Medium-and Long-term Efficacy of Two Ultrasound-guided Intra-articular Injections of onabotulinumtoxinA (Botox®) Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis : a Randomized Double-blind Controlled Trial in Three-parallel Arms (RHIBOTII)

NCT06902805 Phase 2/Phase 3 RECRUITING

The main objective of this study will be to compare the effects of 2 intra-articular injections of onabotulinumtoxinA with those of 1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline and those of 2 intra-articular injections of normal saline on base-of-thumb pain at 6 months after the first injection.

Details

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 2/Phase 3
Status	RECRUITING
Enrolment	120
Start date	2025-12-03
Completion	2028-11

Conditions

• Base-of-thumb Osteoarthritis
• Osteoarthritis

Interventions

• OnabotulinumtoxinA
• Normal saline (placebo)

Primary outcomes

• Base-of-thumb pain on a self-administered 11-point numeric rating scale — 6 months
  French version of the self-administered base-of-thumb pain numeric rating scale (0: no pain to 100: maximal pain)

Countries

France