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

The Third Affiliated hospital of Zhejiang Chinese Medical University

Status: Enrolling

Conditions: Electroacupuncture

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06182943

ZSLL-ZN-2023-011-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 3 patient groups, including a placebo group

electroacupuncture group

Experimental group

Description:

electroacupuncture combined with surrounding acupuncture

Treatment:

Other: electroacupuncture combined with surrounding acupuncture

sham electroacupuncture group

Sham Comparator group

Description:

sham electroacupuncture

Treatment:

Other: sham electroacupuncture

ice compress combined with brake rest group

Placebo Comparator group

Description:

ice compress combined with brake rest

Treatment:

Other: ice compress combined with brake rest