A Multicenter, Prospective Clinical Randomized Controlled Study of the Efficacy of Hyperbaric Oxygen on Acute Ankle Sprain
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Enrollment
- 208
- Primary Endpoint
- AOFAS score
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
hyperbaric oxygen group
The treatment is administered at an atmospheric pressure of 2 ATA, with 100% oxygen inhalation.
Intervention: hyperbaric oxygen therapy (Other)
non hyperbaric oxygen group
The treatment is administered at an atmospheric pressure of 1.4 ATA with an inhaled oxygen fraction of 21%
Intervention: non Hyperbaric Oxygen Therapy (Other)
Outcomes
Primary Outcomes
AOFAS score
Time Frame: 3 years
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.
Baird-Jackson ankle score
Time Frame: 3 years
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.
Secondary Outcomes
- pain scores(3 years)
- ankle swelling(3 years)
- high-frequency ultrasound findings(3 years)
- Ankle MRI(3 years)
- patient's overall evaluation of treatment (PGIC)(3 years)
- HAMA scale score(3 years)