What side effects are associated with this type of intervention?

Corticosteroids, used to reduce inflammation and pain in osteoarthritis, can cause gastrointestinal bleeding, avascular necrosis of bone, and potential rebound pain. NSAIDs, another common treatment, may lead to gastrointestinal issues, cardiovascular risks, and renal complications. Both treatments are effective for symptom relief but do not modify the progression of joint damage.

What prior FDA approvals exist?

The FDA has approved several treatments for osteoarthritis, including nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen, which are commonly used to reduce pain and inflammation. Intraarticular corticosteroid injections are also used for short-term pain relief in patients with moderate to severe osteoarthritis, particularly when other treatments have failed or are contraindicated. These injections work by inhibiting inflammatory mediators and immune responses, thereby reducing inflammation and pain. However, their use is generally limited due to potential side effects and the need for repeated administration.

What other types of research exist?

Promising novel alternatives to corticosteroids for osteoarthritis treatment include: <ol> <li>Pirprofen and CGS 5391B (systemic administration) - These drugs have shown significant protection against osteoarthritic lesions.</li> <li></li> </ol> Tribenoside and Tamoxifen (systemic administration) - Both have demonstrated marked reduction in joint pathology. 3. Tranexamic Acid (intraarticular administration) - This protease inhibitor has exhibited significant anti-osteoarthritic activity. 4. GPA 2163 (intraarticular administration) - An experimental drug that has shown some protection against joint degeneration.

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Corticosteroid

Corticosteroid Injection for Thumb Arthritis

Phase 4

Recruiting

Research Sponsored by Shoulder & Upper Extremity Research Group of Edmonton

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Present clinical and radiographic signs of thumb CMC OA using the American College of Rheumatology (ACR) criteria for the classification of hand osteoarthritis.

Participants must be 40 years old or older at recruitment

Must not have

Previous steroid joint injection to either thumb CMC joint

History of inflammatory arthritis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks, 3 months, 6 months

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial tests two types of injections for adults with thumb arthritis. One injection contains a steroid to reduce inflammation and a numbing medicine for quick pain relief. The other injection contains a saltwater solution and a numbing medicine. The goal is to see which injection is more effective in reducing pain and improving hand function over several months. Steroid injections have been shown to be effective in reducing pain and improving function in various joint conditions.

Who is the study for?

This trial is for individuals over 40 with thumb osteoarthritis, confirmed by clinical and radiographic signs. Candidates must understand English and be able to complete follow-ups. It's not suitable for those with psychiatric illness, inflammatory arthritis history, cognitive impairments, or who are pregnant/breastfeeding.

What is being tested?

The study compares the effectiveness of a corticosteroid (Depo-Medrol) injection versus a saline (placebo) injection in treating thumb joint osteoarthritis over six months. Both treatments include a local anesthetic.

What are the potential side effects?

Corticosteroid injections like Depo-Medrol may cause side effects such as pain at the injection site, increased blood sugar levels, temporary flare-up of joint pain, infection risk at the injection site, and potential weakening of nearby bones.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My thumb joint pain is diagnosed as osteoarthritis by ACR criteria.

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I am 40 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had a steroid injection in my thumb joint.

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I have a history of inflammatory arthritis.

Select...

I am mentally capable of understanding and consenting to treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks, 3 months, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 weeks, 3 months, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Pain with movement

Secondary study objectives

Change in Brief Michigan Hand Outcomes Questionnaire

Change in Pinch Strength

Change in Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH) Questionnaire

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Corticosteroid InjectionExperimental Treatment1 Intervention

Pre-filled opaque syringe containing 40 mg (1cc) of depo-medrol combined with 0.5 cc of 1% lidocaine (or 1cc saline + 0.5 cc 1% lidocaine) will be injected in the symptomatic CMC joint using fluoroscopic imaging to ensure injection into the joint. If both CMC joints are symptomatic, the most symptomatic joint will be injected. If both CMC joints are equally symptomatic, the dominant hand will be injected.

Group II: SalinePlacebo Group1 Intervention

Pre-filled opaque syringe containing 0.5 cc of 1% lidocaine (or 1cc saline + 0.5 cc 1% lidocaine) will be injected in the symptomatic CMC joint using ultrasound imaging to ensure accuracy of injected location. If both CMC joints are symptomatic, the most symptomatic joint will be injected. If both CMC joints are equally symptomatic, the dominant hand will be injected.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Depo-Medrol Injectable Product

2017

Completed Phase 3

~10

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Osteoarthritis (OA) include nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, and platelet-rich plasma (PRP). NSAIDs reduce inflammation and pain by inhibiting cyclooxygenase (COX) enzymes, which decreases prostaglandin production. Corticosteroids, such as those studied in clinical trials, inhibit inflammatory mediators and immune responses, thereby reducing inflammation and pain. PRP delivers high concentrations of growth factors that reduce inflammation and promote tissue repair. Understanding these mechanisms helps OA patients and their doctors choose the most effective treatment tailored to their specific inflammatory and degenerative processes.

Comparative effectiveness of pharmacologic interventions for knee osteoarthritis: a systematic review and network meta-analysis.Pathophysiology and first-line treatment of osteoarthritis.