Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401317
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-30
Brief Title:
Corticosteroid Against Saline Injections for Thumb Osteoarthritis CASITOA
Sponsor:
Université du Québec à Trois-Rivières
Organization:
Université du Québec à Trois-Rivières
Study Overview
Official Title:
Comparison of the Efficacy of Intra-Articular Corticosteroid Injections Versus Saline Solution for Thumb Osteoarthritis Multicentric Double-Blind Pragmatic Randomized Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CASITOA
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
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 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 studys feasibility Participants will be randomly assigned to treatment and the clinicians delivering the intervention will be blinded to the content of the injections The studys 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
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 studys feasibility Participants will be randomly assigned to treatment and the clinicians delivering the intervention will be blinded to the content of the injections The studys 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None