Intervertebral Disc DiseaseNCT07664904
Relationship of Periostin and ODI, EQ-5D
An observational study of Intervertebral Disc Disease, run by Keimyung University Dongsan Medical Center at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Intervertebral Disc Disease
- What is being tested?
- Blood sampling for ELISA
- How many people
- 53 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 22 Jun 2026to 27 Feb 2027
- 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
- No healthy volunteers
- 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
- patients who can fill in the ODI and EQ5D without other's help
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 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites, 2 recruiting
- Recruiting
Ji Hee
Daegu, Daegu, 42601
J Hee Hong, 01046794343, swon13@daum.net
swon13@hanmail.net
- Recruiting
Hong Ji Hee
Daegu
JIHEE Hong, Professor, 01046794343, swon13@daum.net
Sungwon Jung, swon12@daum.net
About this study
Official title: 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.
Read more
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
- Being tested
- Blood sampling for ELISA
- 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.
Blood sampling for ELISAOther
blood sampling to detect the level of periostin and cytokine
| Study group | Role | What they receive |
|---|---|---|
| back pain patient group | Not described Receives: Other: Blood sampling for ELISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying the correlation of periostin level and ODI and EQ5D
Measured: Day1
Secondary outcomes (1)
Identifying the correlation of the periostin level and Cytokine level and Pfirmann grading
Measured: Day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start22 Jun 2026
- Primary completion27 Feb 2027 (estimated)
- Study completion27 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Prospective
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Hee Hong, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664904
- Sponsor's protocol ID
- 2026-04-071
- Status last verified
- Aug 2026
- First submitted
- 15 Jun 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Correlation Between Serum Periostin Levels and Oswestry Disability Index and EQ-5D
- ClinicalTrials.gov ID
- NCT07664904
- Acronym / sponsor ID
- 2026-04-071
- Conditions
- Intervertebral Disc Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- 27 Feb 2027 (estimated)
- Study completion
- 27 Feb 2027 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| back pain patient group | – | Other: Blood sampling for ELISA |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- low back pain population with disc degeneration confirmed in MRI
Key inclusion criteria (4 listed)
- lumbar disc herniation
- lumbar spinal canal stenosis
- patients who have MRI
- patients who can fill in the ODI and EQ5D without other's help
Key exclusion criteria (26 listed)
- allergic disease
- allergic rhinitis
- asthma
- atopic dermatitis
- chronic sinusitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling for ELISAblood sampling to detect the level of periostin and cytokine | Other | back pain patient group |
Primary outcome
Identifying the correlation of periostin level and ODI and EQ5D
Time frame: Day1
1 secondary outcome
Identifying the correlation of the periostin level and Cytokine level and Pfirmann grading
Time frame: Day1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
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 2 sites 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 4 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 2 sites 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?
Identifying the correlation of periostin level and ODI and EQ5D (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.