Hyperbaric Oxygen Therapy in HAMstring Injury (HOTHAM) Trial
Launched by JL TOL · Jul 24, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The HOTHAM Trial is a research study looking at how Hyperbaric Oxygen Therapy (HBOT) can help people heal faster from acute hamstring injuries. The main goals are to find out if this therapy can help athletes return to their sport sooner and reduce the chances of getting injured again in the year after they start playing again. The study will also monitor how well the hamstring heals over time and check for any serious side effects.
To participate in this trial, individuals need to be between 18 and 65 years old and have a recent hamstring injury that occurred within the last week. They should be willing to engage in an exercise program and aim to return to their sport or work duties. However, people with certain conditions, such as chronic injuries, recent surgeries, or specific medical issues, may not be able to join. If eligible, participants can expect to receive HBOT treatment and will be closely observed throughout the healing process.
Gender
ALL
Eligibility criteria
- Inclusion 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)
- Exclusion Criteria:
- • 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
About Jl Tol
JL Tol is a dedicated clinical trial sponsor committed to advancing healthcare through innovative research and development. With a focus on delivering high-quality clinical trials, JL Tol engages in strategic partnerships with healthcare professionals and institutions to explore novel therapies and improve patient outcomes. The organization adheres to the highest ethical standards and regulatory guidelines, ensuring the integrity and reliability of its research. By fostering a collaborative environment, JL Tol aims to bring groundbreaking treatments to market, ultimately enhancing the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Amsterdam, Noord Holland, Netherlands
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported