A study protocol for a randomized controlled trial investigating the inhibitory effect of sphenopalatine ganglion needling on the overactivation of NF-κB signaling pathway in mucosal cells of patients with allergic rhinitis.

Abstract

Background In Chinese clinical practice, the stimulation of sphenopalatine ganglion with a 60mm filiform needle has been utilized for over 50 years to treat rhinitis. Compared to using a 25mm filiform needle to stimulate Xiaguan point on Stomach Channel of Foot Yangming, this method demonstrated superior efficacy in alleviating rhinitis symptoms despite being inserted at the same position. The aim of this study was to investigate the correlation between acupuncture stimulation of sphenopalatine ganglion and ST7 point and their respective therapeutic mechanisms, providing evidence-based medical support for modern acupoint structure research. Methods This study aims to employ a randomized single-blind controlled trial design, enrolling patients diagnosed with allergic rhinitis as the subjects. The intervention method will involve 60mm filiform needle acupuncture targeting the sphenopalatine ganglion, while 25mm filiform needle acupuncture at Xiaguan point will serve as the control. Both groups of patients will receive acupuncture treatment twice a week for a duration of 4 weeks, followed by a 2-week period for monitoring and evaluation.A comparison between the two groups will be conducted regarding the activation pattern of NF-κB signaling pathway, levels of inflammatory factors, and improvements in nasal ventilation function in terms of degree and speed. The objective is to determine whether there is a shared mechanism underlying rhinitis induced by acupuncture at both the sphenopalatine ganglion and Xiaguan point. Discussion Acupuncture of sphenopalatine ganglion provides a non-drug approach for rhinitis treatment. The aim of this study was to compare the therapeutic effects of acupuncture at SPG and ST7 acupoints in terms of symptom improvement, modulation of the NF-κB signaling pathway, and enhancement of nasal ventilation function. This novel investigation will contribute further clinical evidence towards addressing the issue of vague acupoint structure descriptions. However, certain limitations exist within this study, including challenges in evaluating stimulus volume, a relatively short follow-up period, and an insufficient sample size. Trial registration: Chinese Clinical Trial Registry(ChiCTR2300073792),Registered on 20 July 2023.