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| Name | Class |
|---|---|
| Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal | OTHER |
| McGill University | OTHER |
| Université de Montréal | OTHER |
| Centre hospitalier de l'Université de Montréal (CHUM) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline Injection | Experimental | A single injection of saline solution |
|
| Corticosteroid Injection | Active Comparator | Usual care, consisting on a single injection of corticosteroids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline Solution (NaCl 0,9%) | Drug | Ultrasound/fluoroscopy-guided intra-articular injection of 0.25ml of 0.9% saline solution. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline, 1, 3, and 6 months after injection |
| QuickDASH questionnaire (short version of the 30-item Disabilities of the Arm, Shoulder and Hand). |
| Measure | Description | Time Frame |
|---|---|---|
| Second 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tokiko Hamasaki, PhD | Contact | 819-478-5011 | 2903 | tokiko.hamasaki@uqtr.ca |
| Carlos Gevers-Montoro, PhD | Contact | 819-979-0448 | carlos.geversmontoro@mcgill.ca |
| Name | Affiliation | Role |
|---|---|---|
| Tokiko Hamasaki, PhD | Université du Québec à Trois-Rivières | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de l'Université de Montréal - Physiatry | Recruiting | Montreal | Quebec | H2W 1T6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15374852 | Background | 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. | |
| 31600038 | 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. |
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IPD will be shared by the investigators upon reasonable request
Undecided yet
IPD will be shared by the investigators upon reasonable request
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D014222 | Triamcinolone Acetonide |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| OTHER |
| Centre de Recherche du Centre Hospitalier de l'Université de Montréal | OTHER |
2-arm pragmatic randomized controlled pilot trial
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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.
| Triamcinolone Acetonide | Drug | Ultrasound-guided intra-articular injection 0.25ml (10 mg) of triamcinolone. |
|
|
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 |
| 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. | 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. | 24 hours after the injection and at 1-month, 3-month- and 6-month post-injection. |
| Arthroplasty | The number of participants undergoing arthroplasty during the study period will also be compared between groups.. | 1, 3, and 6 months after injection |
| Centre Hospitalier de l'Université de Montréal - Chirurgie plastique | Recruiting | Montreal | Quebec | H2X 0C1 | Canada |
|
| 36918308 | 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. |
| 27238876 | 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. |
| 33432345 | 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. |
| 28027657 | 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. |
| 25956159 | 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. |
| 15361383 | 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. |
| 42191192 | Derived | Gevers-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. |
| D014221 |
| Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |