Neuropathic PainHINSPAINNCT07596823
Hematological Indices and Sympathetic Block Response in Neuropathic Pain
An observational study of Neuropathic Pain and Neuropathic Pain Diagnostic Questionnaire (DN4) ≥ 4, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate the relationship between hematological inflammatory indices and clinical treatment response in patients with neuropathic pain undergoing sympathetic nerve block procedures as part of routine clinical care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain, Neuropathic Pain Diagnostic Questionnaire (DN4) ≥ 4
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 31 Jan 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with neuropathic pain and undergoing sympathetic nerve block procedures in the Algology Clinic of Ankara Bilkent City Hospital.
Who may be able to join
- Age ≥18 years
- Diagnosis of neuropathic pain based on clinical evaluation
- DN4 and/or LANSS scores compatible with neuropathic pain
- Undergoing sympathetic nerve block as part of routine clinical treatment
- Availability of pre-treatment and follow-up hemogram parameters
- Ability to provide written informed consent
Who cannot join
- Age <18 years
- Active infection or acute inflammatory disease
- Active malignancy
- History of hematological disease
- Immunosuppressive therapy or systemic corticosteroid use
- Major surgery or severe trauma within the last month
Show all 9Show fewer
- Pregnancy or breastfeeding
- Autoimmune or rheumatologic inflammatory disease
- Missing follow-up data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, Cankaya, 06680
Ülkü Sabuncu, Assoc Prof, 905337085212, sabuncuulku@gmail.com
About this study
Official title: Hematological Inflammatory Indices as Predictors of Treatment Response to Sympathetic Nerve Blocks in Neuropathic Pain: A Prospective Observational Study
This prospective observational study aims to evaluate the relationship between hematological inflammatory indices and clinical treatment response in patients with neuropathic pain undergoing sympathetic nerve block procedures as part of routine clinical care. Hematological parameters including neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), monocyte-to-lymphocyte ratio (MLR), systemic immune-inflammation index (SII), systemic inflammation response index (SIRI), aggregate index of systemic inflammation (AISI), and red cell distribution width (RDW) will be evaluated before and after treatment. The association between changes in these indices and pain outcomes will be analyzed.
Read the detailed description
Neuropathic pain is a complex chronic pain condition involving inflammatory, neural, and immune-mediated mechanisms. Increasing evidence suggests that systemic inflammatory processes may contribute to the pathophysiology and persistence of neuropathic pain. Hematological inflammatory indices derived from routine complete blood count parameters have recently emerged as inexpensive and accessible biomarkers reflecting systemic inflammatory status.
Although several studies have investigated inflammatory markers in chronic pain syndromes, data regarding the relationship between hematological inflammatory indices and treatment response following sympathetic nerve block interventions in neuropathic pain are limited.
This prospective observational study aims to evaluate whether hematological inflammatory indices are associated with treatment outcomes in neuropathic pain patients treated with sympathetic nerve block procedures as part of routine clinical management. Adult patients diagnosed with neuropathic pain and scheduled for sympathetic nerve block treatment will be prospectively followed for 3 months.
Clinical outcomes including Numeric Rating Scale (NRS), DN4 and/or LANSS neuropathic pain scores, Global Perceived Effect (GPE), and analgesic consumption will be recorded. Hematological indices including NLR, PLR, MLR, SII, SIRI, AISI, and RDW will be calculated using routine hemogram parameters.
The study is designed as a non-interventional, single-center, prospective observational clinical study. The treatment approach will not be altered for research purposes.
- Keywords
- Neuropathic Pain, Sympathetic Nerve, Inflammation
- Medical subject headings
- Neuralgia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neuropathic Pain Cohort | Adult patients diagnosed with neuropathic pain undergoing sympathetic nerve block procedures as part of routine clinical care in the Algology Clinic of Ankara Bilkent City Hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Response at Month 3
Treatment response will be defined as achieving at least 50% reduction in Numeric Rating Scale (NRS) pain score compared with baseline.
NRS 0 means = no pain NRS 10 means= worst pain imaginable
Measured: 3 th month
Secondary outcomes (3)
NRS (Numeric Rating Scale Pain Score)
Change in pain intensity measured by the 0-10 Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measured: Baseline and 3rd month
Change in Hematological Inflammatory Indices
Change in hematological inflammatory indices including NLR, PLR, MLR, SII, SIRI, AISI, and RDW from baseline to follow-up.
Measured: Baseline and 3rd monnth
GPE (Global Perceived Effect)
Patient-reported global improvement after treatment assessed using the Global Perceived Effect scale.Patient-reported overall improvement after treatment assessed using a 7-point Global Perceived Effect scale.
Scale Description:
- = completely recovered
- = much improved
- = slightly improved
- = unchanged
- = slightly worsened
- = much worsened
- = worse than ever Minimum Value: 1 Maximum Value: 7
Interpretation:
Lower scores indicate better clinical improvement.
