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New treatment option for Hamstring Injury
Official title Hyperbaric Oxygen Therapy in HAMstring Injury (HOTHAM) Trial
ClinicalTrials.gov ID: NCT06526728
What this study is testing
What is Hyperbaric oxygen?
Hyperbaric oxygen is an investigational medicine, given as an once-daily, being studied as a potential treatment for hamstring injury.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this study is to learn if Hyperbaric Oxygen Therapy is able to accelerate and improve muscle healing following an acute hamstring injury. The main questions it aims to answer are: 1.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- The participant is male or female, of any ethnic origin
- The participant is between 18 and 65 years old
- The participant has a clinical diagnosis of an acute hamstring injury ≤7 days old, defined as:
- Anamnestic acute injury
- Anamnestic pain in the posterior thigh
You likely can't join if
- The participant is not capable of doing an active exercise program.
- The participant does not have the intention to full sporting activity or duty activities;
- The cause of the hamstring injury is an extrinsic trauma on the posterior thigh;
- The participant has a chronic hamstring injury \>2 months, defined as recurrent pain or tenderness of the hamstring;
- The current injury is a re-injury ≤2months after RTP/RTD after acute ipsilateral hamstring injury;
- Clinical suspicion of a complete proximal tendon avulsions;
See the full eligibility criteria
- The participant is male or female, of any ethnic origin
- The participant is between 18 and 65 years old
- The participant has a clinical diagnosis of an acute hamstring injury ≤7 days old, defined as:
- Anamnestic acute injury
- Anamnestic pain in the posterior thigh
- Localized pain during palpation of hamstring muscle
- Localized pain during passive straight leg raise
- Increased pain during isometric contraction
- The participant is able to start of HBOT treatment ≤7 days)
- The participant is not capable of doing an active exercise program.
- The participant does not have the intention to full sporting activity or duty activities;
- The cause of the hamstring injury is an extrinsic trauma on the posterior thigh;
- The participant has a chronic hamstring injury \>2 months, defined as recurrent pain or tenderness of the hamstring;
- The current injury is a re-injury ≤2months after RTP/RTD after acute ipsilateral hamstring injury;
- Clinical suspicion of a complete proximal tendon avulsions;
- Presence of other concurrent injuries inhibiting rehabilitation;
- The participant is not able to give informed consent;
- There are contra-indications for MRI: Pacemaker, pregnancy and claustrophobia
- There are contra-indications for HBOT:
- Smoking or quit smoking \<3 months prior to injury;
- A previous spontaneous pneumothorax.
- Implantation of ICD or PM not compatible with hyperbaric pressure
- Current or recent (\<6 months) use of cytostatics
- Unable to perform a Valsalva manoeuvre to pressurize the middle ear (pre-existent ear-nose-throat complaints or a current upper airway infection).
- Pregnancy
- Claustrophobia
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, North Holland, Netherlands
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 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, North Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.