The Effects of Hydrogen-rich Formulation for Treatment of Sport-related Soft Tissue Injuries

NCT01759498 | Completed Phase 2 DMC

• 2 other identifiers: 012-12C/4RPP-3
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Soft Tissue Injuries

Keywords

Inflammation; Pain intensity; Flexibility; RICE protocol; Swelling

Outcome Measures

Primary Outcomes (1)

• change in serum C-reactive protein

  every week, up to 2 weeks

Secondary Outcomes (1)

• change in pain intensity during rest and walking

  every week, up to 2 weeks

Other Outcomes (4)

• change in degree of joint swelling

  every week, up to 2 weeks

• change in passive joint flexibility

  every week, up to 2 weeks

• change in plasma viscosity

  every week, up to 2 weeks

Study Arms (3)

HYDRO 2

EXPERIMENTAL

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

ACTIVE COMPARATOR

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

HYDRO

EXPERIMENTAL

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

Interventions

HYDRO DIETARY_SUPPLEMENT

HYDRO

ACTIVE DIETARY_SUPPLEMENT

ACTIVE

HYDRO 2 DIETARY_SUPPLEMENT

HYDRO 2

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• recent history of acute soft-tissue sports injury
• professional athletes

You may not qualify if:

• not ambulatory patients
• clinical findings classed as more severe than grade II

Sponsors & Collaborators

• Center for Health Sciences, Serbia: lead

Study Sites (1)

Center for Health, Exercise and Sport Sciences

Belgrade, 11000, Serbia

Location

Related Publications (4)

• Ostojic SM. Serum alkalinization and hydrogen-rich water in healthy men. Mayo Clin Proc. 2012 May;87(5):501-2. doi: 10.1016/j.mayocp.2012.02.008. No abstract available.

  PMID: 22560529 BACKGROUND

• Jackson MJ. Free radicals generated by contracting muscle: by-products of metabolism or key regulators of muscle function? Free Radic Biol Med. 2008 Jan 15;44(2):132-41. doi: 10.1016/j.freeradbiomed.2007.06.003. Epub 2007 Jun 13.

  PMID: 18191749 BACKGROUND

• 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.

  PMID: 22720117 BACKGROUND

• Ostojic SM, Vukomanovic B, Calleja-Gonzalez J, Hoffman JR. Effectiveness of oral and topical hydrogen for sports-related soft tissue injuries. Postgrad Med. 2014 Sep;126(5):187-95. doi: 10.3810/pgm.2014.09.2813.

  PMID: 25295663 DERIVED

MeSH Terms

Conditions

Soft Tissue Injuries; Inflammation; Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sergej M Ostojic, MD, PhD

  Center for Health, Exercise and Sport Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Human Performance Laboratory

Study Record Dates

• First Submitted: December 25, 2012
• First Posted: January 3, 2013
• Study Start: December 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 1, 2013

Record last verified: 2013-09

Locations

SE (1)