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

Not Applicable

Not yet recruiting

• Conditions: Chronic Ankle Instability; Lateral Ankle Sprain

• Registration Number: NCT07161427
• Lead Sponsor: Guangzhou University of Chinese Medicine

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-30
• Study First Submitted QC: 2025-08-30
• Study First Posted: 2025-09-08
• Last Update Submitted: 2025-09-14
• Last Update Posted: 2025-09-16
• Study Start: 2025-10-01
• Primary Completion: 2026-08-31
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

1. Patients with first-time lateral ankle sprains
2. 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.
3. 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.
4. Auxiliary examinations: No fracture or dislocation was found in the patient during the examination, and no fracture was detected by X-ray examination.
5. The patient's sprain time is more than 3 weeks and within 6 months.
6. 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.
7. The patients' ages range from 18 to 60 years old.
8. The patient voluntarily and is capable of signing the Informed Consent Form.

Exclusion Criteria

1. Those with complete rupture of fractures or soft tissues such as muscles, tendons, and ligaments
2. Patients with severe primary diseases such as heart, liver, kidney, hematopoietic system diseases and mental diseases
3. Patients with tumors or tuberculosis in the ankle joint
4. Patients with rheumatic and rheumatoid arthritis, or gout.
5. 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.
6. Patients with abnormal coagulation function or bleeding tendency, such as those with thrombocytopenia and severe diabetes.
7. Patients during pregnancy and lactation
8. Patients with damaged skin at the necessary needle insertion sites.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	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).	The scoring range of the Visual Analogue Scale (VAS) is 0 - 100 mm, which is used for objectively quantifying the pain level. The participants were instructed to indicate the severity of their ankle pain by marking a point on a continuous horizontal line segment, with 0 mm representing the least pain and 100 mm representing the most severe pain.

Secondary Outcome Measures

Name	Time	Method
active range of motion of the ankle joint	was measured at the baseline, on the 14th day, and during the follow - up period.	Active range of motion (ROM), including plantar flexion, dorsiflexion, inversion and eversion, was measured at the baseline, on the 14th day, and during the follow - up period.
The Star Excursion Balance Test	at the baseline, on the 7th day, on the 14th day, and during the follow-up period.	The Star Excursion Balance Test (SEBT) has sufficient sensitivity and high test-retest reliability in the ankle dynamic balance test.
The Foot and Ankle Ability Measure	at the baseline, on the 14th day, and during the follow - up period.	The Foot and Ankle Ability Measure (FAAM) is a self - assessment scale commonly used for the individual physical function in injuries related to the foot and ankle joint, which is completed by patients. It includes two subscales: Foot and Ankle Ability Measure - Activity of Daily Living (FAAM - ADL) and Foot and Ankle Ability Measure - Sports (FAAM - S). FAAM - ADL (84 points): It covers 21 daily activities such as standing, walking, squatting, standing on tiptoe, walking for different durations, and doing housework. FAAM - S (32 points): It includes 8 sports - related activities such as running, jumping take - off, landing after a jump, and starting or ending a run. The score range of both sub - scales is 0 - 100%. A total score ≥ 80% indicates a satisfactory functional level, and \< 80% indicates functional limitation.
Cumberland Ankle Instability Tool	at the baseline, on the 14th day, and during the follow - up period.	CAIT consists of 9 items, with scores ranging from 0 to 30. The lower the score, the worse the ankle stability. The threshold for identifying people with chronic ankle instability is inconsistent in different language versions. A score of less than 24 in the Chinese version of CAIT is diagnosed as chronic ankle instability. It is measured at baseline, 14 th and 6 th month follow-up.