40 Participants Needed

Corticosteroids vs Saline for Thumb Arthritis

(CASITOA Trial)

Recruiting at 1 trial location
TH
CG
Overseen ByCarlos Gevers-Montoro, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Université du Québec à Trois-Rivières
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores treatments for thumb osteoarthritis, a condition that causes pain and limits thumb movement. Researchers aim to determine if saline injections are as effective as the usual corticosteroid injections (specifically, Triamcinolone Acetonide) in relieving pain and improving hand function. Participants will receive either a saline or corticosteroid injection without knowing which one they receive. The study seeks individuals with thumb pain due to osteoarthritis who have been advised by a doctor that an injection could help. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that steroid injections, such as triamcinolone acetonide, ease joint pain, including in the thumb. One study found these injections can provide short-term pain relief, lasting from a few weeks to a few months. However, some people might experience side effects like higher blood sugar levels and mild pain or swelling at the injection site.

Saline injections, often used as a placebo (inactive treatment) in studies, are usually considered harmless. Recent research suggests they might actually help reduce pain in some cases, though this is still under investigation. Since saline is essentially saltwater, it is generally seen as very safe with minimal risk of side effects.

In summary, both treatments are generally well-tolerated. Steroid injections might cause temporary side effects, while saline is viewed as a low-risk option. These insights might help prospective trial participants weigh the potential risks and benefits of each treatment.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for thumb arthritis because they offer different approaches to managing pain and inflammation. The corticosteroid injection, using Triamcinolone Acetonide, is a standard treatment, known for its quick action in reducing inflammation and offering relief. On the other hand, the saline solution injection, while traditionally not considered active treatment, is being explored for its potential placebo effect and minimal side effects. This comparison could reveal new insights into how much of the relief from injections is due to the active ingredient versus the act of injection itself.

What evidence suggests that this trial's treatments could be effective for thumb arthritis?

This trial will compare the effects of corticosteroid injections with saline injections for thumb osteoarthritis (TMO). Research has shown that corticosteroid injections, such as triamcinolone acetonide, can temporarily relieve TMO pain. Some studies found that these injections reduce pain and improve thumb movement, but the relief may not last long, and repeated use can cause side effects like tissue damage. Meanwhile, recent research suggests that saline injections, which participants in this trial may receive, might also relieve pain. Although traditionally considered inactive, some evidence indicates saline might have a therapeutic effect, possibly due to physical changes or the placebo effect. This suggests saline could be a safer and more affordable option than corticosteroids for TMO.

Who Is on the Research Team?

TH

Tokiko Hamasaki, PhD

Principal Investigator

Université du Québec à Trois-Rivières

Are You a Good Fit for This Trial?

The CASITOA trial is for people with thumb arthritis confirmed by X-ray, experiencing pain at the thumb base. Candidates should be considered suitable for corticosteroid injections over surgery and must understand French or English.

Inclusion Criteria

My TMO diagnosis was confirmed by an X-ray.
I have pain at the base of my thumb.
My doctor recommends a steroid injection for my joint over surgery.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single injection of either corticosteroids or saline solution

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
3 visits (in-person) at 1, 3, and 6 months

Data Collection and Analysis

Data on pain intensity, functional limitations, and adverse events are collected and analyzed

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Saline Solution Injection
  • Triamcinolone Acetonide
Trial Overview This study compares saline solution injections to corticosteroid injections in reducing pain and improving hand function in individuals with thumb osteoarthritis. Participants are randomly assigned to one of the treatments without knowing which they receive (double-blind).
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Saline InjectionExperimental Treatment1 Intervention
Group II: Corticosteroid InjectionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Université du Québec à Trois-Rivières

Lead Sponsor

Trials
48
Recruited
4,500+

Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Collaborator

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54
Recruited
124,000+

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Collaborator

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26
Recruited
9,500+

McGill University

Collaborator

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421
Recruited
1,017,000+

Université de Sherbrooke

Collaborator

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317
Recruited
79,300+

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborator

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389
Recruited
143,000+

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Collaborator

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64
Recruited
33,600+

Les Cliniques MSK

Collaborator

Trials
1
Recruited
40+

Université de Montréal

Collaborator

Trials
223
Recruited
104,000+

Citations

Randomized Placebo Controlled Study of Triamcinolone ...Triamcinolone acetonide extended-release (steroid) injection for carpometacarpal (CMC) joint osteoarthritis may provide improved pain relief ...
New Trends in Injection-Based Therapy for Thumb ...The current evidence suggests a comparable safety profile of PRP to IA HA with self-limited post-injection pain and swelling representing the ...
Use and safety of corticosteroid injections in joints and ...Overall, IACS injections result in short-term pain relief from a few weeks to a few months. The adverse events include an increase in blood ...
Intra-articular corticosteroid injections to manage ...This study demonstrates that there are potentially significant although short-term benefits to be gained from steroid injections into the TMJ.
Basal joint osteoarthritis of the thumb: a prospective trial ...This prospective study uses a validated outcome instrument to examine the effectiveness of a single steroid injection and 3 weeks of splinting ...
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