Fu's Subcutaneous Needling for Pain: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

To evaluate the efficacy and safety of Fu's subcutaneous needling (FSN) for pain management using randomized controlled trials (RCTs), to provide evidence-based guidance for clinical practice and future research.

A systematic literature search was conducted of PubMed, Embase, Scopus, Cochrane Library, Clinical Trials.gov, and Web of Science databases for RCTs published from inception to May 15, 2025. To be included, studies were required to compare FSN with control interventions for treating pain in adults. Study quality was assessed using the Cochrane Risk of Bias tool, and meta-analysis was performed using RevMan 5.4. Outcomes included pain intensity, and pain-related and functional outcomes.

Eight RCTs (n = 519 participants) were included. Compared with controls, FSN was more effective at reducing pain, with a pooled mean difference (MD) of -1.14 (95% confidence interval [CI]: -1.34 to -0.95; P < 0.001) on the visual analog scale. Subgroup analyses confirmed sustained benefits at the 15-day follow-up (MD = -1.79; P < 0.001) and 1-month follow-up (MD = -1.08; P < 0.001) time-points. Secondary outcomes included significant improvements in the Oswestry Disability Index (MD = -6.10; P < 0.001), range of motion (MD = 9.11; P < 0.001), Lysholm score (standardized MD [SMD] = 0.66; P < 0.001), and 36-Item Short-Form Survey (SMD = 0.78; P < 0.001). Adverse events were mild and transient, with no serious adverse effects reported.

FSN is an effective and safe intervention for pain management, and results in greater pain reduction and functional improvement than other non-pharmacological interventions. Future studies should prioritize multicenter RCTs with standardized protocols, extended follow-up, and diverse populations to confirm the long-term efficacy of FSN for pain management.