Botulinum Toxin Injection in the Management of Thumb Carpometacarpal Arthritis: a Randomized Controlled Trial
Overview
- Phase
- Phase 3
- Intervention
- Standard-of-care corticosteroid injections
- Conditions
- Carpometacarpal Sprain
- Sponsor
- Rhode Island Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Thumb Pain
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Control
Patients in this group will receive standard-of-care corticosteroid injections.
Intervention: Standard-of-care corticosteroid injections
Botulinum Toxin
Patients in this group will receive a Botulinum Toxin injection.
Intervention: Botulinum toxin
Outcomes
Primary Outcomes
Thumb Pain
Time Frame: Post-injection VAS scores will then be taken at each subsequent follow-up visit: 2-weeks, 1-month, 6-months, and 1-year (primary study endpoint).
The primary outcome of interest is an improvement of thumb-specific pain scored by a change in the visual analog scale (VAS) pain score. VAS was chosen based on strong evidence supporting its validity in assessing pain in patients with OA. VAS will be measured by asking patients to make a vertical mark on a 10-cm horizontal line with 0 (far-left hash mark) representing no pain and 10 (far-right hash mark) representing the worst pain of their life. Scores will be quantified by measuring the difference in the distance from the left hash mark to the patient's mark in millimeters using a caliper. Based on the literature, the minimal clinically important difference (MCID) for VAS is 1.6 cm and 2.2 cm for substantial clinical benefit (SCB). Pre-injection VAS scores will be taken to first establish a baseline.
Secondary Outcomes
- Grip Strength(2-weeks, 1-month, 6-months, and 1-year (primary study endpoint).)
- Thumb range of motion(2-weeks, 1-month, 6-months, and 1-year (primary study endpoint).)