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

February 7, 2020 updated by: University of Novi Sad, Faculty of Sport and Physical Education

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
    • Vojvodina
      • Novi Sad, Vojvodina, Serbia, 21000
        • Applied Bioenergetics Lab at Faculty of Sport and PE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hydrogen-rich water
Six 30-min ankle baths with hydrogen-rich water (one hydrotherapy every 4 hours)
Procedure: Hydrogen-rich water
Hydrogen-rich water (one hydrotherapy every 4 hours)
ACTIVE_COMPARATOR: RICE protocol for acute injury
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
RICE protocol

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline vs. 24 hours post-intervention
Change in single-leg balance in seconds, higher score means better outcome
Time Frame: Baseline vs. 24 hours post-intervention
Baseline vs. 24 h
Baseline vs. 24 hours post-intervention
Change in serum levels of C-reactive protein
Time Frame: Baseline vs. 24 hours post-intervention
Baseline vs. 24 h
Baseline vs. 24 hours post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Novi Sad, Faculty of Sport and Physical Education

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2019

Primary Completion (ACTUAL)

January 1, 2020

Study Completion (ACTUAL)

January 1, 2020

Study Registration Dates

First Submitted

November 11, 2019

First Submitted That Met QC Criteria

November 15, 2019

First Posted (ACTUAL)

November 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2020

Last Update Submitted That Met QC Criteria

February 7, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-HRW/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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