Injection of Botulinum Toxin for Thumb Carpometacarpal Arthritis

Lifespan

Status and phase: Enrolling; Phase 3

Conditions: Thumb Sprain; Carpometacarpal Sprain; Clostridium; Botulinum

Treatments: Drug: Botulinum toxin; Drug: Standard-of-care corticosteroid injections

Study type: Interventional

Funder types: Other

Identifiers

NCT05990881

2006564-3

Details and patient eligibility

About

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.

Full description

Thumb carpometacarpal (CMC) osteoarthritis (OA) is one of the most common conditions treated by hand surgeons in the US. The treatment algorithm includes a stepwise strategy starting with conservative management and escalating to operative interventions when nonoperative measures fail to control pain or there is progression to a painful joint. Intra-articular injection of steroids represents a mainstay in the treatment approach for patients with thumb CMC OA, but despite its ubiquity, the American College of Rheumatology only conditionally recommends steroid injections due to a lack of evidence. Additionally, steroid injections carry significant risks, including the possibility of tissue atrophy, skin hypopigmentation, and joint arthropathy. As a result, alternative means have been sought to better treat pain and potentially delay the need for surgery. Botulinum toxin (BoNT) may be one such alternative.

BoNT is produced by Clostridium botulinum and exerts temporary neuromodulation by rapidly and strongly binding to presynaptic cholinergic nerve terminals. BoNT has also been shown to inhibit the secretion of pain mediators from the nerve endings of the dorsal root ganglia, reduce local inflammation around nerve endings, deactivate sodium channels, and perform retrograde axonal transport. Due to the growing evidence of efficacy in treating neuropathic pain, the use of BoNT has become incorporated in the management of chronic migraines, trigeminal neuralgia, spinal cord injuries, and post-stroke pain syndrome. Additionally, intra-articular BoNT injections were shown to decrease pain in patients with knee and shoulder refractory arthritis.

The investigators propose that intra-articular BoNT injections may decrease pain in patients with thumb CMC OA through the chemical denervation of articular pain fibers.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (> 18 years old) with a diagnosis of thumb CMC OA
• Diagnosis of thumb CMC OA
• History, clinical exam, and radiographic findings, as done in prior studies on this topic.
• Subjective: thumb or wrist pain at rest or with activity, joint stiffness
• Exam: basal joint tenderness, decreased mobility, deformity, instability
• Radiograph: joint space narrowing, subchondral sclerosis, osteophytes, subchondral cysts, Eaton-Littler stage.
• Failed conservative management with oral pain medication and splinting for at least 3 months.

Exclusion criteria

• Severe osteoarthritis (Eaton-Littler stage 4) or too large osteophytes to allow for injection into the joint space Inflammatory arthritis
• Any concomitant hand conditions (i.e. carpal tunnel, trigger finger, etc)
• Prior significant hand trauma related to the thumb or first CMC joint
• Prior intervention or hand surgery
• Patients with fibromyalgia or complex regional pain syndrome (CRPS)
• Pregnant and breastfeeding patients will also be excluded. We also will exclude individuals attempting to conceive or who could become pregnant within 6-months of treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Control

Active Comparator group

Description:

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

Treatment:

Drug: Standard-of-care corticosteroid injections

Botulinum Toxin

Experimental group

Description:

Patients in this group will receive a Botulinum Toxin injection.

Treatment:

Drug: Botulinum toxin