Corticosteroid Injection for Thumb Arthritis

Recruiting at1 trial location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Shoulder & Upper Extremity Research Group of Edmonton

Disqualifiers: Inflammatory arthritis, Pregnancy, Psychiatric illness, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for 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.

What data supports the effectiveness of the drug Depo-Medrol Injectable Product for thumb arthritis?

Research shows that corticosteroid injections, like Depo-Medrol, can be effective in reducing pain and improving function in people with thumb arthritis. Studies have found that these injections can provide relief for those suffering from osteoarthritis in the thumb joint. ^{1 2 3 4 5}

Is corticosteroid injection for thumb arthritis safe?

Corticosteroid injections for thumb arthritis are generally safe, with studies showing low rates of serious complications. Some minor side effects like pain at the injection site or temporary stiffness may occur, but serious issues like infection or tendon rupture are rare. ^{3 4 6 7 8}

How is the drug Depo-Medrol unique for treating thumb arthritis?

Depo-Medrol is a corticosteroid injection used to reduce inflammation and pain in thumb arthritis by delivering medication directly into the joint, which can provide targeted relief. This method is different from oral medications as it acts locally and may have fewer systemic side effects. ^{1 5 9 10 11}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

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

I am 40 years old or older.

Exclusion Criteria

I have had a steroid injection in my thumb joint.

People who do not speak/read/understand English, have no fixed address or contact, or are unwilling to complete follow-ups

I have a history of inflammatory arthritis.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Consented participants undergo baseline assessment including Quick-DASH, Brief MHQ, grip and pinch strength, socio-demographics, and VAS for pain intensity

1 day

1 visit (in-person)

Treatment

Participants receive either fluoroscopic guided intra-articular corticosteroid injection or saline injection plus local anesthetic

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at 6 weeks, 3 months, and 6 months

6 months

3 visits (in-person)

Treatment Details

Interventions

• Depo-Medrol Injectable Product (Corticosteroid)
• Saline (Other)

Trial Overview 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.

Participant Groups

Group I: Corticosteroid Injection Experimental Treatment 1 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: Saline Placebo Group 1 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.

Who Is Running the Clinical Trial?

Shoulder & Upper Extremity Research Group of Edmonton

Lead Sponsor

Trials

7

Recruited

700+

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Bill Flanagan

University of Alberta

Chief Executive Officer since 2020

LLB from University of Toronto, LLM from Columbia University

Dr. Verna Yiu

University of Alberta

Chief Medical Officer since 2012

MD from University of Alberta, Fellowship in Pediatric Nephrology at Harvard University

Findings from Research

A systematic review of 9 randomized controlled trials involving 504 patients found that injection-based therapies for base of thumb osteoarthritis, including corticosteroids and hyaluronic acid, did not show significant superiority over placebo or each other in terms of pain relief and function.

While corticosteroids demonstrated a reduction in pain on activity compared to hyaluronic acid in a limited analysis, overall evidence remains inconclusive, highlighting the need for more robust studies to determine the effectiveness of injection therapies compared to non-injection treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injection therapy for base of thumb osteoarthritis: a systematic review and meta-analysis. Riley, N., Vella-Baldacchino, M., Thurley, N., et al.[2020]

Intra-articular injections of hyaluronic acid significantly improved functional capacity in patients with thumb osteoarthritis compared to placebo, while corticosteroids showed no significant effect on pain or function at week 12.

At week 24, corticosteroids were effective in reducing pain, whereas hyaluronic acid improved pulp pinch force, indicating that both treatments have distinct benefits for managing thumb osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular injections in thumb osteoarthritis: A systematic review and meta-analysis of randomized controlled trials. Trellu, S., Dadoun, S., Berenbaum, F., et al.[2022]

Intraarticular injection of triamcinolone hexacetonide (TH) combined with lidocaine (LD) significantly improved pain during movement and reduced joint swelling in patients with osteoarthritis of the hand interphalangeal joints compared to lidocaine alone, with results observed as early as one week after treatment.

The study involved 60 patients, primarily women with an average age of 60.7 years, and found no significant adverse effects from the treatment, indicating that TH/LD is a safe and effective option for managing symptoms of osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Triamcinolone Hexacetonide Intraarticular Injection in Interphalangeal Joints: A 12-week Randomized Controlled Trial in Patients with Hand Osteoarthritis. Spolidoro Paschoal, Nde O., Natour, J., Machado, FS., et al.[2017]

In a double-blind, randomized controlled trial involving 40 patients with osteoarthritis of the thumb, corticosteroid injections did not show any significant improvement in pain or joint function compared to placebo at 24 weeks.

