- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: JIHEE Hong
- 전화번호: 01046794343
- 이메일: swon13@daum.net
연구 장소
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Daegu, 대한민국
- 모병
- Hong Ji Hee
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연락하다:
- Sungwon Jung
- 이메일: swon12@daum.net
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연락하다:
- JIHEE Hong, Professor
- 전화번호: 01046794343
- 이메일: swon13@daum.net
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Daegu
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Daegu, Daegu, 대한민국, 42601
- 모병
- Ji Hee
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연락하다:
- J Hee Hong
- 전화번호: 01046794343
- 이메일: swon13@daum.net
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연락하다:
- 이메일: swon13@hanmail.net
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Identifying the correlation of periostin level and ODI and EQ5D
기간: Day1
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Day1
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Identifying the correlation of the periostin level and Cytokine level and Pfirmann grading
기간: Day1
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Day1
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .