- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: JIHEE Hong
- Phone Number: 01046794343
- Email: swon13@daum.net
Study Locations
-
-
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Daegu, South Korea
- Recruiting
- Hong Ji Hee
-
Contact:
- Sungwon Jung
- Email: swon12@daum.net
-
Contact:
- JIHEE Hong, Professor
- Phone Number: 01046794343
- Email: swon13@daum.net
-
-
Daegu
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Daegu, Daegu, South Korea, 42601
- Recruiting
- Ji Hee
-
Contact:
- J Hee Hong
- Phone Number: 01046794343
- Email: swon13@daum.net
-
Contact:
- Email: swon13@hanmail.net
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
back pain patient group
|
blood sampling to detect the level of periostin and cytokine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Identifying the correlation of periostin level and ODI and EQ5D
Time Frame: Day1
|
Day1
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Identifying the correlation of the periostin level and Cytokine level and Pfirmann grading
Time Frame: Day1
|
Day1
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Intervertebral disc disease
- Investigative Techniques
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Punctures
- Surgical Procedures, Operative
- Immunologic Techniques
- Molecular Probe Techniques
- Immunoenzyme Techniques
- Immunoassay
- Immunosorbent Techniques
- Immunohistochemistry
- Blood Specimen Collection
- Enzyme-Linked Immunosorbent Assay
Other Study ID Numbers
- 2026-04-071
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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