Corticosteroid Injection for Thumb Arthritis

Not currently recruiting at 1 trial location

Overseen By Raelee Phillips, LPN

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Shoulder & Upper Extremity Research Group of Edmonton

Disqualifiers: Inflammatory arthritis, Pregnancy, Psychiatric illness, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to treating thumb arthritis by comparing two types of injections. One group will receive a corticosteroid injection (Depo-Medrol, which reduces inflammation) plus a local anesthetic. The other group will receive a saline solution (a placebo) plus a local anesthetic. Researchers aim to determine which treatment better reduces pain and improves hand function over six months. Individuals with thumb arthritis, confirmed by X-rays, might be suitable for this trial. As a Phase 4 trial, this study involves an FDA-approved treatment and seeks to understand its benefits for more patients, offering participants a chance to contribute to valuable research.

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 is the safety track record for these treatments?

Research has shown that Depo-Medrol, which contains methylprednisolone, is usually safe for treating conditions like arthritis. In some studies, a few patients reported increased pain, swelling, or fever after the injection. These symptoms could indicate a joint infection, but they are rare. Most people do not experience serious side effects. Depo-Medrol is often used to manage rheumatoid arthritis, indicating its general safety for joint treatments. However, monitoring for unusual symptoms and informing a doctor if anything arises is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using corticosteroid injections like Depo-Medrol for thumb arthritis because they offer targeted relief directly to the painful joint. Unlike oral medications such as NSAIDs, which can affect the whole body and take longer to work, this injection is delivered right into the affected area, potentially providing faster pain relief with fewer systemic side effects. Additionally, the use of ultrasound or fluoroscopic imaging ensures that the medication is delivered precisely where it's needed, increasing the chance of effective pain management and improved joint function.

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

Research has shown that corticosteroid injections, such as Depo-Medrol, can help with thumb arthritis, particularly in the short term. In this trial, some participants will receive the Corticosteroid Injection, which includes Depo-Medrol. One study found that methylprednisolone, a type of corticosteroid, provided more relief than other treatments initially. However, by six months, the benefits were less noticeable. Another study demonstrated that pain decreased significantly for up to 12 months after steroid injections. Overall, corticosteroids can reduce pain and improve function in thumb arthritis, but their long-term effectiveness may vary. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Depo-Medrol Injectable Product
• Saline

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 239 patients with thumb carpometacarpal arthritis, 59% required a repeat corticosteroid injection and 37.6% eventually underwent surgery, indicating that many patients may need further intervention after initial treatment.

Factors such as advanced arthritis (Eaton stage III/IV), current smoking, and previous hand surgery were linked to a higher likelihood of needing surgery after the initial injection, with one-third of patients with advanced arthritis undergoing surgery within 5 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thumb Carpometacarpal Arthritis: Prognostic Indicators and Timing of Further Intervention Following Corticosteroid Injection. Ostergaard, PJ., Hall, MJ., Dowlatshahi, AS., et al.[2022]

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]

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]

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]

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]

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 134 patients with de Quervain's disease, those treated with a thumb spica cast combined with a methylprednisolone acetate injection showed significantly better functional outcomes compared to those treated with the cast alone.

Both treatment groups demonstrated improvement in pain and function, but the combination therapy resulted in a higher success rate, indicating that adding the injection enhances treatment efficacy.

NCBI (Pubmed)

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. Akhtar, M., Faraz Ul Hassan Shah Gillani, S., Nadeem, RD., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9277790/

Efficacy of corticosteroids for hand osteoarthritis - a systematic ... Intra-articular corticosteroids showed no significant effect on any clinical outcomes over short (4-6 weeks) or longer term (3-12 months) in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9542898/

Evaluation of PROMIS Scores 6 Weeks after Conservative ... PROMIS scores are likely not sensitive enough to detect improvement in thumb CMC arthritis patients after conservative treatment with hand therapy and/or ...

3. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2021.637904/full

New Trends in Injection-Based Therapy for Thumb ... Methylprednisolone appeared more effective in the short-term, but at the sixth month the results showed a remarkable difference in favor of ...

4. acrjournals.onlinelibrary.wiley.com acrjournals.onlinelibrary.wiley.com/doi/10.1002/acr.24084

Efficacy of Nonsurgical Interventions for Trapeziometacarpal ... This systematic review identified nonsurgical interventions for TMO and reviewed their efficacy. The results of a study with moderate quality ...

5. jhandsurg.org jhandsurg.org/article/S0363-5023(14)01433-6/fulltext

Conservative Treatment of Thumb Base Osteoarthritis showed that pain decreased significantly for a period of 12 months in the steroid group and for 6 months in the hyaluronate group. The authors suggested that, ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/011757s125lbl.pdf

DEPO-MEDROL® (methylprednisolone acetate injectable ... A marked increase in pain accompanied by local swelling, further restriction of joint motion, fever, and malaise are suggestive of septic arthritis. If this.

7. medicines.org.uk medicines.org.uk/emc/files/pil.8957.pdf

Patient Information Leaflet Depo-Medrone contains methylprednisolone acetate. Methylprednisolone belongs to a group of medicines called corticosteroids or steroids. Corticosteroids are ...

8. labeling.pfizer.com labeling.pfizer.com/ShowLabeling.aspx?id=13361

depo-medrol For maintenance of patients with rheumatoid arthritis, weekly intramuscular dosage varies from 40 to 120 mg. The usual dosage for patients with skin lesions.

9. medsafe.govt.nz medsafe.govt.nz/profs/datasheet/d/depomedrolinj.pdf

Depo-Medrol® 40 mg/mL Suspension for Injection For maintenance of patients with rheumatoid arthritis, the weekly intramuscular dose will vary from 40 to 120 mg. The usual dosage for patients with.

10. mayoclinic.org mayoclinic.org/drugs-supplements/methylprednisolone-injection-route/description/drg-20075216

Methylprednisolone (injection route) - Side effects & uses It is used to treat a number of different conditions, such as inflammation (swelling), severe allergies, adrenal problems, arthritis, blood ...