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The Hyperbaric Oxygen in HAMstring injury (HOTHAM) trial
EU CTIS ID: 2023-509610-11-00
What this study is testing
To compare the time needed to return to play (athletes) or time needed to return to full unrestricted duty (military personnel) treated with seven daily sessions of hyperbaric oxygen therapy compared to a historical control group (standard care)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The participant is 18-65 years old
- The participant has a clinical diagnosis of an acute hamstring injury ≤7 days old, defined as: a) Anamnestic acute injury; b) Anamnestic pain in the posterior thigh; c) Localized pain during plapation of the hamstring muscle; d) Localized pain during passive straight leg raise test e) Increased pain during isometric contraction
- The participant is able to start HBOT ≤7 days of injury
- Signed informed consent
You likely can't join if
- There are contra-indications for hyperbaric oxygen therapy: Smoking or quit smoking <3 months prior to injury, a previous spontaneous pneumothorax, a ICD or pacemaker not compatible with hyperbaric pressure, Current or recent (6 months) use of cytostatics, Unable to perform a Vasalva manoeuvre to pressurize the middle ear, pregnancy or claustrophobia
- The participant does not have the intention to return to full sporting / -duty activities.
- The cause of the hamstring injury is an extrisic trauma on the posterior thigh
- The participant has a chronic injury (>2 months), defined as reccurent pain or tenderness of the hamstring muscles.
- The current injury is a hamstring re-injury, defined as: A repeat injury <2 months following Return to play / return to full unrestricted duty from a previous hamstring injury;
- The current injury is a complete proximal tendon avulsion (grade III hamstring injury)
See the full eligibility criteria
- The participant is 18-65 years old
- The participant has a clinical diagnosis of an acute hamstring injury ≤7 days old, defined as: a) Anamnestic acute injury; b) Anamnestic pain in the posterior thigh; c) Localized pain during plapation of the hamstring muscle; d) Localized pain during passive straight leg raise test e) Increased pain during isometric contraction
- The participant is able to start HBOT ≤7 days of injury
- Signed informed consent
- There are contra-indications for hyperbaric oxygen therapy: Smoking or quit smoking <3 months prior to injury, a previous spontaneous pneumothorax, a ICD or pacemaker not compatible with hyperbaric pressure, Current or recent (6 months) use of cytostatics, Unable to perform a Vasalva manoeuvre to pressurize the middle ear, pregnancy or claustrophobia
- The participant does not have the intention to return to full sporting / -duty activities.
- The cause of the hamstring injury is an extrisic trauma on the posterior thigh
- The participant has a chronic injury (>2 months), defined as reccurent pain or tenderness of the hamstring muscles.
- The current injury is a hamstring re-injury, defined as: A repeat injury <2 months following Return to play / return to full unrestricted duty from a previous hamstring injury;
- The current injury is a complete proximal tendon avulsion (grade III hamstring injury)
- There are other, concurrent injuries inhibiting rehabilitation
- There are contra-indications for MRI: Incompatible pacemakers/ICD's, pregnancy or claustrophobia.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.