The Effects of Hydrogen-rich Formulation for Treatment of Sport-related Soft Tissue Injuries
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- change in serum C-reactive protein
研究概览
简要总结
Since hydrogen therapy in humans seems to be beneficial for treating inflammation, ischemia-reperfusion injury and oxidative stress, it seems plausible to evaluate the effects of exogenously administered hydrogen as an element of instant management of sport-related soft tissue injuries (e.g. muscle sprain, ligament strain, tendonitis, contusion). The main aim of the present study will be to examine the effects of two-week hydrogen-rich oral and topical administration on the inflammation, recovery and functional abilities in competitive male and female athletes after acute soft-tissue injury. During the season 2012/2013 (from February to June) subjects (36 professional athletes) will be recruited and examined by certified sports medicine specialist in the out-patient clinics of the Center for Health, Exercise and Sport Sciences in the first 24 hours after the sport-related soft tissue injury was sustained. The subjects will be allocated to a double-blind design to three randomly assigned trials. During the period of 2 weeks subjects in the placebo group (PLA) will receive traditional treatment protocol after the soft-tissue injury, consisting of RICE protocol during the first 48 h and sub-acute protocol thereafter. Subjects in the first experimental group will follow the above procedures with additional administration of oral hydrogen-rich capsules (4 capsules three times per day) throughout the study. Subjects in the second experimental group will follow the procedures of first experimental group with additional administration of hydrogen-rick packs 6 times per day for 20 minutes throughout the study. Participants will be evaluated at the beginning of the study (e.g. at the time of the injury report), after 7 and 14 days after baseline testing for: a) serum C-reactive protein, plasma viscosity and interleukin 6 level, b) pain intensity during rest and walking, c) degree of joint swelling, d) passive joint flexibility, and, e) subjective side-effects. The investigators expect that the administration of hydrogen will significantly improve inflammation outcomes (e.g. decrease in serum C-reactive protein) as compared to the placebo, with topical hydrogen administration will additionally improve post-injury recovery outcomes (e.g. pain intensity, degree of swelling). These results could support the hypothesis that hydrogen-rich intervention may be included as an element of immediate treatment for sport-related soft tissue injuries.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •recent history of acute soft-tissue sports injury
- •professional athletes
排除标准
- •not ambulatory patients
- •clinical findings classed as more severe than grade II
结局指标
主要结局
change in serum C-reactive protein
时间窗: every week, up to 2 weeks
次要结局
- change in pain intensity during rest and walking(every week, up to 2 weeks)
研究者
Assoc. Prof. Sergej M. Ostojic, MD, PhD
Head of Human Performance Laboratory
Center for Health, Exercise and Sport Sciences, Serbia
