FibromyalgiaPEARLNCT07677631
Emotional Allodynia Questionnaire (AEQ) in Fibromyalgia (PEARL)
An observational study of Fibromyalgia and Chronic Pain, run by University of Bari at 5 sites in Italy.
Trial summary
The Emotional Allodynia Questionnaire (AEQ) is an 11-item self-report instrument that measures disproportionate emotional reactivity to low-intensity interpersonal cues(perceived unresponsiveness, exclusion, loss of reciprocity), a pattern termed emotional allodynia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Chronic Pain, Nociplastic Pain
- How many people
- 425 participants
- Where
- 5 sitesItaly
- Study dates
- 10 Sep 2025to Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults attending Italian tertiary pain outpatient services. Cases are identified from fibromyalgia services; controls are identified among patients attending the same services for chronic non-cancer pain of defined nociceptive or neuropathic origin. Consecutive eligible patients are considered for enrollment.
Who may be able to join
- Age 18 years or older
- Clinical diagnosis of fibromyalgia confirmed according to the 2016 revision of the ACR criteria
- Chronic non-cancer pain for at least 3 months
- Ability to understand and independently complete self-report questionnaires in Italian
- Willingness to provide written informed consent
- Age 18 years or older
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- Chronic non-cancer pain for at least 3 months with a defined nociceptive or neuropathic generator (e.g., radiologically or surgically documented degenerative, structural, or post-surgical musculoskeletal pain, or neuropathic pain with an identifiable neurological lesion or disease)
- Not meeting the 2016 ACR criteria for fibromyalgia
- Ability to understand and independently complete self-report questionnaires in Italian
- Willingness to provide written informed consent
Who cannot join
- Active oncological disease or cancer-related pain
- Any current or past psychiatric diagnosis except Major Depressive Disorder and Panic Disorder (assessed by clinical history)
- Severe cognitive impairment precluding questionnaire completion
- Inability to understand or complete questionnaires in Italian
- CONTROLS (non-fibromyalgia chronic pain)
- Diagnosis of fibromyalgia or another recognized nociplastic primary pain condition (e.g., primary chronic widespread pain)
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- Active oncological disease or cancer-related pain
- Any current or past psychiatric diagnosis except Major Depressive Disorder and Panic Disorder
- Severe cognitive impairment precluding questionnaire completion
- Inability to understand or complete questionnaires in Italian
- Note: ongoing pharmacological treatment for pain or mental health is not an exclusion criterion in either group; Major Depressive Disorder and Panic Disorder are recorded at baseline and used in covariate-adjusted and stratified analyses.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Italy5 sites, 5 recruiting
- Recruiting
Pain Unit, Policlinico di Bari, University of Bari Aldo Moro (coordinating center)
Bari, 70124
Filomena Puntillo, MD
Alberto Corriero, MD, PhD
- Not yet recruiting
Anesthesia and Pain Therapy Unit, IRCCS AOSP di Bologna, Policlinico S. Orsola-Malpighi
Bologna, 40138
Samolsky Dekel Boaz, MD
- Not yet recruiting
Department of Medical Sciences and Public Health, University of Cagliari
Cagliari
Gabriele Finco, MD
- Not yet recruiting
Department of Women, Child and General and Specialized Surgery, University of Campania Luigi Vanvitelli
Naples
Maria Caterina Pace, MD
Maria Beatrice Passavanti, MD
- Not yet recruiting
Department of Surgery, Dentistry, Pediatrics and Gynecology, University of Verona
Verona
Vittorio Schweiger, MD, PhD
About this study
Official title: Pain, Emotional Allodynia, and Relational Load (PEARL): A Multicenter Validation Study of the Emotional Allodynia Questionnaire in Fibromyalgia
The Emotional Allodynia Questionnaire (AEQ) is an 11-item self-report instrument that measures disproportionate emotional reactivity to low-intensity interpersonal cues(perceived unresponsiveness, exclusion, loss of reciprocity), a pattern termed emotional allodynia. It was preliminarily validated in a single-center fibromyalgia sample. PEARL (validation phase) is a multicenter, prospective, observational psychometric validation study that (1) replicates the internal structure and convergent validity of the AEQ in an independent fibromyalgia sample, (2) tests its known-groups (discriminative) accuracy in separating fibromyalgia from non-fibromyalgia chronic pain of defined nociceptive or neuropathic origin, expressed as the area under the ROC curve (AUC), and (3) assesses test-retest reliability. There is no intervention.
