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NCT Number: NCT06182943

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.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Xianming Lin, Phd

CONTACT

[email protected]

86-18958077816

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

electroacupuncture combined with surrounding acupuncture

Other

electroacupuncture combined with surrounding acupuncture

Sham electroacupuncture

Other

sham electroacupuncture

ice compress combined with brake rest

Other

ice compress combined with brake rest

Primary outcomes

  1. Kofoed

    Time frame: before treatment(baseline,week0), after treatment(week4) and 1 week after treatment(follow-up,week5).

    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.

Secondary outcomes

  1. musculoskeletal ultrasound quantitative measurement

    Time frame: before(baseline,week0)and after treatment(week4).

    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.

  2. circumference of ankle joint

    Time frame: before treatment(baseline,week0), after treatment(week4) and 1 week after treatment(follow-up,week5).

    The circumference of ankle joint was measured in 3 groups before, 3 weeks and after treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Qimiao Hu, Phd

CONTACT

[email protected]

+86 151 5817 5001

Sponsors and collaborators

Lead sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Dec 27, 2023
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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