NCT07776379 The Prediction of Clinical Outcome Using the Serum BDNF Level
| NCT ID | NCT07776379 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Keimyung University Dongsan Medical Center |
| Condition | Chronic Low Back Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2026-08-13 |
| Primary Completion | 2028-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2026-08-13 with a primary completion date of 2028-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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: * 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07776379 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 80 Years, studying Chronic Low Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07776379 currently recruiting?
Yes, NCT07776379 is actively recruiting participants. Contact the research team at swon13@daum.net for enrollment information.
Where is the NCT07776379 trial being conducted?
This trial is being conducted at Daegu, South Korea.
Who is sponsoring the NCT07776379 clinical trial?
NCT07776379 is sponsored by Keimyung University Dongsan Medical Center. The trial plans to enroll 70 participants.