Clinical Evaluation of Surrounding Electroacupuncture in the Treatment of Acute Lateral Ankle Sprain

Not Applicable

Recruiting

• Conditions: Electroacupuncture
• Interventions: Other: sham electroacupuncture; Other: electroacupuncture combined with surrounding acupuncture; Other: ice compress combined with brake rest

• Registration Number: NCT06182943
• Lead Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University

Brief Summary

Comparison and evaluation of the difference in clinical efficacy of electroacupuncture combined with surrounding acupuncture and sham electroacupuncture groups and control group (ice compress combined with brake rest group) in the treatment of ALAS by means of musculoskeletal ultrasound technique.

Detailed Description

1. To evaluate the efficacy and safety of electroacupuncture combined with surrounding acupuncture in the treatment of ALAS,and compare its differences and advantages with traditional therapy.

2. To investigate the effect of electroacupuncture combined with surrounding acupuncture on the physiological and biochemical changes of the affected nerve,muscle and ligament, as well as its mechanism and pathway.

3. To investigate the influence of treatment time,frequency,intensity,stimulation point and other factors on the therapeutic effect and mechanism,further optimize the treatment plan and improve the therapeutic effect and efficiency.

4. To demonstrate the unique advantages and value of acupuncture analgesia,strengthen the concept and practice of integrated Chinese and Western medicine,and make contributions to promoting the application and development of acupuncture analgesia in the field of orthopedics and traumatology.

Study Timeline

• Study Start: 2023-11-23
• Status Verified: 2023-12
• Study First Submitted: 2023-12-01
• Study First Submitted QC: 2023-12-13
• Last Update Submitted: 2023-12-13
• Study First Posted: 2023-12-27
• Last Update Posted: 2023-12-27
• Primary Completion: 2025-06-01
• Study Completion: 2026-11-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Meets the diagnostic criteria for a grade I or II injury;
• Onset time≤48h;
• The patient aged between18 and 60, gender is not limited;
• The skin of the ankle joint on the affected side is intact, without breakage or ulceration;

Exclusion Criteria

• Combined with ankle fracture;
• Grade III injury or complete ligament rupture;
• Those who cannot comply with the treatment program. Those with keloid, localized combination of other skin diseases, and those who are not suitable for electroacupuncture treatment;
• Those with serious cardiovascular, cerebrovascular, hepatic, renal, hematopoietic system or systemic failure, connective tissue disease, hemophilia, diabetes mellitus, malignant tumors, and those who are prone to bleeding tendency.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham electroacupuncture group	sham electroacupuncture	sham electroacupuncture
electroacupuncture group	electroacupuncture combined with surrounding acupuncture	electroacupuncture combined with surrounding acupuncture
ice compress combined with brake rest group	ice compress combined with brake rest	ice compress combined with brake rest

Primary Outcome Measures

Name	Time	Method
Kofoed	before treatment（baseline,week0）, after treatment(week4) and 1 week after treatment（follow-up,week5）.	The Kofoed evaluation system was divided into 3 items, which were evaluated before treatment, 3 weeks after treatment and after treatment. The ankle joint function was evaluated mainly from three aspects of pain, function and range of motion, with a total score of 100.

Secondary Outcome Measures

Name	Time	Method
musculoskeletal ultrasound quantitative measurement	before（baseline,week0）and after treatment(week4).	The thickness of lateral collateral ligament of ankle joint was measured by GE LOGIQ-e portable color Doppler ultrasonography before and after treatment. The frequency of linear array probe was 8 \~ 12 mHz.
circumference of ankle joint	before treatment（baseline,week0）, after treatment(week4) and 1 week after treatment（follow-up,week5）.	The circumference of ankle joint was measured in 3 groups before, 3 weeks and after treatment.

Trial Locations

Locations (1)

The Third Affiliated Hospital of Zhejiang Chinese Medical University; 🇨🇳 Hangzhou, Zhejiang, China