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

Study Overview
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Brief Summary
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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
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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. 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. 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. 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.

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

Conditions
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Electroacupuncture

Intervention / Treatment
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* Other: electroacupuncture combined with surrounding acupuncture
* Other: sham electroacupuncture
* Other: ice compress combined with brake rest


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electroacupuncture group<br>electroacupuncture combined with surrounding acupuncture | Other: electroacupuncture combined with surrounding acupuncture<br>* electroacupuncture combined with surrounding acupuncture<br>|
| Sham Comparator: sham electroacupuncture group<br>sham electroacupuncture | Other: sham electroacupuncture<br>* sham electroacupuncture<br>|
| Placebo Comparator: ice compress combined with brake rest group<br>ice compress combined with brake rest | Other: ice compress combined with brake rest<br>* ice compress combined with brake rest<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kofoed | 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. | before treatment（baseline,week0）, after treatment(week4) and 1 week after treatment（follow-up,week5）. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| musculoskeletal ultrasound quantitative measurement | 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. | before（baseline,week0）and after treatment(week4). | 
| circumference of ankle joint | The circumference of ankle joint was measured in 3 groups before, 3 weeks and after treatment. | before treatment（baseline,week0）, after treatment(week4) and 1 week after treatment（follow-up,week5）. |