Chronic Low Back PainNCT07776379
The Prediction of Clinical Outcome Using the Serum BDNF Level
An observational study of Chronic Low Back Pain and Brain Derived Neurotrophic Factor Level, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial summary
Low back pain (LBP) is one of the most commonly observed conditions in patients over the age of 50 and imposes a substantial socioeconomic burden. Degenerative disc disease is one of the most frequent and important causes of this pain. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Low Back Pain, Brain Derived Neurotrophic Factor Level
- What is being tested?
- Erector Spinae Plane Block and Blood sampling for ELISA
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Aug 2026to 30 May 2028
- 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
- Chronic low back pain patients with or without leg pain due to disc degeneration or spinal stenosis
- Patients who have MRI
Who cannot join
- Secondary low back pain (spine fracture, infection, tumor)
- recent history of spine surgery
- systemic inflammatory disease (rheumatoid arthritis, SLE, ankylosing spondylitis)
- peripheral neuropathy or central nervous system injury
- fibromyalgia
- drugs which can affect the serum BDNF level (anti depressant, anti parkinsonian drug, acetylcholinesterase inhibitor, anti psychotics)
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
swon13@hanmail.net
About this study
Low back pain (LBP) is one of the most commonly observed conditions in patients over the age of 50 and imposes a substantial socioeconomic burden. Degenerative disc disease is one of the most frequent and important causes of this pain. Progressive disc degeneration is characterized by a decline in disc cell number and degradation of the extracellular matrix. Loss of nucleus pulposus (NP) volume and hydration, together with fissure formation within the annulus fibrosus (AF), develop gradually with aging and ultimately lead to functional impairment. Disc degeneration can result from multiple factors, including aging, obesity, genetic predisposition, degeneration of the multifidus and psoas muscles, osteoporosis, inflammation, and oxidative stress. The intervertebral disc consists of the gel-like nucleus pulposus (NP) at its center, the surrounding annulus fibrosus (AF), and the cartilaginous endplates above and below. Because the disc is an avascular structure, its capacity for self-repair is markedly limited.
Erector spinae plane block (ESPB) is a treatment option that can be performed in the outpatient setting for patients with such low back pain. ESPB was first described in 2016 and is a type of interfascial plane block. Unlike neuraxial blocks, it offers the advantage of being both technically straightforward and highly safe. Recent studies indicate that ESPB is increasingly applied to patients with post-spinal-surgery pain or chronic low back pain.
Brain-derived neurotrophic factor (BDNF) is a neurotrophin that regulates neuronal survival, differentiation, and synaptic plasticity within the central nervous system. In the context of pain, BDNF released from primary afferent nociceptors and spinal dorsal horn microglia has been implicated in central sensitization, a key mechanism underlying the transition from acute to chronic pain. Circulating BDNF concentrations have been reported to be associated with pain intensity, disability, and cortical/corticomotor plasticity in patients with chronic low back pain, and some studies have found serum BDNF levels to be significantly elevated in discogenic chronic low back pain compared with controls, while others report reduced circulating BDNF in chronic pain populations - suggesting that the relationship between BDNF and pain chronicity may vary by pain phenotype and warrants further clarification. Because BDNF reflects neuroplastic changes that accompany the development and persistence of chronic pain, it has been proposed as a potential predictor of treatment response. However, no study to date has directly examined whether serum BDNF concentration can predict the clinical outcome of ESPB in patients with low back pain.
- Being tested
- Erector Spinae Plane Block, Blood sampling for ELISA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
erector spinae plane block using ropivacaine
Blood sampling for ELISAOther
blood sampling to detect the level of BDNF
| Study group | Role | What they receive |
|---|---|---|
| back pain patient group | back pain patient group receiving erector spinae plane block Receives: Procedure: Erector Spinae Plane Block; Other: Blood sampling for ELISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success or failure according to BDNF level
Measured: day 60
Secondary outcomes (1)
correlation of BDNF level and Pfirmann grading of MRI
Pfirmann grading (grade I from V) minimum (grade I) and maximum value (grade V) higher score means severe disc degeneration
Measured: day 60
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 Mar 2028 (estimated)
- Study completion30 May 2028 (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
- 70 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
- NCT07776379
- Sponsor's protocol ID
- 2026-04-074
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 21 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 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prediction of Clinical Outcome Using the Serum BDNF Level
- ClinicalTrials.gov ID
- NCT07776379
- Acronym / sponsor ID
- 2026-04-074
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 May 2028 (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.
