Central Sensitisation in Nociceptive and Neuropathic Pain

NCT07321080 | Active Not Recruiting DMC

• 1 other identifier: CEL/U138/25
• Study Type: observational
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain; Nociceptive Pain; Neuropathic Pain; Mixed Pain (Nociceptive and Neuropathic)

Keywords

CHRONIC PAIN; CENTRAL SENSITIZATION; NEUROPATHIC PAIN; NOCICEPTIVE PAIN; MIXED PAIN; LASER-EVOKED POTENTIALS; NEUROPSYCHOLOGICAL ASSESSMENT

Outcome Measures

Primary Outcomes (2)

• neuropsychological assessment

  Central Sensitization Inventory (CSI)

  24 months

• Neuropsychological assessment

  Cognitive functions: Montreal Cognitive Assessment (MoCA)

  24 months

Study Arms (3)

Nociceptive pain

Patients suffering from nociceptive pain

Behavioral: Neuropsychological assessment; Behavioral: Laser evoked potentials

Mixed pain

Patients suffering from mixed pain

Behavioral: Neuropsychological assessment; Behavioral: Laser evoked potentials

Neuropathic pain

Patients suffering from neuropathic pain

Behavioral: Neuropsychological assessment; Behavioral: Laser evoked potentials

Interventions

Neuropsychological assessment BEHAVIORAL

Neuropsychological assessment Standardized and ad hoc test battery for comprehensive neuropsychological assessment

Mixed pain; Neuropathic pain; Nociceptive pain

Laser evoked potentials BEHAVIORAL

Laser evoked potentials

Mixed pain; Neuropathic pain; Nociceptive pain

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The sample size was estimated using G\*Power 3.1 based on the primary outcome measure, the Central Sensitization Inventory (CSI). A one-way ANOVA (omnibus test) comparing three groups (nociceptive pain, neuropathic pain, and mixed pain) with equal allocation (1:1:1) was assumed. The calculation was performed using a moderate effect size (f = 0.25), a two-sided significance level of α = 0.05, and a statistical power of 0.80. Based on these parameters, a minimum sample size of 159 participants was required (53 participants per group). Considering an expected dropout rate of approximately 15% over the 12-month follow-up period, the target enrollment was increased to approximately 185 participants, corresponding to about 62 participants per group.

You may qualify if:

• 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

You may not qualify if:

• Presence of severe psychiatric disorders
• Presence of severe neurological disorders
• Presence of oncological diseases in terminal stage

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

Irccs Centro Neurolesi Bonino Pulejo

Messina, Sicily, 98066, Italy

Location

MeSH Terms

Conditions

Chronic Pain; Nociceptive Pain; Neuralgia

Interventions

Neuropsychological Tests; Laser-Evoked Potentials

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities; Evoked Potentials, Somatosensory; Evoked Potentials; Cortical Excitability; Electrophysiological Phenomena; Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 6, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 20, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)