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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Botox injections can effectively relieve thumb joint pain and arthritis as an alternative to standard steroid injections. Steroid injections often fail to work and can cause concerning side effects. Participants will receive either the usual steroid injections or the experimental Botox treatment. Ideal candidates have persistent thumb pain or stiffness that hasn't improved with medication or splints for at least three months. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that botulinum toxin injections, such as Botox, are usually well-tolerated for joint pain, including thumb arthritis. Some studies found that patients experienced less joint pain after receiving Botox injections. Side effects were mostly mild, such as temporary discomfort at the injection site. The FDA has already approved Botox for other uses, like easing muscle stiffness and treating migraines, indicating its well-known safety profile. However, since using Botox for thumb arthritis remains under study, more research is needed to fully understand its safety and effectiveness for this condition. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for thumb arthritis, which typically involve corticosteroid injections to reduce inflammation, Botulinum Toxin offers a different approach. Researchers are excited about Botulinum Toxin because it works by blocking nerve signals that cause muscle contractions, potentially providing longer-lasting pain relief. Additionally, this treatment might reduce the need for frequent injections compared to corticosteroids, making it a more convenient option for patients. This novel mechanism could change how we manage symptoms and improve quality of life for those with thumb arthritis.

What evidence suggests that botulinum toxin could be an effective treatment for thumb arthritis?

Studies have shown that botulinum toxin, commonly known as Botox, can help reduce pain for people with arthritis at the base of the thumb. In this trial, participants will receive either a Botulinum Toxin injection or standard-of-care corticosteroid injections. Research has indicated that those who received Botox injections reported a significant decrease in pain, with some experiencing a 25.7-point drop on a pain scale. Patients with arthritis in larger joints also found relief with Botox, even when other treatments like steroids didn't work. While more evidence is still needed, early findings suggest Botox could be a promising option for treating thumb arthritis pain. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6042589/

Intra-articular botulinum toxin A for base-of-thumb osteoarthritis

The primary outcome will be the mean change from baseline in base-of-thumb pain on a self-administered 11-point Numeric Rating Scale in 10-point ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01045694

Botulism Toxin Injection as a Treatment for Arthritis of the ...

BTX-A has shown to be effective in treating osteoarthritis of larger joints that undergo frequent use, including cases resistant to steroid injections. The ...

3.

thelancet.com

thelancet.com/journals/lanrhe/article/PIIS2665-9913(22)00129-1/abstract

Intra-articular botulinum toxin A injection for painful base-of ...

The primary outcome was the mean change from baseline in base-of-thumb pain in the previous 48 h on a numeric rating scale at 3 months after injection, analysed ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1877065724000617

Review Efficacy and safety of intra-articular botulinum toxin ...

We found limited evidence of a positive effect of intra-articular BoNT-A on pain in the short term in base-of-thumb osteoarthritis and shoulder pain ( ...

5.

medwirenews.com

medwirenews.com/2022/07/26/botulinum-toxin-a-injection-may-ease-base-of-thumb-osteoarthritis-pain/

Botulinum toxin A injection may ease base-of-thumb ...

At 3 months post-treatment, individuals who received botulinum toxin A reported a mean 25.7-point reduction in base-of-thumb pain. The reduction ...

6.

trials.arthritis.org

trials.arthritis.org/trials/NCT05990881

Injection of Botulinum Toxin for Thumb Carpometacarpal Arthritis

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 ...