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

Official title

Biomechanics-based Fu's Subcutaneous Needling Versus Bracing Combined With Resistance Training in the Treatment of Postacute Lateral Ankle Sprain and the Prevention of Chronic Ankle Instability: A Randomized Controlled Trial Protocol

Overview

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

Interventions

• Procedure Fu's Subcutaneous Needling therapy
  Participants first assume the supine position. After routine disinfection, the Fu's subcutaneous needle is inserted parallelly into the subcutaneous loose connective tissue around the pathologically taut muscles (such as the tibialis anterior, peroneus longus, gastrocnemius, soleus, peroneus brevis, and extensor digitorum longus, etc.). After the needle is fully inserted, fix the protruding part of the hose holder onto the card slot.To minimize the participants' perception of pain, the doctor us
• Behavioral Ankle joint aids combined with exercise therapy
  Participants in the combination therapy group wore ankle orthoses during their daily activities from 9:00 to 20:00 every day for a total of 2 weeks. To ensure standardization, a unified specification is selected for the ankle joint orthosis: Product number: 100159548, the 195R Super Sports Ankle Brace for Inversion/Eversion Sprains and Ligament Fixation by McDavid from the United States. During the treatment with ankle joint orthosis, complete the resistance training every day.

Primary outcome measures

• Visual Analog Scale (VAS) [Time frame: The evaluators measure the outcomes at the baseline, on day 7, day 14, and during the follow - up period (day 28, day 42, 3 months, and 6 months after the start of treatment).]

Secondary outcome measures (4)

• active range of motion of the ankle joint [Time frame: was measured at the baseline, on the 14th day, and during the follow - up period.]
• The Star Excursion Balance Test [Time frame: at the baseline, on the 7th day, on the 14th day, and during the follow-up period.]
• The Foot and Ankle Ability Measure [Time frame: at the baseline, on the 14th day, and during the follow - up period.]
• Cumberland Ankle Instability Tool [Time frame: at the baseline, on the 14th day, and during the follow - up period.]

Eligibility criteria

Inclusion criteria

• Patients with first-time lateral ankle sprains
• The patient presents with symptoms of swelling and aching and weakness in the ankle joint. There may be a feeling of friction during joint movement, and the symptoms are aggravated after long - distance walking or on rainy and overcast days.
• The patient presents with swelling and tenderness in the anteroinferior aspect of the lateral malleolus and the anterolateral aspect of the medial malleolus, and has limited mobility during inversion and flexion-extension.
• Auxiliary examinations: No fracture or dislocation was found in the patient during the examination, and no fracture was detected by X-ray examination.
• The patient's sprain time is more than 3 weeks and within 6 months.
• Those who have not received surgical treatment at other medical institutions before coming to our hospital for treatment, can complete the treatment and accept follow - up.
• The patients' ages range from 18 to 60 years old.
• The patient voluntarily and is capable of signing the Informed Consent Form.

Exclusion criteria

• Those with complete rupture of fractures or soft tissues such as muscles, tendons, and ligaments
• Patients with severe primary diseases such as heart, liver, kidney, hematopoietic system diseases and mental diseases
• Patients with tumors or tuberculosis in the ankle joint
• Patients with rheumatic and rheumatoid arthritis, or gout.
• Patients with acute inflammatory reactions such as redness, swelling, heat and pain and signs of infection in the ankle joint, or those accompanied by severe osteoarthritis.
• Patients with abnormal coagulation function or bleeding tendency, such as those with thrombocytopenia and severe diabetes.
• Patients during pregnancy and lactation
• Patients with damaged skin at the necessary needle insertion sites.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Pierobon A, Raguzzi I, Solino S, Salzberg S, Vuoto T, Gilgado D, Perez Calvo E. Minimal detectable change and reliability of the star excursion balance test in patients with lateral ankle sprain. Physiother Res Int. 2020 Oct;25(4):e1850. doi: 10.1002/pri.1850. Epub 2020 May 26. PMID 32458531
• Goulart Neto AM, Maffulli N, Migliorini F, de Menezes FS, Okubo R. Validation of Foot and Ankle Ability Measure (FAAM) and the Foot and Ankle Outcome Score (FAOS) in individuals with chronic ankle instability: a cross-sectional observational study. J Orthop Surg Res. 2022 Jan 21;17(1):38. doi: 10.1186/s13018-022-02925-9. PMID 35062990
• de Noronha M, Refshauge KM, Herbert RD, Kilbreath SL, Hertel J. Do voluntary strength, proprioception, range of motion, or postural sway predict occurrence of lateral ankle sprain? Br J Sports Med. 2006 Oct;40(10):824-8; discussion 828. doi: 10.1136/bjsm.2006.029645. Epub 2006 Aug 18. PMID 16920769
• Hiller CE, Refshauge KM, Bundy AC, Herbert RD, Kilbreath SL. The Cumberland ankle instability tool: a report of validity and reliability testing. Arch Phys Med Rehabil. 2006 Sep;87(9):1235-41. doi: 10.1016/j.apmr.2006.05.022. PMID 16935061
• Chen L, Zhang Y, Chen C, Chen X, Sun J. 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. J Orthop Surg Res. 2026 Feb 28;21(1):239. doi: 10.1186/s13018-026-06719-1. PMID 41764543

Identifiers

NCT: NCT07161427 · YF 2025 -158-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