NCT07161427

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

Not yet recruiting NA Last updated 16 September 2025

What this trial tests

NA trial testing Fu's Subcutaneous Needling therapy in Chronic Ankle Instability in 62 participants. Not yet recruiting.

Timeline

1 October 2025

Primary endpoint
31 August 2026

1 September 2027

Quick facts

Lead sponsor	Guangzhou University of Chinese Medicine
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	62
Start date	1 October 2025
Primary completion	31 August 2026
Estimated completion	1 September 2027

Drugs / interventions tested

• Fu's Subcutaneous Needling therapy
• Ankle joint aids combined with exercise therapy

Conditions studied

• Chronic Ankle Instability — all drugs for Chronic Ankle Instability →
• Lateral Ankle Sprain — all drugs for Lateral Ankle Sprain →

Sponsor

Guangzhou University of Chinese Medicine

Who can join

Adults 18 to 60, any sex, with Chronic Ankle Instability or Lateral Ankle Sprain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Chen L, Zhang Y, Chen C, Chen X, et al · · 2026 · PMID 41764543 · DOI 10.1186/s13018-026-06719-1