NCT04167202

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

February 10, 2020

Status Verified

February 1, 2020

Enrollment Period

1 month

First QC Date

November 11, 2019

Last Update Submit

February 7, 2020

Conditions

Ankle Injuries

Outcome Measures

Primary Outcomes (1)

  • Change in ankle circumference for joint swelling

    Baseline vs. 24

    Baseline vs. 24 hours post-intervention

Secondary Outcomes (1)

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

    Baseline vs. 24 hours post-intervention

Other Outcomes (3)

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

    Baseline vs. 24 hours post-intervention

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

    Baseline vs. 24 hours post-intervention

  • Change in serum levels of C-reactive protein

    Baseline vs. 24 hours post-intervention

Study Arms (2)

Hydrogen-rich water

EXPERIMENTAL

Six 30-min ankle baths with hydrogen-rich water (one hydrotherapy every 4 hours)

Procedure: Hydrogen-rich water

RICE protocol for acute injury

ACTIVE COMPARATOR

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

Interventions

Hydrogen-rich waterPROCEDURE

Hydrogen-rich water (one hydrotherapy every 4 hours)

Hydrogen-rich water
RICEPROCEDURE

RICE protocol

RICE protocol for acute injury

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • History of a previous ankle sprain during the past 6 months
  • Unwillingness to return for follow-up analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Applied Bioenergetics Lab at Faculty of Sport and PE

Novi Sad, Vojvodina, 21000, Serbia

Location

Related Publications (3)

  • Ostojic SM, Vukomanovic B, Calleja-Gonzalez J, Hoffman JR. Effectiveness of oral and topical hydrogen for sports-related soft tissue injuries. Postgrad Med. 2014 Sep;126(5):187-95. doi: 10.3810/pgm.2014.09.2813.

    PMID: 25295663BACKGROUND

  • Cole AR, Perry DA, Raza A, Nedder AP, Pollack E, Regan WL, van den Bosch SJ, Polizzotti BD, Yang E, Davila D, Afacan O, Warfield SK, Ou Y, Sefton B, Everett AD, Neil JJ, Lidov HGW, Mayer JE, Kheir JN. Perioperatively Inhaled Hydrogen Gas Diminishes Neurologic Injury Following Experimental Circulatory Arrest in Swine. JACC Basic Transl Sci. 2019 Mar 27;4(2):176-187. doi: 10.1016/j.jacbts.2018.11.006. eCollection 2019 Apr.

    PMID: 31061920BACKGROUND

  • Ostojic SM. Should hydrogen therapy be included in a musculoskeletal medicine routine? F1000Res. 2016 Nov 10;5:2659. doi: 10.12688/f1000research.9758.1. eCollection 2016.

    PMID: 28003879BACKGROUND

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Nebojsa Maksimovic, PhD

    Faculty of Sport and PE

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2019

First Posted

November 18, 2019

Study Start

December 1, 2019

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

February 10, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)