Relationship of Periostin and ODI, EQ-5D

NCT07664904 | Recruiting DMC

• 1 other identifier: 2026-04-071
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 2

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.

Conditions

Intervertebral Disc Disease

Outcome Measures

Primary Outcomes (1)

• Identifying the correlation of periostin level and ODI and EQ5D

  Day1

Secondary Outcomes (1)

• Identifying the correlation of the periostin level and Cytokine level and Pfirmann grading

  Day1

Study Arms (1)

back pain patient group

Other: Blood sampling for ELISA

Interventions

Blood sampling for ELISA OTHER

blood sampling to detect the level of periostin and cytokine

back pain patient group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

low back pain population with disc degeneration confirmed in MRI

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Keimyung University Dongsan Medical Center: lead

Study Sites (2)

Ji Hee

Daegu, Daegu, 42601, South Korea

RECRUITING

Hong Ji Hee

Daegu, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood from the patient to measure the level of periostin

MeSH Terms

Conditions

Intervertebral disc disease

Interventions

Blood Specimen Collection; Enzyme-Linked Immunosorbent Assay

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Immunoenzyme Techniques; Immunoassay; Immunologic Techniques; Immunosorbent Techniques; Immunohistochemistry; Molecular Probe Techniques

Central Study Contacts

JIHEE Hong

CONTACT

01046794343; swon13@daum.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 24, 2026
• Study Start: June 22, 2026
• Primary Completion (Estimated): February 27, 2027
• Study Completion (Estimated): February 27, 2027
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)