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

NCT05990881 Phase 3 RECRUITING

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.

Details

Lead sponsor	Rhode Island Hospital
Phase	Phase 3
Status	RECRUITING
Enrolment	50
Start date	2023-08-27
Completion	2026-07

Conditions

• Carpometacarpal Sprain
• Thumb Sprain
• Clostridium; Botulinum

Interventions

• Botulinum toxin
• Standard-of-care corticosteroid injections

Primary outcomes

• Thumb Pain — 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).
  The primary outcome of interest is an improvement of thumb-specific pain scored by a change in the visual analog scale (VAS) pain score. VAS was chosen based on strong evidence supporting its validity in assessing pain in patients with OA. VAS will be measured by asking patients to make a vertical mark on a 10-cm horizontal line with 0 (far-left hash mark) representing no pain and 10 (far-right hash mark) representing the worst pain of their life. Scores will be quantified by measuring the difference in the distance from the left hash mark to the patient's mark in millimeters using a caliper. Based on the literature, the minimal clinically important difference (MCID) for VAS is 1.6 cm and 2.2 cm for substantial clinical benefit (SCB). Pre-injection VAS scores will be taken to first establish a baseline.

Countries

United States