RecruitingPhase 3

Injection of Botulinum Toxin for Thumb Carpometacarpal Arthritis

United States50 participantsStarted 2023-08-27

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Thumb Pain

Timeframe: 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).

Trial details

NCT IDNCT05990881

SponsorRhode Island Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Reena A Bhatt, MD

(401) 444-2701 RBhatt@brownhealth.org