Botulinum Toxin Injection in the Management of Thumb Carpometacarpal Arthritis: a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Rhode Island
235 Plain Street
RECRUITING
Providence
Contact Information
Primary
Reena A Bhatt, MD
RBhatt@brownhealth.org
(401) 444-2701
Backup
Vinay Rao, MD
vinayrao33@gmail.com
8133856534
Time Frame
Start Date: 2023-08-27
Estimated Completion Date: 2026-07
Participants
Target number of participants: 50
Treatments
Active_comparator: Control
Patients in this group will receive standard-of-care corticosteroid injections.
Experimental: Botulinum Toxin
Patients in this group will receive a Botulinum Toxin injection.
Related Therapeutic Areas
Sponsors
Leads: Rhode Island Hospital

This content was sourced from clinicaltrials.gov