Hyperbaric Oxygen Therapy in HAMstring Injury (HOTHAM) Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time to return to full unrestricted play / time to return to full unrestricted duty.
研究概览
简要总结
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:
- Does Hyperbaric Oxygen Therapy accelerates the time needed to return to play/-duty following hamstring injury.
- 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.
详细描述
Trial objectives and endpoints Primary objective(s) Endpoint for the primary objective
To Compare the time needed to return to play (RTP) or -full unrestricted duty (RTD) after seven daily sessions of HBOT to a historical control group (standard care). • Time needed to return to play (days) / time needed to return to full unrestricted duty (days) defined as:
- RTP: Number of days from initial injury until the athlete is cleared to resume full unrestricted training
- RTP: Number of days from initial injury until soldier is cleared to resume full unrestricted (physical) duty activities.
Secondary objective(s), if applicable Endpoint(s) for secondary objectives Clinically assess the hamstring injury over time (Baseline, week 2 and at RTP/RTD) • Patient reported hamstring scores: Tenger activity score, Functional Assessment scale for acute hamstring injuries and psychological readiness.
- Maximum and mean pain scores (0-10) assessed with the visual analog scale, at injury, at rest and during sprinting.
- Physical examination including:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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).
- •Pregnancy
- •Claustrophobia
研究组 & 干预措施
Treatment Arm
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
干预措施: Hyperbaric oxygen (Drug)
结局指标
主要结局
Time to return to full unrestricted play / time to return to full unrestricted duty.
时间窗: From date of inclusion until the date of progresion to return to full unrestricted play or -duty. Assessed to up to 1 year
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.
次要结局
- 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.)
- Re-injury registration(2- and 12 months following injury)
研究者
JL Tol
Professor of Sports Medicine, Principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)