Ankle Injuries
Conditions
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)
Interventions
PROCEDUREHydrogen-rich water
Hydrogen-rich water (one hydrotherapy every 4 hours)
PROCEDURERICE
RICE protocol
Sponsors
University of Novi Sad, Faculty of Sport and Physical Education
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ankle circumference for joint swelling | Baseline vs. 24 hours post-intervention | Baseline vs. 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in VAS score for pain (0-10), higher score means worse outcome | Baseline vs. 24 hours post-intervention | Baseline vs. 24 h |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in ankle mobility for maximal dorsiflexion in centimeters, higher score means worse outcome | Baseline vs. 24 hours post-intervention | Baseline vs. 24 h |
| Change in single-leg balance in seconds, higher score means better outcome | Baseline vs. 24 hours post-intervention | Baseline vs. 24 h |
| Change in serum levels of C-reactive protein | Baseline vs. 24 hours post-intervention | Baseline vs. 24 h |
Countries
Serbia
Outcome results
None listed