Injection of Botulinum Toxin for Thumb Carpometacarpal Arthritis

Conditions

• Carpometacarpal Sprain
• Clostridium; Botulinum
• Thumb Sprain

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Botulinum toxin — DRUG
  Patients in this group will receive an injection of Botulinum toxin.
• Standard-of-care corticosteroid injections — DRUG
  Patients in this group will receive an injection of corticosteroid injections, which are considered standard of care.

Study Details

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.

Key Dates

Start date

Aug 27, 2023

Status verified

Nov 2024

Primary completion

Dec 31, 2025

Completion

Jul 31, 2026

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Thumb Pain [ Time Frame: 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). ]

Central Contacts

• Reena A Bhatt, MD
  (401) 444-2701
  [email protected]
• Vinay Rao, MD
  8133856534
  [email protected]

Locations (1)

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