The Effect of Hyperbaric Oxygen Therapy (HBOT) for Acceleration Recovery After Anterior Cruciate Ligament Reconstruction (ACLR): a Prospective, Randomized Control Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- International Knee Documentation Committee
研究概览
简要总结
The aim of the current study is to evaluate the effect of HBOT for acceleration recovery after ACLR.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects willing and able to read, understand and sign an informed consent
- •Anterior cruciate ligament tear for reconstruction (with or without meniscal repair).
排除标准
- •Inability to attend scheduled clinic visits and/or comply with the study protocol
- •Additional injury
- •An inability to perform MRI.
- •Active malignancy
- •Chest pathology incompatible with pressure changes (including active asthma)
- •Ear or sinus pathology incompatible with pressure changes
- •History of epilepsy
- •Claustrophobia
- •Previous knee surgery
- •Participation in another study
研究组 & 干预措施
hyperbaric oxygen therapy (HBOT) active treatment
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.
干预措施: hyperbaric oxygen therapy (Device)
hyperbaric oxygen therapy (HBOT) Sham treatment
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.
干预措施: hyperbaric oxygen therapy (Device)
结局指标
主要结局
International Knee Documentation Committee
时间窗: Change from Baseline immediately after the intervention
The aim of the international knee documentation committee (IKDC) is to detect improvement or deterioration in symptoms, function, and sport activity following knee impairment. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
次要结局
- Knee MRI(Change from Baseline immediately after the intervention)
- Laxity ligament test(Change from Baseline immediately after the intervention)
- physical measurement - ROM(Change from Baseline immediately after the intervention)
- physical measurement - Edema(Change from Baseline immediately after the intervention)
- physical measurement - Vas for pain(Change from Baseline immediately after the intervention)
- physical measurement - Maximal quadriceps power by dynamometer(Change from Baseline immediately after the intervention)
- Functional scores- (PROM)(Change from Baseline immediately after the intervention)
- Functional scores - Vas for global rating of knee function(Change from Baseline immediately after the intervention)
- Short form health survey (sf-36)(Change from Baseline immediately after the intervention)
- Functional measurement(Change from Baseline immediately after the intervention)
- Functional measurement - (SEBT)(Change from Baseline immediately after the intervention)
- Functional measurement - Single Hop test(Change from Baseline immediately after the intervention)
研究者
Shay Efrati
Prof.
Assaf-Harofeh Medical Center