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临床试验/NCT03750253
NCT03750253Unknown不适用

Extracorporeal Shock Wave Therapy for Pain-Relief After Arthroscopy for Osteochondral Lesions of the Talus

Southwest Hospital, China1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2013年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
15
试验地点
1
主要终点
Change of VAS scores before and after shock wave therapy

研究概览

简要总结

Arthroscopic surgery is effective in treating osteochondral lesions of the talus. However, there are still some patients with postoperative ankle pain. This study aims to investigate the clinical efficacy of shock wave adjuvant therapy in the treatment of postoperative pain caused by cartilage injury of talus after arthroscopy and to provide basis for further popularization and application.

详细描述

Arthroscopic surgery is effective in treating osteochondral lesions of the talus. However, there are still some patients with postoperative ankle pain. This study was conducted to investigate the clinical efficacy of shock wave therapy in the treatment of postoperative pain caused by cartilage injury of talus after arthroscopy.

Patients with osteochondral lesions of the talus treated by arthroscopic microfracture surgery and still complained ankle pain three months after surgery were enrolled. Radial extracorporeal shock wave therapy was used to give energy to the injured region of the talus and the adjacent area.Treatment was done once a week for 5 consecutive weeks. After shock wave therapy,the patients were followed by Visual Analogue Scale (VAS), the American Orthopaedic Foot and Ankle Society ankle-hindfoot scale(AOFAS-AHFS) , and followed finally by Magnetic Resonance Imaging(MRI) of the ankle.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For arthroscopy:
  • Ankle pain, aggravated after exercise or weight-bearing activity, accompanied by lameness, joint stiffness and dysfunction for at least 3 months
  • No talar collapse
  • Talar cartilage injury cases before stage Ⅳ of Hepple classification
  • For shock wave therapy:
  • Patients with micro-fractures treated with arthroscopic treatment of talar cartilage injury and were treated with routine rehabilitation training after arthroscopy
  • Patients who till complained obvious ankle pain 3 months after surgery

排除标准

  • Severe cardiovascular and cerebrovascular diseases
  • Hemorrhagic diseases, coagulation disorders
  • Bone immaturity
  • Thrombosis
  • Use of anti-immune agents
  • Various types of tumor patients
  • Pregnant women
  • History of mental illness
  • Patients who could not be followed
  • Patients with other lower extremity injuries after surgery and were unwilling to participate in the study

研究组 & 干预措施

Extracorporeal Shock Wave Therapy

Other

Extracorporeal Shock Wave Therapy to relieve pain after arthroscopy for osteochondral lesions of talus

干预措施: Extracorporeal Shock Wave Therapy (Other)

结局指标

主要结局

Change of VAS scores before and after shock wave therapy

时间窗: 6 weeks, 12 weeks and last follow-up at an average of 2 years after shock wave therapy

The Visual Analogue Scale scores of the patients before and after the shock wave therapy are recorded. The scale ranges from 0-10 points, and decreases of the value represent a better outcome. The data analyses are performed with SPSS version 16.0 statistical software. Continuous variables are expressed as mean ± standard deviation, and 95% confidence intervals are determined. The data are compared by paired t test or rank-sum test. P value \< 0.05 is considered as statistically significant.

次要结局

  • Change of AOFAS scores before and after shock wave therapy(6 weeks, 12 weeks and last follow-up last follow-up at an average of 2 years after shock wave therapy)

研究者

发起方
Southwest Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaojun Duan

Deputy Director of the Center for Joint Surgery

Southwest Hospital, China

研究点 (1)

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