Fu's subcutaneous needling versus bracing combined with exercise therapy in the treatment of postacute lateral ankle sprain and the prevention of chronic ankle instability: a randomized controlled trial protocol.

introductionFu's Subcutaneous Needling (FSN) is an acupuncture technique that involves horizontally inserting a disposable needle into the subcutaneous loose connective tissue layer to target tightened muscles through a unique manipulation called swaying movement. This technique employs fan-shaped oscillations of the needle at approximately 60°, performing 45 reciprocal motions within 30 s, without penetrating the muscle layer. The mechanical stimulation helps relax chronically tense muscles, improve blood circulation, and alleviate local ischemia, and is often combined with the reperfusion approach (RA) to enhance therapeutic outcomes. Characterized by simplicity, rapid effect, and minimal side effects, FSN has been demonstrated to be effective for ankle sprain. However, it remains unclear how its efficacy compares to the functional bracing and exercise therapy currently recommended in clinical guidelines. Therefore, this study aims to compare it with the combination of ankle bracing and exercise therapy to explore the effects of FSN on improving ankle balance ability, joint function, and pain relief, and to verify whether it helps prevent recurrent sprains after lateral ankle sprain (LAS) and improve the relevant predictive indicators of chronic ankle instability (CAI), so as to provide evidence-based basis for clinical decision-making. METHODS AND ANALYSIS: This study is a randomized, parallel-controlled, single-center prospective clinical study. A total of 80 subjects with postacute LAS will be enrolled and randomly assigned to either the FSN group or the combined treatment group, with 40 cases in each group. The FSN group will receive Fu's subcutaneous needling treatment three times per week for the first 4 weeks, followed by once per week for the next 4 weeks (8 weeks in total). The combined treatment group will wear an ankle brace during daily activities and complete a phased, supervised program of exercise training targeting both muscle strengthening and neuromuscular control for 8 weeks. A follow-up period of one year will be conducted after the treatment. The primary efficacy outcome is the change in the Ankle-GO Score from baseline to 8 weeks after treatment. Secondary outcomes include the Cumberland Ankle Instability Tool (CAIT), active range of motion (ROM) of the ankle joint, Visual Analog Scale (VAS), and the rate of sprain recurrence, all of which will be used to demonstrate the clinical efficacy. ETHICS AND DISSEMINATION: This clinical trial, conducted in full compliance with the Declaration of Helsinki, has been approved by the Institutional Review Board of Guangdong Provincial Hospital of Chinese Medicine and is registered with ClinicalTrials.gov under identifier NCT07161427.