NCT07776366 Study of Correlation Between the Level of Intradiscal Periostin Expression and Pfirrmann Grading
| NCT ID | NCT07776366 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Keimyung University Dongsan Medical Center |
| Condition | Chronic Low Back Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-08-13 |
| Primary Completion | 2027-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2026-08-13 with a primary completion date of 2027-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * lumbar disc herniation * lumbar spinal canal stenosis * patients who have MRI Exclusion Criteria: * allergic disease * allergic rhinitis * asthma * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07776366 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 80 Years, studying Chronic Low Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07776366 currently recruiting?
Yes, NCT07776366 is actively recruiting participants. Contact the research team at swon13@daum.net for enrollment information.
Where is the NCT07776366 trial being conducted?
This trial is being conducted at Daegu, South Korea.
Who is sponsoring the NCT07776366 clinical trial?
NCT07776366 is sponsored by Keimyung University Dongsan Medical Center. The trial plans to enroll 20 participants.