Spinal StenosisNCT07232836
Cytokines, Neuroplasticity Modulators, and Biomarkers in Spinal Canal Stenosis and Endoscopic Decompression
A study testing Endoscopic Spinal Canal Decompression in people with Spinal Stenosis and Ligamentum Flavum Hypertrophy, run by Poznan University of Physical Education at 1 site in Poland.
Trial summary
Research Rationale and Study Design Lumbar spinal stenosis (LSS) is a common degenerative musculoskeletal disorder characterized by narrowing of the spinal canal, often leading to pain and disability. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Spinal Stenosis, Ligamentum Flavum Hypertrophy
- What is being tested?
- Endoscopic Spinal Canal Decompression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 17 Nov 2025to 31 Dec 2030
- Phase
- Interventional
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spinal stenosis in the lumbar spine with a referral for surgical treatment using endoscopic spinal decompression.
- Age: 40-90 years.
- Current MRI results.
- Consent to participate in the study.
- Inclusion Criteria for the control no spinal stenosis group:
- Intervertebral disc herniation in the lumbar spine with a referral for surgical treatment using endoscopic discectomy.
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- Age: 18-40 years.
- Current MRI results.
- Consent to participate in the study.
Who cannot join
- History of:
- rheumatoid arthritis of the intervertebral joints,
- joint pain located elsewhere if it is more severe than the pain caused by stenosis,
- pathologies and/or medications that may disturb the balance between pro- and anti-inflammatory factors (e.g. inflammatory diseases, rheumatoid arthritis, ankylosing spondylitis, acute infection),
- uncontrolled diabetes, poorly controlled hypertension, clinically significant liver function impairment, acute coronary event, unstable angina pectoris, symptoms of heart failure, pacemaker implantation,
- neurological diseases within the last 6 months,
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- previous spine surgery at the lumbar level,
- mechanical injuries to the spine after an accident,
- advanced osteoporosis,
- pregnancy, lactation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi w Poznaniu
Poznan, Wielkopolska, 61-545
Marzena E Ratajczak, PhD, +48604773816, mratajczak@awf.poznan.pl
Wojciech Jarosz, PhD, +48 61 835 52 46, jarosz@awf.poznan.pl
About this study
Official title: The Role of Cytokines and Neuroplasticity Modulators in the Development of Spinal Canal Stenosis and the Identification of Biomarkers for the Biochemical Evaluation of Treatment in Patients Undergoing Endoscopic Spinal Canal Decompression
Research Rationale and Study Design Lumbar spinal stenosis (LSS) is a common degenerative musculoskeletal disorder characterized by narrowing of the spinal canal, often leading to pain and disability. One of the primary contributors to this condition is hypertrophy (thickening) of the ligamentum flavum (LF), along with facet joint degeneration, intervertebral disc herniation, and ligament ossification. However, the pathophysiological mechanisms behind these changes remain incompletely understood.
Histological changes in hypertrophied LF include fibrocartilaginous metaplasia, type II collagen proliferation, ossification, calcium crystal deposition, and degeneration of elastic and collagen fibers. Both mechanical stress and inflammatory processes, particularly macrophage infiltration, are considered key contributors to degeneration, especially in the aging population. Yet, inflammation linked to systemic metabolic disorders-such as obesity and sarcopenia-may also significantly influence the degeneration of spinal structures.
Read more
Metabolic Inflammation and the Role of Adipokines Recent research has highlighted the role of adipokines in the pathogenesis of degenerative spinal and joint diseases. Disrupted lipid metabolism and chronic low-grade inflammation contribute to tissue remodeling, extracellular matrix (ECM) degradation, and ectopic fat deposition in spinal structures.
Epidural fat, normally present in the spinal canal, can become inflamed and secrete pro-inflammatory cytokines, potentially affecting adjacent tissues such as muscles and ligaments. Conditions like spinal epidural lipomatosis, which is associated with obesity, exemplify this pathological mechanism.
While adipokines like leptin and visfatin have been previously associated with LF ossification and degeneration, the presence and role of others-such as adipsin, vaspin, resistin, lipocalin-2, progranulin, chemerin, omentin-1, and GDF-15-have not yet been studied in LF or epidural fat. Given their known effects on inflammation and ECM remodeling, these molecules are strong candidates for involvement in spinal canal narrowing.
Research Hypotheses and Objectives
This study hypothesizes that adipose tissue-derived cytokines, particularly from epidural fat, contribute to LF degeneration and LSS through inflammatory and metabolic signaling. The main research objectives are to:
- Identify differences in biomarker concentrations in LF, paraspinal muscle, and epidural fat from patients with and without LSS.
