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

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.

Study Overview

• Status: Recruiting
• Conditions: Electroacupuncture
• Intervention / Treatment: Other: electroacupuncture combined with surrounding acupuncture; Other: sham electroacupuncture; Other: ice compress combined with brake rest

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 Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qimiao Hu, Phd; Phone Number: +86 151 5817 5001; Email: huqimiao315@126.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The Third Affiliated hospital of Zhejiang Chinese Medical University
      • Contact: Xianming Lin, Phd; Phone Number: 86-18958077816; Email: linxianming66@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: electroacupuncture group; electroacupuncture combined with surrounding acupuncture	Other: electroacupuncture combined with surrounding acupuncture; electroacupuncture combined with surrounding acupuncture
Sham Comparator: sham electroacupuncture group; sham electroacupuncture	Other: sham electroacupuncture; sham electroacupuncture
Placebo Comparator: ice compress combined with brake rest group; ice compress combined with brake rest	Other: ice compress combined with brake rest; ice compress combined with brake rest

What is the study measuring?

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）.

Collaborators and Investigators

• Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
• Investigators: Study Chair: Xianming Lin, Phd, The Third Affiliated hospital of Zhejiang Chinese Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): November 22, 2026

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Estimated): December 27, 2023

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries
• Other Study ID Numbers: ZSLL-ZN-2023-011-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No