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Injection of Botulinum Toxin for Thumb Carpometacarpal Arthritis

NCT05990881 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-11-20

No results posted yet for this study

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.

Conditions

  • Carpometacarpal Sprain
  • Thumb Sprain
  • Clostridium; Botulinum

Interventions

DRUG

Botulinum toxin

Patients in this group will receive an injection of Botulinum toxin.

DRUG

Standard-of-care corticosteroid injections

Patients in this group will receive an injection of corticosteroid injections, which are considered standard of care.

Sponsors & Collaborators

  • Rhode Island Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-27
Primary Completion
2025-12-31
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05990881 on ClinicalTrials.gov