The Effect of Extracorporeal Shock Wave Therapy (ESWT) in Acute Traumatic Complete (AIS A) and Incomplete (AIS B-D) Cross-sectional Lesions on Motor and Sensory Function Within Six Months After Injury: A Two-arm Three-stage Adaptive, Prospective, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AUVA
- 入组人数
- 246
- 试验地点
- 30
- 主要终点
- changes in total motor scores (TMSC) = TMSC after 6 month minus TMSC at baseline
研究概览
简要总结
It has been hypothesized that there are two mechanisms of acute traumatic spinal cord injury (SCI): the primary mechanical damage and the secondary injury due to additional pathological processes initiated by the primary injury. Neurological damage due to laceration, contusion, distraction or compression of the spinal cord is called ''primary injury''. This mechanical injury leads to a cascade of biochemical and pathological changes, described as ''secondary injury'', which occurs minutes to weeks after the initial trauma and causes further neurological deterioration. This secondary cascade involves vascular changes, an inflammatory response, neurotoxicity, apoptosis and glial scarring, and further compromises neurological impairment after traumatic spinal cord injury. Edema, ischemia and loss of autoregulation continue to spread bi-directionally from the initial lesion along the spinal cord for up to 72 hours after the trauma.
It has been postulated that the damage caused by the primary injury mechanism is irreversible and therapeutic approaches in recent years have focused on modulating the secondary injury cascade.
Researchers found significantly greater numbers of myelinated fibers in peripheral nerves after a single ESWT application in an experimental model on rats after a homotopic nerve autograft into the sciatic nerve.
In another study a spinal cord ischemia model in mice was performed. ESWT was applied immediately after surgery and the treated animals showed a significantly better motor function and decreased neuronal degeneration compared to the control group within the first 7 days after surgery.
Researchers investigated the effect of low-energy ESWT for the duration of three weeks on a thoracic spinal cord contusion injury model in rats. Animals in the ESWT group demonstrated significantly better locomotor improvement and reduced neuronal loss compared to the control animals at 7, 35, and 42 days after contusion.
It has been postulated previously, that ESWT improves the metabolic activity of various cell types and induces an improved rate of axonal regeneration.
ESWT might be a promising therapeutic strategy in the treatment of traumatic SCI.
The underlying study aims to investigate the effect of ESWT after acute traumatic spinal cord injury in humans within 48 hours of trauma in order to intervene in the secondary injury phase with the objective to reduce the extent of neuronal damage.
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)
盲法说明
Stratified block randomization with a block size of four and a 1:1 allocation will be used to assign participants to one of two groups (treatment vs. placebo). Three neurological levels of injury will be used for stratification.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute traumatic spinal injuries who are awake, responsive, and oriented at admission
- •Patients from the age of 18 years
- •Admission to hospital within 24 hours after injury
- •Written consent to participate in the study
- •Participation in the Austrian Spinal Cord Injury Study (ASCIS)-Registry (only for the Austrian hospitals)
排除标准
- •Patients who cannot cooperate or are not capable to give consent to participate
- •Serious traumatic brain injuries that prevent accurate participation in study procedures and/or adequacy of informed consent Participation in other interventional clinical trials
- •Serious concomitant injuries that prevent the neurological initial assessment
- •Preexisting neurological conditions that affect the primary endpoint of the study and potentially mask or reduce the therapeutic effect of the ESWT application
- •High dose administration of corticosteroids
- •Complete spinal cord transection
- •Patients with pacemakers or implantable defibrillators
- •Patients who are using devices which are sensitive to electromagnetic radiation
- •(potential) Pregnancy
- •Patients with tumors
- •Patients with severe coagulation disorders
结局指标
主要结局
changes in total motor scores (TMSC) = TMSC after 6 month minus TMSC at baseline
时间窗: day 0 to 6 month
greater improvement in motor and sensory function (the AIS grade) can be achieved in patients after spinal trauma (AIS A-D) by applying a single extracorporeal shockwave therapy compared to the control group.
次要结局
- American Spinal Injury Association (ASIA) Impaiment Scale (AIS) grade(day 0 to 6 month)
- adverse events (AEs)(day 0 to 21 days)
- Pencil grip: yes/no(day 0 to 6 month)
- degree of spasticity(day 0 to 6 month)
- Walking ability (yes/no)(day 0 to 6 month)
- Urological function(day 0 to 6 month)
- Nine-Hole Peg Test (NHPT) (if feasible)(day 0 to 6 month)
- Pinch grip: yes/no(day 0 to 6 month)
- Clenched grip: yes/no(day 0 to 6 month)
- Lumbrical grip: yes/no(day 0 to 6 month)
- Plantar reflex (left/right: yes/no)(day 0 to 6 month)
- Independence in everyday life(day 0 to 6 month)
- Grasp and Release Test (GRT)(day 0 to 6 month)
研究者
Wolfgang Schaden
Deputy Medical Director of Austrian Workers´ Compensation Board (AUVA)
AUVA