- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07367503
SIII and Spontaneous Regression in Lumbar Disc Herniation (SIII-LDH)
Investigation of the Role of Systemic Immune-Inflammatory Index in Spontaneously Regressing Lumbar Disc Hernias
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Lumbar disc herniation (LDH) is a common spinal disorder that may be managed conservatively or surgically depending on clinical severity and response to treatment. Inflammatory and immune-mediated mechanisms are known to contribute to disc degeneration and symptom progression; however, reliable and easily accessible biomarkers that may assist in treatment decision-making remain limited. The Systemic Immune-Inflammatory Index (SIII), derived from peripheral blood neutrophil, platelet, and lymphocyte counts, has emerged as a comprehensive indicator reflecting systemic inflammatory and immune status.
This retrospective observational study evaluated patients diagnosed with lumbar disc herniation who were followed in the Neurosurgery Clinic between June 1, 2020, and January 30, 2023. Demographic characteristics, clinical and neurological findings at admission, comorbidities, treatment modality, laboratory parameters, and radiological findings were obtained from medical records. Patients were categorized into three groups: those managed conservatively with medical treatment, those who underwent surgical intervention, and healthy individuals included as a control group.
Peripheral blood parameters, including neutrophil and lymphocyte counts, were recorded, and the neutrophil-to-lymphocyte ratio (NLR) and SIII values were calculated. Comparisons of inflammatory markers were performed among the medical treatment, surgical treatment, and control groups to assess differences related to disease severity and treatment approach.
The analysis demonstrated significantly higher neutrophil counts, NLR, and SIII values in patients who required surgical treatment compared with both medically treated patients and healthy controls. These findings indicate that elevated systemic inflammatory indices are associated with more severe clinical presentations requiring surgical intervention.
Overall, this study aims to clarify the clinical relevance of SIII in lumbar disc herniation and to explore its potential role as an adjunct biomarker for evaluating disease severity and supporting treatment decisions in routine clinical practice.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Center
-
Çanakkale, Center, Turkey (Türkiye), 17020
- Çanakkale Onsekiz Mart University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Dagnosis of lumbar disc herniation confirmed by magnetic resonance imaging (MRI)
- Follow-up at the Department of Neurosurgery between June 1, 2020, and January 30, 2023
- Availability of baseline complete blood count and inflammatory marker data
- For the surgical group: Patients who underwent single-level, unilateral lumbar microdiscectomy (LMD) for acute lumbar disc herniation
- For the medical treatment group: Patients with single-level, unilateral lumbar disc herniation who did not undergo surgery and demonstrated spontaneous regression during follow-up after medical treatment
- For the control group: Individuals without spinal disease who applied to the outpatient clinic with headache complaints and had available routine blood test results
Exclusion Criteria:
- Previous medical or surgical treatment for lumbar disc pathology
- Presence of systemic inflammatory disease
- Rheumatic disease
- Tumoral or malignant pathology
- History of spinal trauma
- Active infection at the time of blood sampling
- Congenital spinal anomalies
- Incomplete clinical, laboratory, or radiological data
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
No intervention the group and healty
|
|
|
Other: Surgical treatment group
Already operated
|
Lumbar disc herniation surgecal treatment
|
|
Other: Medical treatment group
Already have a treatment protocol
|
Lumbar disc herniation medical treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Systemic Immune-Inflammatory Index (SIII)
Time Frame: At baseline (at initial diagnosis)
|
Calculated from peripheral blood neutrophil, platelet, and lymphocyte counts.
|
At baseline (at initial diagnosis)
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Oliveira CB, Maher CG, Pinto RZ, Traeger AC, Lin CWC, Chenot JF, et al. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. European Spine Journal [Internet]. 2018 Nov 1 [cited 2024 Apr 29];27(11):2791-803. Available from: https://link.springer.com/article/10.1007/s00586-018-5673-2 2. Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, et al. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis [Internet]. 2014 Jun 1 [cited 2024 Apr 29];73(6):968-74. Available from: https://ard.bmj.com/content/73/6/968 3. Lagerbäck T, Fritzell P, Hägg O, Nordvall D, Lønne G, Solberg TK, et al. Effectiveness of surgery for sciatica with disc herniation is not substantially affected by differences in surgical incidences among three countries: results from the Danish, Swedish and Norwegian spine registries. Eur Spine J [Internet]. 2019 Nov 1 [cited 2024 Apr 29];28(11):2562-71. Available from: https://pubmed.ncbi.nlm.nih.gov/30269234/ 4. Johansen JG. Demonstration of anterior intervertebral disc herniation by CT. Neuroradiology. 1987 Mar;29(2):214. 5. Teplick JG, Haskin ME. Spontaneous regression of herniated nucleus pulposus. AJR Am J Roentgenol [Internet]. 1985 [cited 2024 Apr 29];145(2):371-5. Available from: https://pubmed.ncbi.nlm.nih.gov/3875236/
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- COMU-BS-1
- THD-2023-4339 (Other Grant/Funding Number: Çanakkale Onsekiz Mart University's Scientific Research Coordination Unit)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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