Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05990881

Injection of Botulinum Toxin for Thumb Carpometacarpal Arthritis

Led by Rhode Island Hospital · Updated on 2024-11-20

50

Participants Needed

1

Research Sites

148 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Injection of Botulinum Toxin for Thumb Carpometacarpal Arthritis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients (> 18 years old) diagnosed with thumb carpometacarpal osteoarthritis (CMC OA)
  • Diagnosis confirmed by history, clinical exam, and radiographic findings
  • Symptoms include thumb or wrist pain at rest or with activity, joint stiffness
  • Physical exam showing basal joint tenderness, decreased mobility, deformity, or instability
  • Radiographs showing joint space narrowing, subchondral sclerosis, osteophytes, or subchondral cysts
  • Failed conservative treatment with oral pain medication and splinting for at least 3 months
Not Eligible

You will not qualify if you...

  • Severe osteoarthritis (Eaton-Littler stage 4) or large osteophytes preventing joint injection
  • Presence of inflammatory arthritis
  • Other hand conditions like carpal tunnel syndrome or trigger finger
  • Prior significant hand trauma related to thumb or first CMC joint
  • Previous hand surgery or intervention
  • Diagnosis of fibromyalgia or complex regional pain syndrome (CRPS)
  • Pregnant or breastfeeding individuals, or those planning pregnancy within 6 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

235 Plain Street

Providence, Rhode Island, United States, 02905

Actively Recruiting

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Research Team

R

Reena A Bhatt, MD

CONTACT

V

Vinay Rao, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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