Hyperbaric Oxygen Therapy in HAMstring Injury (HOTHAM) Trial
JL Tol
50 participants
Oct 30, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- 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 Criteria17
- 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
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06526728