The Effects of Hydrogen-rich Formulation for Treatment of Sport-related Soft Tissue Injuries
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Soft Tissue Injuries |
Dietary Supplement: HYDRO Dietary Supplement: ACTIVE Dietary Supplement: HYDRO 2 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
- change in serum C-reactive protein [ Time Frame: every week, up to 2 weeks ] [ Designated as safety issue: No ]
- change in pain intensity during rest and walking [ Time Frame: every week, up to 2 weeks ] [ Designated as safety issue: No ]
- change in degree of joint swelling [ Time Frame: every week, up to 2 weeks ] [ Designated as safety issue: No ]
- change in passive joint flexibility [ Time Frame: every week, up to 2 weeks ] [ Designated as safety issue: No ]
- change in plasma viscosity [ Time Frame: every week, up to 2 weeks ] [ Designated as safety issue: No ]
- change in serum interleukin 6 [ Time Frame: every week, up to 2 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 36 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: HYDRO 2
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.
|
Dietary Supplement: HYDRO 2 |
|
Active Comparator: ACTIVE
During the period of 2 weeks subjects will receive traditional treatment protocol after the soft-tissue injury, consisting of RICE protocol during the first 48 h (e.g. rest, ice packs for 20 minutes every 2 hours, compression with elastic bandage, elevation of the injured area above the level of the heart at all possible times) and sub-acute protocol thereafter (e.g. passive stretching 3 times per day for 90 sec, isometric strength exercise with 3 sets with 15 repetitions, 30 min of pain-free weight-bearing exercise).
|
Dietary Supplement: ACTIVE |
|
Experimental: HYDRO
Subjects in the first experimental group will follow the PLA procedures with additional administration of oral hydrogen-rich capsules (4 capsules three times per day) throughout the study.
|
Dietary Supplement: HYDRO |
Eligibility| Ages Eligible for Study: | 18 Years to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- recent history of acute soft-tissue sports injury
- professional athletes
Exclusion Criteria:
- not ambulatory patients
- clinical findings classed as more severe than grade II
Contacts and Locations| Serbia | |
| Center for Health, Exercise and Sport Sciences | |
| Belgrade, Serbia, 11000 | |
| Principal Investigator: | Sergej M Ostojic, MD, PhD | Center for Health, Exercise and Sport Sciences |
More Information
Additional Information:
Publications:
| Responsible Party: | Assoc. Prof. Sergej M. Ostojic, MD, PhD, Head of Human Performance Laboratory, Center for Health, Exercise and Sport Sciences, Serbia |
| ClinicalTrials.gov Identifier: | NCT01759498 History of Changes |
| Other Study ID Numbers: | 012-12C/4, RPP-3 |
| Study First Received: | December 25, 2012 |
| Last Updated: | December 31, 2012 |
| Health Authority: | Serbia: Ethics Committee |
Keywords provided by Center for Health, Exercise and Sport Sciences, Serbia:
|
Inflammation Pain intensity Flexibility RICE protocol Swelling |
Additional relevant MeSH terms:
|
Soft Tissue Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013