Ultrasound-Guided Pulsed Radiofrequency Versus Perineural Platelet Rich Plasma Injection for Treatment of Idiopathic Carpal Tunnel Syndrome, A Prospective Randomized Controlled Study
试验速览
- 阶段
- 1 期
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Evaluate effect of pulsed radiofrequency versus platelet rich plasma injection on pain mediators
研究概览
简要总结
Aim of the study The aim of the study is to evaluate the role of pulsed radiofrequency versus platelet rich plasma injection in treatment of idiopathic mild to moderate carpal tunnel syndrome Patients will be classified into three equal groups using randomized closed envelop method into three groups.
Control Group ( n=25):Patients will receive median nerve perineural injection of bupivacaine with mehylprednisolone under ultrasound guidance.
PRF Group ( n=25):Patients will receive median nerve pulsed radiofrequency (PRF) and median nerve perineural injection of bupivacaine under ultrasound guidance PRP Group (n=25): Patients will receive median nerve perineural injection of platelet-rich plasma (PRP) under ultrasound guidance
Measurements (will be done before the procedure, one week ,two month and four months after procedure except SNCV and serum CRP and TNF α (tumor necrosis factor alpha)will be done before the procedure and after four months only):
- VAS (visual analogue pain scale)
- BCTQ (Boston carpal tunnel Questionnaire)
- Degree of paresthesia tested by Reverse Phalen's test.
- CSA (cross sectional area)0 of the median nerve will be measured by the same pain therapist involved in the study.
- SNCV (nerve conduction velocity study): performed by same physiotherapist not involved in the study before and after intervention.
- Serum Tumor necrosis factor alpha (TNF α).
- C-reactive protein (CRP)
- Complications will be recorded and managed. Items 1,2 and 3 will be measured by a pain therapist not involved in this study
详细描述
Introduction Carpal Tunnel Syndrome (CTS) is the most common form of entrapment neuropathy. CTS is defined as a symptomatic compression neuropathy of the median nerve at the level of the wrist, characterized physiologically by evidence of increased pressure within the carpal tunnel and decreased function of the nerve at this level.
Diagnosis of CTS is mainly a clinical one based on the history and physical examination by Tinnel's test Phanel's test and Reverse Phalen's test.The Reverse Phalen's test is more appropriate clinical test for truly compressing the carpal tunnel and provoking symptoms of CTS The gold standard of diagnosis is nerve conduction velocity study (SNCV) and ultrasonography. SNCV is highly specific and it rules out neuropathies and demyelinating disease but it has a considerable false negative rate of 10-20% . Ultrasonography has high sensitivity (89%) and specificity (83%) for the diagnosis of CTS.
Median nerve cross-sectional area (CSA) is used for the assessment and the grading of median nerve pathology. While patients hold their wrists in a neutral position with the palm up and fingers semi-extended, the CSA of the median nerve will be measured in ellipse adjusted to maximum transverse and anteroposterior diameter at the proximal inlet of the carpal tunnel at the level of the pisiform bone. The normal CSA is 9 mm2. The cross-section area cutoff points that discriminate between different grades of CTS severity are 10-15 mm2 for mild to moderate symptoms, and >15 mm2 for severe symptoms PRF treatment is well established intervention technique for treatment of CT.Although the mechanism of action of PRF is not yet known but it has been postulated that PRF has a neuromodulatory effect as it modifies the neuronal membranes and selectively targets the small diameter C and A -ᶑ fibers PRP is autologous fraction of human blood that encompasses a bigger concentration of platelets than baseline levels of blood. PRP contains platelet degradation production the form of multiple growth factors such as are transforming growth factor beta (TGF beta),vascular endothelial growth factor (VEGF) platelet-derived growth factor (PDGF), and epithelial growth factor (EGF). PRP therapies aim to enhance the self-healing ability of human body, by exposing the injured tissue to a high concentration of autologous growth factors. Increased Schwann cell proliferation, myelinization, axonal regeneration, and better nerve healing after injury have been reported.
The immune system has increasingly been implicated in numerous neurological disorders. Patients with CTS have adaptive changes in the homeostasis of memory T cells and an increase in systemic inflammatory response modulating cytokines/chemokines. Which is a prominent feature of neuroinflammation and elevated levels of certain cytokines such as TNFα, IL-6 (interlukin 6), and IL-1β, have been demonstrated in patients with painful peripheral neuropathies.
Aim of the study The aim of the study is to evaluate the role of pulsed radiofrequency versus platelet rich plasma injection in treatment of idiopathic mild to moderate carpal tunnel syndrome
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
- 30 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged (30-50) years of both gender.
- •Patients with mild to moderate idiopathic CTS.
- •Patient who are failed to respond to conservative treatment (such as splint, medications, physical therapy) for at least three months
排除标准
- •Severe CTS and secondary CTS
研究组 & 干预措施
Control Group
Patients will receive median nerve perineural injection of bupivacaine with mehylprednisolone under ultrasound guidance
干预措施: mehylprednisolone injection (Drug)
PRF Group
Patients will receive median nerve pulsed radiofrequency (PRF) and median nerve perineural injection of bupivacaine under ultrasound guidance
干预措施: pulsed radiofrequency (PRF) (Device)
PRP Group
Patients will receive median nerve perineural injection of platelet-rich plasma (PRP) under ultrasound guidance
干预措施: platelet-rich plasma (Biological)
结局指标
主要结局
Evaluate effect of pulsed radiofrequency versus platelet rich plasma injection on pain mediators
时间窗: four month
We will measure the level of TNF to all participant
Evaluate the role of pulsed radiofrequency versus platelet rich plasma injection in treatment of idiopathic mild to moderate carpal tunnel syndrome
时间窗: four month
We will evaluate the median nerve by NCV to all participant
次要结局
- Numbness relief assessment(four month)
- Pain relief assessment(four month)
