InflammationSIII-LDHNCT07367503
SIII and Spontaneous Regression in Lumbar Disc Herniation
A study testing Lumbar disc herniation treatment and Lumbar disc herniation surgery in people with Inflammation and Neutrophil, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Neutrophil, Lymphocyte
- What is being tested?
- Lumbar disc herniation treatment and Lumbar disc herniation surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çanakkale Onsekiz Mart University
Çanakkale, Center, 17020
About this study
Official title: Investigation of the Role of Systemic Immune-Inflammatory Index in Spontaneously Regressing Lumbar Disc Hernias
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.
Read the 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.
- Conditions
- Inflammation, Neutrophil, Lymphocyte, Neurosurgery
- Being tested
- Lumbar disc herniation treatment, Lumbar disc herniation surgery
- Keywords
- Inflammation, neutrophil, lymphocyte, neurosurgery
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar disc herniation treatmentOther
Lumbar disc herniation medical treatment
Lumbar disc herniation surgeryOther
Lumbar disc herniation surgecal treatment
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No intervention the group and healty |
| Surgical treatment group | Other | Already operated Receives: Other: Lumbar disc herniation surgery |
| Medical treatment group | Other | Already have a treatment protocol Receives: Other: Lumbar disc herniation treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic Immune-Inflammatory Index (SIII)
Calculated from peripheral blood neutrophil, platelet, and lymphocyte counts.
Measured: At baseline (at initial diagnosis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Jun 2020
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Akar, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367503
- Sponsor's protocol ID
- COMU-BS-1
- Other IDs
- THD-2023-4339
- Acronym
- SIII-LDH
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Role of Systemic Immune-Inflammatory Index in Spontaneously Regressing Lumbar Disc Hernias
- ClinicalTrials.gov ID
- NCT07367503
- Acronym / sponsor ID
- SIII-LDH / COMU-BS-1
- Conditions
- Inflammation, Neutrophil, Lymphocyte, Neurosurgery
- Keywords
- Inflammation, neutrophil, lymphocyte, neurosurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 26 Jan 2026 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No intervention the group and healty |
| Surgical treatment group | Other | Other: Lumbar disc herniation surgeryAlready operated |
| Medical treatment group | Other | Other: Lumbar disc herniation treatmentAlready have a treatment protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Previous medical or surgical treatment for lumbar disc pathology
- Presence of systemic inflammatory disease
- Rheumatic disease
- Tumoral or malignant pathology
- History of spinal trauma
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 |
|---|---|---|
| Lumbar disc herniation treatmentLumbar disc herniation medical treatment | Other | Medical treatment group |
| Lumbar disc herniation surgeryLumbar disc herniation surgecal treatment | Other | Surgical treatment group |
Primary outcome
Systemic Immune-Inflammatory Index (SIII)
Time frame: At baseline (at initial diagnosis)
Calculated from peripheral blood neutrophil, platelet, and lymphocyte counts.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- BackgroundOliveira 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/
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar disc herniation treatment and Lumbar disc herniation surgery in people with Inflammation and Neutrophil, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 26 Jan 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic Immune-Inflammatory Index (SIII) (time frame: At baseline (at initial diagnosis)). 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 NCT07367503, which also lists 1 linked publication.
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 26 Jan 2026.