Read the detailed description
Design: multicenter (Italian tertiary pain centers), observational, case-control psychometric validation study. Cases are adults with fibromyalgia (2016 ACR criteria); controls are adults with chronic non-cancer pain of defined nociceptive or neuropathic origin who do not meet fibromyalgia criteria. Group membership reflects clinical diagnosis and is not assigned by the investigators.
Assessment: the primary assessment is cross-sectional at baseline (T0). All enrolled participants (cases and controls) are reassessed once for test-retest reliability (T1) at approximately 40 days (plus or minus 10 days). The battery comprises the AEQ, Central Sensitization Inventory (CSI), Pain Catastrophizing Scale (PCS), Beck Depression Inventory-II (BDI-II), State-Trait Anxiety Inventory (STAI-Y forms 1 and 2), Difficulties in Emotion Regulation Scale (DERS), and a Visual Analog Scale (VAS) for pain. Questionnaires are self-administered on paper with physician-verified completeness at the point of care, then transcribed into a secure online data-collection form.
Sample size: two targets. The fibromyalgia cohort comprises 274 patients (137 per depression stratum, sized for internal consistency and depression-stratified estimation; PASS 2024 v24.0.5). For the known-groups discriminative analysis, 151 evaluable non-fibromyalgia chronic pain controls are required, sized on precision for a 95% confidence interval of width 0.10 around an anticipated AUC of 0.80 (Hanley-McNeil standard-error method, PASS 2024 v24.0.9); the 97-per-group level is the minimum to test an AUC of 0.80 against a null of 0.70 (two-sided alpha 0.05, 80% power; Hanley-McNeil / Obuchowski-McClish).
Primary analysis: ROC analysis with the AEQ total score as classifier and diagnostic group as the reference (fibromyalgia = positive); the AUC is tested against 0.70 with its 95% CI. A covariate-adjusted logistic-regression sensitivity analysis (age, sex, depressive comorbidity) and a center-adjusted analysis are pre-specified. Secondary analyses include convergent and discriminant validity, exploratory and confirmatory factor analysis, test-retest ICC, AEQ-CSI median-split phenotyping (Resilient, Emotional Allodynia, Central Sensitization, Mixed), a pre-specified depression-stratified analysis, and exploratory unsupervised clustering.
Protocol amendment (version 2.1, 5 September 2026). The statistical analysis plan is revised as follows: (1) latent profile analysis on the continuous scores replaces latent class analysis as the primary model-based method for unsupervised phenotyping; (2) discriminant validity by the Fornell-Larcker criterion is examined against the Pain Catastrophizing Scale in addition to the DERS; (3) the AUC is additionally reported, descriptively, within the nociceptive and neuropathic subgroups of the control cohort. Eligibility, procedures, participant burden and consent are unchanged.
- Conditions
- Fibromyalgia, Chronic Pain, Nociplastic Pain
- Keywords
- Emotional Allodynia Questionnaire, Fibromyalgia, Nociplastic pain, Psychometric validation, Central sensitization, Emotion regulation
- Medical subject headings
- Fibromyalgia, Chronic Pain, Nociplastic Pain, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia cases | Adults with fibromyalgia diagnosed per the 2016 ACR criteria. | |
| Non-fibromyalgia chronic pain controls | Adults with chronic non-cancer pain of defined nociceptive or neuropathic origin who do not meet the 2016 ACR criteria for fibromyalgia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal consistency of the Emotional Allodynia Questionnaire (AEQ) in fibromyalgia cases
Internal consistency reliability of the AEQ, an 11-item self-report questionnaire (total score range 0-44), in fibromyalgia cases, assessed using Cronbach's alpha and McDonald's omega, each reported with 95% confidence intervals.
Measured: Baseline (T0)
Factorial structure of the Emotional Allodynia Questionnaire (AEQ)
Latent factor structure of the 11-item AEQ self-report questionnaire, assessed by exploratory factor analysis and a single-factor confirmatory factor analysis (CFA). Reported as CFA model fit indices: comparative fit index (CFI), Tucker-Lewis index (TLI), root mean square error of approximation (RMSEA), and standardized root mean square residual (SRMR).
Measured: Baseline (T0)
Known-groups discriminative accuracy of the AEQ (AUC)
Discriminative accuracy of the AEQ total score (11-item self-report questionnaire) in distinguishing fibromyalgia cases from non-fibromyalgia chronic pain controls, reported as the area under the receiver operating characteristic (ROC) curve (AUC, range 0-1) with 95% confidence interval, tested against a null value of 0.70.
