Ankle InjuriesHRWAACNCT04167202
Hydrotherapy With Hydrogen-rich Water vs. RICE Protocol Following Acute Ankle Sprain
A study testing Hydrogen-rich water and RICE in people with Ankle Injuries, run by University of Novi Sad, Faculty of Sport and Physical Education at 1 site in Serbia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Ankle Injuries
- What is being tested?
- Hydrogen-rich water and RICE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Dec 2019to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- History of a previous ankle sprain during the past 6 months
- Unwillingness to return for follow-up analysis
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Applied Bioenergetics Lab at Faculty of Sport and PE
Novi Sad, Vojvodina, 21000
About this study
Official title: Hydrotherapy With Hydrogen-rich Water Compared With RICE Protocol Following Acute Ankle Sprain in Professional Athletes: a Randomized Non-inferiority Trial
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.
Read the 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)
- 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
- Ankle Injuries
- Being tested
- Hydrogen-rich water, RICE
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogen-rich waterProcedure or surgery
Hydrogen-rich water (one hydrotherapy every 4 hours)
RICEProcedure or surgery
RICE protocol
| Study group | Role | What they receive |
|---|---|---|
| Hydrogen-rich water | Experimental | Six 30-min ankle baths with hydrogen-rich water (one hydrotherapy every 4 hours) Receives: Procedure: Hydrogen-rich water |
| RICE protocol for acute injury | Active comparator | 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 Receives: Procedure: RICE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ankle circumference for joint swelling
Baseline vs. 24
Measured: Baseline vs. 24 hours post-intervention
Secondary outcomes (1)
Change in VAS score for pain (0-10), higher score means worse outcome
Baseline vs. 24 h
Measured: Baseline vs. 24 hours post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start1 Dec 2019
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nebojsa Maksimovic, PhD, Study chair, Faculty of Sport and PE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167202
- Sponsor's protocol ID
- 1-HRW/2019
- Acronym
- HRWAAC
- Status last verified
- Feb 2020
- First submitted
- 11 Nov 2019
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25295663Cole 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.
PubMed 31061920Ostojic 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.
PubMed 28003879
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrotherapy With Hydrogen-rich Water Compared With RICE Protocol Following Acute Ankle Sprain in Professional Athletes: a Randomized Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT04167202
- Acronym / sponsor ID
- HRWAAC / 1-HRW/2019
- Conditions
- Ankle Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical EducationUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrogen-rich water | Experimental | Procedure: Hydrogen-rich waterSix 30-min ankle baths with hydrogen-rich water (one hydrotherapy every 4 hours) |
| RICE protocol for acute injury | Active comparator | Procedure: RICERICE 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- History of a previous ankle sprain during the past 6 months
- Unwillingness to return for follow-up analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrogen-rich waterHydrogen-rich water (one hydrotherapy every 4 hours) | Procedure or surgery | Hydrogen-rich water |
| RICERICE protocol | Procedure or surgery | RICE protocol for acute injury |
Primary outcome
Change in ankle circumference for joint swelling
Time frame: Baseline vs. 24 hours post-intervention
Baseline vs. 24
1 secondary outcome
Change in VAS score for pain (0-10), higher score means worse outcome
Time frame: Baseline vs. 24 hours post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Background: PubMed 25295663Ostojic 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.
- Background: PubMed 31061920Cole 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.
- Background: PubMed 28003879Ostojic 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nebojsa Maksimovic, PhD study chair
Faculty of Sport and PE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrogen-rich water and RICE in people with Ankle Injuries, run by University of Novi Sad, Faculty of Sport and Physical Education at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ankle circumference for joint swelling (time frame: Baseline vs. 24 hours post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04167202, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.