- Determine correlations between tissue and blood biomarker levels and clinical parameters such as pain, disability, and body mass.
- Select potential biomarkers for monitoring surgical outcomes of spinal decompression.
- Identify cytokines that modulate LF inflammation and metabolism.
- Evaluate the direct effects of adipokines on LF cell behavior in vitro. Study Design and Methods Study population:
- 100 patients undergoing lumbar spine surgery at the Orthopaedic-Rehabilitation Clinical Hospital in Poznań:
- 50 with LSS (ages 40-90)
- 50 with disc herniation only (ages 18-40; control group) Tissue collection (intraoperative):
- Ligamentum flavum
- Paraspinal muscles
- Epidural adipose tissue Blood samples:
- Collected from all participants:
- Within 48 hours before surgery
- Two months post-surgery Clinical assessments:
- Disability and pain scales
- Preoperative MRI scans Laboratory analysis:
- Molecular testing:
- mRNA expression of selected cytokines and adipokines using PCR
- Protein levels determined via ELISA in both serum and tissue homogenates • Cell culture studies:
- One-third of collected tissue is used to establish primary cell cultures from LF, paraspinal muscles, and epidural fat
- Cells will be stimulated with conditioned media from epidural fat and with selected recombinant cytokines (e.g., vaspin, lipocalin-2, GDF-15)
- Experiments will assess the gene and protein expression of key molecules involved in inflammation, ECM remodeling, bone metabolism, fibrosis, and matrix degradation. The goal is to clarify the local and systemic roles of adipokines and inflammation in the pathogenesis of LF hypertrophy and LSS. This knowledge may aid in identifying biomarkers for disease progression and therapeutic targets for non-surgical interventions in the future.
Read the detailed description
Spinal stenosis is a common musculoskeletal disorder that causes pain or disability in patients. However, the pathogenesis of this disease is complex and has not yet been fully elucidated. Lumbar spinal canal stenosis results from degenerative changes in structures located behind the spinal cord, such as hypertrophy of the ligamentum flavum (LF), as well as ligament calcification, degeneration and hypertrophy of the facet joints and/or herniation of intervertebral discs located anterior to the spinal cord. The pathology of LF hypertrophy includes fibrocartilaginous changes associated with type II collagen proliferation, ossification, calcium crystal deposition, degeneration of collagen and elastic fibers, and chondroid metaplasia of ligament fibroblasts. Numerous scientific studies have attempted to explore the etiology of hypertrophy and ossification of spinal ligaments, considering systemic, local, genetic, and environmental factors. However, the mechanism of degeneration development is still not fully understood. Besides mechanical stress and increased collagen synthesis (fibrosis) in the ligament, which make age a major risk factor, the presence of inflammation and macrophage infiltration is considered a significant contributor to degeneration development.
Therefore, it is reasonable to assume that the presence of inflammation associated with other health conditions-especially chronic ones-may, to an unknown extent, influence the course of spinal structure degeneration. Currently, obesity and sarcopenia are drawing particular attention as disorders affecting all systems of the human body. Since their prevalence is increasing, a thorough understanding of their consequences on individual organs has significant social and practical importance for prevention and health protection.
An increasing number of reports indicate that disturbances in lipid metabolism and the secretion of pro-inflammatory adipokines and cytokines are deeply involved in regulating cellular phenotypes and fates, extracellular matrix metabolism, and inflammation in the pathophysiological processes of degenerative spinal and joint diseases. Metabolic disorders can affect bone metabolism and lead to ectopic ossification and fat deposition not only in spinal ligaments but also in other spinal structures. Also noteworthy is the influence of the adipokinome on the development of musculoskeletal degenerative disorders. Even anatomically present epidural fat in the spinal canal may become inflamed and spontaneously secrete inflammatory cytokines, potentially modifying the function of adjacent tissues, such as paraspinal muscles and ligaments. It is worth mentioning that spinal epidural lipomatosis, characterized by an excess of fat tissue in the epidural space leading to spinal canal stenosis, is strongly associated with obesity.
