跳至主要内容
临床试验/NCT07776366
NCT07776366招募中不适用

Study of Correlation Between the Level of Intradiscal Periostin Expression and Pfirrmann Grading

Keimyung University Dongsan Medical Center1 个研究点 分布在 1 个国家目标入组 20 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
20
试验地点
1
主要终点
identifying the correlation of intradiscal periostin level and Pfirmann grading

研究概览

简要总结

Intervertebral disc degeneration (IVDD) is a well-recognized musculoskeletal condition that imposes a substantial socioeconomic burden and is an important cause of low back pain. IVDD can result from a variety of factors, including aging, obesity, genetic predisposition, degeneration of the multifidus and psoas muscles, osteoporosis, inflammation, and oxidative stress. The intervertebral disc (IVD) within the spine is composed of a gel-like nucleus pulposus (NP) at its center, a surrounding annulus fibrosus (AF), and cartilaginous endplates above and below. The NP and AF produce a water-rich extracellular matrix (ECM), which contributes to normal functioning of the spinal column.

Various internal and external stimuli cause dysfunction of the NP and AF, and excessive metabolic activity of the endplates leads to endplate degeneration and calcification, ultimately resulting in disc degeneration. In addition to aging and mechanical overload, increased oxidative stress and inflammatory cytokine release further accelerate IVDD.

Periostin is a component of the ECM that is associated with mechanical stress, inflammation, and aging, and has been closely linked to the development and progression of IVDD. Periostin binds to ECM molecules within the IVD and is involved in disc maintenance and repair; however, excessive ECM turnover induces and accelerates disc degeneration. Periostin affects IVD degeneration through pathways related to mechanical stress and inflammation, and serum periostin levels have been reported to be elevated in patients with more advanced disc degeneration. A recent study demonstrated a strong correlation between serum periostin concentration and the Pfirrmann grading system. However, measuring periostin concentration through blood sampling has limitations, as serum periostin levels can also increase similarly in patients with a history of head and neck cancer or allergic disease. Therefore, it is necessary to directly assess the degree of periostin expression within the intervertebral disc itself and to determine whether it shows a meaningful correlation with the Pfirrmann grading system. In addition, periostin is known to be more abundant in the AF than in the NP, but this has not previously been demonstrated through actual staining of disc tissue; this study therefore aims to compare the degree of periostin expression between the NP and AF using immunohistochemical staining.

Pfirrmann et al. developed a reliable, MRI-based grading system that is the most commonly used method for evaluating IVDD. The Pfirrmann grading system is based on analysis of T2-weighted MR sagittal images of the IVD, incorporating disc homogeneity, morphology, the distinction between the AF and NP boundary, T2 signal intensity, and disc height.

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

  • •lumbar disc herniation
  • •lumbar spinal canal stenosis
  • •patients who have MRI

排除标准

  • •allergic disease
  • •allergic rhinitis
  • •atopic dermatitis
  • •chronic sinusitis
  • •history of cancer
  • •fracture within 6 months
  • •severe osteoporosis
  • •knee osteoarthritis
  • •hip osteoarthritis
  • •spinal surgery within 6 months
  • •myocardiac infarction
  • •heart failure
  • •liver cirrhosis

研究组 & 干预措施

back pain patient group

back pain patient group requiring spine surgery

干预措施: posterior lumbar interbody fusion (Procedure)

back pain patient group

back pain patient group requiring spine surgery

干预措施: lumbar discectomy (Procedure)

结局指标

主要结局

identifying the correlation of intradiscal periostin level and Pfirmann grading

时间窗: day1

次要结局

  • identifying the correlation of intradiscal periostin and inflammatory cytokine level(day1)

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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