Fu's Subcutaneous Needling for Postacute Lateral Ankle Sprain and Prevention of Chronic Ankle Instability

Introduction: Fu's Subcutaneous Needling (FSN) is a new type of acupuncture treatment method based on the subcutaneous tissue sweeping technique, and it has been proven to have a good therapeutic effect on ankle sprain. However, at present, the difference between its curative effect and the ankle joint orthosis and exercise therapy recommended by the Guidelines remains unclear. Therefore, this study aims to explore the improvement effects of FSN on pain relief, joint function improvement, and ankle balance ability by comparing with ankle orthosis combined with exercise therapy. Verify whether it is more helpful in preventing the progression of lateral ankle sprain (LAS) to chronic ankle instability (CAI) and provide evidence-based basis for clinical decision-making. Methods and analysis: This study is a randomized, parallel - controlled, single - center prospective clinical study. This study will include 60 subjects with postacute lateral ankle sprain and divide them into the FSN group and the combined treatment group. There are 30 cases in each group. The FSN group will be treated with Fu's subcutaneous needling three times a week for a total of two weeks. The Combined treatment group will wear ankle orthotics from 9:00 to 20:00, and complete resistance exercise training every day for a total of two weeks.Patients will be followed up for 6 months after the treatment. The main efficacy index is the change value of the Visual Analog Scale (VAS) compared to the baseline after 2 weeks of treatment. The secondary indicators include active range of motion (ROM) of the ankle joint, Star Excursion Balance Test (SEBT), and the Foot and Ankle Ability Measure (FAAM) to prove the clinical efficacy. Ethics and dissemination: This study strictly adheres to the ethical guidelines of the Declaration of Helsinki.This study has passed the review of the Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine. Approval No.: YF 2025 - 158 - 01. All subjects will sign a written informed consent form. The research results will be publicly published in journals indexed by SCI. Keywords: Fu's subcutaneous needling, Ankle sprain, Postacute lateral ankle sprain, Chronic ankle instability, Functional rehabilitation, Balance, Non-surgical therapy

NCT Number	NCT07161427
Lead Sponsor	Guangzhou University of Chinese Medicine
Conditions	Chronic Ankle Instability, Lateral Ankle Sprain
Enrollment	62 participants
Start Date	2025-10-01
Primary Completion	2026-08-31 (estimated)
Study Completion	2027-09-01 (estimated)
Updated on ClinicalTrials.gov	2025-09-16