While some short-term improvements were noted in both the steroid and placebo groups, ultimately, intra-articular steroid injections did not provide a clinical benefit for patients with moderate to severe osteoarthritis in the carpometacarpal joint.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of intra-articular corticosteroid injection of the carpometacarpal joint of the thumb in osteoarthritis. Meenagh, GK., Patton, J., Kynes, C., et al.[2018]

Intra-articular (IA) therapies, such as corticosteroids and hyaluronic acid, provide short-term symptomatic relief for hand osteoarthritis (OA), with corticosteroids showing faster pain relief compared to hyaluronic acid, although long-term efficacy data is lacking.

Investigational IA treatments like prolotherapy and platelet-rich plasma show promise but are limited by small sample sizes and potential serious side effects, highlighting the need for more robust studies to assess their safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, Safety, and Accuracy of Intra-articular Therapies for Hand Osteoarthritis: Current Evidence. Oo, WM., Hunter, DJ.[2023]

In a study of 19,120 intra-articular steroid injections for base of thumb osteoarthritis over 19 years, serious complications were very rare, occurring in only 0.04% of cases within 90 days.

About 50% of patients required further procedures, with only 22.4% undergoing surgery, indicating that while injections are common, most patients do not need additional surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low rate of subsequent surgery and serious complications following intra-articular steroid injection for base of thumb osteoarthritis: national cohort analysis. Lane, JCE., Craig, RS., Rees, JL., et al.[2021]

In a study of 58 patients with 77 cases of trigger finger, 61% experienced symptom resolution after a single corticosteroid injection, demonstrating the efficacy of this treatment protocol.

Overall, nearly 90% of patients benefited from corticosteroid injections, with minimal local side effects and no serious complications like infections or tendon ruptures, indicating a safe approach to managing flexor tenosynovitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of flexor tenosynovitis of the hand ('trigger finger') with corticosteroids. A prospective study of the response to local injection. Anderson, B., Kaye, S.[2022]

Inadvertent injection of methylprednisolone acetate into the eye during vitrectomy can lead to severe retinal toxicity, resulting in significant vision loss and complications such as retinal necrosis and optic nerve damage.

This case highlights the critical need for careful identification of medications during eye surgeries to prevent serious adverse effects associated with incorrect injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retinal necrosis secondary to inadvertent intravitreal methylprednisolone acetate (depo-medrol) injection during pars plana vitrectomy. Yonekawa, Y., Sun, G., D'Amico, DJ., et al.[2014]

Fluoroscopy-guided joint injections using long-acting anesthetics and corticosteroids can effectively help diagnose and treat joint pain by localizing the source of pain, which is often complicated by referred pain from adjacent areas.

The choice of corticosteroid for injection, such as Depomedrol for cost-effectiveness or Aristospan for better solubility in rheumatoid arthritis, can influence treatment outcomes, highlighting the importance of selecting the appropriate medication based on the patient's condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anesthetic and Corticosteroid Joint Injections: A Primer. Newberg, AH.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Injection therapy for base of thumb osteoarthritis: a systematic review and meta-analysis. [2020]

2. France pubmed.ncbi.nlm.nih.gov

Intra-articular injections in thumb osteoarthritis: A systematic review and meta-analysis of randomized controlled trials. [2022]

3. Pakistan pubmed.ncbi.nlm.nih.gov

Methylprednisolone acetate injection with casting versus casting alone for the treatment of De-Quervain's Tenosynovitis: a randomized controlled trial. [2021]

4. Canada pubmed.ncbi.nlm.nih.gov

Effectiveness of Triamcinolone Hexacetonide Intraarticular Injection in Interphalangeal Joints: A 12-week Randomized Controlled Trial in Patients with Hand Osteoarthritis. [2017]

5. England pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of intra-articular corticosteroid injection of the carpometacarpal joint of the thumb in osteoarthritis. [2018]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy, Safety, and Accuracy of Intra-articular Therapies for Hand Osteoarthritis: Current Evidence. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Low rate of subsequent surgery and serious complications following intra-articular steroid injection for base of thumb osteoarthritis: national cohort analysis. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Treatment of flexor tenosynovitis of the hand ('trigger finger') with corticosteroids. A prospective study of the response to local injection. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Retinal necrosis secondary to inadvertent intravitreal methylprednisolone acetate (depo-medrol) injection during pars plana vitrectomy. [2014]

10. United States pubmed.ncbi.nlm.nih.gov

Anesthetic and Corticosteroid Joint Injections: A Primer. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Thumb Carpometacarpal Arthritis: Prognostic Indicators and Timing of Further Intervention Following Corticosteroid Injection. [2022]