the Efficacy of Hyperbaric Oxygen on Acute Ankle Sprain

ConditionAnkle Sprain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Unilateral ankle sprain;

Swelling, bruising, and pain at the site of the sprain;

Injury occurring within 72 hours;

MRI examination clearly shows ligament damage.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • hyperbaric oxygen therapy

    Other intervention

    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)

  • non Hyperbaric Oxygen Therapy

    Other intervention

    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)

Treatment groups

208 Participants
are divided into 2 treatment groups
Group A: hyperbaric oxygen groupExperimental treatment 1 intervention
Group B: non hyperbaric oxygen groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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