Botulinum Toxin in Raynaud’s Phenomenon: A Single Center Double-blinded Randomized Controlled Trial

BACKGROUND: Raynaud’s phenomenon (RP) is a vasospastic disorder that can cause significant pain, functional impairment, and digital ischemia. Botulinum toxin type A (BTX-A) has emerged as a potential treatment, but high-quality evidence remains limited. This double-blind, randomized controlled trial evaluated the efficacy of BTX-A injections in improving pain, function, and physiologic perfusion measures in patients with refractory RP. METHODS: Adults with RP and persistent symptoms despite medical therapy were equally randomized to receive peri-arterial injections of placebo, 50 units of BTX-A, or 100 units of BTX-A per hand. Participants were assessed at baseline and at four, 12, and 24 weeks post-injection. The primary outcome was change in visual analog scale (VAS) pain. Secondary outcomes included PROMIS Upper Extremity function, QuickDASH, Raynaud’s Condition Score, subjective hand value, fingertip temperature, and fingertip oxygen saturation. RESULTS: Twenty-four subjects were enrolled, with 20 completing 24-week follow-up. There were no significant differences between BTX-A and placebo groups for change in VAS pain at any time point, although a nonsignificant reduction in pain was observed at four weeks post-injection in the pooled BTX-A group (−0.94 ± 0.60; p=0.13). By-arm analyses showed similar trends without dose–response effects. Secondary outcomes, including functional scores and physiologic parameters, showed no between-group differences through 24 weeks. CONCLUSION: BTX-A did not demonstrate statistically significant improvements in pain, function, or digital perfusion compared with placebo among patients with refractory RP. Larger, adequately powered studies with standardized injection techniques and stratified patient groups are needed to clarify the role of BTX-A in Raynaud’s management.