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Hyperbaric Oxygen Therapy in HAMstring Injury (HOTHAM) Trial

ConditionHamstring Injury
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJL Tol

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

The participant is male or female, of any ethnic origin

The participant is between 18 and 65 years old

Anamnestic acute injury

Anamnestic pain in the posterior thigh

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Hyperbaric oxygen

    Drug

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Treatment ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Time to return to full unrestricted play / time to return to full unrestricted duty.

Number of days from initial injury until the athlete is cleard to resume full unrestricted training / Number of days from initial injury until soldier is cleared to resume full unrestricted (physical) duty activities.

Time frame
From date of inclusion until the date of progresion to return to full unrestricted play or -duty. Assessed to up to 1 year

Secondary outcomes

1

Re-injury registration

Number of re-injuries

Time frame
2- and 12 months following injury
2

Clinical assessment

Clinically assess the hamstring injury over time (Patient reported hamstring scores, Pain scores), physical assessment (palpation, flexibility and isometric strength testing).

Time frame
Baseline, week 2 and at return to full restricted play/-duty (assessed up to 1 year following injury)
3

Radiologic assessment

Radiologic assessment of the hamstring injury over time using MRI derived parameters: Aspect of the injury on MRI images by a radiologist.

Time frame
Baseline and week 2
4

Adverse events

Number of AE-and SAE's

Time frame
Baseline up until 1 week following last treatment session.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

JL Tol

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Sponsor institution

Source ClinicalTrials.gov
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