Effect of Pulsed Mode Radiofrequency on Dorsal Root Ganglion on Tumor Necrotic Factor α Level in Lumbar Disc Related Radicular Pain
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Modified Oswestry Back Disability Score
研究概览
简要总结
Lumbar radiculopathy is a term that describes symptoms of pain, numbness, and/or weakness that radiate along the sciatic nerve from the lower back to the buttocks and leg (1). Lumbar radiculopathy is a relevant health problem that affects quality of life, resulting in high health costs and economic loss worldwide (2). The reported prevalence of sciatica varies widely from 1.2% and 43% in the general population (3).
Although initially believed to be a primary mechanical insult to the nerve root and dorsal root ganglion, lumbar radiculopathy is possibly caused by inflammatory changes in the nerve root (4). The role of cytokine-mediated neuroimmune interactions in the development and persistence of pain has been extensively studied (5,6,7).
Intraneural application of pro-inflammatory cytokines induces behavioral signs associated with pain (8). Anti-inflammatory cytokine treatment effectively reduces hyperalgesia (9). Inflammatory cytokine inhibitors provided long-lasting analgesia in an inflammatory neuropathic pain model. On the basis of these findings, we evaluated whether cytokine profiles differ between severe and mild human sciatica, as well as whether distinct cytokine profiles provide relevant information regarding lumbar radiculopathy pathogenesis. (10,11).
Tumor necrosis factor-alpha (TNF-α) is a pleiotropic cytokine that can stimulate inflammatory responses of synapses and myelin sheath, promote cellular apoptosis because of its cytotoxic effect, and induce nerve swelling and neuropathic pain (12).
TNF-α influences neural survival, exerting both neuroprotective and neurodegenerative actions (13). Following peripheral nerve injury, upregulation of TNF-α expression has been documented in several neuropathic pain models (14).
Pulsed radiofrequency (PRF) is a relatively new developed technique that is a variation of conventional radiofrequency treatment. PRF treatment does not allow temperatures above 42°C at the tip of the electrode. PRF provides advantage avoiding thermal tissue destruction and pain sequelae in management of pain. Recently, it has been recommended for treatment of chronic pain (15).
Electromagnetic field which is thought to be responsible for the clinical effect of pulsed RF spread from active tip of electrode to around the electrode. The most intense part of the electromagnetic field is pointed tip of the electrode (16). It is a minimally invasive technique that involves application of electric fields to nerves to inhibit nociceptive stimuli and prevent pain transmission. PRF can be considered when conventional treatments have intolerable side effects or do not sufficiently relieve pain (17).
Working mechanism of PRF which is recently more preferred technique to treat chronic pain due to not forming tissue damage and less painful procedure is not exactly known but it is considered to act neuromodulation (18).
The aim of this work is to compare the effect of transforaminal injection of Steroids alone versus Radiofrequency pulsed mode on dorsal root ganglion combined with transforaminal steroids injection on TNF-α level in lumbar disc related radicular pain
详细描述
This is a prospective randomized controlled trial that will be carried out on 80 patients diagnosed as having symptomatic lumbar disc prolapse.
The study will be planned by taking the local ethics committee approval and patients' written consent. Between 20-75 years of age, 40 patients will receive pulsed radiofrequency on dorsal root ganglion combined with transforaminal steroids injection procedure and 30 patients will receive transforaminal steroid injection. All patients are suffering more than 3 months long chronic pain syndrome.
Patients will be informed about the technique, at the level of cooperation that can provide this information to understand and work with patients who have the level of cooperation that can provide this information to understand and agree to participate in work will be included in the study. Patients included in the study will be given an appointment for the procedure and Written consent will be obtained from all participants .The patients will be recruited from the neurology and pain clinic of Beni-Suef University Hospital, in the period from March 2022 to September 2022.
Inclusion criteria:
Patients diagnosed as having symptomatic lumbar disc prolapse based on the following:
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed as having symptomatic lumbar disc prolapse based on the following:
- •Clinical evidence of disc pulge in the form of disc related radicular pain of >3 months duration, not responding to conservative treatment and interfering with daily activities
- •Radiological demonstration of posterolateral lumbar disc pulge by MRI lumbosacral
- •Age range is between 30-80 years
排除标准
- •Patients with spinal deformities
- •Patients with a previous history of spinal trauma
- •Patients with previous spinal surgery
- •Patients with radiological evidence of any inflammatory or neoplastic lesion affecting the spinal cord or vertebral column
- •Patients with severe lumbar disc herniation causing lower limb weakness or sphincteric troubles
- •Patient with pain rather than radicular neuropathic pain as Facet osteoarthritis, Sacroiliitis, Hip osteoarthritis, Discogenic, Pyriformis syndrome.
- •Patients with contraindications to interventions (coagulopathy, sepsis, or allergy to the used drugs)
- •Patients with contraindications for MRI examination (e.g., metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body).
- •History of G6PD deficiency in patients who are candidates to receive ozone therapy.
- •Suspected spondylodiscitis.
研究组 & 干预措施
Radiofrequency group
Radiofrequency pulsed mode on dorsal root ganglion combined with transforaminal steroids injection
干预措施: Radiofrequency pulsed mode on dorsal root ganglion combined with transforaminal steroids injection (Procedure)
Steroids group
Transforaminal injection of Steroids alone
干预措施: Transforaminal injection of Steroids alone (Drug)
结局指标
主要结局
Modified Oswestry Back Disability Score
时间窗: 3 months
Functional disability
Numeric Rating Scale
时间窗: 3 months
Pain intensity
The Short Assessment of Patient Satisfaction
时间窗: 3 months
Patient's satisfaction
次要结局
未报告次要终点
研究者
Mona Hussein
Associate professor of Neurology
Beni-Suef University
