The Hyperbaric Oxygen in HAMstring injury (HOTHAM) trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amsterdam UMC

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

27 Oct 2024 → ongoing

Decision date (initial)

2024-04-22

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

ZonMW · NOC-NSF

External identifiers

EU CT number

2023-509610-11-00

WHO UTN

U1111-1300-6247

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

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 objectives 4

1. To clinically assess the hamstring injury over time (baseline, week 2 and at return to play/return to full unrestricted duty)
2. To investigate MRI changes over time pre and post hyperbaric oxygen therapy (baseline and week 2)
3. Registration of re-injury rates at 2- and 12 months following return to play/return to full unrestricted duty
4. To assess the safety of seven daily sessions of hyperbaric oxygen therapy in patients with a hamstring injury

Conditions and MedDRA coding

Acute hamstring injury

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. The participant is 18-65 years old
2. 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
3. The participant is able to start HBOT ≤7 days of injury
4. Signed informed consent

Exclusion criteria 8

1. 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
2. The participant does not have the intention to return to full sporting / -duty activities.
3. The cause of the hamstring injury is an extrisic trauma on the posterior thigh
4. The participant has a chronic injury (>2 months), defined as reccurent pain or tenderness of the hamstring muscles.
5. 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;
6. The current injury is a complete proximal tendon avulsion (grade III hamstring injury)
7. There are other, concurrent injuries inhibiting rehabilitation
8. There are contra-indications for MRI: Incompatible pacemakers/ICD's, pregnancy or claustrophobia.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Time needed to return to play (days) for athletes or time needed to return to full unrestricted duty (days) for military personnel.

Secondary endpoints 6

1. Patient reported hamstring scores: Tenger activity score, Functional assessment scale for acute hamstring injuries and psychological readiness.
2. Maximum and mean pain scores (0-10) assessed with the visual analog scale, at injury, at rest and during sprinting
3. Physical examination including: - Palpation: Location and dimension of painful area/lesion, presence of hematoma or – swelling o Pain with isometric contraction against resistance - Hamstring flexibility tests: Passive straight leg raise, Active knee extension test. - Hamstring isometric strength (Hand hold dynamometer)
4. MRI derived parameters: Aspect of the injury on T1 and T2- weighted images scored by a radiologist using a standardized form.
5. Number of re-injury at 2- and 12 months following return to play/ return to full unrestricted duty.
6. Number of (serious)adverse events from inclusion to ≤7 days following the last hyperbaric oxygen treatment session.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amsterdam UMC

Sponsor organisation

Amsterdam UMC

Address

De Boelelaan 1117

City

Amsterdam

Postcode

1081 HV

Country

Netherlands

Scientific contact point

Organisation

Amsterdam UMC

Contact name

JL Tol

Public contact point

Organisation

Amsterdam UMC

Contact name

M.J.K. Mokkenstorm

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications