NCT07664904 Relationship of Periostin and ODI, EQ-5D
| NCT ID | NCT07664904 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Keimyung University Dongsan Medical Center |
| Condition | Intervertebral Disc Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 53 participants |
| Start Date | 2026-06-22 |
| Primary Completion | 2027-02-27 |
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 53 participants in total. It began in 2026-06-22 with a primary completion date of 2027-02-27.
⚠ 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
The intervertebral disc degeneration (IVDD) is a widely recognized musculoskeletal disorder that impose a substantial socioeconomic burden and respresents one of the most important causes of low back pain. IVDD can result from a variety of factors, including aging, obesity, genetic predispositioin, degeneration of of the multifidus and psoas muscles, osteoporosis, inflammation, and oxidative stress. The IVD consists of a central gelatinous nucleus pulposus (NP), an outer annulus fibrosus (AF), and superior and inferior cartilaginous endplates. The NP and AF produce a water-rich extracellular matrix (ECM), which is essential for normal trunk function. Dysfunction of the NP and AF, together with excessive metabolic activity of the enplates triggered by various intrinsic and extrinsic stimuli, leads to endplate degeneration and calcification, and ultimately to IVDD. In addition to aging and mechanical overload, increased oxidative stress and pro-inflammatrory cytokine secretion further accelerate the progression of IVDD. Periostin is an ECM protein which is associated with mechanical stress, inflammation, and aging, and is known to be closely involved in the development and progression of IVDD. Periostin binds to ECM molecule within the IVD and participates in its maintenance and repair; however, excessive ECM turn over drives IVD degeneration and its progression. Periostin influences IVD degeneration through mechanical stress and inflammatory pathways, and serum periostin levels are elevated in patients with severe IVD degeneration. A recent study demonstrated strong corrrelation between serum periostin concentration and the Pfirmann grading system. The Oswestry disability index is a validated scale that measures functional disability in patients with spinal pain, and the EQ-5D is a breif questionnaire used to assess health related quality of life. Because serum periostin levels reflect the severity of IVDD, periostin may also influence patient's functional disability and quality of life. However, whether serum periostin concentration correlates with functional disability and quality of life has not yet been studied.
Eligibility Criteria
Inclusion Criteria: * lumbar disc herniation * lumbar spinal canal stenosis * patients who have MRI * patients who can fill in the ODI and EQ5D without other's help Exclusion Criteria: * allergic disease * allergic rhinitis * asthma * atopic dermatitis * chronic sinusitis * history of cancer * fracture within 6 months * severe osteoporosis * knee osteoarthritis * hip osteoarthrtis * spinal surgery within 6 months * myocardiac infarction * heart failure * liver cirrhosis * chronic kidney disease * rhematoid disease * systemic lupus erythematosus * ankylosing spondylitis * Crohn's disease * Ulcerative colitis * systemic steroid user * acute or chronic infection * BMI \> 30 * uncontrolled hypertension * uncontrolled diabetes * recent history of vaccination
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07664904 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 80 Years, studying Intervertebral Disc Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07664904 currently recruiting?
Yes, NCT07664904 is actively recruiting participants. Contact the research team at swon13@daum.net for enrollment information.
Where is the NCT07664904 trial being conducted?
This trial is being conducted at Daegu, South Korea, Daegu, South Korea.
Who is sponsoring the NCT07664904 clinical trial?
NCT07664904 is sponsored by Keimyung University Dongsan Medical Center. The trial plans to enroll 53 participants.