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临床试验/NCT06335602
NCT06335602Unknown不适用

The Evaluation of Traditional Chinese Medicine Intervention for Post-operative Edema After Cruciate Ligament Reconstruction

Chang Gung Memorial Hospital0 个研究点目标入组 120 人开始时间: 2024年3月30日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
主要终点
Leg girth measurement

研究概览

简要总结

There are loads of research on knee surgery, including surgical methods, rehabilitation strategies, and complication prevention. Whether it is general surgery or endoscopic surgery, there may be postoperative joint swelling, which may last for several weeks depending on the patient's condition. Therefore, reducing swelling as soon as possible is important in post-operative treatment. Swelling of the knee joint may increase soft tissue tension, causing pain and discomfort, and affecting the range of motion and functional recovery of the joint. It may also affect wound healing and increase the risk of complications such as infection and thrombosis. Most clinical research related to traditional Chinese medicine focuses on reducing pain, and little attention is paid to reducing swelling, relatively. Nevertheless most relevant literatures discuss total knee replacement surgery.

Cruciate ligament surgery is very common in sports medicine orthopedics. It is expected that ordinary patients get function recovery quickly after surgery, and athletes can return to play as soon as possible. This study is a prospective study, with partially double-blinded, randomized controlled study design. The investigators are aiming to TCM intervention for knee swelling after cruciate ligament surgery, and evaluation of postoperative swelling and functional improvement. TCM intervention methods are laser acupuncture and external application of herbal medicine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Willing to sign informed consent
  • Age between 18-50 years old male and female patients
  • First time receiving cruciate ligament reconstruction
  • Willing to accept TCM intervention and follow up

排除标准

  • Repeat surgical intervention
  • History of serious acupuncture syncope
  • History of severe allergic response of herbal packing or drug-induced dermatitis
  • History of other diseases that cause knee joint swelling, such as rheumatoid arthritis, knee joint infection, gouty arthritis, connective tissue disease, tumor, or cardiac/renal failure.

结局指标

主要结局

Leg girth measurement

时间窗: before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation

lower limb multiple girth measurement

次要结局

  • Tegner score(before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation)
  • WOMAC(before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation)
  • VAS(before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

YI-WEN HSIEH

Attending physician

Chang Gung Memorial Hospital

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