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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое electroacupuncture combined with surrounding acupuncture
  electroacupuncture combined with surrounding acupuncture
• Другое sham electroacupuncture
  sham electroacupuncture
• Другое ice compress combined with brake rest
  ice compress combined with brake rest

Первичные конечные точки

• Kofoed [Срок оценки: before treatment（baseline,week0）, after treatment(week4) and 1 week after treatment（follow-up,week5）.]

Вторичные конечные точки (2)

• musculoskeletal ultrasound quantitative measurement [Срок оценки: before（baseline,week0）and after treatment(week4).]
• circumference of ankle joint [Срок оценки: before treatment（baseline,week0）, after treatment(week4) and 1 week after treatment（follow-up,week5）.]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Third Affiliated Hospital of Zhejiang Chinese Medical University — Ханчжоу

Идентификаторы

NCT: NCT06182943 · ZSLL-ZN-2023-011-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