Chronic Low Back Pain (CLBP)NCT07807839
Study of Correlation Between Serum BDNF Levels and Pfirmann Grading and IL- 1β
An observational study of Chronic Low Back Pain (CLBP), run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial summary
Brain-derived neurotrophic factor (BDNF) is a protein belonging to the neurotrophin family, known to be involved in neuronal survival, growth, and synaptic plasticity. Recent studies suggest that the role of BDNF may extend beyond the central nervous system to include inflammatory responses and degenerative changes in… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Low Back Pain (CLBP)
- What is being tested?
- blood sampling for ELISA
- Type of treatment
- Surgery or procedure
- How many people
- 59 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 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 with disc degeneration confirmed in MRI
Who may be able to join
- lumbar disc herniation
- lumbar spinal canal stenosis
- patients who have MRI
Who cannot join
- spine fracture
- spine infection
- spine tumor
- rhematoid arthritis
- ankylosing spondylitis
- systemic lupus erythematosus
Show all 9Show fewer
- peripheral neuropathy
- fibromyalgia
- patient taking antidepressant, antipsychotics, acetylcholiesterase inhibitor
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Ji Hee
Daegu, Daegu, 42601
J Hee Hong, 01046794343, swon13@daum.net
Sungwon Jung, swon12@hanmail.net
About this study
Brain-derived neurotrophic factor (BDNF) is a protein belonging to the neurotrophin family, known to be involved in neuronal survival, growth, and synaptic plasticity. Recent studies suggest that the role of BDNF may extend beyond the central nervous system to include inflammatory responses and degenerative changes in peripheral tissues. In particular, BDNF expression has been confirmed within intervertebral disc tissue, with degenerated discs showing increased BDNF expression compared to normal discs, and this expression has been reported to increase further with the severity of degeneration Intervertebral disc degeneration is closely associated with intradiscal nerve ingrowth (neoinnervation) and the resulting generation of pain, and BDNF has been reported as a factor mediating this nerve ingrowth and pain sensitization (central/peripheral sensitization) within the disc. Interleukin-1 beta (IL-1β), a representative inflammatory cytokine of disc degeneration, is known as a key mediator that promotes extracellular matrix degradation within disc tissue and induces neoinnervation and sensitization. Because BDNF secretion from neurons and immune cells has also been reported to increase in inflammatory environments, a potential interaction between IL-1β and BDNF has been proposed Accordingly, this study aims to measure serum BDNF concentrations in patients presenting with low back and leg pain due to disc degeneration or spinal stenosis, and to analyze whether these levels show a consistent correlation with Pfirrmann grading on MRI and serum IL-1β concentration.
- Conditions
- Chronic Low Back Pain (CLBP)
- Being tested
- blood sampling for ELISA
- Keywords
- low back pain, serum BDNF
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampling for ELISAProcedure or surgery
blood sampling to detect the level of BDNF
| Study group | Role | What they receive |
|---|---|---|
| back pain patient group | Not described Receives: Procedure: blood sampling for ELISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Idenfifying the correlation of BDNF level and Pfirmann grading
Measured: day 1
Secondary outcomes (1)
Idnetifying the correlation of BDNF level and IL-1β
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Sep 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 Pain (CLBP)Studies 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
- 59 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
- NCT07807839
- Sponsor's protocol ID
- 2026-07-243
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 8 Sep 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Correlation Between Serum BDNF Levels and Pfirmann Grading and IL- 1β
- ClinicalTrials.gov ID
- NCT07807839
- Acronym / sponsor ID
- 2026-07-243
- Conditions
- Chronic Low Back Pain (CLBP)
- Keywords
- low back pain, serum BDNF
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 8 Sep 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.
Brain-derived neurotrophic factor (BDNF) is a protein belonging to the neurotrophin family, known to be involved in neuronal survival, growth, and synaptic plasticity. Recent studies suggest that the role of BDNF may extend beyond the central nervous system to include inflammatory responses and degenerative changes in peripheral tissues. In particular, BDNF expression has been confirmed within intervertebral disc tissue, with degenerated discs showing increased BDNF expression compared to normal discs, and this expression has been reported to increase further with the severity of degeneration Intervertebral disc degeneration is closely associated with intradiscal nerve ingrowth (neoinnervation) and the resulting generation of pain, and BDNF has been reported as a factor mediating this nerve ingrowth and pain sensitization (central/peripheral sensitization) within the disc. Interleukin-1 beta (IL-1β), a representative inflammatory cytokine of disc degeneration, is known as a key mediator that promotes extracellular matrix degradation within disc tissue and induces neoinnervation and sensitization. Because BDNF secretion from neurons and immune cells has also been reported to increase in inflammatory environments, a potential interaction between IL-1β and BDNF has been proposed Accordingly, this study aims to measure serum BDNF concentrations in patients presenting with low back and leg pain due to disc degeneration or spinal stenosis, and to analyze whether these levels show a consistent correlation with Pfirrmann grading on MRI and serum IL-1β concentration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| back pain patient group | – | Procedure: 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 (3 listed)
- lumbar disc herniation
- lumbar spinal canal stenosis
- patients who have MRI
Key exclusion criteria (9 listed)
- spine fracture
- spine infection
- spine tumor
- rhematoid arthritis
- ankylosing spondylitis
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 BDNF | Procedure or surgery | back pain patient group |
Primary outcome
Idenfifying the correlation of BDNF level and Pfirmann grading
Time frame: day 1
1 secondary outcome
Idnetifying the correlation of BDNF level and IL-1β
Time frame: day 1
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 8 Sep 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.
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 (CLBP), 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 9 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 8 Sep 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?
Idenfifying the correlation of BDNF level and Pfirmann grading (time frame: day 1). 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 8 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.