Status:
RECRUITING
Injection of Botulinum Toxin for Thumb Carpometacarpal Arthritis
Lead Sponsor:
Rhode Island Hospital
Conditions:
Carpometacarpal Sprain
Thumb Sprain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 jo...
Detailed Description
Thumb carpometacarpal (CMC) osteoarthritis (OA) is one of the most common conditions treated by hand surgeons in the US. The treatment algorithm includes a stepwise strategy starting with conservative...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05990881
Start Date
August 27 2023
End Date
July 1 2026
Last Update
November 20 2024
Active Locations (1)
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1
235 Plain Street
Providence, Rhode Island, United States, 02905