The Experience of Nociceptive and Neuropathic Pain: Differences in Levels of Central Sensitization
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Neuropsychological assessment
研究概览
简要总结
This study aims to investigate differences in central sensitization among patients with chronic nociceptive pain, neuropathic pain, and mixed pain conditions. Chronic pain is a complex and multidimensional phenomenon involving sensory, cognitive, emotional, and behavioral components, often sustained by mechanisms of central sensitization that contribute to pain persistence and treatment resistance.
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.
详细描述
This is an observational, prospective, longitudinal cohort study designed to examine central sensitization and its multidimensional correlates in patients with chronic pain. The study will be conducted at the IRCCS Centro Neurolesi "Bonino-Pulejo", P.O. "Piemonte", Messina, Italy.
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 90 years
- •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
排除标准
- •Presence of severe psychiatric disorders
- •Presence of severe neurological disorders
- •Presence of oncological diseases in terminal stage
研究组 & 干预措施
Nociceptive pain
Patients suffering from nociceptive pain
干预措施: Neuropsychological assessment (Behavioral)
Nociceptive pain
Patients suffering from nociceptive pain
干预措施: Laser evoked potentials (Behavioral)
Mixed pain
Patients suffering from mixed pain
干预措施: Neuropsychological assessment (Behavioral)
Mixed pain
Patients suffering from mixed pain
干预措施: Laser evoked potentials (Behavioral)
Neuropathic pain
Patients suffering from neuropathic pain
干预措施: Neuropsychological assessment (Behavioral)
Neuropathic pain
Patients suffering from neuropathic pain
干预措施: Laser evoked potentials (Behavioral)
结局指标
主要结局
Neuropsychological assessment
时间窗: 24 months
Cognitive functions: Montreal Cognitive Assessment (MoCA)
neuropsychological assessment
时间窗: 24 months
Central Sensitization Inventory (CSI)
次要结局
未报告次要终点
研究者
Anna Anselmo
Psychologist
IRCCS Centro Neurolesi Bonino Pulejo