Central Sensitisation in Nociceptive and Neuropathic Pain
NCT ID: NCT07321080
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
185 participants
OBSERVATIONAL
2025-12-15
2027-12-20
Brief Summary
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Using a multidimensional assessment approach, the study integrates self-report questionnaires, neuropsychological evaluation, psychological measures, treatment adherence assessment, and neurophysiological investigation through laser-evoked potentials (LEP). Participants will be evaluated at baseline and after 12 months to explore differences between pain types and longitudinal changes in central sensitization, cognitive functioning, emotional status, and engagement with treatment.
The findings are expected to improve the understanding of neurobiological and psychosocial mechanisms underlying different chronic pain phenotypes and to support more personalized and effective pain management strategies.
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Detailed Description
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The study population consists of adult patients (18-90 years) suffering from chronic pain and referred to the pain outpatient clinic or hospitalized in pain therapy units. Based on standardized screening instruments for pain classification (Douleur Neuropathique en 4 Questions - DN4 and PainDETECT Questionnaire - PD-Q), participants will be stratified into three cohorts: nociceptive pain, neuropathic pain, and mixed pain. The mixed group includes patients with overlapping nociceptive and neuropathic features or pain conditions that are not clearly classifiable within a single category, including nociplastic pain mechanisms.
All participants will undergo a comprehensive evaluation at baseline (T0) and at 12-month follow-up (T1). The assessment protocol includes measures of pain intensity and central sensitization (Numeric Pain Rating Scale, Central Sensitization Inventory), neurophysiological assessment of nociceptive pathways using laser-evoked potentials (LEP), cognitive screening (Montreal Cognitive Assessment), psychological status (Beck Depression Inventory and State-Trait Anxiety Inventory), pain-related self-efficacy (Pain Self-Efficacy Questionnaire), treatment engagement (Patient Health Engagement Scale), and medication adherence (Morisky Medication Adherence Scale).
Participants will also be stratified according to their pharmacological treatment at baseline, including non-steroidal anti-inflammatory drugs, paracetamol, opioids, cannabinoids, anticonvulsants/gabapentinoids, antidepressants, topical agents, and combination therapies. Changes in treatment during the follow-up period will be documented.
The primary objective is to compare levels of central sensitization among nociceptive, neuropathic, and mixed pain groups using both subjective (CSI) and objective (LEP) measures. Secondary objectives include the characterization of cognitive, psychological, and behavioral profiles associated with each pain type and the evaluation of longitudinal changes over time.
This multidimensional and longitudinal approach aims to clarify the role of central sensitization across different chronic pain phenotypes and to support more tailored and integrated therapeutic strategies.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Nociceptive pain
Patients suffering from nociceptive pain
Neuropsychological assessment
Neuropsychological assessment Standardized and ad hoc test battery for comprehensive neuropsychological assessment
Laser evoked potentials
Laser evoked potentials
Mixed pain
Patients suffering from mixed pain
Neuropsychological assessment
Neuropsychological assessment Standardized and ad hoc test battery for comprehensive neuropsychological assessment
Laser evoked potentials
Laser evoked potentials
Neuropathic pain
Patients suffering from neuropathic pain
Neuropsychological assessment
Neuropsychological assessment Standardized and ad hoc test battery for comprehensive neuropsychological assessment
Laser evoked potentials
Laser evoked potentials
Interventions
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Neuropsychological assessment
Neuropsychological assessment Standardized and ad hoc test battery for comprehensive neuropsychological assessment
Laser evoked potentials
Laser evoked potentials
Eligibility Criteria
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Inclusion Criteria
* Presence of chronic pain
* Diagnosis of nociceptive pain, neuropathic pain, mixed pain, or nociplastic pain
* Patients referring to the pain outpatient clinic
* Patients hospitalized in pain therapy units
* Ability to understand the study procedures and provide written informed consent
Exclusion Criteria
* Presence of severe neurological disorders
* Presence of oncological diseases in terminal stage
18 Years
90 Years
ALL
No
Sponsors
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IRCCS Centro Neurolesi Bonino Pulejo
OTHER
Responsible Party
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Anna Anselmo
Psychologist
Locations
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Irccs Centro Neurolesi Bonino Pulejo
Messina, Sicily, Italy
Countries
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Other Identifiers
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CEL/U138/25
Identifier Type: -
Identifier Source: org_study_id
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