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

Not Applicable

Completed

• Conditions: Ankle Injuries
• Interventions: Procedure: RICE; Procedure: Hydrogen-rich water

• Registration Number: NCT04167202
• Lead Sponsor: University of Novi Sad, Faculty of Sport and Physical Education

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)

Study Timeline

• Study First Submitted: 2019-11-11
• Study First Submitted QC: 2019-11-15
• Study First Posted: 2019-11-18
• Study Start: 2019-12-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-07
• Last Update Posted: 2020-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RICE protocol for acute injury	RICE	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
Hydrogen-rich water	Hydrogen-rich water	Six 30-min ankle baths with hydrogen-rich water (one hydrotherapy every 4 hours)

Primary Outcome Measures

Name	Time	Method
Change in ankle circumference for joint swelling	Baseline vs. 24 hours post-intervention	Baseline vs. 24

Secondary Outcome Measures

Name	Time	Method
Change in VAS score for pain (0-10), higher score means worse outcome	Baseline vs. 24 hours post-intervention	Baseline vs. 24 h

Trial Locations

Locations (1)

Applied Bioenergetics Lab at Faculty of Sport and PE; 🇷🇸 Novi Sad, Vojvodina, Serbia