The Association Between Proinflammatory Cytokines, Microbial Infection and Clinical Manifestation in Sciatica Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Microbial culture and cytokines levels assessed from inter-vertebral disc samples
研究概览
简要总结
All patients scheduled for lumbar spine surgery due to discogenic low back pain and/or sciatica, will be screened by the principal investigator for presence of inclusion/exclusion criteria. Their baseline neurological function before surgery will be assessed and recorded for recruitment into one of the three study groups. MRI scans will be assessed for the calculation of disc protrusion size. Experimental sensory and pain assessments and questionnaires will be performed at list 24 hours before surgery. Blood sample for pro-inflammatory mediator will be obtained at the same time as the experimental sensory and pain tests. Pre-operative pain and MPQ will be assessed pre-operatively (back and leg pain separately), and again on day 30 after surgery. Blood tests for ESR, CRP will be drawn before surgery, during the surgery, and on 30 after surgery. During surgery, intervertebral disc material will be harvested and divided into 4 specimens for culture and inflammatory mediator analysis. Repeat neurological assessment will be performed 30 after surgery.
详细描述
The clinical manifestation of disc degeneration and/or disc herniation can be low back pain and/or sciatica. The patterns of sensory and motor signs and symptoms that develop after neuropathy vary between individual patients with disc degeneration and/or disc herniation. The expression of these sensory signs (hyperalgesia, allodynia, and sensory loss), which we call the individual somatosensory profile, reflects pathophysiological mechanisms in damaged and surviving afferent nerve fibers such as conduction block, ectopic impulse generation, peripheral sensitization, and central sensitization. In addition, studies have been conducted in search of a microbial origin responsible for the observed inflammatory reaction in discogenic low back pain and sciatica. However, the studies tested mixed cohorts of patients in terms of clinical symptoms (low back pain alone, sciatica, both), length of symptoms (acute and chronic), and tissue cultured (disc, bone). We hypothesize that the possible infectious etiology of the observed inflammatory reaction seen in acute disc herniation and sciatica may be different from that of chronic low back pain due to disc degeneration.
We further suspect that the immununogenicity of an acute disc herniation causing neurological deficit may be different from a similar disc herniation not causing a deficit, and still different from chronic degenerated discs without herniation or neurological deficit. Despite the frequent occurrence of low back pain and sciatica in the general population their underling mechanisms are poorly understood.
Aims and hypotheses of study
(1) To test the differences in disc microbial cultures and in levels of disc and blood cytokines, between patients suffering disc degeneration / herniation and spinal stenosis (controls), and (2) to assess the relationship between clinical manifestations and sensory profiles of these patients and levels of cytokines found in disc tissue and blood.
Ouer hypotheses are: (1) patients suffering from disc degeneration / herniation or spinal stenosis will differ in microbial culture and cytokines levels, with higher levels of positive microbial disc culture and cytokines in the disc herniation group, (2) proinflamtory cytokines levels will correlate with hyperalgesic (rather than hypoalgesic) sensory profiles.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable of understanding the purpose and instructions of the study and signing an informed consent.
排除标准
- •Patients suffering for disc degeneration / herniation or spinal stenosis, scheduled to undergo lumbar spinal surgery for decompression and/or fusion (discectomy, laminectomy, foraminotomy, fusion).
结局指标
主要结局
Microbial culture and cytokines levels assessed from inter-vertebral disc samples
时间窗: two years
Number of positive microbial culture and pro-inflammatory cytokines levels assessed by real-time PCR from intervertebral disc samples
次要结局
未报告次要终点
研究者
Eisenberg Elon MD
Elon Eisenberg MD Professor of Neurology and Pain Medicine Head, Pain Research Unit Institute of Pain Medicine Rambam Health Care Campus
Rambam Health Care Campus