So far, it has been confirmed that adipokines and their receptors, although primarily located in white adipose tissue, are also present in joint cartilage and spinal bone marrow. Adipokines may promote ligamentum flavum degeneration by stimulating inflammatory responses and promoting pathological changes. Leptin has been shown to significantly correlate with the number of vertebrae affected by ligamentous ossification. Fan et al. discovered that leptin markedly upregulates alkaline phosphatase and osteocalcin mRNA expression in ligamentum flavum cells. High levels of visfatin have also been found in the ligamenta flava of patients with confirmed ossification. There is no available data on the presence and role of other adipose tissue-derived cytokines such as adipsin, vaspin, resistin, lipocalin-2, progranulin, chemerin, omentin-1, or growth differentiation factor-15 (GDF-15) in the ligamentum flavum. It is highly likely that these cytokines are also involved in the development of spinal canal stenosis, which constitutes our research hypothesis. The presence and levels of these cytokines in epidural fat tissue in patients with stenosis, compared to those without spinal canal narrowing, have not been studied to date. Since studies confirm that chronic systemic inflammation affects various tissues and local inflammation significantly affects neighboring structures, we hypothesize that ligaments, paraspinal muscles, intervertebral discs, etc., may be particularly vulnerable to cytokines secreted by epidural fat tissue. Previous in vitro studies confirmed that a local environment rich in cytokines such as IL-6, IL-1α, nitric oxide donor (SNAP), and prostaglandin E2 changes the gene expression of collagens I, V, XI, and osteocalcin in ligamentum flavum cells. However, the impact of the mentioned adipokines on the development of ligamentum flavum degeneration has not yet been determined.
The study will involve examining the concentrations of cytokines (especially adipokines) and neuroplasticity modulators and their mRNA expression in tissues routinely removed from patients with spinal stenosis and disc herniation during surgery, as well as collecting blood from patients twice, before the procedure and during a follow-up visit two months after the procedure.
Objectives
- To identify differences in selected biomarker concentrations in samples of ligamentum flavum, paraspinal muscles, and epidural fat collected from the lumbar region of patients with stenosis compared to those without spinal canal degeneration.
- To determine whether the expression of selected biomarkers in tissues correlates with their presence in the patients' blood and whether they relate to the degree of degeneration, disability, pain intensity, and body mass.
- To select potential biomarkers for monitoring the effectiveness of spinal canal decompression surgery by comparing biomarker levels before surgery and two months into recovery.
- To identify potential proteins that modulate metabolism and inflammation in the ligamentum flavum.
- To evaluate the impact of selected cytokines and adipokinome of epidural fat tissue on metabolism and inflammation in ligamentum flavum cell cultures.
Study Population Description
The study will involve 100 patients from the Orthopaedic-Rehabilitation Clinical Hospital of the Poznań University of Medical Sciences, including both men and women:
- 50 patients with lumbar spinal canal stenosis, aged 40-90 years
- 50 patients with intervertebral disc herniation, aged 18-40 years, requiring surgical treatment Participants will undergo surgery provided they give informed consent to use their tissues in scientific research.
- The study group will undergo endoscopic spinal canal decompression, involving the removal of tissues (bone, ligament, joint) compressing neural structures, and possibly removing a displaced intervertebral disc fragment.
- The control group will undergo isolated intervertebral disc herniation surgery, involving the removal of the displaced disc fragment.
Methods Before surgery (within 48h) and two months post-op, 20 ml of venous blood will be drawn from each patient.
During surgery, the following samples will be collected:
- Paraspinal muscle tissue
- Ligamentum flavum
- Epidural fat tissue
The study will use the following methods/tools:
- Standardized questionnaires for disability and pain intensity
- MRI of the lumbar spine (routinely performed before surgery)
- Molecular testing
- mRNA expression of cytokines (GDF-15, adipsin, vaspin, resistin, lipocalin-2, progranulin, chemerin, omentin-1) will be measured using PCR.
- Immunoassays using commercial ELISA kits will be performed on tissue homogenates and serum to determine proteins concentrations (GDF-15, adipsin, vaspin, resistin, lipocalin-2, progranulin, chemerin, omentin-1)
- Cell culture and stimulation of cells with cytokines and medium obtained from adipose tissue One-third of the biological material will be allocated for cell culture studies. Samples of the ligamentum flavum, paraspinal muscles, and epidural adipose tissue will be collected directly after surgery and placed in sterile containers with appropriate transport media.
All samples will be immediately transported to the cell culture laboratory under sterile conditions, in the shortest possible time from collection. Upon arrival at the laboratory, they will undergo appropriate, pre-established cell isolation protocols, tailored to the characteristics of each tissue type.
After the exposure period, the expression of mRNA and protein levels of cytokines, fibrosis markers, bone markers, extracellular matrix proteins, matrix degradation enzymes will be measured in the conditioned medium collected from the cultures of myocytes and ligamentum flavum fibroblasts.
