Ultrasound Guided Placental Growth Factor Vs Platelet Rich Plasma Injection in Peripheral Nerve Injury: an Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 主要终点
- efficacy of placental growth factor injection guided by ultrasound and nerve conduction
研究概览
简要总结
The goal of this clinical trial is to learn if placental growth factor injection and platelet rich plasma injection works to treat peripheral nerve injury in adults. and the role of nerve conduction study and neuromuscular ultrasound
The main questions it aims to answer are:
Does placental growth factor improve outcome after peripheral nerve injury? Does platelet rich plasma improve outcome after peripheral nerve injury? Researchers will compare drug both drugs to each other and will follow up the results via NCS and NMUS
Participants will be classified into 3 random groups:
one group will receive perineural injection of placental growth factor, the other group will receive peri neural PRP injection, third group will only be followed up without intervention Follow up of each patients will be done at 3 and 6 months
详细描述
Traumatic nerve injuries, particularly involving the median and ulnar nerves, pose significant clinical challenges and can lead to considerable morbidity Neuropathic pain, which can arise from nerve lesions, may persist for months or even years after the apparent healing of the affected tissues , Moreover, weakness or paralysis of specific muscles can impair grip strength and fine motor skills, making daily tasks challenging, and the chronic disability affects patient's quality of life.
Neuromuscular US is a non-invasive technique to diagnose peripheral nerve injuries, basic findings in nerve trauma may include focal enlargements suggesting a neuroma in continuity, disorganization of the internal fascicular structure, as well as partial or complete nerve transection.
Growth factors play a pivotal role in the process of nerve regeneration by promoting cellular growth, survival, and differentiation.
Placenta extract contains a variety of growth factors, such as: Vascular Endothelial Growth Factor (VEGF), Transforming Growth Factor-beta (TGF-β), Fibroblast Growth factor (FGF) and insulin-like growth factor (IGF), It also includes cytokines and proteins that support healing and modulate inflammatory responses(6)placental extract use showed a significant improvement in pain and range of motion in knee osteoarthritis, Fibromyalgia and Rheumatoid arthritis (RA).
Another rich source of growth factors is platelet-rich plasma (PRP) it allows gradual and sustained release of neurotrophic signaling molecules such as nerve growth factor (NGF), Brain-Derived Neurotrophic Factor (BDNF), IGF-1, platelet-derived growth factor (PDGF), VEGF, and hepatocyte growth factor (HGF) and neurotropic factors (fibrin, fibronectin, and vitronectin) Studies on PRP and placental extract effect on nerve injuries are also still limited which needs further experimentation to understand its effect, and ability of regeneration of various neural components.
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
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients older than 16 yrs old.
- •Patients with traumatic median or ulnar nerve injury who are complaining of symptoms or functional disability.
- •Patients with these injuries for more than 3 months
排除标准
- •1- Presence of other causes of nerve affection (entrapment, Diabetes, etc).
研究组 & 干预措施
group will receive placental growth factor injection
干预措施: perineural injection (Drug)
group will receive platelet rich plasma injection
干预措施: perineural injection (Drug)
结局指标
主要结局
efficacy of placental growth factor injection guided by ultrasound and nerve conduction
时间窗: one year
pre and post injection follow up will be done my measuring the nerve conduction velocity and amplitude , and by determining the cross sectional area of the nerve by ultrasound
efficacy of platelet rich plasma injection guided by ultrasound and nerve conduction
时间窗: one year
pre and post injection parameters of nerve conduction as velocity and amplitude will be measured as will as parameters of ultrasound such as cross sectional area
次要结局
- diagnosis and follow up of patients by nerve conduction study and neuromuscular US(one year)
研究者
Sara Taher Mohamed Amin
Main investigator
Assiut University