Chronic PainALGOSNCT07321080
Central Sensitisation in Nociceptive and Neuropathic Pain
An observational study of Chronic Pain and Nociceptive Pain, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Pain, Nociceptive Pain, Neuropathic Pain
- What is being tested?
- Neuropsychological assessment and Laser evoked potentials
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 185 participants
- Where
- 1 siteItaly
- Study dates
- 15 Dec 2025to 20 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Presence of severe psychiatric disorders
- Presence of severe neurological disorders
- Presence of oncological diseases in terminal stage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Experience of Nociceptive and Neuropathic Pain: Differences in Levels of Central Sensitization
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.
Read the detailed description
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.
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
- Chronic Pain, Nociceptive Pain, Neuropathic Pain, Mixed Pain (Nociceptive and Neuropathic)
- Being tested
- Neuropsychological assessment, Laser evoked potentials
- Keywords
- CHRONIC PAIN, CENTRAL SENSITIZATION, NEUROPATHIC PAIN, NOCICEPTIVE PAIN, MIXED PAIN, LASER-EVOKED POTENTIALS, NEUROPSYCHOLOGICAL ASSESSMENT
- Medical subject headings
- Chronic Pain, Nociceptive Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological assessmentBehavioural
Neuropsychological assessment Standardized and ad hoc test battery for comprehensive neuropsychological assessment
Laser evoked potentialsBehavioural
Laser evoked potentials
| Study group | Role | What they receive |
|---|---|---|
| Nociceptive pain | Patients suffering from nociceptive pain Receives: Behavioral: Neuropsychological assessment; Behavioral: Laser evoked potentials | |
| Mixed pain | Patients suffering from mixed pain Receives: Behavioral: Neuropsychological assessment; Behavioral: Laser evoked potentials | |
| Neuropathic pain | Patients suffering from neuropathic pain Receives: Behavioral: Neuropsychological assessment; Behavioral: Laser evoked potentials |
What is being measured
The primary outcome is the main question the study is designed to answer.
neuropsychological assessment
Central Sensitization Inventory (CSI)
Measured: 24 months
Neuropsychological assessment
Cognitive functions: Montreal Cognitive Assessment (MoCA)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start15 Dec 2025
- Primary completion15 Dec 2027 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Anselmo, IRCCS Centro Neurolesi Bonino Pulejo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321080
- Sponsor's protocol ID
- CEL/U138/25
- Acronym
- ALGOS
- Status last verified
- Apr 2026
- First submitted
- 22 Dec 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anselmo A, Corallo F, Pagano M, Cardile D, Floridia D, Panasiti R, Micali G, Bonanno L, Calabro RS, Cappadona I. Central sensitization across nociceptive, neuropathic, and mixed chronic pain: a multidimensional longitudinal study protocol integrating neurophysiological, cognitive, and psychological measures. Pain Manag. 2026 Jun 16:1-9. doi: 10.1080/17581869.2026.2688379. Online ahead of print.
PubMed 42304633
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Experience of Nociceptive and Neuropathic Pain: Differences in Levels of Central Sensitization
- ClinicalTrials.gov ID
- NCT07321080
- Acronym / sponsor ID
- ALGOS / CEL/U138/25
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nociceptive pain | – | Behavioral: Neuropsychological assessment, Behavioral: Laser evoked potentialsPatients suffering from nociceptive pain |
| Mixed pain | – | Behavioral: Neuropsychological assessment, Behavioral: Laser evoked potentialsPatients suffering from mixed pain |
| Neuropathic pain | – | Behavioral: Neuropsychological assessment, Behavioral: Laser evoked potentialsPatients suffering from neuropathic pain |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Presence of severe psychiatric disorders
- Presence of severe neurological disorders
- Presence of oncological diseases in terminal stage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological assessmentNeuropsychological assessment Standardized and ad hoc test battery for comprehensive neuropsychological assessment | Behavioural | Mixed pain, Neuropathic pain, Nociceptive pain |
| Laser evoked potentialsLaser evoked potentials | Behavioural | Mixed pain, Neuropathic pain, Nociceptive pain |
Primary outcome
neuropsychological assessment
Time frame: 24 months
Central Sensitization Inventory (CSI)
Neuropsychological assessment
Time frame: 24 months
Cognitive functions: Montreal Cognitive Assessment (MoCA)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Derived from this study: PubMed 42304633Anselmo A, Corallo F, Pagano M, Cardile D, Floridia D, Panasiti R, Micali G, Bonanno L, Calabro RS, Cappadona I. Central sensitization across nociceptive, neuropathic, and mixed chronic pain: a multidimensional longitudinal study protocol integrating neurophysiological, cognitive, and psychological measures. Pain Manag. 2026 Jun 16:1-9. doi: 10.1080/17581869.2026.2688379. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Nociceptive Pain, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neuropsychological assessment (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07321080, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.