- Conditions
- Spinal Stenosis, Ligamentum Flavum Hypertrophy
- Being tested
- Endoscopic Spinal Canal Decompression
- Keywords
- adipokines, biomarkers, endoscopic spinal canal decompression, inflammation, epidural adipose tissue
- Medical subject headings
- Spinal Stenosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Spinal Canal DecompressionProcedure or surgery
Patients from the study group will undergo endoscopic decompression of the spinal canal, which involves the removal of tissues (bone, ligament, joint) causing compression of the neural structures of the spine and the possible removal of an abnormally displaced fragment of the intervertebral disc.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Stenosis | Experimental | Not described Receives: Procedure: Endoscopic Spinal Canal Decompression |
| No Spinal Stenosis | No intervention | Tissues collected during surgery from people without spinal stenosis. |
| No intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adipokines concentration in the epidural adipose tissue, paraspinal muscles, ligamentum flavum and blood.
Measured: Day 0 and Month 2
Neuroplasticity modulators concentration in the epidural adipose tissue, paraspinal muscles, ligamentum flavum and blood.
Measured: Day 0 and Month 2
Secondary outcomes (5)
Low back pain on visual analogue scale
A horizontal or vertical line, 10 cm in length (0 to 10 scale) "0" represents "no pain" (or no symptom), and ten represents the "worst imaginable pain" (or most severe symptom).
Measured: Day 0 and Month 2
Oswestry Disability Index
A self-reported questionnaire assessing how back pain affects a patient's ability to manage everyday life. The maximum score is 50 points, the minimum is 0. Higher scores mean worse outcome (more severe disability).
Measured: Day 0 and Month 2
Thickness of the ligamentum flavum
MRI
Measured: Before intervention
Diameter of the spinal canal
MRI
Measured: Before intervention.
Schizas Scale
Measured: Before intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start17 Nov 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Spinal StenosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Collaborators
- Poznan University of Medical Sciences
- Responsible party
- Principal investigator, Marzena Ratajczak, Poznan University of Physical Education
- Investigators
- Marzena Ratajczak, PhD, Principal investigator, Poznan University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232836
- Sponsor's protocol ID
- PoznanUPhyEd no. 5
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Tarabeih N, Shalata A, Trofimov S, Kalinkovich A, Livshits G. Growth and differentiation factor 15 is a biomarker for low back pain-associated disability. Cytokine. 2019 May;117:8-14. doi: 10.1016/j.cyto.2019.01.011. Epub 2019 Feb 15.
PubMed 30776685Fujita N, Hosogane N, Hikata T, Iwanami A, Watanabe K, Shiono Y, Okada E, Ishikawa M, Tsuji T, Shimoda M, Horiuchi K, Nakamura M, Matsumoto M, Ishii K. Potential Involvement of Obesity-Associated Chronic Inflammation in the Pathogenesis of Idiopathic Spinal Epidural Lipomatosis. Spine (Phila Pa 1976). 2016 Dec 1;41(23):E1402-E1407. doi: 10.1097/BRS.0000000000001646.
PubMed 27105459Xiang Q, Wu Z, Zhao Y, Tian S, Lin J, Wang L, Jiang S, Sun Z, Li W. Cellular and molecular mechanisms underlying obesity in degenerative spine and joint diseases. Bone Res. 2024 Dec 11;12(1):71. doi: 10.1038/s41413-024-00388-8.
PubMed 39658574Endo T, Koike Y, Hisada Y, Fujita R, Suzuki R, Tanaka M, Tsujimoto T, Shimamura Y, Hasegawa Y, Kanayama M, Yamada K, Iwata A, Sudo H, Ishii M, Iwasaki N, Takahata M. Aggravation of Ossified Ligamentum Flavum Lesion Is Associated With the Degree of Obesity. Global Spine J. 2023 Jun;13(5):1325-1331. doi: 10.1177/21925682211031514. Epub 2021 Oct 6.
PubMed 34615403Zhang H, Hong Z, Jiang Z, Hu W, Hu J, Zhu R. miR-29b-3p Affects the Hypertrophy of Ligamentum Flavum in Lumbar Spinal Stenosis and its Mechanism. Biochem Genet. 2025 Apr;63(2):1824-1838. doi: 10.1007/s10528-024-10811-8. Epub 2024 Apr 16.
PubMed 38625592Furusawa N, Baba H, Maezawa Y, Uchida K, Wada M, Imura S, Fukuda M. Calcium crystal deposition in the ligamentum flavum of the lumbar spine. Clin Exp Rheumatol. 1997 Nov-Dec;15(6):641-7.
PubMed 9444420Szpalski M, Gunzburg R. Lumbar spinal stenosis in the elderly: an overview. Eur Spine J. 2003 Oct;12 Suppl 2(Suppl 2):S170-5. doi: 10.1007/s00586-003-0612-1. Epub 2003 Sep 9.
PubMed 13680315Silwal P, Nguyen-Thai AM, Alexander PG, Sowa GA, Vo NV, Lee JY. Cellular and Molecular Mechanisms of Hypertrophy of Ligamentum Flavum. Biomolecules. 2024 Oct 10;14(10):1277. doi: 10.3390/biom14101277.
