NCT05990881 Injection of Botulinum Toxin for Thumb Carpometacarpal Arthritis
| NCT ID | NCT05990881 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Rhode Island Hospital |
| Condition | Carpometacarpal Sprain |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-08-27 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 50 participants in total. It began in 2023-08-27 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05990881 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Carpometacarpal Sprain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05990881 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 50 participants.
Is NCT05990881 currently recruiting?
Yes, NCT05990881 is actively recruiting participants. Contact the research team at RBhatt@brownhealth.org for enrollment information.
Where is the NCT05990881 trial being conducted?
This trial is being conducted at Providence, United States.
Who is sponsoring the NCT05990881 clinical trial?
NCT05990881 is sponsored by Rhode Island Hospital. The trial plans to enroll 50 participants.