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RecruitingNCT07776379Updated Aug 21, 2026

The Prediction of Clinical Outcome Using the Serum BDNF Level

An observational study in Chronic Low Back Pain and Brain Derived Neurotrophic Factor Level, sponsored by Keimyung University Dongsan Medical Center. Recruiting at 1 site in South Korea. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Keimyung University Dongsan Medical Center · Observational

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Ages
20 Years to 80 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Chronic Low Back Pain
  • Brain Derived Neurotrophic Factor Level

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03

In context

Low Back Pain

2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.

This study's planned enrollment of 70 is below the median of 100 across 481 observational studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

Keimyung University Dongsan Medical Center is the lead sponsor of 86 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

low back pain population with disc degeneration confirmed in MRI

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Chronic low back pain patients with or without leg pain due to disc degeneration or spinal stenosis
  • Patients who have MRI

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • back pain patient group

    back pain patient group receiving erector spinae plane block

    Procedure: Erector Spinae Plane Block · Other: Blood sampling for ELISA

Interventions

  • ProcedureErector Spinae Plane Block

    erector spinae plane block using ropivacaine

  • OtherBlood sampling for ELISA

    blood sampling to detect the level of BDNF

06

What researchers measure

Primary outcomes

  1. Success or failure according to BDNF level

    Time frame: 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

    Time frame: day 60

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Mar 2028, 19 months after the start.

Of 175 non-industry observational studies under Low Back Pain, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 48. This study's planned 19 months is below that.

Counting every sponsor, half of 185 studies reached it within 24 months; a quarter within 10 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2026
First posted
Aug 20, 2026
StartActual
Aug 13, 2026
Primary completionEst.
Mar 30, 2028
CompletionEst.
May 30, 2028
Last update
Aug 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07776379
Lead sponsor
Keimyung University Dongsan Medical Center
Responsible party
Ji Hee Hong (professor, Keimyung University Dongsan Medical Center) — Principal investigator
First posted
Aug 20, 2026
Start date
Aug 13, 2026
Primary completion
Mar 30, 2028 (estimated)
Completion
May 30, 2028 (estimated)
Last update
Aug 21, 2026

Study contacts

JIHEE Hong
Contact
swon13@daum.net
01046794343
JIHEE Hong
Contact
swon12@daum.net
+821046794343

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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