An interventional study of hyperbaric oxygen therapy and non Hyperbaric Oxygen Therapy in Ankle Sprain, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Prevention
Investigators recruited 208 patients with acute ankle sprain who were from the Rehabilitation Department of the Second Affiliated Hospital of Zhejiang University, School of Medicine from January 2026 to November 2028. Perform the improvement in AOFAS scores and Baird-Jackson ankle scores study and Rehabilitation assessments followed up after 3 years.
In baseline, 208 patients with i acute ankle sprain were recruited from the Rehabilitation Department of the Second Affiliated Hospital of Zhejiang University School of Medicine from January 2026 to December 2028, and were followed up after 3 years.
Perform the improvement in AOFAS scores and Baird-Jackson ankle scores study and Rehabilitation assessments followed up after 3 years. The Hyperbaric oxygen group treatment was administered at an atmospheric pressure of 2 ATA, with 100% oxygen inhalation. Oxygen was inhaled for 40 minutes (20 minutes of oxygen inhalation, 5-minute rest, 20 minutes of oxygen inhalation, decompression), once daily for 14 consecutive days. The control group treatment at an atmospheric pressure of 1.4 ATA, inhaling 21% oxygen by volume. Oxygen inhalation schedule: 40 minutes (inhale oxygen for 20 minutes, rest for 5 minutes, inhale oxygen for 20 minutes, decompression), once a day for 14 consecutive days.
Two person analyzed the above data, and record abnormal results.
352 studies on the registry are indexed under Ankle Injuries; 72 are open to participants now.
This study's planned enrollment of 208 is above the median of 56 across 273 interventional studies indexed under Ankle Injuries.
Browse Ankle Injuries studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
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Exclusion Criteria:
The treatment is administered at an atmospheric pressure of 2 ATA, with 100% oxygen inhalation.
Other: hyperbaric oxygen therapy
The treatment is administered at an atmospheric pressure of 1.4 ATA with an inhaled oxygen fraction of 21%
Other: non Hyperbaric Oxygen Therapy
The treatment is administered at an atmospheric pressure of 2 ATA, with 100% oxygen inhalation. Oxygen inhalation time: 40 minutes (inhaling oxygen for 20 minutes, resting for 5 minutes, inhaling oxygen for 20 minutes, decompression), once daily, for 14 consecutive days. (Commenced immediately after randomisation)
The treatment is administered at an atmospheric pressure of 1.4 ATA with an inhaled oxygen fraction of 21%, oxygen inhalation time: 40 minutes (20 minutes of oxygen inhalation, 5 minutes rest, 20 minutes of oxygen inhalation, decompression), once daily, for 14 consecutive days. (Commences immediately after randomisation)
AOFAS score
Improvement of American Orthopaedic Foot \& Ankle Society Score （AOFAS scores）in acute ankle sprains with early HBO treatment. Usually scored from 0 to 100, higher scores mean a better outcome.
Time frame: 3 years
Baird-Jackson ankle score
Improvement of Baird-Jackson Ankle Evaluation Score（Baird-Jackson ankle scores） in acute ankle sprains with early HBO treatment. Usually scored from 0 to 100., higher scores mean a better outcome.
Time frame: 3 years
pain scores
The effects of hyperbaric oxygen on improvements in pain scores Visual Analog Scale (VAS) (resting VAS and walking VAS) in patients with acute ankle sprain. Usually scored from 0 to 10. higher scores mean a worth outcome.
Time frame: 3 years
ankle swelling
Measure the ankle joint circumference at the level of the medial malleolus tip, in millimeters, on both the affected and healthy sides, and calculate the degree of swelling. The more swollen the joints, the worth the outcome.
Time frame: 3 years
high-frequency ultrasound findings
Observe the damage and healing of ligaments and surrounding tissues. The better the continuity of the ligaments and surrounding tissues, the better the outcome.
Time frame: 3 years
Ankle MRI
Observe the damage and healing of ligaments and surrounding tissues. The higher the MRI signal, the worse the outcome.
Time frame: 3 years
patient's overall evaluation of treatment (PGIC)
The doctor asks the patient about their overall feeling regarding the treatment: 'Has there been any improvement?' Choose one as your answer: Number 1 indicates significant improvement; Number 2 indicates slight improvement; Number 3 indicates no change; Number 4 indicates worsening due to the treatment. higher scores mean a worth outcome.
Time frame: 3 years
HAMA scale score
the effects of hyperbaric oxygen on change in Hamilton Anxiety Scale（HAMA scale score）in patients with acute ankle sprain. Each item is rated on a five-point scale from 0 to 4. The total score reflects the overall severity of anxiety and can be used to assess treatment effects and changes in the condition. Total score ≥29: Possible severe anxiety. Total score ≥21: Definitely significant anxiety. Total score ≥14: Definitely anxiety. Total score ≥7: Possible anxiety. Total score \<7: No anxiety symptoms. higher scores mean a worse outcome.
Time frame: 3 years
No study locations are listed for this record.
Plan to share: No
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Second Affiliated Hospital, School of Medicine, Zhejiang University