Skip to main content
OpenTrials
Completed

NCT Number: NCT04167202

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ankle Injuries Leg Injuries Wounds and Injuries

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Applied Bioenergetics Lab at Faculty of Sport and PE

Novi Sad, Vojvodina, 21000, Serbia

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrogen-rich water

Procedure

Hydrogen-rich water (one hydrotherapy every 4 hours)

RICE

Procedure

RICE protocol

Primary outcomes

  1. Change in ankle circumference for joint swelling

    Time frame: Baseline vs. 24 hours post-intervention

    Baseline vs. 24

Secondary outcomes

  1. Change in VAS score for pain (0-10), higher score means worse outcome

    Time frame: Baseline vs. 24 hours post-intervention

    Baseline vs. 24 h

Other outcomes

  1. Change in ankle mobility for maximal dorsiflexion in centimeters, higher score means worse outcome

    Time frame: Baseline vs. 24 hours post-intervention

    Baseline vs. 24 h

  2. Change in single-leg balance in seconds, higher score means better outcome

    Time frame: Baseline vs. 24 hours post-intervention

    Baseline vs. 24 h

  3. Change in serum levels of C-reactive protein

    Time frame: Baseline vs. 24 hours post-intervention

    Baseline vs. 24 h

Sponsors and collaborators

Lead sponsor

University of Novi Sad, Faculty of Sport and Physical Education

Other

Registry information

Official study title

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

Acronym: HRWAAC

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 18, 2019
Registry last updated
Feb 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.