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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorThe Third Affiliated hospital of Zhejiang Chinese Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • electroacupuncture combined with surrounding acupuncture

    Other intervention

    electroacupuncture combined with surrounding acupuncture

  • sham electroacupuncture

    Other intervention

    sham electroacupuncture

  • ice compress combined with brake rest

    Other intervention

    ice compress combined with brake rest

Treatment groups

84 Participants
are divided into 3 treatment groups
Group A: electroacupuncture groupExperimental treatment 1 intervention
Group B: sham electroacupuncture groupSham comparator 1 intervention
Group C: ice compress combined with brake rest groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

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

Secondary outcomes

1

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.

Time frame
before(baseline,week0)and after treatment(week4).
2

circumference of ankle joint

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

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

Other outcomes

Sponsors and contacts

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