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

Electroacupuncture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06182943
• Other study ID #: ZSLL-ZN-2023-011-01
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2023
• Est. completion date: November 22, 2026

Study information

• Verified date: December 2023
• Source: The Third Affiliated hospital of Zhejiang Chinese Medical University
• Contact: Qimiao Hu, Phd
• Phone: +86 151 5817 5001
• Email: huqimiao315[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: November 22, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ankle Injuries
• Electroacupuncture

Intervention

Other:
• electroacupuncture combined with surrounding acupuncture
electroacupuncture combined with surrounding acupuncture
• sham electroacupuncture
sham electroacupuncture
• ice compress combined with brake rest
ice compress combined with brake rest

Locations

Country	Name	City	State
China	The Third Affiliated Hospital of Zhejiang Chinese Medical University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The Third Affiliated hospital of Zhejiang Chinese Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).