【ChiCTR2000040213】Clinical Effectiveness of Hypertonic Dextrose Prolotherapy in Chronic Ankle Instability: A Randomized Clinical Trial

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基本信息

登记号

ChiCTR2000040213

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2020-11-25

临床申请受理号

靶点

适应症

Chronic ankle instability

试验通俗题目

Clinical Effectiveness of Hypertonic Dextrose Prolotherapy in Chronic Ankle Instability: A Randomized Clinical Trial

试验专业题目

Clinical Effectiveness of Hypertonic Dextrose Prolotherapy in Chronic Ankle Instability: A Randomized Clinical Trial

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临床试验信息

试验目的

The primary aim of this study is to assess the clinical effectiveness of DPT versus normal saline in improving the self-reported functional ankle instability among individuals with CAI in one-year period. Our secondary aims are to evaluate the objective ankle function, quality of life, incidents of recurrent ankle sprain and cost-effectiveness.

试验分类

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试验类型

随机平行对照

试验分期

Ⅱ期

随机化

Randomization will be done in a 1:1 ratio using the Random Allocation Software by a statistician.

盲法

Double-blind

试验项目经费来源

There was no funding support for this study.

试验范围

目标入组人数

实际入组人数

第一例入组时间

2020-12-01

试验终止时间

2024-12-30

是否属于一致性

入选标准

The inclusion criteria include age >=18 years old, with a diagnosis of CAI, defined as having at least 1 significant ankle sprain, and at least 2 episodes of giving way in the 6 months prior to study enrollment ,and a Cumberland Ankle Instability Tool (CAIT) score <=24. Clinically confirmed lateral ankle laxity with positive anterior drawer test (anterior talofibular ligament involvement) and ultrasound confirmed ATFL laxity by the length change of ATFL under stress ( maximum anterior draw position) and at rest >20%.；

排除标准

The exclusion criteria include acute ankle sprain <=6 months; complete tear of ATFL confirmed by USG or MRI; a history of previous surgeries to the musculoskeletal structures (ie, bones, joint structures, nerves) in either lower extremity; acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months that impacted joint integrity and function (ie, sprains, fractures), resulting in at least 1 interrupted day of desired physical activity; a history of a fracture in either lower extremity requiring realignment; high ankle sprain, generalized ligament laxity; pregnancy; on anti-coagulant therapy; prior ATFL or ankle injections within 3 months; inflammatory or post-infectious ankle arthritis, such as clinically diagnosed rheumatoid arthritis, gouty arthritis, psoriatic arthritis and septic arthritis; history of corn allergy and co-morbidity or lifestyle preventing participation in the study protocol.；

研究者信息

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试验机构

The Chinese University of Hong Kong

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