Botulinum toxin injection for thumb arthritis pain
Botulinum Toxin Injection in the Management of Thumb Carpometacarpal Arthritis: a Randomized Controlled Trial
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 |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rhode Island Hospital Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT05990881 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with thumb carpometacarpal OA who have not found relief from conservative management.
Not a fit: Patients with severe osteoarthritis, inflammatory arthritis, or other significant hand conditions may not benefit from this study.
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 performed: While botulinum toxin has shown promise in treating various pain conditions, its use specifically for thumb arthritis is novel and not yet widely tested.
Eligibility criteria
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 this trial is running
Providence, Rhode Island
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.