Status:
RECRUITING
Hyperbaric Oxygen Therapy in HAMstring Injury (HOTHAM) Trial
Lead Sponsor:
JL Tol
Conditions:
Hamstring Injury
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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...
Detailed Description
Trial objectives and endpoints Primary objective(s) Endpoint for the primary objective To Compare the time needed to return to play (RTP) or -full unrestricted duty (RTD) after seven daily sessions o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06526728
Start Date
October 30 2024
End Date
March 1 2028
Last Update
November 20 2024
Active Locations (1)
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1
Amsterdam UMC
Amsterdam, North Holland, Netherlands, 1105AZ