Abstract
OBJECTIVE: Chronic non-specific neck pain (CNNP) is a prevalent cause of disability worldwide, yet effective and safe treatment options remain limited. This study aimed to evaluate the clinical efficacy of Fu's Subcutaneous Needling (FSN) therapy compared with standard acupuncture and to explore its effect on muscle elasticity using shear wave elastography (SWE). METHODS: In this randomized controlled trial, 70 patients with CNNP were assigned to receive either FSN therapy (n = 35) or filiform needle acupuncture (n = 35). Clinical outcomes were assessed using the Neck Disability Index (NDI) and Visual Analogue Scale (VAS) before and after treatment and at one-month follow-up. SWE was used to quantify the elasticity modulus of the upper trapezius muscle. RESULTS: Both groups showed significant improvement after treatment; however, the FSN group demonstrated greater reductions in NDI and VAS scores (p < 0.05). SWE values decreased significantly following FSN therapy (p < 0.05) but not after filiform acupuncture. Moreover, SWE values correlated strongly with NDI and VAS scores (p < 0.05). No adverse events were reported. CONCLUSION: FSN therapy is a safe and minimally invasive treatment that provides a relatively good improvement in pain and disability compared with standard acupuncture, while simultaneously restoring muscle elasticity. The integration of SWE as an objective biomarker highlights both the clinical effectiveness and mechanistic insights of FSN, supporting its role as a relatively effective non-pharmacological intervention for CNNP. CLINICAL TRIAL REGISTRATION: Identifier ChiCTR2200062436.