Botox Injections for Thumb Arthritis

Overseen By Reena A Bhatt, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Rhode Island Hospital

Disqualifiers: Severe osteoarthritis, Inflammatory arthritis, Fibromyalgia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 1 day

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this clinical trial is to gather information on the safety and effectiveness of botulinum toxin injection (or Botox) in the treatment of thumb joint pain/arthritis. People with thumb joint pain or arthritis usually receive steroid injections to help with the pain. However, this medicine does not always work well and also carries known important side effects. There is currently no alternative to this injection medicine. This clinical trial seeks to investigate botulinum toxin as a possible alternative to steroid injection. The difference between Botox and steroid injections is that they are different medicines and work in different ways. Botox, as it is being used in this study, is not FDA-approved. It is therefore considered an investigational medicine.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants should have failed conservative management with oral pain medication and splinting for at least 3 months, which might imply that you can continue with those treatments.

What data supports the effectiveness of the drug Botox for treating thumb arthritis?

Research suggests that Botox (Botulinum toxin A) injections can help reduce pain and improve function in joint conditions, including thumb arthritis, by relaxing muscles and reducing inflammation. Studies have shown that Botox can be effective in managing pain in other joint-related conditions, such as rheumatoid arthritis and hand tremors, indicating its potential benefit for thumb arthritis. ^{1 2 3 4 5}

Is Botox safe for treating thumb arthritis?

The research articles provided do not contain specific safety data for Botox or Botulinum Toxin injections for thumb arthritis. Therefore, no relevant safety information is available from these studies. ^{6 7 8 9 10}

How is the drug Botox different from other treatments for thumb arthritis?

Botox injections for thumb arthritis are unique because they involve injecting the drug directly into the joint (intra-articular), which may help reduce pain and improve function by targeting the nerves in the joint, unlike traditional treatments that often focus on reducing inflammation or providing pain relief through oral medications or surgery. ^{1 2 5 11 12}

Eligibility Criteria

This trial is for adults over 18 with thumb joint pain or arthritis who haven't improved after at least 3 months of oral pain meds and splinting. It's not for those with severe arthritis, other hand conditions, past significant hand trauma, pregnancy, or plans to conceive soon.

Inclusion Criteria

I've tried pain medication and splinting for over 3 months without improvement.

I have pain, stiffness, or changes in shape or movement in my thumb joint.

Radiograph: joint space narrowing, subchondral sclerosis, osteophytes, subchondral cysts, Eaton-Littler stage

Exclusion Criteria

I have inflammatory arthritis.

Prior significant hand trauma related to the thumb or first CMC joint

My severe arthritis or bone spurs prevent joint injections.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a Botulinum Toxin injection or a standard-of-care corticosteroid injection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

4 visits (in-person) at 2-weeks, 1-month, 6-months, and 1-year

Treatment Details

Interventions

• Botulinum Toxin
• Standard-of-care corticosteroid injections

Trial Overview The study compares the safety and effectiveness of botulinum toxin (Botox) injections versus standard steroid injections in treating thumb joint pain/arthritis. Botox is investigational and not FDA-approved for this use.

Participant Groups

Group I: Botulinum Toxin Experimental Treatment 1 Intervention

Patients in this group will receive a Botulinum Toxin injection.

Group II: Control Active Control 1 Intervention

Patients in this group will receive standard-of-care corticosteroid injections.

Botulinum Toxin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Botox for:

• Facial wrinkles
• Blepharospasm
• Strabismus
• Axillary hyperhidrosis
• Migraine prophylaxis
• Overactive bladder
• Neurogenic detrusor overactivity

Approved in European Union as Botox for:

• Facial wrinkles
• Blepharospasm
• Strabismus
• Axillary hyperhidrosis
• Migraine prophylaxis
• Overactive bladder
• Neurogenic detrusor overactivity
• Spasticity

Approved in Canada as Botox for:

• Facial wrinkles
• Blepharospasm
• Strabismus
• Axillary hyperhidrosis
• Migraine prophylaxis
• Overactive bladder
• Neurogenic detrusor overactivity
• Spasticity

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials

275

Recruited

71,400+

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]

A randomized double-blind controlled trial will assess the efficacy of intra-articular botulinum toxin A (BTA) injections combined with splinting in 60 patients with trapeziometacarpal osteoarthritis, focusing on pain reduction over 3, 6, and 12 months.

