Hyperbaric Oxygen Therapy in HAMstring Injury (HOTHAM) Trial

NCT06526728 | Recruiting Phase 3

• 1 other identifier: 2024.0395
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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. 1.Does Hyperbaric Oxygen Therapy accelerates the time needed to return to play/-duty following hamstring injury.
2. 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

Hamstring Injury

Outcome Measures

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.

  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 (4)

• Re-injury registration

  2- and 12 months following injury

• Clinical assessment

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

• Radiologic assessment

  Baseline and week 2

• Adverse events

  Baseline up until 1 week following last treatment session.

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Participants will be subjected to seven once-daily sessions of hyperbaric oxygen therapy. Generic Name: Oxygen Dosage: 100% Frequency: Once-daily Duration per treatment session: 115-120 minutes

Drug: Hyperbaric oxygen

Interventions

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 Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• JL Tol: lead

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

MeSH Terms

Interventions

Hyperbaric Oxygenation

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Central Study Contacts

Milo J.K. Mokkenstorm, MD MSc

CONTACT

+31 681076920; m.j.mokkenstorm@amsterdamumc.nl

Prof. Dr. J.L. Tol

CONTACT

j.l.tol@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Sports Medicine, Principal investigator

Model Details: 50 study participants will be treated with seven once-daily sessions of hyperbaric oxygen therapy following hamstring injury.

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 30, 2024
• Study Start: October 30, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)