Clinical trial NCT04167202: Hydrotherapy With Hydrogen-rich Water vs. RICE Protocol Following Acute Ankle Sprain
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
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Injuries
Lead sponsor: University of Novi Sad, Faculty of Sport and Physical Education
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Change in ankle circumference for joint swelling
timeFrame: Baseline vs. 24 hours post-intervention
Secondary outcomes:
measure: Change in VAS score for pain (0-10), higher score means worse outcome
timeFrame: Baseline vs. 24 hours post-intervention
Other outcomes:
measure: Change in ankle mobility for maximal dorsiflexion in centimeters, higher score means worse outcome
timeFrame: Baseline vs. 24 hours post-intervention
measure: Change in single-leg balance in seconds, higher score means better outcome
timeFrame: Baseline vs. 24 hours post-intervention
measure: Change in serum levels of C-reactive protein
timeFrame: Baseline vs. 24 hours post-intervention
Locations:
city: Novi Sad
country: Serbia
facility: Applied Bioenergetics Lab at Faculty of Sport and PE
state: Vojvodina
Study officials:
affiliation: Faculty of Sport and PE
name: Nebojsa Maksimovic, PhD
role: STUDY_CHAIR
References:
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.
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.
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.