An observational study in Chronic Low Back Pain and Spinal Stenosis Lumbar, sponsored by Keimyung University Dongsan Medical Center. Recruiting at 1 site in South Korea. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Keimyung University Dongsan Medical Center · Observational
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.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's planned enrollment of 20 is below the median of 100 across 481 observational studies indexed under Low Back Pain.
Browse Low Back Pain studies →Keimyung University Dongsan Medical Center is the lead sponsor of 86 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
low back pain population who requires spine surgery
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Exclusion Criteria:
back pain patient group requiring spine surgery
Procedure: posterior lumbar interbody fusion · Procedure: lumbar discectomy
posterior lumbar interbody fusion
lumbar discectomy
identifying the correlation of intradiscal periostin level and Pfirmann grading
Time frame: day1
identifying the correlation of intradiscal periostin and inflammatory cytokine level
Time frame: day1
Plan to share: No
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Started Aug 2026 (actual). Primary completion is estimated for Aug 2027, 12 months after the start.
Of 175 non-industry observational studies under Low Back Pain, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 48. This study's planned 12 months is below that.
Counting every sponsor, half of 185 studies reached it within 24 months; a quarter within 10 and three quarters within 48.
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Keimyung University Dongsan Medical Center