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Hyperbaric Oxygen Therapy: efficacy and Safety for Ankle Sprain

Efficacy and Safety of Hyperbaric Oxygen Therapy for Ankle Sprain

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032210246
Enrollment
70
Registered
2021-08-17
Start date
2023-06-09
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sports-Related Ankle Sprain Ankle Sprain, HBO

Interventions

Based on the random allocation, the group of HBO (Hyperbaric oxygen therapy) will be treated with HBO therapy for 3 days (within 5 days), 100 minutes per day, in addition to the standard therapy.
Hyperbaric Oxygen Therapy

Sponsors

Yasui Youichi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Sports related one side ankle sprain with indication of non-surgical treatment 2) Able to start HBO therapy within 5 days after the injury 3) Over 18 years old and older 4) Signed written informed consent

Exclusion criteria

Exclusion criteria: 1) Cases with fracutre or cartilage injury 2) Cases of ankle sprain history within 3 months before the injury 3) Cases with disorientation and normal decision making impacted 4) Cases with inner ear injury or those patients who cannot relieve ear pressure 5) Cases with pneumothorax on chest X-ray, untreated pneumothorax, surgical history on the chest, or chronic bronchial asthma 6) Cases with a history of eye surgery for retinal detachment, or cases being treated with the gas applied to their eye's 7) Claustrophobia 8) Pregnant woman or possibly pregnant women 9) Cases with nasal obstruction or upper respiratory tract symptoms 10) Cases without pain or discomfort to hop 20 times in a row 11) Cases considered by the investigator or any sub-investigator as inappropriate for this study for any reason

Design outcomes

Primary

MeasureTime frame
Percent change of Karlsson score from baseline toDay 7(counting from the injury)

Secondary

MeasureTime frame
1) Absolute change of Karlsson score from baseline to Day 7 2) Absolute change and percent change of SAFEQ, Karlsson (Day 7~), ROM(range of motion) 3) SAFEQ, Karlsson score, ROM, pain(+/-), edema(+/-), 20 times hop (yes/no), time of slide hop(both injured and not-injured sides), number of foot lift (both injured and not-injured sides) at Day7/14/21/28/35/42 4) Absolute change and percent change of edemaand instability measured by ankle echo 5) Time to able to each hop test 6) Time to return to the team practice (for those non-athletes, time to return to play sport) 7) Absolute change of Karlsson score from baseline to Day 7 8) Karlsson score change from baseline to the firstday of HBO therapy 9) Recurrent injury rate by D90 or D180 in each treatment group

Contacts

Public ContactYouichi Yasui

Department of Sport and Medical Science, Teikyo University

youichiy41@gmail.com+81-42-690-5588

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026