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

Primary Purpose

Ankle Injuries

Status

Completed

Phase

Not Applicable

Locations

Serbia

Study Type

Interventional

Intervention

Hydrogen-rich water

RICE

About this trial

This is an interventional treatment trial for Ankle Injuries

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Applied Bioenergetics Lab at Faculty of Sport and PE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hydrogen-rich water

RICE protocol for acute injury

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in ankle circumference for joint swelling

Baseline vs. 24

Secondary Outcome Measures

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

Baseline vs. 24 h

Full Information

NCT ID

NCT04167202

First Posted

November 11, 2019

Last Updated

February 7, 2020

Sponsor

University of Novi Sad, Faculty of Sport and Physical Education

1. Study Identification

Unique Protocol Identification Number

NCT04167202

Brief Title

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

Acronym

HRWAAC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

December 1, 2019 (Actual)

Primary Completion Date

January 1, 2020 (Actual)

Study Completion Date

January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Novi Sad, Faculty of Sport and Physical Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ankle Injuries

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hydrogen-rich water

Arm Type

Experimental

Arm Description

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

Arm Title

RICE protocol for acute injury

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Hydrogen-rich water

Intervention Description

Hydrogen-rich water (one hydrotherapy every 4 hours)

Intervention Type

Procedure

Intervention Name(s)

RICE

Intervention Description

RICE protocol

Primary Outcome Measure Information:

Title

Change in ankle circumference for joint swelling

Description

Baseline vs. 24

Time Frame

Baseline vs. 24 hours post-intervention

Secondary Outcome Measure Information:

Title

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

Description

Baseline vs. 24 h

Time Frame

Baseline vs. 24 hours post-intervention

Other Pre-specified Outcome Measures:

Title

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

Description

Baseline vs. 24 h

Time Frame

Baseline vs. 24 hours post-intervention

Title

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

Description

Baseline vs. 24 h

Time Frame

Baseline vs. 24 hours post-intervention

Title

Change in serum levels of C-reactive protein

Description

Baseline vs. 24 h

Time Frame

Baseline vs. 24 hours post-intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nebojsa Maksimovic, PhD

Organizational Affiliation

Faculty of Sport and PE

Official's Role

Study Chair

Facility Information:

Facility Name

Applied Bioenergetics Lab at Faculty of Sport and PE

City

Novi Sad

State/Province

Vojvodina

ZIP/Postal Code

21000

Country

Serbia

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25295663

Citation

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.

Results Reference

background

PubMed Identifier

31061920

Citation

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.

Results Reference

background

PubMed Identifier

28003879

Citation

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.

Results Reference

background

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

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