Chronic Low Back PainNCT07776366
Study of Correlation Between the Level of Intradiscal Periostin Expression and Pfirrmann Grading
An observational study of Chronic Low Back Pain and Spinal Stenosis Lumbar, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial summary
Intervertebral disc degeneration (IVDD) is a well-recognized musculoskeletal condition that imposes a substantial socioeconomic burden and is an important cause of low back pain. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Low Back Pain, Spinal Stenosis Lumbar
- What is being tested?
- posterior lumbar interbody fusion and lumbar discectomy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Aug 2026to 30 Aug 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 who requires spine surgery
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 14Show fewer
- fracture within 6 months
- severe osteoporosis
- knee osteoarthritis
- hip osteoarthritis
- spinal surgery within 6 months
- myocardiac infarction
- heart failure
- liver cirrhosis
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
South Korea1 site, 1 recruiting
- Recruiting
Ji Hee
Daegu, Daegu, 42601
J Hee Hong, 01046794343, swon13@daum.net
Sungwon Jung, swon13@hanmail.net
About this study
Intervertebral disc degeneration (IVDD) is a well-recognized musculoskeletal condition that imposes a substantial socioeconomic burden and is an important cause of low back pain. IVDD can result from a variety of factors, including aging, obesity, genetic predisposition, degeneration of the multifidus and psoas muscles, osteoporosis, inflammation, and oxidative stress. The intervertebral disc (IVD) within the spine is composed of a gel-like nucleus pulposus (NP) at its center, a surrounding annulus fibrosus (AF), and cartilaginous endplates above and below. The NP and AF produce a water-rich extracellular matrix (ECM), which contributes to normal functioning of the spinal column.
Various internal and external stimuli cause dysfunction of the NP and AF, and excessive metabolic activity of the endplates leads to endplate degeneration and calcification, ultimately resulting in disc degeneration. In addition to aging and mechanical overload, increased oxidative stress and inflammatory cytokine release further accelerate IVDD.
Read more
Periostin is a component of the ECM that is associated with mechanical stress, inflammation, and aging, and has been closely linked to the development and progression of IVDD. Periostin binds to ECM molecules within the IVD and is involved in disc maintenance and repair; however, excessive ECM turnover induces and accelerates disc degeneration. Periostin affects IVD degeneration through pathways related to mechanical stress and inflammation, and serum periostin levels have been reported to be elevated in patients with more advanced disc degeneration. A recent study demonstrated a strong correlation between serum periostin concentration and the Pfirrmann grading system. However, measuring periostin concentration through blood sampling has limitations, as serum periostin levels can also increase similarly in patients with a history of head and neck cancer or allergic disease. Therefore, it is necessary to directly assess the degree of periostin expression within the intervertebral disc itself and to determine whether it shows a meaningful correlation with the Pfirrmann grading system. In addition, periostin is known to be more abundant in the AF than in the NP, but this has not previously been demonstrated through actual staining of disc tissue; this study therefore aims to compare the degree of periostin expression between the NP and AF using immunohistochemical staining.
Pfirrmann et al. developed a reliable, MRI-based grading system that is the most commonly used method for evaluating IVDD. The Pfirrmann grading system is based on analysis of T2-weighted MR sagittal images of the IVD, incorporating disc homogeneity, morphology, the distinction between the AF and NP boundary, T2 signal intensity, and disc height.