If successful, this study could establish BTA as a safe and effective complementary treatment for TMC osteoarthritis, potentially improving pain management and hand function in affected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular botulinum toxin A for base-of-thumb osteoarthritis: protocol for a randomised trial (RHIBOT). Gil, C., Abdoul, H., Campagna, R., et al.[2020]

In a study of 91 patients with medically refractory hand tremor, onabotulinumtoxinA (onaBoNT-A) injections led to significant improvements in tremor severity and function, with 80.2% reporting moderate to marked improvement at their first follow-up and 85.7% at their last follow-up.

The treatment was found to be safe, with only 12.2% of injections resulting in non-disabling and transient adverse events, primarily limb weakness, indicating that onaBoNT-A is a viable option for managing hand tremors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum Toxin for the Treatment of Hand Tremor. Niemann, N., Jankovic, J.[2023]

A patient with chronic radial collateral ligament insufficiency of the thumb underwent successful autograft tendon reconstruction followed by an ultrasound-guided injection of botulinum toxin A into the adductor pollicis muscle, which helped reduce deforming forces on the reconstruction.

One year after the procedure, the patient was pain-free and had a stable radial collateral ligament, suggesting that botulinum toxin may improve outcomes in RCL repair by neutralizing muscle forces that can hinder recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botox and Thumb MCP Radial Collateral Ligament Reconstruction. Cates, RA., Brault, JS., Kakar, S.[2020]

Intra-articular Botulinum toxin A (BoNT/A) injections significantly improved pain and function in two rheumatoid arthritis patients with persistent monoarthritis, showing over 40% improvement after treatment.

The benefits of the treatment lasted for 15-18 months, with complete resolution of ankle swelling by 15 months and metatarsophalangeal joint swelling by one month, suggesting BoNT/A could be a promising alternative for patients who do not respond to corticosteroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular botulinum toxin A as an adjunctive therapy for refractory joint pain in patients with rheumatoid arthritis receiving biologics: a report of two cases. Singh, JA., Mahowald, ML.[2020]

A systematic review of 31 studies involving over 1 million rheumatoid arthritis patients found no significant differences in safety between various biological therapies, including TNF inhibitors and non-TNF therapies, suggesting they are comparably safe.

Abatacept was associated with a lower risk of cardiovascular events compared to TNF inhibitors, indicating it may be a safer option for patients concerned about heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of biological therapy in patients with rheumatoid arthritis in administrative health databases: A systematic review and meta-analysis. de Queiroz, MJ., de Castro, CT., Albuquerque, FC., et al.[2022]

In a study of 872 patients treated with biologic agents for inflammatory arthritis, 86.3% did not experience any adverse events (AEs), indicating a generally favorable safety profile for these medications.

While 16.4% of patients reported AEs, serious adverse events (SAEs) were rare, occurring in only 1.8% of patients, suggesting that the benefits of biologics in managing inflammatory arthritis outweigh the risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Safety Profile of Biologics Used in Rheumatology: A Six-Year Observational Pharmacovigilance Study in the Calabria Region. Gagliardi, A., Iaquinta, FS., Grembiale, RD., et al.[2022]

In a study of 260 patients with systemic-onset juvenile idiopathic arthritis (JIA), serious adverse events were more frequently reported in patients treated with canakinumab and tocilizumab, highlighting the need for careful monitoring of these biologics.

