Corticosteroid Against Saline Injections for Thumb Osteoarthritis (CASITOA)

Thumb Osteoarthritis Clinical Trial

— CASITOA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06401317
• Other study ID #: CASITOA
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: May 2024
• Source: Université du Québec à Trois-Rivières
• Contact: Tokiko Hamasaki, PhD
• Phone: +1-514-433-8160
• Email: tokiko.hamasaki[@]uqtr.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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, multicenter, double-blind randomized trial, adhering to PRECIS-2 guidelines.

The pilot randomized controlled trial will assess the feasibility of a multicenter 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• aged =18 years

• diagnosis of TMO was confirmed by X-ray

• 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 respond in 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 unable to provide informed consent due to physical or mental incapacity.

Related Conditions & MeSH terms

• Osteoarthritis
• Thumb Osteoarthritis

Intervention

Drug:
• Saline Hypertonic Solution
Ultrasound-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.

Locations

Country	Name	City	State
n/a

Sponsors (9)

Lead Sponsor	Collaborator
Université du Québec à Trois-Rivières	Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Centre hospitalier de l'Université de Montréal (CHUM), Les Cliniques MSK, McGill University, Université de Montréal, Université de Sherbrooke

References & Publications (8)

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. — View Citation

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. — View Citation

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. Erratum In: Ann Rheum Dis. 2005 Aug;64(8):1248. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of participant recruitment	The number of participants recruited per week, divided by those assessed for eligibility and those included	Through study completion (estimated time, 1 year)
Other	Rate of participants completing the initial assessment	The number of participants completing initial assessments, divided by those recruited	Through study completion (estimated time, 1 year)
Other	Rate of participants receiving the injection	The number of participants receiving the injection, divided by those recruited	Through study completion (estimated time, 1 year)
Other	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)
Other	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
Other	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
Other	Hospital Anxiety and Depression Scale	14-item questionnaire to assess anxiety and depression symptoms among non-psychiatric patients. It generates an Anxiety score and a Depression one from 0 to 21 where a higher score indicates greater distress. Anxiety Scores = 10 and Depression Scores = 7 are considered clinically significant.	Baseline, 1, 3, and 6 months after injection
Other	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.
Primary	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
Secondary	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.	Baseline, 1, 3, and 6 months after injection