Steroid Injections for Osteoarthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates whether a special timed-release steroid injection can reduce pain and improve thumb function in individuals with osteoarthritis in the thumb joint. The main treatment tested is Triamcinolone Acetonide Extended Release Injection, compared to a placebo (a harmless shot with no active medicine). Suitable candidates have a confirmed case of thumb osteoarthritis and frequently experience significant thumb pain. Participants will receive an injection and attend follow-up visits to assess effectiveness. As a Phase 2 trial, this research measures the treatment's efficacy in an initial, smaller group, allowing participants to contribute to important findings.
Will I have to stop taking my current medications?
You will need to stop taking opioid or over-the-counter pain medications during the study. This will be monitored and recorded in a log.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that triamcinolone acetonide extended-release injections are generally safe. In studies on osteoarthritis, most participants tolerated the injections well, with safety consistent across both older and younger patients.
This treatment releases the steroid slowly, resulting in lower levels of the drug entering the bloodstream at once, which can reduce the risk of side effects. Some participants experienced minor side effects, such as soreness at the injection site, but these were usually mild.
The FDA has already approved triamcinolone acetonide for treating knee osteoarthritis, indicating its relative safety. However, since this trial is in an early stage, researchers are still assessing its safety for treating thumb osteoarthritis.12345Why do researchers think this study treatment might be promising for osteoarthritis?
Most treatments for osteoarthritis, such as nonsteroidal anti-inflammatory drugs (NSAIDs) and standard corticosteroid injections, provide temporary relief by reducing inflammation. However, Triamcinolone Acetonide Extended Release Injection is unique because it offers an extended release formulation. This means it can provide longer-lasting pain relief compared to traditional steroid injections, potentially reducing the need for frequent treatments. Researchers are excited about this treatment because it targets inflammation over a more extended period, which could improve patient comfort and compliance with fewer injections.
What evidence suggests that this treatment might be an effective treatment for osteoarthritis?
Research has shown that triamcinolone acetonide extended-release injections, which participants in this trial may receive, can effectively reduce pain. In other studies, patients with osteoarthritis who received these injections in their joints experienced pain relief for 5–6 months. This treatment often provides quick pain relief, starting in just four days. Additionally, it can improve physical abilities, such as standing up from a chair, for up to 12 weeks after the injection. These findings suggest that this injection might help reduce thumb pain and improve function for those with thumb joint osteoarthritis.56789
Are You a Good Fit for This Trial?
Adults over 18 with X-ray confirmed thumb osteoarthritis (Eaton stages I-III) and significant pain can join this study. They must not take opioids or OTC pain meds during the trial, avoid pregnancy, and have no history of severe reactions to the drug being tested or similar drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a Triamcinolone acetonide extended-release or saline placebo injection in the CMC joint
Follow-up
Participants are monitored for pain reduction and thumb function improvement
What Are the Treatments Tested in This Trial?
Interventions
- Triamcinolone Acetonide Extended Release Injection
Triamcinolone Acetonide Extended Release Injection is already approved in United States for the following indications:
- Osteoarthritis pain of the knee
Find a Clinic Near You
Who Is Running the Clinical Trial?
Marie Badalamente
Lead Sponsor