Ireland
--:--IST
Recruiting Phase 3

Hyperbaric Oxygen Therapy in HAMstring Injury (HOTHAM) Trial

NCT06526728 · tracked via the Priya Life Science Netherlands tracker
Sponsor
JL Tol
Phase
Phase 3
Started
2024-10-30
Last updated
2024-11-20

Condition(s) studied

Hamstring Injury

Investigational drug(s) / intervention(s)

Hyperbaric oxygen →

Hyperbaric oxygen: Participants will be subjected to seven once-daily sessions of hyperbaric oxygen therapy. Each session will last 115-120 minutes whereby the chambre will be pressurized to 2.4 ATA during which participants will breathe 100% (pure) oxygen.

Study summary

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. Does Hyperbaric Oxygen Therapy accelerates the time needed to return to play/-duty following hamstring injury.
2. Does Hyperbaric Oxygen Therapy decrease the amount of reinjuries within 1 year following Return to play/-duty? Besides these questions this study will clinically and radiologically evaluate the healing process over time as well as the occurrence of (serious) adverse events.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Time to return to full unrestricted play / time to return to full unrestricted duty. — From date of inclusion until the date of progresion to return to full unrestricted play or -duty. Assessed to up to 1 year
    Number of days from initial injury until the athlete is cleard to resume full unrestricted training / Number of days from initial injury until soldier is cleared to resume full unrestricted (physical) duty activities.

Trial sites (1)

FacilityCityRegionStatus
Amsterdam UMC Amsterdam North Holland Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06526728 on ClinicalTrials.gov ↗ ← All trials in the Netherlands