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RecruitingNCT07664904Updated Aug 18, 2026

Relationship of Periostin and ODI, EQ-5D

An observational study in Intervertebral Disc Disease, sponsored by Keimyung University Dongsan Medical Center. Recruiting at 2 sites in South Korea. Open to participants aged 20 Years to 80 Years. 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
Other
Time perspective
Prospective
Enrollment
53
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • 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 53 is below 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
No
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
  • patients who can fill in the ODI and EQ5D without other's help

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 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 user
  • acute or chronic infection
  • > 30
  • uncontrolled hypertension
  • uncontrolled diabetes
  • recent history of 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
Other
Time perspective
Prospective
Enrollment
53 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • back pain patient group

    Other: Blood sampling for ELISA

Interventions

  • OtherBlood sampling for ELISA

    blood sampling to detect the level of periostin and cytokine

06

What researchers measure

Primary outcomes

  1. Identifying the correlation of periostin level and ODI and EQ5D

    Time frame: Day1

Secondary outcomes

  1. Identifying the correlation of the periostin level and Cytokine level and Pfirmann grading

    Time frame: Day1

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2026 (actual). Primary completion is estimated for Feb 2027, 8 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 15, 2026
First posted
Jun 24, 2026
StartActual
Jun 22, 2026
Primary completionEst.
Feb 27, 2027
CompletionEst.
Feb 27, 2027
Last update
Aug 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
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
NCT07664904
Lead sponsor
Keimyung University Dongsan Medical Center
Responsible party
Ji Hee Hong (Professor, Keimyung University Dongsan Medical Center) — Principal investigator
First posted
Jun 24, 2026
Start date
Jun 22, 2026
Primary completion
Feb 27, 2027 (estimated)
Completion
Feb 27, 2027 (estimated)
Last update
Aug 18, 2026

Study contacts

JIHEE Hong
Contact
swon13@daum.net
01046794343

Oversight

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

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