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Clinical Trial Summary

The traditional treatment of soft tissue injuries consists of the RICE protocol - rest, ice, compression, and elevation, followed for up to 72 hours after a trauma. Although designed as an immediate therapy to reduce inflammation that occurs after an acute injury, the RICE might not be the best way to promote healing due to limiting blood flow. Molecular hydrogen (H2) has recently been put forward as a possible adjuvant treatment in musculoskeletal medicine, yet limited data are available concerning its effectiveness as a first-aid intervention.


Clinical Trial Description

Experimental protocol

- Randomized controlled parallel-group trial

- Acute (24 h) post-injury intervention:

- Hydrogen-rich water hydrotherapy

- RICE protocol

- First sessions given immediately after an initial examination (~ 60 min after the injury).

- Source of hydrogen-rich water = HRW Natural Health Products Inc. (New Westminster, BC, Canada)

o Formulation (7g/ tablets, 800mg Magnesium) dissolved into a 3-L stationary whirlpool with water (20°C)

- No other interventions during the period of evaluation

Outcomes assessed at baseline (pre-intervention) and at 24-h follow up:

- Figure-of-eight method of measuring ankle joint swelling

- Visual analogue score (VAS) score for pain at rest and during movement

- Weight-bearing lunge test (WBLT)

- Single leg balance test (SLBT) with eyes open and closed

- Serum inflammatory biomarkers (IL-1ß, TNF-α, CRP) • Early termination criteria: serious subjective side effects (e.g. tingling, discoloration of skin, burning, itching, rash) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04167202
Study type Interventional
Source University of Novi Sad, Faculty of Sport and Physical Education
Contact
Status Completed
Phase N/A
Start date December 1, 2019
Completion date January 1, 2020

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