PubMed 39456209Carregaro RL, Tottoli CR, Rodrigues DDS, Bosmans JE, da Silva EN, van Tulder M. Low back pain should be considered a health and research priority in Brazil: Lost productivity and healthcare costs between 2012 to 2016. PLoS One. 2020 Apr 1;15(4):e0230902. doi: 10.1371/journal.pone.0230902. eCollection 2020.
PubMed 32236113
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Cytokines and Neuroplasticity Modulators in the Development of Spinal Canal Stenosis and the Identification of Biomarkers for the Biochemical Evaluation of Treatment in Patients Undergoing Endoscopic Spinal Canal Decompression
- ClinicalTrials.gov ID
- NCT07232836
- Acronym / sponsor ID
- PoznanUPhyEd no. 5
- Conditions
- Spinal Stenosis, Ligamentum Flavum Hypertrophy
- Keywords
- adipokines, biomarkers, endoscopic spinal canal decompression, inflammation, epidural adipose tissue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Collaborators
- Poznan University of Medical Sciences
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 18 Nov 2025 (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.
Research Rationale and Study Design Lumbar spinal stenosis (LSS) is a common degenerative musculoskeletal disorder characterized by narrowing of the spinal canal, often leading to pain and disability. One of the primary contributors to this condition is hypertrophy (thickening) of the ligamentum flavum (LF), along with facet joint degeneration, intervertebral disc herniation, and ligament ossification. However, the pathophysiological mechanisms behind these changes remain incompletely understood.
Histological changes in hypertrophied LF include fibrocartilaginous metaplasia, type II collagen proliferation, ossification, calcium crystal deposition, and degeneration of elastic and collagen fibers. Both mechanical stress and inflammatory processes, particularly macrophage infiltration, are considered key contributors to degeneration, especially in the aging population. Yet, inflammation linked to systemic metabolic disorders-such as obesity and sarcopenia-may also significantly influence the degeneration of spinal structures.
Metabolic Inflammation and the Role of Adipokines Recent research has highlighted the role of adipokines in the pathogenesis of degenerative spinal and joint diseases. Disrupted lipid metabolism and chronic low-grade inflammation contribute to tissue remodeling, extracellular matrix (ECM) degradation, and ectopic fat deposition in spinal structures.
Epidural fat, normally present in the spinal canal, can become inflamed and secrete pro-inflammatory cytokines, potentially affecting adjacent tissues such as muscles and ligaments. Conditions like spinal epidural lipomatosis, which is associated with obesity, exemplify this pathological mechanism.
While adipokines like leptin and visfatin have been previously associated with LF ossification and degeneration, the presence and role of others-such as adipsin, vaspin, resistin, lipocalin-2, progranulin, chemerin, omentin-1, and GDF-15-have not yet been studied in LF or epidural fat. Given their known effects on inflammation and ECM remodeling, these molecules are strong candidates for involvement in spinal canal narrowing.
Research Hypotheses and Objectives
This study hypothesizes that adipose tissue-derived cytokines, particularly from epidural fat, contribute to LF degeneration and LSS through inflammatory and metabolic signaling. The main research objectives are to:
- Identify differences in biomarker concentrations in LF, paraspinal muscle, and epidural fat from patients with and without LSS.
- Determine correlations between tissue and blood biomarker levels and clinical parameters such as pain, disability, and body mass.
- Select potential biomarkers for monitoring surgical outcomes of spinal decompression.
- Identify cytokines that modulate LF inflammation and metabolism.
- Evaluate the direct effects of adipokines on LF cell behavior in vitro. Study Design and Methods Study population:
- 100 patients undergoing lumbar spine surgery at the Orthopaedic-Rehabilitation Clinical Hospital in Poznań:
- 50 with LSS (ages 40-90)
- 50 with disc herniation only (ages 18-40; control group) Tissue collection (intraoperative):
- Ligamentum flavum
- Paraspinal muscles
- Epidural adipose tissue Blood samples:
- Collected from all participants:
- Within 48 hours before surgery
- Two months post-surgery Clinical assessments:
- Disability and pain scales
- Preoperative MRI scans Laboratory analysis:
- Molecular testing:
- mRNA expression of selected cytokines and adipokines using PCR
- Protein levels determined via ELISA in both serum and tissue homogenates • Cell culture studies:
- One-third of collected tissue is used to establish primary cell cultures from LF, paraspinal muscles, and epidural fat
- Cells will be stimulated with conditioned media from epidural fat and with selected recombinant cytokines (e.g., vaspin, lipocalin-2, GDF-15)
- Experiments will assess the gene and protein expression of key molecules involved in inflammation, ECM remodeling, bone metabolism, fibrosis, and matrix degradation. The goal is to clarify the local and systemic roles of adipokines and inflammation in the pathogenesis of LF hypertrophy and LSS. This knowledge may aid in identifying biomarkers for disease progression and therapeutic targets for non-surgical interventions in the future.
