The Hyperbaric Oxygen in HAMstring injury (HOTHAM) trial

Phase 1

• Conditions: Acute hamstring injury; MedDRA version: 21.1Level: LLTClassification code: 10019109Term: Hamstring injury Class: 10022117; MedDRA version: 21.1Level: LLTClassification code: 10064106Term: Hamstring tendon injury Class: 10022117; MedDRA version: 21.1Level: LLTClassification code: 10037305Term: Pulled hamstring Class: 10022117; MedDRA version: 20.0Level: LLTClassification code: 10041774Term: Sprained hamstring Class: 10022117; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: CTIS2023-509610-11-00
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-18
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

The participant is 18-65 years old, The participant has a clinical diagnosis of an acute hamstring injury =7 days old, defined as: a) Anamnestic acute injury; b) Anamnestic pain in the posterior thigh; c) Localized pain during plapation of the hamstring muscle; d) Localized pain during passive straight leg raise test e) Increased pain during isometric contraction, The participant is able to start HBOT =7 days of injury, Signed informed consent

Exclusion Criteria

There are contra-indications for hyperbaric oxygen therapy: Smoking or quit smoking <3 months prior to injury, a previous spontaneous pneumothorax, a ICD or pacemaker not compatible with hyperbaric pressure, Current or recent (6 months) use of cytostatics, Unable to perform a Vasalva manoeuvre to pressurize the middle ear, pregnancy or claustrophobia, The participant does not have the intention to return to full sporting / -duty activities., The cause of the hamstring injury is an extrisic trauma on the posterior thigh, The participant has a chronic injury (>2 months), defined as reccurent pain or tenderness of the hamstring muscles., The current injury is a hamstring re-injury, defined as: A repeat injury <2 months following Return to play / return to full unrestricted duty from a previous hamstring injury;, The current injury is a complete proximal tendon avulsion (grade III hamstring injury), There are other, concurrent injuries inhibiting rehabilitation, There are contra-indications for MRI: Incompatible pacemakers/ICD's, pregnancy or claustrophobia.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the time needed to return to play (athletes) or time needed to return to full unrestricted duty (military personnel) treated with seven daily sessions of hyperbaric oxygen therapy compared to a historical control group (standard care);Secondary Objective: To clinically assess the hamstring injury over time (baseline, week 2 and at return to play/return to full unrestricted duty), To investigate MRI changes over time pre and post hyperbaric oxygen therapy (baseline and week 2), Registration of re-injury rates at 2- and 12 months following return to play/return to full unrestricted duty, To assess the safety of seven daily sessions of hyperbaric oxygen therapy in patients with a hamstring injury;Primary end point(s): Time needed to return to play (days) for athletes or time needed to return to full unrestricted duty (days) for military personnel.