NCT04167202

Hydrotherapy With Hydrogen-rich Water vs. RICE Protocol Following Acute Ankle Sprain

Hydrotherapy With Hydrogen-rich Water Compared With RICE Protocol Following Acute Ankle Sprain in Professional Athletes: a Randomized Non-inferiority Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Novi Sad, Faculty of Sport and Physical Education · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Detailed 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)

Conditions

• Ankle Injuries

Interventions

Type	Name	Description
PROCEDURE	Hydrogen-rich water	Hydrogen-rich water (one hydrotherapy every 4 hours)
PROCEDURE	RICE	RICE protocol

Timeline

• Start date: 2019-12-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2019-11-18
• Last updated: 2020-02-10

Locations

1 site across 1 country: Serbia