Detailed description
Spinal stenosis is a common musculoskeletal disorder that causes pain or disability in patients. However, the pathogenesis of this disease is complex and has not yet been fully elucidated. Lumbar spinal canal stenosis results from degenerative changes in structures located behind the spinal cord, such as hypertrophy of the ligamentum flavum (LF), as well as ligament calcification, degeneration and hypertrophy of the facet joints and/or herniation of intervertebral discs located anterior to the spinal cord. The pathology of LF hypertrophy includes fibrocartilaginous changes associated with type II collagen proliferation, ossification, calcium crystal deposition, degeneration of collagen and elastic fibers, and chondroid metaplasia of ligament fibroblasts. Numerous scientific studies have attempted to explore the etiology of hypertrophy and ossification of spinal ligaments, considering systemic, local, genetic, and environmental factors. However, the mechanism of degeneration development is still not fully understood. Besides mechanical stress and increased collagen synthesis (fibrosis) in the ligament, which make age a major risk factor, the presence of inflammation and macrophage infiltration is considered a significant contributor to degeneration development.
Therefore, it is reasonable to assume that the presence of inflammation associated with other health conditions-especially chronic ones-may, to an unknown extent, influence the course of spinal structure degeneration. Currently, obesity and sarcopenia are drawing particular attention as disorders affecting all systems of the human body. Since their prevalence is increasing, a thorough understanding of their consequences on individual organs has significant social and practical importance for prevention and health protection.
An increasing number of reports indicate that disturbances in lipid metabolism and the secretion of pro-inflammatory adipokines and cytokines are deeply involved in regulating cellular phenotypes and fates, extracellular matrix metabolism, and inflammation in the pathophysiological processes of degenerative spinal and joint diseases. Metabolic disorders can affect bone metabolism and lead to ectopic ossification and fat deposition not only in spinal ligaments but also in other spinal structures. Also noteworthy is the influence of the adipokinome on the development of musculoskeletal degenerative disorders. Even anatomically present epidural fat in the spinal canal may become inflamed and spontaneously secrete inflammatory cytokines, potentially modifying the function of adjacent tissues, such as paraspinal muscles and ligaments. It is worth mentioning that spinal epidural lipomatosis, characterized by an excess of fat tissue in the epidural space leading to spinal canal stenosis, is strongly associated with obesity.
So far, it has been confirmed that adipokines and their receptors, although primarily located in white adipose tissue, are also present in joint cartilage and spinal bone marrow. Adipokines may promote ligamentum flavum degeneration by stimulating inflammatory responses and promoting pathological changes. Leptin has been shown to significantly correlate with the number of vertebrae affected by ligamentous ossification. Fan et al. discovered that leptin markedly upregulates alkaline phosphatase and osteocalcin mRNA expression in ligamentum flavum cells. High levels of visfatin have also been found in the ligamenta flava of patients with confirmed ossification. There is no available data on the presence and role of other adipose tissue-derived cytokines such as adipsin, vaspin, resistin, lipocalin-2, progranulin, chemerin, omentin-1, or growth differentiation factor-15 (GDF-15) in the ligamentum flavum. It is highly likely that these cytokines are also involved in the development of spinal canal stenosis, which constitutes our research hypothesis. The presence and levels of these cytokines in epidural fat tissue in patients with stenosis, compared to those without spinal canal narrowing, have not been studied to date. Since studies confirm that chronic systemic inflammation affects various tissues and local inflammation significantly affects neighboring structures, we hypothesize that ligaments, paraspinal muscles, intervertebral discs, etc., may be particularly vulnerable to cytokines secreted by epidural fat tissue. Previous in vitro studies confirmed that a local environment rich in cytokines such as IL-6, IL-1α, nitric oxide donor (SNAP), and prostaglandin E2 changes the gene expression of collagens I, V, XI, and osteocalcin in ligamentum flavum cells. However, the impact of the mentioned adipokines on the development of ligamentum flavum degeneration has not yet been determined.
The study will involve examining the concentrations of cytokines (especially adipokines) and neuroplasticity modulators and their mRNA expression in tissues routinely removed from patients with spinal stenosis and disc herniation during surgery, as well as collecting blood from patients twice, before the procedure and during a follow-up visit two months after the procedure.
