The Effects of Hydrogen-rich Formulation for Treatment of Sport-related Soft Tissue Injuries
Condition: Soft Tissue Injuries
MeSH terms: Soft Tissue Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    


Intervention name(s): HYDRO; ACTIVE; HYDRO 2
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Inflammation; Pain intensity; Flexibility; RICE protocol; Swelling