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal, McGill University, Université de Montréal, Centre hospitalier de l'Université de Montréal (CHUM), Centre de Recherche du Centre Hospitalier de l'Université de Montréal
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, retention, 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 2-arm pragmatic randomized controlled pilot trial
| Arm | Type | Receives |
|---|---|---|
| Saline Injection | Experimental | Drug: Saline Solution (NaCl 0,9%)A single injection of saline solution |
| Corticosteroid Injection | Active comparator | Drug: Triamcinolone AcetonideUsual care, consisting on a single injection of corticosteroids |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline Solution (NaCl 0,9%)Also: Saline solutionUltrasound/fluoroscopy-guided intra-articular injection of 0.25ml of 0.9% saline solution. | Drug | Saline Injection |
| Triamcinolone AcetonideAlso: CorticosteroidUltrasound-guided intra-articular injection 0.25ml (10 mg) of triamcinolone. | Drug | Corticosteroid Injection |
Primary outcome
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
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
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'.
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).
4 secondary outcomes
Trapeziometacarpal pain intensity
Time frame: 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
Concomitant analgesic use
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Background: PubMed 15374852Dahaghin 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.
- Background: PubMed 31600038Hamasaki 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.
- Background: PubMed 36918308Hamasaki 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.
- Background: PubMed 27238876Altman 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.
- Background: PubMed 33432345Ayub 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.
- Background: PubMed 28027657Saltzman 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.
- Background: PubMed 25956159Loudon 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.
- Background: PubMed 15361383Meenagh 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.
- Derived from this study: PubMed 42191192Gevers-Montoro C, Freire V, Harris PG, Ruel M, Luong DH, Bureau NJ, Bois MC, Aribert M, Efanov JI, Filali-Mouhim A, Piche M, Hamasaki T. Non-inferiority of saline versus corticosteroid injections for trapeziometacarpal osteoarthritis: a protocol for a pilot and feasibility randomised controlled trial. BMJ Open. 2026 May 26;16(5):e111844. doi: 10.1136/bmjopen-2025-111844.
- Individual participant dataSharing planned: Yes. IPD will be shared by the investigators upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tokiko Hamasaki, PhD principal investigator
Université du Québec à Trois-Rivières
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Saline Solution (NaCl 0,9%) and Triamcinolone Acetonide in people with Trapeziometacarpal Osteoarthritis, run by Université du Québec à Trois-Rivières at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tokiko Hamasaki, PhD (819-478-5011 ext. 2903, tokiko.hamasaki@uqtr.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of participant recruitment (time frame: Through study completion (estimated time, 1 year)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06401317, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.