Hydrotherapy With Hydrogen-rich Water Compared With RICE Protocol Following Acute Ankle Sprain in Professional Athletes: a Randomized Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in ankle circumference for joint swelling
研究概览
简要总结
The traditional treatment of soft tissue injuries consists of the RICE protocol - rest, ice, compression, and elevation, followed for up to 72 hours after a trauma. Although designed as an immediate therapy to reduce inflammation that occurs after an acute injury, the RICE might not be the best way to promote healing due to limiting blood flow. Molecular hydrogen (H2) has recently been put forward as a possible adjuvant treatment in musculoskeletal medicine, yet limited data are available concerning its effectiveness as a first-aid intervention.
详细描述
Experimental protocol
-
Randomized controlled parallel-group trial
-
Acute (24 h) post-injury intervention:
-
Hydrogen-rich water hydrotherapy
-
RICE protocol
-
First sessions given immediately after an initial examination (~ 60 min after the injury).
-
Source of hydrogen-rich water = HRW Natural Health Products Inc. (New Westminster, BC, Canada)
o Formulation (7g/ tablets, 800mg Magnesium) dissolved into a 3-L stationary whirlpool with water (20°C)
- No other interventions during the period of evaluation
Outcomes assessed at baseline (pre-intervention) and at 24-h follow up:
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
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 35 years
- •Body mass index 19 - 25 kg/m2
- •Free of major chronic diseases or acute disorders
- •Acute ankle sprain incurred during sport-related activity
排除标准
- •History of a previous ankle sprain during the past 6 months
- •Unwillingness to return for follow-up analysis
研究组 & 干预措施
Hydrogen-rich water
Six 30-min ankle baths with hydrogen-rich water (one hydrotherapy every 4 hours)
干预措施: Hydrogen-rich water (Procedure)
RICE protocol for acute injury
RICE protocol include: (1) rest, (2) ice packs every 20 min every 3 hours (total of 8 sessions), (3) compression with elastic bandage for 24 h, and (4) leg elevation at all possible times of the injured area above the level of the heart
干预措施: RICE (Procedure)
结局指标
主要结局
Change in ankle circumference for joint swelling
时间窗: Baseline vs. 24 hours post-intervention
Baseline vs. 24
次要结局
- Change in VAS score for pain (0-10), higher score means worse outcome(Baseline vs. 24 hours post-intervention)