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Intervertebral Disc DiseaseNCT07662668

The Effect of NSAID on Serum Periostin

An observational study of Intervertebral Disc Disease, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Low back pain (LBP) is one of the most prevalent musculoskeletal disorders worldwide and constitutes a major source of disability and socioeconomic burden. Intervertebral disc degeneration (IVDD) is recognized as one of the primary etiological contributors to LBP, and its prevalence increases substantially with age. Read more about this study

Who is it for?
Ages 20 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Intervertebral Disc Disease
How many people
144 participants
Where
1 siteSouth Korea
Study dates
22 Jun 2026to 30 May 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: low back pain population with disc degeneration confirmed in MRI

Who may be able to join

  • lumbar disc herniation
  • lumbar spinal canal stenosis
  • patients who have MRI

Who cannot join

  • allergic disease
  • allergic rhinitis
  • asthma
  • atopic dermatitis
  • chronic sinusitis
  • history of cancer
Show all 26Show fewer
  • fracture within 6 months
  • severe osteoporosis
  • knee osteoarthritis
  • hip osteoarthritis
  • spinal surgery within 6 months
  • myocardiac infarction
  • heart failure
  • liver cirrhosis
  • chronic kidney disease
  • rheumatoid 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 hisory vaccination

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

JIHEE Hong contact

01046794343

swon13@daum.net

Sungwon Jung contact

swon12@daum.net

South Korea1 site, 1 recruiting
  • Hong Ji Hee

    Daegu

    JIHEE Hong, Professor, 01046794343, swon13@daum.net

    Sungwon Jung, swon12@daum.net

    Recruiting

Other trials in South Korea

About this study

Official title: The Effect of Non-steroidal Antiinflammatory Drug on the Serum Periostin Level in Patients of Degenerative Disc Disease

Low back pain (LBP) is one of the most prevalent musculoskeletal disorders worldwide and constitutes a major source of disability and socioeconomic burden. Intervertebral disc degeneration (IVDD) is recognized as one of the primary etiological contributors to LBP, and its prevalence increases substantially with age. The intervertebral disc (IVD) is a complex fibrocartilaginous structure composed of a central gelatinous nucleus pulposus (NP), a surrounding annulus fibrosus (AF), and superior and inferior cartilaginous endplates. The NP and AF cells synthesize a water-rich extracellular matrix (ECM) that confers the disc with its biomechanical properties, enabling load distribution and flexibility of the spinal column.

Under physiological conditions, ECM homeostasis within the IVD is tightly regulated; however, various intrinsic and extrinsic stimuli can disrupt this balance and initiate the degenerative cascade. IVDD has been attributed to a multitude of factors, including aging, obesity, genetic predisposition, mechanical overload, degeneration of the multifidus and psoas muscles, osteoporosis, oxidative stress, and chronic low-grade inflammation. Dysfunction of NP and AF cells, compounded by excessive endplate metabolic activity, leads to progressive endplate calcification, loss of disc hydration, structural failure of the AF, and ultimately irreversible IVDD. Among these contributing factors, elevated oxidative stress and increased secretion of pro-inflammatory cytokines-such as interleukin-1β (IL-1β), tumor necrosis factor-α (TNF-α), and interleukin-6 (IL-6)-have been shown to markedly accelerate the progression of IVDD by promoting ECM catabolism and suppressing anabolic repair processes.

Read more

Periostin (gene symbol: POSTN) is a matricellular ECM protein originally identified in the periosteum and periodontal ligament. It belongs to the fasciclin superfamily and plays a critical role in ECM assembly, tissue remodeling, and cell-matrix interactions. Periostin has been identified as a key mediator of mechanical stress responses, inflammatory signaling, and aging-related tissue changes, and is increasingly recognized as an important contributor to musculoskeletal pathology. Within the IVD, periostin binds to structural ECM molecules-including fibronectin, tenascin-C, and collagens-and participates in disc maintenance and repair. Conversely, dysregulated periostin expression promotes excessive ECM turnover and accelerates IVD degeneration through both mechanosensory and pro-inflammatory pathways. Importantly, serum periostin levels have been reported to be significantly elevated in patients with severe IVDD, and a recent clinical study demonstrated a strong positive correlation between serum periostin concentration and the Pfirrmann grading system, the most widely used MRI-based classification of disc degeneration severity.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most commonly prescribed pharmacological treatments for LBP, recommended in current clinical guidelines as first-line analgesic therapy. NSAIDs exert their primary effects through inhibition of cyclooxygenase (COX) enzymes, thereby suppressing prostaglandin synthesis and attenuating the inflammatory cascade. Beyond analgesia, NSAIDs may modulate the systemic inflammatory milieu in patients with IVDD by reducing circulating pro-inflammatory cytokine levels. Periostin expression is known to be upregulated by inflammatory mediators, including IL-4, IL-13, and TNF-α, and is closely linked to the overall inflammatory burden. It is therefore plausible that NSAID use may indirectly attenuate serum periostin elevation in patients with IVDD-related LBP; however, direct evidence for this hypothesis is currently lacking.

To date, no study has systematically compared serum periostin and inflammatory cytokine concentrations among patients with IVDD-related LBP who are using NSAIDs, those who are not using NSAIDs, and healthy controls without LBP. Elucidating these differences would not only advance our understanding of the role of systemic inflammation and ECM remodeling in IVDD pathophysiology, but would also help clarify whether NSAID use influences the biomarker profile of affected patients-with important implications for patient stratification and biomarker-guided management.

Keywords
intervertebral disc disease
Medical subject headings
Intervertebral disc disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07662668
Study groupRoleWhat they receive
NSAID taking groupNSAID taking group with low back pain
non-NSAID taking groupnon-NSAID taking group with low back pain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the level of serum periostin

    Measured: Day1

Secondary outcomes (1)
  1. The level of serum inflammatory cytokine

    Measured: Day1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2026
  2. Study start22 Jun 2026
  3. Primary completion30 May 2028 (estimated)
  4. Study completion30 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07662668
Sponsor's protocol ID
2026-04-072
Status last verified
Aug 2026
First submitted
17 Jun 2026
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Intervertebral Disc Disease, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact JIHEE Hong (01046794343, swon13@daum.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the level of serum periostin (time frame: Day1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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