TITLE:
Fu’s Subcutaneous Needling for Knee Osteoarthritis: A Randomized Controlled Trial Evaluating Clinical Efficacy and Inflammatory Mechanisms
AUTHORS:
Zixuan Ou, Shuyi Tan, Chuanlin Lu, Lihui Yu, Guangjin Zhou, Jiaen Yang, Ning Jia
KEYWORDS:
Fu’s Subcutaneous Needling, Knee Osteoarthritis, Inflammatory Cytokines, Randomized Controlled Trial, Sodium Hyaluronate, Meloxicam
JOURNAL NAME:
Journal of Biosciences and Medicines,
Vol.14 No.7,
July
17,
2026
ABSTRACT: Background: Knee osteoarthritis (KOA) is a highly prevalent degenerative joint disease. Quadriceps muscle atrophy and chronic inflammation mediated by pro-inflammatory cytokines are increasingly recognized as key drivers of KOA progression. Fu’s Subcutaneous Needling (FSN) is a modern acupuncture technique targeting tightened muscles, but its medium-term clinical efficacy and anti-inflammatory mechanisms remain unclear. Objective: To evaluate the clinical efficacy of FSN compared with intra-articular sodium hyaluronate (SH) injection and oral meloxicam (MLX) in treating KOA, and to investigate its effects on serum inflammatory mediators. Methods: In this parallel-group, assessor-blinded randomized controlled trial, 120 patients with Kellgren-Lawrence grade II-III KOA were randomly assigned (1:1:1) to receive FSN (n = 40, 3 sessions/week for 2 weeks), SH injection (n = 40, once/week for 5 weeks), or MLX (n = 40, 7.5 mg/day for 2 weeks). The prespecified primary endpoint was the between-group difference in VAS pain score at post-treatment (Week 2 for FSN and MLX; Week 5 for SH), with the WOMAC index at post-treatment as a coprimary endpoint. To control for multiplicity across two coprimary outcomes and four assessment time points, the significance level for primary comparisons was adjusted using Bonferroni correction (adjusted α = 0.05/8 = 0.00625). Secondary outcomes included Lysholm knee score, range of motion (ROM), SF-12 quality-of-life score, and serum CRP, IL-1, and TNF-α. Assessments were conducted at baseline, Week 1, post-treatment, and Month 3. Results: All 120 randomized patients received at least one dose of the assigned intervention and were included in the modified intention-to-treat analysis; all 120 completed the study. At post-treatment, the FSN group demonstrated significantly lower VAS scores (1.5 ± 1.6) compared with both SH (3.2 ± 1.9, p α decreased by 38.5% in FSN versus 20.1% in SH and 15.5% in MLX. Conclusions: FSN therapy provides superior and sustained clinical improvement in pain, function, and quality of life for KOA patients compared with SH injection and oral MLX. The concomitant reductions in CRP, IL-1, and TNF-α are significantly correlated with clinical improvement, suggesting an association between inflammatory marker suppression and therapeutic response. Whether FSN improves KOA through restoration of periarticular muscle function remains a hypothesis that requires direct measurement in future studies.