Hyperbaric Oxygen Therapy in HAMstring Injury (HOTHAM) Trial

Recruiting now · Phase 3

Conditions studied: Hamstring Injury

In brief

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.

Key facts

Study ID

NCT06526728

Run by

JL Tol

People needed

50

Starts

2024-10-30

Expected to finish

2028-03-01

Last updated by the study team

2024-11-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify 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
• 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)

You may not qualify 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;
• 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 it is running

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

Full record on ClinicalTrials.gov

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