Objectives
- To identify differences in selected biomarker concentrations in samples of ligamentum flavum, paraspinal muscles, and epidural fat collected from the lumbar region of patients with stenosis compared to those without spinal canal degeneration.
- To determine whether the expression of selected biomarkers in tissues correlates with their presence in the patients' blood and whether they relate to the degree of degeneration, disability, pain intensity, and body mass.
- To select potential biomarkers for monitoring the effectiveness of spinal canal decompression surgery by comparing biomarker levels before surgery and two months into recovery.
- To identify potential proteins that modulate metabolism and inflammation in the ligamentum flavum.
- To evaluate the impact of selected cytokines and adipokinome of epidural fat tissue on metabolism and inflammation in ligamentum flavum cell cultures.
Study Population Description
The study will involve 100 patients from the Orthopaedic-Rehabilitation Clinical Hospital of the Poznań University of Medical Sciences, including both men and women:
- 50 patients with lumbar spinal canal stenosis, aged 40-90 years
- 50 patients with intervertebral disc herniation, aged 18-40 years, requiring surgical treatment Participants will undergo surgery provided they give informed consent to use their tissues in scientific research.
- The study group will undergo endoscopic spinal canal decompression, involving the removal of tissues (bone, ligament, joint) compressing neural structures, and possibly removing a displaced intervertebral disc fragment.
- The control group will undergo isolated intervertebral disc herniation surgery, involving the removal of the displaced disc fragment.
Methods Before surgery (within 48h) and two months post-op, 20 ml of venous blood will be drawn from each patient.
During surgery, the following samples will be collected:
- Paraspinal muscle tissue
- Ligamentum flavum
- Epidural fat tissue
The study will use the following methods/tools:
- Standardized questionnaires for disability and pain intensity
- MRI of the lumbar spine (routinely performed before surgery)
- Molecular testing
- mRNA expression of cytokines (GDF-15, adipsin, vaspin, resistin, lipocalin-2, progranulin, chemerin, omentin-1) will be measured using PCR.
- Immunoassays using commercial ELISA kits will be performed on tissue homogenates and serum to determine proteins concentrations (GDF-15, adipsin, vaspin, resistin, lipocalin-2, progranulin, chemerin, omentin-1)
- Cell culture and stimulation of cells with cytokines and medium obtained from adipose tissue One-third of the biological material will be allocated for cell culture studies. Samples of the ligamentum flavum, paraspinal muscles, and epidural adipose tissue will be collected directly after surgery and placed in sterile containers with appropriate transport media.
All samples will be immediately transported to the cell culture laboratory under sterile conditions, in the shortest possible time from collection. Upon arrival at the laboratory, they will undergo appropriate, pre-established cell isolation protocols, tailored to the characteristics of each tissue type.
After the exposure period, the expression of mRNA and protein levels of cytokines, fibrosis markers, bone markers, extracellular matrix proteins, matrix degradation enzymes will be measured in the conditioned medium collected from the cultures of myocytes and ligamentum flavum fibroblasts.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Spinal Stenosis | Experimental | Procedure: Endoscopic Spinal Canal Decompression |
| No Spinal Stenosis | No intervention | –Tissues collected during surgery from people without spinal stenosis. |
| No intervention | No intervention | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Spinal stenosis in the lumbar spine with a referral for surgical treatment using endoscopic spinal decompression.
- Age: 40-90 years.
- Current MRI results.
- Consent to participate in the study.
- Intervertebral disc herniation in the lumbar spine with a referral for surgical treatment using endoscopic discectomy.
Key exclusion criteria (10 listed)
- rheumatoid arthritis of the intervertebral joints,
- joint pain located elsewhere if it is more severe than the pain caused by stenosis,
- pathologies and/or medications that may disturb the balance between pro- and anti-inflammatory factors (e.g. inflammatory diseases, rheumatoid arthritis, ankylosing spondylitis, acute infection),
- uncontrolled diabetes, poorly controlled hypertension, clinically significant liver function impairment, acute coronary event, unstable angina pectoris, symptoms of heart failure, pacemaker implantation,
- neurological diseases within the last 6 months,
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 |
|---|---|---|
| Endoscopic Spinal Canal DecompressionPatients from the study group will undergo endoscopic decompression of the spinal canal, which involves the removal of tissues (bone, ligament, joint) causing compression of the neural structures of the spine and the possible removal of an abnormally displaced fragment of the intervertebral disc. | Procedure or surgery | Spinal Stenosis |
Primary outcome
Adipokines concentration in the epidural adipose tissue, paraspinal muscles, ligamentum flavum and blood.
Time frame: Day 0 and Month 2
Neuroplasticity modulators concentration in the epidural adipose tissue, paraspinal muscles, ligamentum flavum and blood.
