Ultrashort wave therapy for chronic rhinosinusitis with nasal polyps: protocol for a randomized, double-blind, sham-controlled trial.

Background: Chronic rhinosinusitis with nasal polyps (CRSwNP) is characterized by persistent sinonasal inflammation and substantially impairs quality of life. Current treatments, including corticosteroids, surgery, and biologics, are limited by side effects and high recurrence rates. Ultrashort wave (USW) therapy, a non-invasive modality with purported anti-inflammatory effects, lacks robust evidence for its efficacy in CRSwNP.

Methods: This single-center, double-blind, sham-controlled trial will randomize 150 patients with CRSwNP to receive either active USW therapy (50 mA, 27.12 MHz) or sham treatment for 20 min daily over 2 weeks, alongside standard medical care. The sole primary outcome is the change in the 22-item Sino-Nasal Outcome Test (SNOT-22) score from baseline to the 12-month follow-up. Key secondary outcomes include the change in the Lund-Kennedy endoscopic score at the 12-month follow-up. The primary outcome will be analyzed using a linear mixed-effects model, and sensitivity analyses will be conducted to handle missing data.

Discussion: This trial aims to address a critical evidence gap regarding the efficacy of USW therapy for CRSwNP. If effective, USW therapy could offer a non-invasive adjunct, potentially reducing the burden of corticosteroids, surgery, and biologics while improving long-term patient outcomes. The findings will provide crucial evidence to inform clinical guidelines and direct future research.

Trial registration: Chinese Clinical Trial Registry (ChiCTR2400092411). Registered on November 16, 2024.