- Conditions
- Chronic Low Back Pain, Spinal Stenosis Lumbar
- Being tested
- posterior lumbar interbody fusion, lumbar discectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterior lumbar interbody fusionProcedure or surgery
posterior lumbar interbody fusion
lumbar discectomyProcedure or surgery
lumbar discectomy
| Study group | Role | What they receive |
|---|---|---|
| back pain patient group | back pain patient group requiring spine surgery Receives: Procedure: posterior lumbar interbody fusion; Procedure: lumbar discectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
identifying the correlation of intradiscal periostin level and Pfirmann grading
Measured: day1
Secondary outcomes (1)
identifying the correlation of intradiscal periostin and inflammatory cytokine level
Measured: day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start13 Aug 2026
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 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
- NCT07776366
- Sponsor's protocol ID
- 2026-04-070
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Correlation Between the Level of Intradiscal Periostin Expression and Pfirrmann Grading
- ClinicalTrials.gov ID
- NCT07776366
- Acronym / sponsor ID
- 2026-04-070
- Conditions
- Chronic Low Back Pain, Spinal Stenosis Lumbar
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 20 Aug 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.
Intervertebral disc degeneration (IVDD) is a well-recognized musculoskeletal condition that imposes a substantial socioeconomic burden and is an important cause of low back pain. IVDD can result from a variety of factors, including aging, obesity, genetic predisposition, degeneration of the multifidus and psoas muscles, osteoporosis, inflammation, and oxidative stress. The intervertebral disc (IVD) within the spine is composed of a gel-like nucleus pulposus (NP) at its center, a surrounding annulus fibrosus (AF), and cartilaginous endplates above and below. The NP and AF produce a water-rich extracellular matrix (ECM), which contributes to normal functioning of the spinal column.
Various internal and external stimuli cause dysfunction of the NP and AF, and excessive metabolic activity of the endplates leads to endplate degeneration and calcification, ultimately resulting in disc degeneration. In addition to aging and mechanical overload, increased oxidative stress and inflammatory cytokine release further accelerate IVDD.
Periostin is a component of the ECM that is associated with mechanical stress, inflammation, and aging, and has been closely linked to the development and progression of IVDD. Periostin binds to ECM molecules within the IVD and is involved in disc maintenance and repair; however, excessive ECM turnover induces and accelerates disc degeneration. Periostin affects IVD degeneration through pathways related to mechanical stress and inflammation, and serum periostin levels have been reported to be elevated in patients with more advanced disc degeneration. A recent study demonstrated a strong correlation between serum periostin concentration and the Pfirrmann grading system. However, measuring periostin concentration through blood sampling has limitations, as serum periostin levels can also increase similarly in patients with a history of head and neck cancer or allergic disease. Therefore, it is necessary to directly assess the degree of periostin expression within the intervertebral disc itself and to determine whether it shows a meaningful correlation with the Pfirrmann grading system. In addition, periostin is known to be more abundant in the AF than in the NP, but this has not previously been demonstrated through actual staining of disc tissue; this study therefore aims to compare the degree of periostin expression between the NP and AF using immunohistochemical staining.
Pfirrmann et al. developed a reliable, MRI-based grading system that is the most commonly used method for evaluating IVDD. The Pfirrmann grading system is based on analysis of T2-weighted MR sagittal images of the IVD, incorporating disc homogeneity, morphology, the distinction between the AF and NP boundary, T2 signal intensity, and disc height.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| back pain patient group | – | Procedure: posterior lumbar interbody fusion, Procedure: lumbar discectomyback pain patient group requiring spine surgery |
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 who requires spine surgery
Key inclusion criteria (3 listed)
- lumbar disc herniation
- lumbar spinal canal stenosis
- patients who have MRI
Key exclusion criteria (14 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 |
|---|---|---|
| posterior lumbar interbody fusionposterior lumbar interbody fusion | Procedure or surgery | back pain patient group |
| lumbar discectomylumbar discectomy | Procedure or surgery | back pain patient group |
Primary outcome
identifying the correlation of intradiscal periostin level and Pfirmann grading
Time frame: day1
1 secondary outcome
identifying the correlation of intradiscal periostin and inflammatory cytokine level
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 25 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.
JIHEE Hong contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low Back Pain and Spinal Stenosis Lumbar, 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 14 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 25 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?
identifying the correlation of intradiscal periostin level and Pfirmann grading (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 25 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.