- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Ülkü Sabuncu, Assoc prof
- Telefonnummer: 905337085212
- E-post: sabuncuulku@gmail.com
Studiesteder
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Cankaya
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Ankara, Cankaya, Tyrkia (Türkiye), 06680
- Rekruttering
- Ankara Bilkent City Hospital
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Ta kontakt med:
- Ülkü Sabuncu, Assoc prof
- Telefonnummer: 905337085212
- E-post: sabuncuulku@gmail.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Treatment Response at Month 3
Tidsramme: 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
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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NRS (Numeric Rating Scale Pain Score)
Tidsramme: Baseline and 3rd month
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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
Tidsramme: 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)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 13579
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