Hydrotherapy With Hydrogen-rich Water vs. RICE Protocol Following Acute Ankle Sprain
NCT ID: NCT04167202
Last Updated: 2020-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2019-12-01
2020-01-01
Brief Summary
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Detailed Description
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* 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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hydrogen-rich water
Six 30-min ankle baths with hydrogen-rich water (one hydrotherapy every 4 hours)
Hydrogen-rich water
Hydrogen-rich water (one hydrotherapy every 4 hours)
RICE protocol for acute injury
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
RICE
RICE protocol
Interventions
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Hydrogen-rich water
Hydrogen-rich water (one hydrotherapy every 4 hours)
RICE
RICE protocol
Eligibility Criteria
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Inclusion Criteria
* 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
* Unwillingness to return for follow-up analysis
18 Years
35 Years
ALL
No
Sponsors
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University of Novi Sad, Faculty of Sport and Physical Education
OTHER
Responsible Party
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Principal Investigators
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Nebojsa Maksimovic, PhD
Role: STUDY_CHAIR
Faculty of Sport and PE
Locations
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Applied Bioenergetics Lab at Faculty of Sport and PE
Novi Sad, Vojvodina, Serbia
Countries
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References
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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.
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.
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.
Other Identifiers
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1-HRW/2019
Identifier Type: -
Identifier Source: org_study_id
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