While overall tolerance to biologics was acceptable, specific risks such as infections were notably higher in patients treated with anakinra, and macrophage activation syndrome occurred more frequently in those receiving canakinumab and tocilizumab compared to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term surveillance of biologic therapies in systemic-onset juvenile idiopathic arthritis: data from the German BIKER registry. Klein, A., Klotsche, J., Hügle, B., et al.[2021]

Biological therapies for autoimmune rheumatic diseases, such as rheumatoid arthritis and spondyloarthritides, have improved treatment outcomes but come with potential safety concerns, including risks of infections, infusion reactions, and other serious side effects.

The Brazilian Society of Rheumatology conducted a comprehensive review of safety data over the last two decades, categorizing risks by drug class and providing guidelines for safe use, including considerations for pregnancy and lactation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Safe use of biological therapies for the treatment of rheumatoid arthritis and spondyloarthritides]. Mota, LM., Cruz, BA., Brenol, CV., et al.[2017]

Anti-TNF treatments can effectively reduce inflammation and sub-clinical atherosclerosis in rheumatoid arthritis patients, but they also pose significant risks, including severe infections and alterations in lipid profiles.

There is ongoing debate about the safety of anti-TNF drugs, particularly regarding their potential to increase the risk of demyelinating diseases, making them unsuitable for patients with multiple sclerosis or similar conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concerns about the safety of anti-TNF agents when treating rheumatic diseases. Atzeni, F., Nucera, V., Gerratana, E., et al.[2022]

An 88-year-old woman with multiple health issues experienced significant pain relief and improved function after receiving intra-articular Botox® injections for chronic knee osteoarthritis.

The positive outcomes were measured using validated assessment tools, indicating that Botox® can be an effective treatment option for managing knee osteoarthritis pain in older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond the muscular effects - onabotulinumtoxinA injections for pain control in chronic knee osteoarthritis: a case report. Ko, GD., Lam, KI., Looi, J., et al.[2020]

In a case series of 11 patients with chronic arthritis, intra-articular injections of Botulinum toxin Type A (BoNT/A) resulted in a significant average pain reduction of 55% in lower extremity joints and 71% in shoulder pain, demonstrating its potential efficacy for refractory joint pain.

No immediate or delayed adverse effects were reported, suggesting that BoNT/A injections are a safe option for patients who have not responded to other treatments, with pain relief lasting from 3 to 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long term effects of intra-articular botulinum toxin A for refractory joint pain. Mahowald, ML., Singh, JA., Dykstra, D.[2022]

References

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

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

2. England pubmed.ncbi.nlm.nih.gov

Intra-articular botulinum toxin A for base-of-thumb osteoarthritis: protocol for a randomised trial (RHIBOT). [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Botulinum Toxin for the Treatment of Hand Tremor. [2023]

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

Botox and Thumb MCP Radial Collateral Ligament Reconstruction. [2020]

5. France pubmed.ncbi.nlm.nih.gov

Intra-articular botulinum toxin A as an adjunctive therapy for refractory joint pain in patients with rheumatoid arthritis receiving biologics: a report of two cases. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Safety of biological therapy in patients with rheumatoid arthritis in administrative health databases: A systematic review and meta-analysis. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Real-World Safety Profile of Biologics Used in Rheumatology: A Six-Year Observational Pharmacovigilance Study in the Calabria Region. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Long-term surveillance of biologic therapies in systemic-onset juvenile idiopathic arthritis: data from the German BIKER registry. [2021]

9. Brazil pubmed.ncbi.nlm.nih.gov

[Safe use of biological therapies for the treatment of rheumatoid arthritis and spondyloarthritides]. [2017]

10. England pubmed.ncbi.nlm.nih.gov

Concerns about the safety of anti-TNF agents when treating rheumatic diseases. [2022]

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

Beyond the muscular effects - onabotulinumtoxinA injections for pain control in chronic knee osteoarthritis: a case report. [2020]

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

Long term effects of intra-articular botulinum toxin A for refractory joint pain. [2022]