Low back pain (LBP) is one of the most commonly observed conditions in patients over the age of 50 and imposes a substantial socioeconomic burden. Degenerative disc disease is one of the most frequent and important causes of this pain. Progressive disc degeneration is characterized by a decline in disc cell number and degradation of the extracellular matrix. Loss of nucleus pulposus (NP) volume and hydration, together with fissure formation within the annulus fibrosus (AF), develop gradually with aging and ultimately lead to functional impairment. Disc degeneration can result from multiple factors, including aging, obesity, genetic predisposition, degeneration of the multifidus and psoas muscles, osteoporosis, inflammation, and oxidative stress. The intervertebral disc consists of the gel-like nucleus pulposus (NP) at its center, the surrounding annulus fibrosus (AF), and the cartilaginous endplates above and below. Because the disc is an avascular structure, its capacity for self-repair is markedly limited.
Erector spinae plane block (ESPB) is a treatment option that can be performed in the outpatient setting for patients with such low back pain. ESPB was first described in 2016 and is a type of interfascial plane block. Unlike neuraxial blocks, it offers the advantage of being both technically straightforward and highly safe. Recent studies indicate that ESPB is increasingly applied to patients with post-spinal-surgery pain or chronic low back pain.
Brain-derived neurotrophic factor (BDNF) is a neurotrophin that regulates neuronal survival, differentiation, and synaptic plasticity within the central nervous system. In the context of pain, BDNF released from primary afferent nociceptors and spinal dorsal horn microglia has been implicated in central sensitization, a key mechanism underlying the transition from acute to chronic pain. Circulating BDNF concentrations have been reported to be associated with pain intensity, disability, and cortical/corticomotor plasticity in patients with chronic low back pain, and some studies have found serum BDNF levels to be significantly elevated in discogenic chronic low back pain compared with controls, while others report reduced circulating BDNF in chronic pain populations - suggesting that the relationship between BDNF and pain chronicity may vary by pain phenotype and warrants further clarification. Because BDNF reflects neuroplastic changes that accompany the development and persistence of chronic pain, it has been proposed as a potential predictor of treatment response. However, no study to date has directly examined whether serum BDNF concentration can predict the clinical outcome of ESPB in patients with low back pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| back pain patient group | – | Procedure: Erector Spinae Plane Block, Other: Blood sampling for ELISAback pain patient group receiving erector spinae plane block |
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 (2 listed)
- Chronic low back pain patients with or without leg pain due to disc degeneration or spinal stenosis
- Patients who have MRI
Key exclusion criteria (6 listed)
- Secondary low back pain (spine fracture, infection, tumor)
- recent history of spine surgery
- systemic inflammatory disease (rheumatoid arthritis, SLE, ankylosing spondylitis)
- peripheral neuropathy or central nervous system injury
- fibromyalgia
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 |
|---|---|---|
| Erector Spinae Plane Blockerector spinae plane block using ropivacaine | Procedure or surgery | back pain patient group |
| Blood sampling for ELISAblood sampling to detect the level of BDNF | Other | back pain patient group |
Primary outcome
Success or failure according to BDNF level
Time frame: day 60
1 secondary outcome
correlation of BDNF level and Pfirmann grading of MRI
Time frame: day 60
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 21 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.
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 Brain Derived Neurotrophic Factor Level, 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 2 inclusion and 6 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 21 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?
Success or failure according to BDNF level (time frame: day 60). 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 21 Aug 2026.