NCT07367503

Brief Summary

This study aimed to investigate the role of the Systemic Immune-Inflammatory Index (SIII) in patients with lumbar disc herniation (LDH) and to evaluate its potential clinical relevance in relation to treatment modality.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

2.7 years

First QC Date

January 18, 2026

Last Update Submit

January 18, 2026

Conditions

InflammationNeutrophilLymphocyteNeurosurgery

Keywords

Inflammationneutrophillymphocyteneurosurgery

Outcome Measures

Primary Outcomes (1)

  • Systemic Immune-Inflammatory Index (SIII)

    Calculated from peripheral blood neutrophil, platelet, and lymphocyte counts.

    At baseline (at initial diagnosis)

Study Arms (3)

Control group

NO INTERVENTION

No intervention the group and healty

Surgical treatment group

OTHER

Already operated

Other: Lumbar disc herniation surgery

Medical treatment group

OTHER

Already have a treatment protocol

Other: Lumbar disc herniation treatment

Interventions

Lumbar disc herniation treatmentOTHER

Lumbar disc herniation medical treatment

Medical treatment group
Lumbar disc herniation surgeryOTHER

Lumbar disc herniation surgecal treatment

Surgical treatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çanakkale Onsekiz Mart University

Çanakkale, Center, 17020, Turkey (Türkiye)

Location

Related Publications (1)

  • 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/

    BACKGROUND

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

January 18, 2026

First Posted

January 26, 2026

Study Start

June 1, 2020

Primary Completion

January 30, 2023

Study Completion

January 30, 2023

Last Updated

January 26, 2026

Record last verified: 2026-01

Locations

TU(1)