the Efficacy of Hyperbaric Oxygen on Acute Ankle Sprain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: hyperbaric oxygen therapy, non Hyperbaric Oxygen Therapy.
- Who it may be relevant to
- Registry conditions: Ankle Sprain. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter, Prospective Clinical Randomized Controlled Study of the Efficacy of Hyperbaric Oxygen on Acute Ankle Sprain
Overview
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.
Interventions
- 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)
Primary outcome measures
- AOFAS score [Time frame: 3 years]
- Baird-Jackson ankle score [Time frame: 3 years]
Secondary outcome measures (6)
- pain scores [Time frame: 3 years]
- ankle swelling [Time frame: 3 years]
- high-frequency ultrasound findings [Time frame: 3 years]
- Ankle MRI [Time frame: 3 years]
- patient's overall evaluation of treatment (PGIC) [Time frame: 3 years]
- HAMA scale score [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- Unilateral ankle sprain;
- Swelling, bruising, and pain at the site of the sprain;
- Injury occurring within 72 hours;
- MRI examination clearly shows ligament damage.
Exclusion criteria
- X-ray shows ankle fracture;
- Ankle has skin lesions or skin diseases;
- History of lower limb and pelvic surgery;
- Obvious neurological or psychiatric disorders that may interfere with assessment;
- Severe ligament injuries or joint instability requiring surgical treatment;
- Previous ankle injuries, persistent pain or functional limitations;
- Pneumothorax, severe emphysema, active bleeding, or other diseases with contraindications for hyperbaric oxygen therapy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07405281 · 2025-1461