Abstract
BACKGROUND: Knee osteoarthritis (KOA) is a common degenerative disease. Small needle-knife (SNK) therapy combined with exercise therapy has attracted increasing attention. However, its effectiveness requires further evaluation. OBJECTIVE: To systematically evaluate the clinical efficacy of SNK combined with exercise therapy in KOA patients. METHODS: Randomized controlled trials(RCTs) comparing small needle-knife (SNK) plus exercise with exercise alone were identified from major databases (PubMed, EMBASE, Cochrane Library and others) from inception to March 14, 2025. Primary outcomes included overall treatment efficacy, pain measured by the visual analogue scale (VAS), function assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Lequesne Index, and knee stability assessed by the Lysholm score. Meta-analyses were performed using fixed- or random-effects models according to heterogeneity (I(2) and Q test). Risk of bias was assessed with the Cochrane Risk of Bias 2.0 tool (RoB 2), and the certainty of evidence with the GRADE approach. The protocol was prospectively registered in PROSPERO. RESULTS: Ten RCTs were included. Results showed that SNK combined with exercise significantly improved clinical efficacy (RR = 1.30; 95% CI [1.19, 2.42]). Compared with exercise alone, combination therapy significantly relieved pain (VAS: MD = -1.64; 95% CI [-2.20, -1.05]), improved function (WOMAC: MD = -14.65; 95% CI [-19.48, -9.83]; Lequesne index: MD = -2.23; 95% CI [-3.59, -0.86]), and enhanced knee stability (Lysholm score: MD = 9.20; 95% CI [1.67, 16.74]). ROB2 assessment showed that 60% of studies had low risk, and 40% had some concerns. All outcome measures were supported by high-quality evidence according to the GRADE framework. CONCLUSION: The combination of SNK and exercise shows clinically significant improvements in KOA. Nevertheless, additional high-quality studies are required to corroborate these findings.