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临床试验/NCT07097532
NCT07097532进行中(未招募)不适用

Cutaneous Silent Period-Based Comparison of Dorsal Root Ganglion Pulsed Radiofrequency and Transforaminal Epidural Steroid Injection in Lumbar Radicular Pain

ahmet başarı2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年7月8日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
54
试验地点
2
主要终点
Change in Cutaneous Silent Period (CSP) Parameters

研究概览

简要总结

This prospective clinical study compares the effects of two interventional treatments, dorsal root ganglion pulsed radiofrequency (DRG-PRF) and transforaminal epidural steroid injection (TFESI), on patients with lumbar radicular pain (LRP). A third group of healthy individuals is included as a control group to provide baseline cutaneous silent period (CSP) values.

The CSP is a neurophysiological marker of spinal inhibition. The study aims to evaluate whether these treatments affect pain levels, functional disability, and CSP parameters over time. Participants with LRP will receive either DRG-PRF or TFESI, while healthy controls will undergo CSP testing only.

The findings may provide insight into the effects of these interventions on segmental nociceptive processing and inform treatment strategies for neuropathic low back pain.

详细描述

Lumbar radicular pain (LRP) is one of the most common causes of low back pain (1). It frequently results from disc herniation at the L4-5 or L5-S1 levels or from irritation of spinal nerve roots due to other degenerative conditions (2). Transforaminal epidural steroid injection (TFESI) and dorsal root ganglion pulsed radiofrequency (DRG-PRF) are minimally invasive interventional procedures used in the treatment of this condition. However, data objectively comparing the effects of these interventions on segmental nociceptive processing in humans are limited (3,4).

This prospective clinical study aims to evaluate both the clinical and neurophysiological effects of DRG-PRF and TFESI in individuals with LRP. The cutaneous silent period (CSP), a non-invasive electrophysiological marker that reflects spinal inhibitory function, will be used as an objective assessment tool. CSP is a polysynaptic spinal reflex in which a nociceptive stimulus conducted via A-delta fibers causes temporary suppression of voluntary motor activity (5). It represents the electrophysiological correlate of a protective reflex involving both sensory and motor pathways and enables functional assessment of thinly myelinated sensory fibers using standard neurophysiological equipment (6).

The study will include three groups: a DRG-PRF group, a TFESI group, and a healthy control group with no spinal pathology. Participants in the DRG-PRF and TFESI groups will be randomly allocated to treatment arms according to their order of presentation at the outpatient clinic. All participants will undergo baseline CSP recordings. In the treatment groups, CSP will be reassessed on Day 1, Week 1, and Month 1 following the intervention. CSP measurements will be conducted by an experienced electrophysiologist who is blinded to the treatment group. In addition, pain severity using the Numeric Rating Scale (NRS) and functional disability using the Oswestry Disability Index (ODI) will be evaluated in the treatment groups.

The DRG-PRF group will receive fluoroscopy-guided pulsed radiofrequency treatment at the L4-5 and L5-S1 lumbar levels using a standard 42°C protocol. The TFESI group will receive transforaminal corticosteroid injections at the same spinal levels. All procedures will be performed under sterile conditions by an experienced pain specialist.

The primary outcome of the study is to assess changes in CSP parameters, specifically onset latency and duration. Secondary outcomes include changes in pain intensity and functional capacity. The inclusion of a healthy control group will allow for comparison of CSP responses against normative values.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

盲法说明

The outcome assessor responsible for CSP measurements is blinded to group allocation. No other parties are masked.

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

入选标准

  • Age between 18 and 65 years
  • Clinically and radiologically confirmed lumbar radicular pain (LRP) due to unilateral intervertebral disc herniation, confirmed by MRI and physical examination
  • Symptom duration greater than 3 months
  • Baseline pain score of ≥4 on the 11-point Numerical Rating Scale (NRS-11)
  • Inadequate response to conservative treatment (e.g., medication or physical therapy)

排除标准

  • Unstable or uncontrolled psychiatric illness
  • Pregnancy
  • Bleeding diathesis
  • Known allergy to any procedural agent (e.g., local anesthetics, corticosteroids, contrast media)
  • Prior lumbar surgery
  • Spondylolisthesis
  • Compression fracture
  • Bilateral or sequestered disc herniation
  • Moderate-to-severe spinal stenosis
  • Diabetes mellitus
  • Polyneuropathy
  • Fibromyalgia
  • Movement disorders
  • Regular use of antidepressants or tramadol
  • Regular use of pregabalin or gabapentin
  • Chronic alcohol use
  • Noncompliance with follow-up

结局指标

主要结局

Change in Cutaneous Silent Period (CSP) Parameters

时间窗: Baseline, Day 1, Week 1, and Month 1 post-procedure

Evaluation of changes in electrophysiological parameters of the cutaneous silent period (CSP), including onset latency, offset latency, and duration, recorded from the tibialis anterior muscle following sural nerve stimulation. These parameters are used to assess segmental spinal inhibitory function and to evaluate the modulatory effects of dorsal root ganglion pulsed radiofrequency (DRG-PRF) and transforaminal epidural steroid injection (TFESI) in patients with lumbar radicular pain.

Change in Cutaneous Silent Period (CSP) Parameters

时间窗: Baseline, Day 1, Week 1, and Month 1 post-procedure

Evaluation of changes in electrophysiological parameters of the cutaneous silent period (CSP), including onset latency, offset latency, and duration, recorded from the tibialis anterior muscle following sural nerve stimulation. These parameters are used to assess segmental spinal inhibitory function and to evaluate the modulatory effects of dorsal root ganglion pulsed radiofrequency (DRG-PRF) and transforaminal epidural steroid injection (TFESI) in patients with lumbar radicular pain.

次要结局

  • Change in Clinical Outcomes: Pain Intensity and Functional Disability(Baseline, Day 1, Week 1, and Month 1 post-procedure)
  • Change in Clinical Outcomes: Pain Intensity and Functional Disability(Baseline, Day 1, Week 1, and Month 1 post-procedure)

研究者

发起方
ahmet başarı
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

ahmet başarı

Pain Specialist

Kayseri City Hospital

研究点 (2)

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