Ankle Sprain
Conditions
Keywords
acute ankle sprain, hyperbaric oxygen
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.
Interventions
OTHERhyperbaric 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)
OTHERnon 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)
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AOFAS score | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| pain scores | 3 years | 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. |
| ankle swelling | 3 years | 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. |
| high-frequency ultrasound findings | 3 years | Observe the damage and healing of ligaments and surrounding tissues. The better the continuity of the ligaments and surrounding tissues, the better the outcome. |
| Ankle MRI | 3 years | Observe the damage and healing of ligaments and surrounding tissues. The higher the MRI signal, the worse the outcome. |
| patient's overall evaluation of treatment (PGIC) | 3 years | 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. |
| HAMA scale score | 3 years | 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. |
Contacts
CONTACTBing Xiong, MD
PRINCIPAL_INVESTIGATORBing Xiong
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Outcome results
None listed