Time Frame:
Month 3
Measured: 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
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 Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ülkü Sabuncu, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596823
- Sponsor's protocol ID
- 13579
- Acronym
- HINSPAIN
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly available due to privacy and ethical restrictions.
Publications
Babaoglu G, Sabuncu U, Dadali S, Costu A, Akcaboy EY. Discriminative role of inflammatory indices in clinical response to ganglion impar blockade: A retrospective cohort study. Medicine (Baltimore). 2026 Feb 6;105(6):e47638. doi: 10.1097/MD.0000000000047638.
PubMed 41650048
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hematological Inflammatory Indices as Predictors of Treatment Response to Sympathetic Nerve Blocks in Neuropathic Pain: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07596823
- Acronym / sponsor ID
- HINSPAIN / 13579
- Keywords
- Neuropathic Pain, Sympathetic Nerve, Inflammation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 19 May 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 prospective observational study aims to evaluate the relationship between hematological inflammatory indices and clinical treatment response in patients with neuropathic pain undergoing sympathetic nerve block procedures as part of routine clinical care. Hematological parameters including neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), monocyte-to-lymphocyte ratio (MLR), systemic immune-inflammation index (SII), systemic inflammation response index (SIRI), aggregate index of systemic inflammation (AISI), and red cell distribution width (RDW) will be evaluated before and after treatment. The association between changes in these indices and pain outcomes will be analyzed.
Detailed description
Neuropathic pain is a complex chronic pain condition involving inflammatory, neural, and immune-mediated mechanisms. Increasing evidence suggests that systemic inflammatory processes may contribute to the pathophysiology and persistence of neuropathic pain. Hematological inflammatory indices derived from routine complete blood count parameters have recently emerged as inexpensive and accessible biomarkers reflecting systemic inflammatory status.
Although several studies have investigated inflammatory markers in chronic pain syndromes, data regarding the relationship between hematological inflammatory indices and treatment response following sympathetic nerve block interventions in neuropathic pain are limited.
This prospective observational study aims to evaluate whether hematological inflammatory indices are associated with treatment outcomes in neuropathic pain patients treated with sympathetic nerve block procedures as part of routine clinical management. Adult patients diagnosed with neuropathic pain and scheduled for sympathetic nerve block treatment will be prospectively followed for 3 months.
Clinical outcomes including Numeric Rating Scale (NRS), DN4 and/or LANSS neuropathic pain scores, Global Perceived Effect (GPE), and analgesic consumption will be recorded. Hematological indices including NLR, PLR, MLR, SII, SIRI, AISI, and RDW will be calculated using routine hemogram parameters.
The study is designed as a non-interventional, single-center, prospective observational clinical study. The treatment approach will not be altered for research purposes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuropathic Pain Cohort | – | –Adult patients diagnosed with neuropathic pain undergoing sympathetic nerve block procedures as part of routine clinical care in the Algology Clinic of Ankara Bilkent City Hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with neuropathic pain and undergoing sympathetic nerve block procedures in the Algology Clinic of Ankara Bilkent City Hospital.
Key inclusion criteria (6 listed)
- Age ≥18 years
- Diagnosis of neuropathic pain based on clinical evaluation
- DN4 and/or LANSS scores compatible with neuropathic pain
- Undergoing sympathetic nerve block as part of routine clinical treatment
- Availability of pre-treatment and follow-up hemogram parameters
Key exclusion criteria (9 listed)
- Age <18 years
- Active infection or acute inflammatory disease
- Active malignancy
- History of hematological disease
- Immunosuppressive therapy or systemic corticosteroid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment Response at Month 3
Time frame: 3 th month
Treatment response will be defined as achieving at least 50% reduction in Numeric Rating Scale (NRS) pain score compared with baseline. NRS 0 means = no pain NRS 10 means= worst pain imaginable
3 secondary outcomes
NRS (Numeric Rating Scale Pain Score)
Time frame: Baseline and 3rd month
Change in Hematological Inflammatory Indices
Time frame: Baseline and 3rd monnth
GPE (Global Perceived Effect)
Time frame: 3rd month
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 29 Jun 2026.
- Results publication: PubMed 41650048Babaoglu G, Sabuncu U, Dadali S, Costu A, Akcaboy EY. Discriminative role of inflammatory indices in clinical response to ganglion impar blockade: A retrospective cohort study. Medicine (Baltimore). 2026 Feb 6;105(6):e47638. doi: 10.1097/MD.0000000000047638.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly available due to privacy and ethical restrictions.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain and Neuropathic Pain Diagnostic Questionnaire (DN4) ≥ 4, run by Ankara City Hospital Bilkent 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 9 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 29 Jun 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?
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 Ülkü Sabuncu, Assoc prof (905337085212, sabuncuulku@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Response at Month 3 (time frame: 3 th month). 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 NCT07596823, 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 29 Jun 2026.