AzTrials
AzTrials

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.

Recruiting

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

Sites and contacts
Official record
Search all trials

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

01046794343

swon13@daum.net

JIHEE Hong contact

swon13@daum.net

South Korea1 site, 1 recruiting
  • Ji Hee

    Daegu, Daegu, 42601

    J Hee Hong, 01046794343, swon13@daum.net

    Sungwon Jung, swon13@hanmail.net

    Recruiting

Other trials in South Korea

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.

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 groups in NCT07776366
Study groupRoleWhat they receive
back pain patient groupback 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.

  1. identifying the correlation of intradiscal periostin level and Pfirmann grading

    Measured: day1

Secondary outcomes (1)
  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.

  1. First posted20 Aug 2026
  2. Study start13 Aug 2026
  3. Primary completion30 Aug 2027 (estimated)
  4. Study completion30 Aug 2027 (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
Cohort
Time perspective
Prospective
Enrolment
20 participants (estimated)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in