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

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Ankle Injuries

Intervention / Treatment
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* Procedure: Hydrogen-rich water
* Procedure: RICE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 - 35 years Body mass index 19 - 25 kg/m2 Free of major chronic diseases or acute disorders Acute ankle sprain incurred during sport-related activity Exclusion Criteria: History of a previous ankle sprain during the past 6 months Unwillingness to return for follow-up analysis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrogen-rich water<br>Six 30-min ankle baths with hydrogen-rich water (one hydrotherapy every 4 hours) | Procedure: Hydrogen-rich water<br>* Hydrogen-rich water (one hydrotherapy every 4 hours)<br>|
| Active Comparator: RICE protocol for acute injury<br>RICE protocol include: (1) rest, (2) ice packs every 20 min every 3 hours (total of 8 sessions), (3) compression with elastic bandage for 24 h, and (4) leg elevation at all possible times of the injured area above the level of the heart | Procedure: RICE<br>* RICE protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ankle circumference for joint swelling | Baseline vs. 24 | Baseline vs. 24 hours post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in VAS score for pain (0-10), higher score means worse outcome | Baseline vs. 24 h | Baseline vs. 24 hours post-intervention |