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

University of Novi Sad, Faculty of Sport and Physical Education

Status: Completed

Conditions: Ankle Injuries

Treatments: Procedure: RICE; Procedure: Hydrogen-rich water

Study type: Interventional

Funder types: Other

Identifiers

NCT04167202

1-HRW/2019

Details and patient eligibility

About

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.

Full 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)

Enrollment: 18 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Hydrogen-rich water

Experimental group

Description:

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

Treatment:

Procedure: Hydrogen-rich water

RICE protocol for acute injury

Active Comparator group

Description:

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

Treatment:

Procedure: RICE