NCT07405281

the Efficacy of Hyperbaric Oxygen on Acute Ankle Sprain

A Multicenter, Prospective Clinical Randomized Controlled Study of the Efficacy of Hyperbaric Oxygen on Acute Ankle Sprain

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 208 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ankle Sprain

Interventions

Type	Name	Description
OTHER	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)
OTHER	non Hyperbaric Oxygen Therapy	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)

Timeline

• Start date: 2026-03-01
• Primary completion: 2029-03-01
• Completion: 2029-03-01
• First posted: 2026-02-12
• Last updated: 2026-02-12