Gait Analysis Following Single-shot Hyaluronic Acid Supplementation: a Pilot Randomised Double-blinded Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Gait Speed
研究概览
简要总结
This is a pilot, double-blind, randomised trial that investigates which gait parameters are more sensitive following a single bolus injection of hyaluronic acid with mannitol, hyaluronic acid with sorbitol, or saline placebo for knee osteoarthritis. Outcome measures are gait analysis through a inertial sensors (Physilog), Knee Society Score (KSS), University of California Los Angeles (UCLA) activity-scale and EuroQol 5Dimensions. Follow-up will be of 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of primary knee OA Ahlbäck II-III and signed consent forms.
排除标准
- •recent history of infection, diabetes, neurological impairment, chronic venous or lymphatic stasis, pain medication of level 2 or 3, psychiatric conditions, contraindications for HA joint injection and previous HA or steroid injections in the last six months.
研究组 & 干预措施
hyaluronic acid with mannitol
干预措施: hyaluronic acid with mannitol (Drug)
hyaluronic acid with sorbitol
干预措施: hyaluronic acid with sorbitol (Drug)
saline
干预措施: Placebos (Drug)
结局指标
主要结局
Gait Speed
时间窗: 4 weeks following injection
measured over the 30m of the test trial using an inertial-based system (Physilog, BioAGM, CH) following a previously validated protocol. Spatiotemporal parameters are analysed (i.e. gait speed, cadence, limping...)
次要结局
- UCLA- activity scale(4 weeks following injection)
- EuroQool -5 dimensions self-reported scale of quality of life(4 weeks following injection)
- KSS specific knee mobility scale(4 weeks following injection)
- Visual Analogue Scale (VAS) pain(4 weeks following injection)
研究者
Brigitte Jolles, MD
Professor
University of Lausanne Hospitals