- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07596823
Hematological Indices and Sympathetic Block Response in Neuropathic Pain (HINSPAIN)
Hematological Inflammatory Indices as Predictors of Treatment Response to Sympathetic Nerve Blocks in Neuropathic Pain: A Prospective Observational Study
Study Overview
Status
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ülkü Sabuncu, Assoc Prof
- Phone Number: 905337085212
- Email: sabuncuulku@gmail.com
Study Locations
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Cankaya
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Ankara, Cankaya, Turkey (Türkiye), 06680
- Ankara Bilkent City Hospital
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Contact:
- Ülkü Sabuncu, Assoc Prof
- Phone Number: 905337085212
- Email: sabuncuulku@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Pregnancy or breastfeeding
- Autoimmune or rheumatologic inflammatory disease
- Missing follow-up data
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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 th month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NRS (Numeric Rating Scale Pain Score)
Time Frame: Baseline and 3rd month
|
Change in pain intensity measured by the 0-10 Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
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Baseline and 3rd month
|
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Change in Hematological Inflammatory Indices
Time Frame: Baseline and 3rd monnth
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Change in hematological inflammatory indices including NLR, PLR, MLR, SII, SIRI, AISI, and RDW from baseline to follow-up.
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Baseline and 3rd monnth
|
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GPE (Global Perceived Effect)
Time Frame: 3rd month
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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:
Interpretation: Lower scores indicate better clinical improvement. Time Frame: Month 3 |
3rd month
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13579
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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