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临床试验/NCT05053477
NCT05053477Unknown1 期

Ultrasound-Guided Pulsed Radiofrequency Versus Perineural Platelet Rich Plasma Injection for Treatment of Idiopathic Carpal Tunnel Syndrome, A Prospective Randomized Controlled Study

Alexandria University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2018年9月1日最近更新:
适应症
干预措施
相关药物

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):

  1. VAS (visual analogue pain scale)
  2. BCTQ (Boston carpal tunnel Questionnaire)
  3. Degree of paresthesia tested by Reverse Phalen's test.
  4. CSA (cross sectional area)0 of the median nerve will be measured by the same pain therapist involved in the study.
  5. SNCV (nerve conduction velocity study): performed by same physiotherapist not involved in the study before and after intervention.
  6. Serum Tumor necrosis factor alpha (TNF α).
  7. C-reactive protein (CRP)
  8. 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

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

Active Comparator

Patients will receive median nerve perineural injection of bupivacaine with mehylprednisolone under ultrasound guidance

干预措施: mehylprednisolone injection (Drug)

PRF Group

Active Comparator

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

Active Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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