Relationship of Periostin and ODI, EQ-5D

Официальное название

Study of Correlation Between Serum Periostin Levels and Oswestry Disability Index and EQ-5D

Обзор

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.

Вмешательства

• Другое Blood sampling for ELISA
  blood sampling to detect the level of periostin and cytokine

Первичные конечные точки

• Identifying the correlation of periostin level and ODI and EQ5D [Срок оценки: Day1]

Вторичные конечные точки (1)

• Identifying the correlation of the periostin level and Cytokine level and Pfirmann grading [Срок оценки: Day1]

Критерии участия

Критерии включения

• lumbar disc herniation
• lumbar spinal canal stenosis
• patients who have MRI
• patients who can fill in the ODI and EQ5D without other's help

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

South Korea · 2 центра

• Ji Hee — Daegu
• Hong Ji Hee — Daegu

Идентификаторы

NCT: NCT07664904 · 2026-04-071

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