Ankle SprainNCT07405281
the Efficacy of Hyperbaric Oxygen on Acute Ankle Sprain
A study testing hyperbaric oxygen therapy and non Hyperbaric Oxygen Therapy in people with Ankle Sprain, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ankle Sprain
- What is being tested?
- hyperbaric oxygen therapy and non Hyperbaric Oxygen Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Unilateral ankle sprain;
- Swelling, bruising, and pain at the site of the sprain;
- Injury occurring within 72 hours;
- MRI examination clearly shows ligament damage.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Prospective Clinical Randomized Controlled Study of the Efficacy of Hyperbaric Oxygen on Acute Ankle Sprain
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.
Read the 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
- Being tested
- hyperbaric oxygen therapy, non Hyperbaric Oxygen Therapy
- Keywords
- acute ankle sprain, hyperbaric oxygen
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperbaric oxygen therapyOther
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 TherapyOther
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)
| Study group | Role | What they receive |
|---|---|---|
| hyperbaric oxygen group | Experimental | The treatment is administered at an atmospheric pressure of 2 ATA, with 100% oxygen inhalation. Receives: Other: hyperbaric oxygen therapy |
| non hyperbaric oxygen group | Sham comparator | The treatment is administered at an atmospheric pressure of 1.4 ATA with an inhaled oxygen fraction of 21% Receives: Other: non Hyperbaric Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
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.
Measured: 3 years
Secondary outcomes (6)
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.
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 3 years
Ankle MRI
Observe the damage and healing of ligaments and surrounding tissues. The higher the MRI signal, the worse the outcome.
Measured: 3 years
patient's overall evaluation of treatment (PGIC)
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.
Measured: 3 years
HAMA scale score
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bing Xiong, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405281
- Sponsor's protocol ID
- 2025-1461
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Clinical Randomized Controlled Study of the Efficacy of Hyperbaric Oxygen on Acute Ankle Sprain
- ClinicalTrials.gov ID
- NCT07405281
- Acronym / sponsor ID
- 2025-1461
- Conditions
- Ankle Sprain
- Keywords
- acute ankle sprain, hyperbaric oxygen
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyperbaric oxygen group | Experimental | Other: hyperbaric oxygen therapyThe treatment is administered at an atmospheric pressure of 2 ATA, with 100% oxygen inhalation. |
| non hyperbaric oxygen group | Sham comparator | Other: non Hyperbaric Oxygen TherapyThe treatment is administered at an atmospheric pressure of 1.4 ATA with an inhaled oxygen fraction of 21% |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Unilateral ankle sprain;
- Swelling, bruising, and pain at the site of the sprain;
- Injury occurring within 72 hours;
- MRI examination clearly shows ligament damage.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyperbaric oxygen therapyThe 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 | hyperbaric oxygen group |
| non Hyperbaric Oxygen TherapyThe 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) | Other | non hyperbaric oxygen group |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Ankle Sprain
Not yet recruiting
Functional Recovery After a Recent Lateral Ankle Sprain With Early Initiation of Rehabilitation: Changes in the Ankle-GO Score and Its Association With Return to Sport and Recurrent Sprains.
Ankle Sprain
Recruiting
Enovis High Ankle Sprain Brace Testing
Athletes in Cutting Sports
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bing Xiong principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Questions about this trial
What is this clinical trial studying?
A study testing hyperbaric oxygen therapy and non Hyperbaric Oxygen Therapy in people with Ankle Sprain, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bing Xiong, MD (86-13516803156, 2202030@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AOFAS score (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.