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RecruitingNCT07662668Updated Aug 18, 2026

The Effect of NSAID on Serum Periostin

An observational study in Intervertebral Disc Disease, sponsored by Keimyung University Dongsan Medical Center. Recruiting at 1 site in South Korea. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by Keimyung University Dongsan Medical Center · Observational

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
144
Ages
20 Years to 80 Years
Sex
All
01

Study 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. 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.

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.

02

Conditions studied

  • Intervertebral Disc Disease

Keywords

  • intervertebral disc disease
03

In context

Intervertebral disc disease

63 studies on the registry are indexed under Intervertebral disc disease; 18 are open to participants now.

This study's planned enrollment of 144 is above the median of 120 across 22 observational studies indexed under Intervertebral disc disease.

Browse Intervertebral disc disease studies →

Lead sponsor

Keimyung University Dongsan Medical Center is the lead sponsor of 86 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

low back pain population with disc degeneration confirmed in MRI

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • allergic disease
  • allergic rhinitis
  • asthma
  • atopic dermatitis
  • chronic sinusitis
  • history of cancer
  • 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 user
  • acute or chronic infection
  • > 30
  • uncontrolled hypertension
  • uncontrolled diabetes
  • recent hisory vaccination
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
144 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • NSAID taking group

    NSAID taking group with low back pain

  • non-NSAID taking group

    non-NSAID taking group with low back pain

06

What researchers measure

Primary outcomes

  1. the level of serum periostin

    Time frame: Day1

Secondary outcomes

  1. The level of serum inflammatory cytokine

    Time frame: Day1

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07662668
Lead sponsor
Keimyung University Dongsan Medical Center
Responsible party
Ji Hee Hong (Professor, Keimyung University Dongsan Medical Center) — Principal investigator
First posted
Jun 23, 2026
Start date
Jun 22, 2026
Primary completion
May 30, 2028 (estimated)
Completion
May 30, 2028 (estimated)
Last update
Aug 18, 2026

Study contacts

JIHEE Hong
Contact
swon13@daum.net
01046794343
Sungwon Jung
Contact
swon12@daum.net

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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