Actively Recruiting
Hyperbaric Oxygen Therapy in HAMstring Injury (HOTHAM) Trial
Led by JL Tol · Updated on 2024-11-20
50
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hyperbaric Oxygen Therapy in HAMstring Injury (HOTHAM) Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or less, defined by acute injury history, pain in the posterior thigh, pain during hamstring palpation, pain during passive straight leg raise, and increased pain during isometric contraction
- The participant is able to start HBOT treatment within 7 days after injury
You will not qualify if you...
- The participant is not capable of doing an active exercise program
- The participant does not intend to return to full sporting or duty activities
- The hamstring injury is caused by external trauma to the posterior thigh
- The participant has a chronic hamstring injury longer than 2 months, defined as recurrent pain or tenderness
- The current injury is a reinjury occurring less than 2 months after return to play or duty following a previous acute ipsilateral hamstring injury
- Clinical suspicion of a complete proximal tendon avulsion
- Presence of other injuries that prevent rehabilitation
- The participant is unable to give informed consent
- Contraindications for MRI such as having a pacemaker, pregnancy, or claustrophobia
- Contraindications for HBOT including smoking or quitting smoking less than 3 months before injury, previous spontaneous pneumothorax, implantation of ICD or pacemaker incompatible with pressure, recent or current use of cytostatics within 6 months, inability to perform a Valsalva maneuver due to ear-nose-throat issues or upper airway infection, pregnancy, or claustrophobia
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Amsterdam UMC
Amsterdam, North Holland, Netherlands, 1105AZ
Actively Recruiting
Research Team
M
Milo J.K. Mokkenstorm, MD MSc
CONTACT
P
Prof. Dr. J.L. Tol
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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