Hyperbaric Oxygen Therapy: efficacy and Safety for Ankle Sprain

JRCT ID: jRCTs032210246

Registered date:17/08/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Sports-Related Ankle Sprain
• Date of first enrollment: 09/06/2023
• Target sample size: 70
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Percent change of Karlsson score from baseline toDay 7(counting from the injury)

Secondary Outcome

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) Recovery rate of sport level at D90/D180
5) Absolute change and percent change of edemaand instability measured by ankle echo
6) Time to able to each hop test
7) Time to return to the team practice (for those non-athletes, time to return to play sport)
8) Absolute change of Karlsson score from baseline to Day 7
9) Karlsson score change from baseline to the firstday of HBO therapy
10) Recurrent injury rate by D90 or D180 in each treatment group

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Yasui Youichi
• Source(s) of Monetary Support: MEXT Research Grant