The efficacy of electroacupuncture combined with Micro-Needle-Knife for allergic rhinitis: study protocol for a randomized controlled trial

Introduction Allergic rhinitis (AR), classified as a hypersensitivity disorder profoundly impairing human quality of life, presents substantial clinical complexities. Among these, the management of moderate-to-severe AR cases constitutes a particularly challenging clinical scenario, which seriously affects their daily life, study, sleep, and mood. The efficacy of conventional treatments for AR remains suboptimal, necessitating an urgent exploration of alternative approaches to identify simpler, more convenient, effective, and cost-efficient therapeutic options for clinical AR management. This trial is designed to rigorously assess the efficacy and safety of electroacupuncture (EA) combined with Micro-Needle-Knife therapy as a novel therapeutic modality for patients with moderate-to-severe allergic rhinitis. Methods and analysis This study protocol is a randomized controlled, patient-assessor-blinded trial. The trial will have a treatment period of 4 weeks and a follow-up period of 3 months. 90 eligible participants will be randomly assigned to the EA combined with Micro-Needle-Knife group and the drug group in a 1:1 ratio. The evaluation of all study parameters will be conducted across five distinct temporal phases: baseline assessment (week 0), two consecutive intervention phases (weeks 2 and 4), and two subsequent follow-up intervals (weeks 8 and 16). The primary outcome is the Total Nasal Symptom Score (TNSS). Secondary outcomes include Total Non-nasal Symptom Score (TNNSS), Rhinitis Quality of Life Questionnaire (RQLQ), serum chemokine Eotaxin, Inter Cellular Adhesion Molecule-1 (ICAM-1), and Eosinophil Cationic Protein (ECP). All adverse events will be evaluated during the trial. Conclusions This study will preliminarily evaluate if EA combined with Micro-Needle-Knife is effective and safe in the treatment of AR. Clinical trial registration https://clinicaltrials.gov/study/NCT06890260 ; identifier: NCT06890260.