跳至主要内容
临床试验/NCT03868995
NCT03868995Unknown不适用

The Efficacy of Hypertonic Dextrose Injection to Anterior Talofibular Ligament Sprain: A Randomized Controlled Trial

Taipei Medical University WanFang Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Ankle pain

研究概览

简要总结

Anterior talofibular ligament is the most injured ligament in ankle sprain. Investigators will include ankle sprain patients who have ankle pain or instability more than 3 months. Ultrasonography will be done for confirm ligament injury. Participants will be randomized into two groups. Participants in dextrose injection group will accept dextrose 15% injection to tendon and enthesis. In the other hand, subcutaneous sham injection to control group. Pain condition, stability test and function test, will be evaluated in 1 week, 4 weeks and 12 weeks after injection.

详细描述

Background: Sprains constitute most of ankle injury and 85% ankle sprain is inversion injury. The conventional treatment includes medication, physical therapy, bracing and steroid injection. Anterior talofibular ligament is the most injured ligament in ankle sprain. Although the response of acute ligament sprain is usually quickly, treatment of chronic ligament sprain is difficult. Chronic pain and ankle instability is the most common symptom in chronic ankle sprain. Dextrose prolotherapies been used for treating soft tissue injury such as osteoarthritis, tendinopathy and ligament sprain. However, there is not randomized control trial for hypertonic dextrose injection to chronic ankle sprain.

Methods: Investigators will include 40 ankle sprain patients who have ankle pain or instability sensation more than 3 months. Ultrasonography will be done for confirm ligament injury. Participants will be randomized into two groups. Dextrose injection group will accept dextrose 15% injection to tendon and enthesis. Otherwise, investigators will do subcutaneous sham injection to control group. Investigators will measure pain threshold and peak pressure by algometer, the degree of ankle instability by ultrasound, the proprioception by single leg standing, and foot and ankle questionnaire. The examination will be done before injection, immediately after injection, 1 week, 4 weeks and 12 weeks after injection.To our hypothesis, investigators suggest dextrose prolotherapy injection could decrease pain and improved proprioception.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic ankle sprain more than 3months with chronic ankle pain or instability sensation
  • Ultrasound diagnosed anterior talofibular ligament sprain

排除标准

  • Acute ankle sprain less than 3 months
  • Lower limb fracture history
  • Cognitive impairment
  • Other neurological or muscular disorders
  • Sever pain could not tolerate examination

结局指标

主要结局

Ankle pain

时间窗: Change from baseline VAS at 12 week

visual analogue scale(VAS), range 0-10, the higher scale the worsen pain

次要结局

  • Ankle proprioception(Change from baseline of difference of ankle degree at 12 weeks)
  • Ankle function(Change from baseline FADI at 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验