ChiCTR2000040213已完成2 期
Clinical Effectiveness of Hypertonic Dextrose Prolotherapy in Chronic Ankle Instability: A Randomized Clinical Trial
There was no funding support for this study.3 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2020年12月1日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 3
- 主要终点
- 坎伯蘭踝關節不穩評估問卷
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- Double
入排标准
- 年龄范围
- 18 至 —（—）
- 性别
- All
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 <=
- •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.
研究组 & 干预措施
Group 1
Anterior talofibular ligament dextrose injection 16 weeks
Group 2
Anterior talofibular ligament normal saline injection 16 weeks
结局指标
主要结局
坎伯蘭踝關節不穩評估問卷
时间窗: 第 0，16，26，52 星期
次要结局
- 研究前後一年內踝關節扭傷的有關狀況(第 0, 16, 26, 52 个星期)
- 星型平衡測試(第 0，16，26，52 星期)
- 健康問卷(第 0，16，26，52 星期)
- 身體健康狀況及醫療服務使用情況(第 0，16，26，52 星期)
- Assessment the success of blinding(第 52 个星期)
- 足踝能力指數測試(第 0，16，26，52 星期)
研究者
研究点 (3)
Loading locations...
相似试验
招募中
2/3 期
A STUDY COMPARING TWO TYPES OF NASAL RINSES SALT WATER AND MINERALIZED SALT WATER FOR PEOPLE WITH CHRONIC SINUS DISEASE AFTER SINUS SURGERY TO SEE WHICH HELPS RECOVERY BETTERCTRI/2025/09/094679Indira Gandhi medical College and hospital Shimla70
招募中
3 期
Efficacy of early continuous infusion of hypertonic saline solution on the neurological outcome at 6 months in traumatic brain injured patients. A single-blinded, multicenter, randomized, controlled clinical trial with blinded evaluation of the primary outcome.2024-520205-39-00Centre Hospitalier Universitaire De Nantes760
尚未招募
Phase 3 4
Plasmalyte or normal saline: the future of IV fluids.CTRI/2024/06/068479Jipmer intramural grant126
招募中
3 期
Efficacy of Early Continuous Infusion of HSS on the Neurological Outcome at 6 Months in TBI Patients.NCT07319208Nantes University Hospital760
已完成
不适用
Evaluation of a Hypertonic Seawater Aerosol Therapy Solution in Adults and ChildrenNCT07267689Laboratoires Gilbert110