Clinical trial NCT06182943: Clinical Evaluation of Surrounding Electroacupuncture in the Treatment of Acute Lateral Ankle Sprain
Official title: Clinical Evaluation of Surrounding Electroacupuncture in the Treatment of Acute Lateral Ankle Sprain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Electroacupuncture
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Kofoed
timeFrame: before treatment（baseline,week0）, after treatment(week4) and 1 week after treatment（follow-up,week5）.
Secondary outcomes:
measure: musculoskeletal ultrasound quantitative measurement
timeFrame: before（baseline,week0）and after treatment(week4).
measure: circumference of ankle joint
timeFrame: before treatment（baseline,week0）, after treatment(week4) and 1 week after treatment（follow-up,week5）.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
affiliation: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: Xianming Lin, Phd
role: STUDY_CHAIR
References: