Botulinum toxin injection for thumb arthritis pain
Official title: Botulinum Toxin Injection in the Management of Thumb Carpometacarpal Arthritis: a Randomized Controlled Trial
Run by Rhode Island Hospital · NCT05990881 · Data updated 2026-11-12
This study is testing if botulinum toxin injections can help relieve thumb arthritis pain for people who haven't found relief with other treatments.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Rhode Island Hospital Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Status | Recruiting |
| Started | August 27, 2023 |
| Main results expected | December 2025 |
| Study ends | July 2026 |
| Registry record updated | November 20, 2024 |
| Trial ID | NCT05990881 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 with thumb carpometacarpal OA who have not found relief from conservative management.
✕Probably not a fit
Patients with severe osteoarthritis, inflammatory arthritis, or other significant hand conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the safety and effectiveness of botulinum toxin injections as an alternative treatment for thumb carpometacarpal osteoarthritis (OA) pain. Traditionally, steroid injections are used for this condition, but they come with significant risks and limited efficacy. The study aims to evaluate how botulinum toxin, which works by modulating nerve signals and reducing inflammation, can provide relief for patients who have not responded to conservative treatments. Participants will receive either botulinum toxin or standard corticosteroid injections to compare outcomes.
Why it matters
Potential benefit: If successful, this treatment could offer a safer and more effective option for patients suffering from thumb arthritis pain.
How similar studies have gone: While botulinum toxin has shown promise in treating various pain conditions, its use specifically for thumb arthritis is novel and not yet widely tested.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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235 Plain Street
Providence, Rhode Island, United States Recruiting
Study contacts
- Study coordinator: Reena A Bhatt, MD
- Email: RBhatt@brownhealth.org
- Phone: (401) 444-2701
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.