Measured: Baseline (T0)
Secondary outcomes (6)
Convergent validity of the Emotional Allodynia Questionnaire (AEQ)
Convergent validity reported as Spearman rank correlation coefficients (rho, range -1 to 1) between the AEQ total score and the Central Sensitization Inventory (CSI), Pain Catastrophizing Scale (PCS), Beck Depression Inventory-II (BDI-II), State-Trait Anxiety Inventory (STAI-Y), and Difficulties in Emotion Regulation Scale (DERS).
Measured: Baseline (T0)
Discriminant validity of the Emotional Allodynia Questionnaire (AEQ) versus the DERS
Discriminant validity of the AEQ relative to the DERS, reported as (a) a chi-square statistic for dissociation across AEQ and DERS median-split groups and (b) the Fornell-Larcker criterion, comparing the AEQ's average variance extracted (AVE) with the squared AEQ-DERS correlation (proportions, range 0-1).
Measured: Baseline (T0)
Test-retest reliability of the Emotional Allodynia Questionnaire (AEQ) total score
Test-retest reliability of the AEQ total score (11-item self-report questionnaire) in the full enrolled sample (cases and controls), reported as the intraclass correlation coefficient (ICC, range 0-1; two-way mixed-effects model, absolute agreement, single rater) with 95% confidence interval.
Measured: Baseline (T0) and retest at approximately 40 days (plus or minus 10 days)
AEQ score distribution across AEQ-CSI median-split phenotypes
Distribution of the AEQ total score (points, range 0-44) across the four AEQ-CSI median-split phenotypes (Resilient, Emotional Allodynia, Central Sensitization, Mixed), and between-phenotype differences on validated measures not used to define them (PCS, BDI-II, STAI-Y, DERS total scores)
Measured: Baseline (T0)
Floor and ceiling effects of the Emotional Allodynia Questionnaire (AEQ)
Reported as the percentage of participants (%) scoring at the minimum (floor) and at the maximum (ceiling) of the AEQ total score (11-item self-report questionnaire, total score range 0-44).
Measured: Baseline (T0)
Depression-stratified internal consistency and convergent validity of the AEQ
Computed separately within fibromyalgia cases stratified by presence vs. absence of major depressive disorder, reported as Cronbach's alpha (range 0-1) and Spearman correlation coefficients (rho, range -1 to 1) of the AEQ total score with CSI, PCS, BDI-II, STAI-Y, and DERS.
Measured: Baseline (T0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start10 Sep 2025
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 425 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Collaborators
- Universita di Verona, University of Campania Luigi Vanvitelli, University of Cagliari, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Responsible party
- Principal investigator, Alberto Corriero, MD, PhD, University of Bari Aldo Moro
- Investigators
- Alberto Corriero, MD, PhD, Principal investigator, University of Bari Aldo Moro, Pain and ICU Section
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677631
- Sponsor's protocol ID
- PEARL-MC-2026
- Other IDs
- 2451/CEL
- Acronym
- PEARL
- Status last verified
- Sep 2026
- First submitted
- 20 Jun 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly. Under Italian data protection regulations and the EU General Data Protection Regulation (GDPR), participant-level data from this study cannot be made publicly available. The working dataset is pseudonymized and held on secure institutional systems. De-identified data supporting the main findings may be made available from the corresponding author upon reasonable request, subject to a data-sharing agreement and compliance with applicable data-protection requirements.
Publications
Corriero A, Giglio M, Pilolla A, Galdini F, Mucci O, Vurro M, Fornarelli F, Di Venosa C, Trerotoli P, Puntillo F. The Emotional Allodynia Questionnaire: Preliminary Validation and Clinical Phenotyping in Fibromyalgia. J Pain Res. 2026 Jun 3;19:607309. doi: 10.2147/JPR.S607309. eCollection 2026.
PubMed 42261300Corriero A, Giglio M, Pilolla A, Trerotoli P, Schweiger V, Polati E, Pace MC, Passavanti MB, Finco G, Sardo S, Dekel BGS, Sorella MC, Di Venosa C, Costantino E, De Orsi D, Puntillo F. Pain, Emotional Allodynia, and Relational Load (PEARL): Protocol of a Multicenter Observational Case-Control Study Validating the Emotional Allodynia Questionnaire in Fibromyalgia. J Clin Med. 2026 Sep 19;15(18):7299. doi: 10.3390/jcm15187299.
