The Effect of Hyperbaric Oxygen Therapy for Acceleration Recovery After Anterior Cruciate Ligament Reconstruction(ACLR)

Shamir Medical Center (Assaf-Harofeh)

Status: Enrolling

Conditions: Anterior Cruciate Ligament Reconstruction

Treatments: Device: hyperbaric oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06493851

166-23

Details and patient eligibility

About

The aim of the current study is to evaluate the effect of HBOT for acceleration recovery after ACLR.

Full description

ACL rapture (Anterior cruciate ligament reconstruction rehabilitation) is a common injury in sports and cause severe functional problem. The big concern with this injury is the time to return to sport, this is the interest of the athlete.

The preferred treatment today when it comes to active athletes is to have an anterior cruciate ligament reconstruction (ACLR) ,the return to high function and sports after anterior cruciate ligament reconstruction (ACLR) surgery lasts about 8 months.

In the last few years, knowledge has been accumulating regarding the effectiveness of the new hyperbaric oxygen protocols in accelerating the healing of wounds and tissue damage. it was found that Hyperbaric oxygen therapy (HBOT) for ligament injuries in mice improves the quality and speed of recovery. The effect of HBOT on the rate of ligament healing has not yet been properly tested in humans.

The constant search for accelerated recovery in sports injuries along with the benefit of the HBOT in tissue healing processes encouraged the need to investigate the rate of recovery after a sports injury under HBOT. Two previous human studies in which medial collateral tear was tested showed positive effect on pain, physical outcome (decreased edema, range of motion and maximal knee flex) and accelerate the return to play. These findings with the fact that ACL injuries are common among athletes and can limit return to sports, reinforce the need to examine the effect of HBOT following ACLR in the terms of improving and speeding up recovery.

The aim of the current study is to evaluate the effect of HBOT for acceleration recovery after ACLR.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects willing and able to read, understand and sign an informed consent
2. Age 18-45
3. Anterior cruciate ligament tear for reconstruction (with or without meniscal repair).

Exclusion criteria

1. Inability to attend scheduled clinic visits and/or comply with the study protocol
2. Additional injury
3. An inability to perform MRI.
4. Active malignancy
5. Chest pathology incompatible with pressure changes (including active asthma)
6. Ear or sinus pathology incompatible with pressure changes
7. History of epilepsy
8. Claustrophobia
9. Previous knee surgery
10. Participation in another study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

hyperbaric oxygen therapy (HBOT) active treatment

Active Comparator group

Description:

The HBOT protocol consists of 6 weeks protocol including 5 daily HBOT sessions per week (total of 30), each session lasts 90 minutes, of 100% oxygen at 2 atmosphere absolute (ATA) with 5-minute air breaks every 20 minutes.

Treatment:

Device: hyperbaric oxygen therapy

hyperbaric oxygen therapy (HBOT) Sham treatment

Sham Comparator group

Description:

The sham HBOT protocol consists of 6 weeks protocol including 5 daily sham HBOT sessions per week (total of 30), each session includes breathing 21% oxygen by mask in a sham multiplace chamber. Sham pressure will go up to 1.2 ATA during the first five minutes of the session (to stimulate the pressure sensation in the ears), and then decrease during the next 5 minutes to 1.03 ATA for 90 minutes with 5-minute air breaks every 20 minutes.

Treatment:

Device: hyperbaric oxygen therapy