Time frame: Day 0 and Month 2
5 secondary outcomes
Low back pain on visual analogue scale
Time frame: Day 0 and Month 2
Oswestry Disability Index
Time frame: Day 0 and Month 2
Thickness of the ligamentum flavum
Time frame: Before intervention
Diameter of the spinal canal
Time frame: Before intervention.
Schizas Scale
Time frame: Before intervention.
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 16 Sep 2026.
- Background: PubMed 30776685Tarabeih N, Shalata A, Trofimov S, Kalinkovich A, Livshits G. Growth and differentiation factor 15 is a biomarker for low back pain-associated disability. Cytokine. 2019 May;117:8-14. doi: 10.1016/j.cyto.2019.01.011. Epub 2019 Feb 15.
- Background: PubMed 27105459Fujita N, Hosogane N, Hikata T, Iwanami A, Watanabe K, Shiono Y, Okada E, Ishikawa M, Tsuji T, Shimoda M, Horiuchi K, Nakamura M, Matsumoto M, Ishii K. Potential Involvement of Obesity-Associated Chronic Inflammation in the Pathogenesis of Idiopathic Spinal Epidural Lipomatosis. Spine (Phila Pa 1976). 2016 Dec 1;41(23):E1402-E1407. doi: 10.1097/BRS.0000000000001646.
- Background: PubMed 39658574Xiang Q, Wu Z, Zhao Y, Tian S, Lin J, Wang L, Jiang S, Sun Z, Li W. Cellular and molecular mechanisms underlying obesity in degenerative spine and joint diseases. Bone Res. 2024 Dec 11;12(1):71. doi: 10.1038/s41413-024-00388-8.
- Background: PubMed 34615403Endo T, Koike Y, Hisada Y, Fujita R, Suzuki R, Tanaka M, Tsujimoto T, Shimamura Y, Hasegawa Y, Kanayama M, Yamada K, Iwata A, Sudo H, Ishii M, Iwasaki N, Takahata M. Aggravation of Ossified Ligamentum Flavum Lesion Is Associated With the Degree of Obesity. Global Spine J. 2023 Jun;13(5):1325-1331. doi: 10.1177/21925682211031514. Epub 2021 Oct 6.
- Background: PubMed 38625592Zhang H, Hong Z, Jiang Z, Hu W, Hu J, Zhu R. miR-29b-3p Affects the Hypertrophy of Ligamentum Flavum in Lumbar Spinal Stenosis and its Mechanism. Biochem Genet. 2025 Apr;63(2):1824-1838. doi: 10.1007/s10528-024-10811-8. Epub 2024 Apr 16.
- Background: PubMed 9444420Furusawa N, Baba H, Maezawa Y, Uchida K, Wada M, Imura S, Fukuda M. Calcium crystal deposition in the ligamentum flavum of the lumbar spine. Clin Exp Rheumatol. 1997 Nov-Dec;15(6):641-7.
- Background: PubMed 13680315Szpalski M, Gunzburg R. Lumbar spinal stenosis in the elderly: an overview. Eur Spine J. 2003 Oct;12 Suppl 2(Suppl 2):S170-5. doi: 10.1007/s00586-003-0612-1. Epub 2003 Sep 9.
- Background: PubMed 39456209Silwal P, Nguyen-Thai AM, Alexander PG, Sowa GA, Vo NV, Lee JY. Cellular and Molecular Mechanisms of Hypertrophy of Ligamentum Flavum. Biomolecules. 2024 Oct 10;14(10):1277. doi: 10.3390/biom14101277.
- Background: PubMed 32236113Carregaro RL, Tottoli CR, Rodrigues DDS, Bosmans JE, da Silva EN, van Tulder M. Low back pain should be considered a health and research priority in Brazil: Lost productivity and healthcare costs between 2012 to 2016. PLoS One. 2020 Apr 1;15(4):e0230902. doi: 10.1371/journal.pone.0230902. eCollection 2020.
- Individual participant dataSharing planned: Yes
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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.
Marzena Ratajczak, PhD principal investigator
Poznan University of Physical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Spinal Canal Decompression in people with Spinal Stenosis and Ligamentum Flavum Hypertrophy, run by Poznan University of Physical Education at 1 site in Poland.
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 9 inclusion and 10 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 16 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 Poland. 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 Marzena Ratajczak, PhD (+48 604773816, mratajczak@awf.poznan.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adipokines concentration in the epidural adipose tissue, paraspinal muscles, ligamentum flavum and blood. (time frame: Day 0 and Month 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07232836, which also lists 9 linked publications.
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 16 Sep 2026.