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Study on Hyperbaric Oxygen Therapy for Acute Hamstring Injury in Athletes and Military Personnel

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment called Hyperbaric Oxygen Therapy on individuals with an acute hamstring injury. An acute hamstring injury is a sudden injury to the muscles at the back of the thigh, often causing pain and difficulty in movement. The treatment involves using oxygen in a special way, where it is delivered under higher pressure than normal, which is believed to help in healing the injury faster.

The study will use two forms of oxygen: Conoxia, 100% v/v, medicinal gas, compressed and Conoxia® Vloeibaar, 100% v/v, medicinal gas, cryogenic. Both forms of oxygen are administered through inhalation, meaning participants will breathe in the oxygen. The main goal of the study is to compare how quickly athletes and military personnel can return to their activities after receiving this treatment, compared to those who receive standard care.

Participants in the study will undergo seven daily sessions of hyperbaric oxygen therapy. The study will also collect information on various aspects of recovery, such as pain levels, physical examination results, and MRI findings, which is a type of imaging that helps visualize the injury. Additionally, the study will monitor for any re-injuries and any adverse events that may occur during the treatment period. The trial aims to provide insights into whether this therapy can effectively speed up recovery from hamstring injuries.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Eligibility is determined based on age (18-65 years) and a clinical diagnosis of an acute hamstring injury that is 7 days old or less.

    The participant must be able to start hyperbaric oxygen therapy (HBOT) within 7 days of the injury.

    Informed consent is required to participate in the trial.

  2. Step 2

    Treatment sessions

    The treatment involves seven daily sessions of hyperbaric oxygen therapy.

    The therapy uses Conoxia, a medicinal gas administered through inhalation.

    The gas is provided in two forms: compressed and cryogenic.

  3. Step 3

    Primary outcome assessment

    The main goal is to measure the time needed to return to play for athletes or to full unrestricted duty for military personnel.

  4. Step 4

    Secondary outcome assessment

    Patient-reported hamstring scores are collected, including activity and functional assessment scales.

    Pain levels are assessed using a visual analog scale, both at rest and during activities like sprinting.

    Physical examinations are conducted to evaluate pain, flexibility, and strength of the hamstring.

    MRI scans are used to analyze the injury's appearance.

    The number of re-injuries is tracked at 2 and 12 months after returning to play or duty.

    Adverse events are monitored from the start of the trial to 7 days after the last treatment session.

Who can join the trial?

8 criteria

  • The participant is between 18 and 65 years old.
  • The participant has a clinical diagnosis of an acute hamstring injury that is 7 days old or less. This means:
    • The injury happened suddenly.
    • There is pain in the back of the thigh.
    • There is pain when touching the hamstring muscle.
    • There is pain when lifting the leg straight while lying down.
    • There is increased pain when trying to contract the muscle without moving it.
    • The participant can start HBOT (hyperbaric oxygen therapy) within 7 days of the injury.
    • The participant has signed an informed consent form, which means they understand the study and agree to take part.

Who cannot join the trial?

5 criteria

  • Individuals who do not have an acute hamstring injury. This means the injury must be recent and affect the muscles at the back of the thigh.
  • People who are not within the specified age range for the study. The study is open to certain age groups only.
  • Participants who are not athletes or military personnel, as the study focuses on these groups.
  • Individuals who cannot undergo hyperbaric oxygen therapy. This is a treatment where a person breathes pure oxygen in a pressurized room or chamber.
  • People who are part of a vulnerable population, which means groups that might need special protection or care.
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Verified sites

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  • Amsterdam UMC

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    The NetherlandsAmsterdam, The Netherlands

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Investigated drugs

Hyperbaric Oxygen Therapy is a treatment where patients breathe pure oxygen in a pressurized room or chamber. In this trial, it is used to help athletes and military personnel recover faster from hamstring injuries. The therapy aims to speed up healing by increasing the amount of oxygen in the blood, which can help reduce swelling and promote tissue repair. Participants in the trial receive seven daily sessions of this therapy to see if it helps them return to their activities more quickly compared to standard care.

What is already known about the treatment

Hyperbaric Oxygen Therapy – This treatment involves breathing pure oxygen in a pressurized room or chamber, which is administered in a specialized facility. It is currently being studied in clinical trials for its effectiveness in treating acute hamstring injuries. The main therapeutic indication is to potentially speed up recovery time for athletes and military personnel. The mechanism of action involves increasing the amount of oxygen in the blood, which can enhance healing by reducing swelling and inflammation and promoting tissue repair. It is classified under physical therapy treatments rather than traditional pharmacological categories.

Investigated diseases

Acute Hamstring Injury – This condition involves a sudden strain or tear in the hamstring muscles located at the back of the thigh. It typically occurs during activities that involve sprinting, jumping, or sudden changes in direction. The injury is characterized by sharp pain at the back of the thigh, swelling, and bruising. As the injury progresses, individuals may experience difficulty walking or bending the knee. Recovery involves a gradual return to normal activities, with the severity of the injury influencing the duration of healing. Proper rest and rehabilitation are crucial to prevent re-injury.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509610-11-00Estimated enrolment50 patientsSponsorAmsterdam UMC Stichting

sourced from the EU Clinical Trials Register and site verification

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