- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07664904
Relationship of Periostin and ODI, EQ-5D
Study of Correlation Between Serum Periostin Levels and Oswestry Disability Index and EQ-5D
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: JIHEE Hong
- Telefonnummer: 01046794343
- E-post: swon13@daum.net
Studiesteder
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-
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Daegu, Sør -Korea
- Rekruttering
- Hong Ji Hee
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Ta kontakt med:
- Sungwon Jung
- E-post: swon12@daum.net
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Ta kontakt med:
- JIHEE Hong, Professor
- Telefonnummer: 01046794343
- E-post: swon13@daum.net
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-
Daegu
-
Daegu, Daegu, Sør -Korea, 42601
- Rekruttering
- Ji Hee
-
Ta kontakt med:
- J Hee Hong
- Telefonnummer: 01046794343
- E-post: swon13@daum.net
-
Ta kontakt med:
- E-post: swon13@hanmail.net
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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back pain patient group
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blood sampling to detect the level of periostin and cytokine
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Identifying the correlation of periostin level and ODI and EQ5D
Tidsramme: Day1
|
Day1
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Identifying the correlation of the periostin level and Cytokine level and Pfirmann grading
Tidsramme: Day1
|
Day1
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Mellomvirvelskivssykdom
- Undersøkelsesteknikker
- Prøvehåndtering
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og prosedyrer
- Diagnose
- Punkteringer
- Kirurgiske prosedyrer, operativ
- Immunologiske teknikker
- Molekylære sondeteknikker
- Immunoenzymteknikker
- Immunoassay
- Immunosorberende teknikker
- Immunohistokjemi
- Blodprøveinnsamling
- Enzymkoblet immunosorbent assay
Andre studie-ID-numre
- 2026-04-071
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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