Using Hyperbaric Oxygen Therapy to Heal Hamstring Injuries

Hyperbaric Oxygen Therapy in HAMstring Injury (HOTHAM) Trial

This study is testing if Hyperbaric Oxygen Therapy can help people recover faster from hamstring injuries compared to standard treatment.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other)
• Locations: 1 site (Amsterdam, North Holland)
• Trial ID: NCT06526728 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of Hyperbaric Oxygen Therapy (HBOT) in accelerating recovery from acute hamstring injuries. Participants will undergo seven daily sessions of HBOT, and their recovery times will be compared to a historical control group receiving standard care. The study will also assess the healing process through clinical evaluations and MRI imaging, as well as track the occurrence of reinjuries within one year. Key metrics include the time to return to play and various pain and functional assessments.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 18 to 65 with a clinical diagnosis of an acute hamstring injury that is less than 7 days old.

Not a fit: Patients with chronic hamstring injuries or those unable to participate in an active exercise program may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly reduce recovery time and reinjury rates for patients with hamstring injuries.

How similar studies have performed: While the use of Hyperbaric Oxygen Therapy is gaining interest, this specific application for hamstring injuries is relatively novel and has not been extensively tested in prior studies.

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

Where this trial is running

Amsterdam, North Holland

• Amsterdam UMC — Amsterdam, North Holland, Netherlands (RECRUITING)

Study contacts

• Study coordinator: Milo J.K. Mokkenstorm, MD MSc

Conditions: Hamstring Injury