跳至主要内容
临床试验/NCT07776379
NCT07776379招募中不适用

The Prediction of Clinical Outcome Using the Serum BDNF Level

Keimyung University Dongsan Medical Center1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年8月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
1
主要终点
Success or failure according to BDNF level

研究概览

简要总结

Low back pain (LBP) is one of the most commonly observed conditions in patients over the age of 50 and imposes a substantial socioeconomic burden. Degenerative disc disease is one of the most frequent and important causes of this pain. Progressive disc degeneration is characterized by a decline in disc cell number and degradation of the extracellular matrix. Loss of nucleus pulposus (NP) volume and hydration, together with fissure formation within the annulus fibrosus (AF), develop gradually with aging and ultimately lead to functional impairment. Disc degeneration can result from multiple factors, including aging, obesity, genetic predisposition, degeneration of the multifidus and psoas muscles, osteoporosis, inflammation, and oxidative stress. The intervertebral disc consists of the gel-like nucleus pulposus (NP) at its center, the surrounding annulus fibrosus (AF), and the cartilaginous endplates above and below. Because the disc is an avascular structure, its capacity for self-repair is markedly limited.

Erector spinae plane block (ESPB) is a treatment option that can be performed in the outpatient setting for patients with such low back pain. ESPB was first described in 2016 and is a type of interfascial plane block. Unlike neuraxial blocks, it offers the advantage of being both technically straightforward and highly safe. Recent studies indicate that ESPB is increasingly applied to patients with post-spinal-surgery pain or chronic low back pain.

Brain-derived neurotrophic factor (BDNF) is a neurotrophin that regulates neuronal survival, differentiation, and synaptic plasticity within the central nervous system. In the context of pain, BDNF released from primary afferent nociceptors and spinal dorsal horn microglia has been implicated in central sensitization, a key mechanism underlying the transition from acute to chronic pain. Circulating BDNF concentrations have been reported to be associated with pain intensity, disability, and cortical/corticomotor plasticity in patients with chronic low back pain, and some studies have found serum BDNF levels to be significantly elevated in discogenic chronic low back pain compared with controls, while others report reduced circulating BDNF in chronic pain populations - suggesting that the relationship between BDNF and pain chronicity may vary by pain phenotype and warrants further clarification. Because BDNF reflects neuroplastic changes that accompany the development and persistence of chronic pain, it has been proposed as a potential predictor of treatment response. However, no study to date has directly examined whether serum BDNF concentration can predict the clinical outcome of ESPB in patients with low back pain.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Chronic low back pain patients with or without leg pain due to disc degeneration or spinal stenosis
  • •Patients who have MRI

排除标准

  • •Secondary low back pain (spine fracture, infection, tumor)
  • •recent history of spine surgery
  • •systemic inflammatory disease (rheumatoid arthritis, SLE, ankylosing spondylitis)
  • •peripheral neuropathy or central nervous system injury
  • •fibromyalgia
  • •drugs which can affect the serum BDNF level (anti depressant, anti parkinsonian drug, acetylcholinesterase inhibitor, anti psychotics)

研究组 & 干预措施

back pain patient group

back pain patient group receiving erector spinae plane block

干预措施: Erector Spinae Plane Block (Procedure)

back pain patient group

back pain patient group receiving erector spinae plane block

干预措施: Blood sampling for ELISA (Other)

结局指标

主要结局

Success or failure according to BDNF level

时间窗: day 60

次要结局

  • correlation of BDNF level and Pfirmann grading of MRI(day 60)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ji Hee Hong

professor

Keimyung University Dongsan Medical Center

研究点 (1)

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