Abstract
BACKGROUND Micro-needle knife (MNK) therapy releases the superficial fascia to alleviate pain and improve joint function in patients with acute ankle sprains (AAS). We aimed to evaluate the efficacy and safety of MNK therapy vs that of acupuncture. MATERIAL AND METHODS This blinded assessor, randomized controlled trial allocated 80 patients with AAS to 2 parallel groups in a 1: 1 ratio. The experimental group received MNK therapy; the control group underwent conventional acupuncture treatment at specified acupoints. Clinical efficacy differences between the 2 groups before (time-point 1 [TP1]) and after treatment (TP2) were evaluated using the visual analogue scale (VAS) and Kofoed ankle score. Safety records and evaluations of adverse events were documented. One-month follow-up after treatment (TP3) was conducted to assess the intervention scheme's reliability. RESULTS VAS and Kofoed ankle scores significantly improved in both groups. No patients dropped due to adverse events. At TP1, there were no significant differences between the 2 groups in terms of VAS and Kofoed scores (P>0.05). However, at TP2, efficacy of MNK therapy in releasing the superficial fascia was significantly superior to that of acupuncture treatment (P<0.001). At TP3, no significant differences in scores existed between the groups (P>0.05). CONCLUSIONS This study demonstrates that 6 sessions of MNK therapy to release the superficial fascia safely and effectively alleviated pain and enhanced ankle joint function in patients with AAS, surpassing the efficacy of conventional acupuncture treatment. Future studies should increase the sample size and introduce additional control groups to further validate the superior clinical efficacy of this intervention.