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The Effects of Formulation for Treatment of Soft Tissue Injuries

This study has been completed.

Sponsor: Center for Health, Exercise and Sport Sciences, Serbia

Information provided by (Responsible Party): Assoc. Prof. Sergej M. Ostojic, MD, PhD, Center for Health, Exercise and Sport Sciences, Serbia

ClinicalTrials.gov Identifier: NCT01759498

First received: December 25, 2012 , Last updated: September 27, 2013 , History of Changes

Purpose

Since hydrogen therapy in humans seems to be beneficial for treating inflammation, injury and oxidative stress, it seems plausible to evaluate the effects of exogenously administered hydrogen as an element of instant management of 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 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 clinics of the Center for Health, Exercise and Sport Sciences in the first 24 hours after the soft tissue injury was sustained. The subjects will be allocated to a 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 injury, consisting of RICE protocol during the first 48 h and protocol thereafter. Subjects in the first experimental group will follow the above procedures with additional administration of oral 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 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 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 The investigators expect that the administration of hydrogen will significantly improve inflammation outcomes (e.g. decrease in serum protein) as compared to the placebo, with topical hydrogen administration will additionally improve recovery outcomes (e.g. pain intensity, degree of swelling). These results could support the hypothesis that intervention may be included as an element of immediate treatment for soft tissue injuries.

ConditionInterventionPhase
Soft Tissue InjuriesDietary Supplement: HYDROPhase 2
Dietary Supplement: ACTIVE
Dietary Supplement: HYDRO 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

Resource links provided by NLM:

MedlinePlus related topics: Edema Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by Center for Health, Exercise and Sport Sciences, Serbia:

Primary Outcome Measures:

change in serum protein [ Time Frame: every week, up to 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

change in pain intensity during rest and walking [ Time Frame: every week, up to 2 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:

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 ]

Enrollment:36
Study Start Date:December 2012
Study Completion Date:September 2013
Primary Completion Date:June 2013 (Final data collection date for primary outcome measure)
ArmsAssigned
Interventions
Experimental: HYDRO 2Dietary
Subjects in the second experimental group will follow the procedures of first experimental group with additional administration ofSupplement:
packs 6 times per day for 20 minutes throughout the study.HYDRO 2
Active Comparator: ACTIVEDietary
During the period of 2 weeks subjects will receive traditional treatment protocol after the injury, consisting of RICESupplement:
protocol during the first 48 h (e.g. rest, ice packs for 20 minutes every 2 hours, compression with elastic bandage, elevation ofACTIVE
the injured area above the level of the heart at all possible times) and 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
exercise).
Experimental: HYDRODietary
Subjects in the first experimental group will follow the PLA procedures with additional administration of oralSupplement:
capsules (4 capsules three times per day) throughout the study.HYDRO

Additional Information:

Related Info

Publications:

Ostojic SM. Serum alkalinization and water in healthy men. Mayo Clin Proc. 2012 doi: 10.1016/j.mayocp.2012.02.008.

Jackson MJ. Free radicals generated by contracting muscle: of metabolism or key regulators of muscle function? Free Radic Biol Med. 2008 Jan doi: 10.1016/j.freeradbiomed.2007.06.003. Epub 2007 Jun 13. Review.

Ohno K, Ito M, Ichihara M, Ito M. Molecular hydrogen as an emerging therapeutic medical gas for neurodegenerative and other diseases. Oxid Med Cell Longev. 2012;2012:353152. doi: 10.1155/2012/353152. Epub 2012 Jun 8. Review.

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:History of Changes
Other Study ID Numbers:
Study First Received:December 25, 2012
Last Updated:September 27, 2013
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 January 21, 2015

Author: Life Enthusiast