PubMed 42796071
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain, Emotional Allodynia, and Relational Load (PEARL): A Multicenter Validation Study of the Emotional Allodynia Questionnaire in Fibromyalgia
- ClinicalTrials.gov ID
- NCT07677631
- Acronym / sponsor ID
- PEARL / PEARL-MC-2026
- Conditions
- Fibromyalgia, Chronic Pain, Nociplastic Pain
- Keywords
- Emotional Allodynia Questionnaire, Fibromyalgia, Nociplastic pain, Psychometric validation, Central sensitization, Emotion regulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 425 participants (estimated)
- Lead sponsor
- University of BariUniversity, hospital or other
- Collaborators
- Universita di Verona, University of Campania Luigi Vanvitelli, University of Cagliari, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 1 Jul 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.
The Emotional Allodynia Questionnaire (AEQ) is an 11-item self-report instrument that measures disproportionate emotional reactivity to low-intensity interpersonal cues(perceived unresponsiveness, exclusion, loss of reciprocity), a pattern termed emotional allodynia. It was preliminarily validated in a single-center fibromyalgia sample. PEARL (validation phase) is a multicenter, prospective, observational psychometric validation study that (1) replicates the internal structure and convergent validity of the AEQ in an independent fibromyalgia sample, (2) tests its known-groups (discriminative) accuracy in separating fibromyalgia from non-fibromyalgia chronic pain of defined nociceptive or neuropathic origin, expressed as the area under the ROC curve (AUC), and (3) assesses test-retest reliability. There is no intervention.
Detailed description
Design: multicenter (Italian tertiary pain centers), observational, case-control psychometric validation study. Cases are adults with fibromyalgia (2016 ACR criteria); controls are adults with chronic non-cancer pain of defined nociceptive or neuropathic origin who do not meet fibromyalgia criteria. Group membership reflects clinical diagnosis and is not assigned by the investigators.
Assessment: the primary assessment is cross-sectional at baseline (T0). All enrolled participants (cases and controls) are reassessed once for test-retest reliability (T1) at approximately 40 days (plus or minus 10 days). The battery comprises the AEQ, Central Sensitization Inventory (CSI), Pain Catastrophizing Scale (PCS), Beck Depression Inventory-II (BDI-II), State-Trait Anxiety Inventory (STAI-Y forms 1 and 2), Difficulties in Emotion Regulation Scale (DERS), and a Visual Analog Scale (VAS) for pain. Questionnaires are self-administered on paper with physician-verified completeness at the point of care, then transcribed into a secure online data-collection form.
Sample size: two targets. The fibromyalgia cohort comprises 274 patients (137 per depression stratum, sized for internal consistency and depression-stratified estimation; PASS 2024 v24.0.5). For the known-groups discriminative analysis, 151 evaluable non-fibromyalgia chronic pain controls are required, sized on precision for a 95% confidence interval of width 0.10 around an anticipated AUC of 0.80 (Hanley-McNeil standard-error method, PASS 2024 v24.0.9); the 97-per-group level is the minimum to test an AUC of 0.80 against a null of 0.70 (two-sided alpha 0.05, 80% power; Hanley-McNeil / Obuchowski-McClish).
Primary analysis: ROC analysis with the AEQ total score as classifier and diagnostic group as the reference (fibromyalgia = positive); the AUC is tested against 0.70 with its 95% CI. A covariate-adjusted logistic-regression sensitivity analysis (age, sex, depressive comorbidity) and a center-adjusted analysis are pre-specified. Secondary analyses include convergent and discriminant validity, exploratory and confirmatory factor analysis, test-retest ICC, AEQ-CSI median-split phenotyping (Resilient, Emotional Allodynia, Central Sensitization, Mixed), a pre-specified depression-stratified analysis, and exploratory unsupervised clustering.
Protocol amendment (version 2.1, 5 September 2026). The statistical analysis plan is revised as follows: (1) latent profile analysis on the continuous scores replaces latent class analysis as the primary model-based method for unsupervised phenotyping; (2) discriminant validity by the Fornell-Larcker criterion is examined against the Pain Catastrophizing Scale in addition to the DERS; (3) the AUC is additionally reported, descriptively, within the nociceptive and neuropathic subgroups of the control cohort. Eligibility, procedures, participant burden and consent are unchanged.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia cases | – | –Adults with fibromyalgia diagnosed per the 2016 ACR criteria. |
| Non-fibromyalgia chronic pain controls | – | –Adults with chronic non-cancer pain of defined nociceptive or neuropathic origin who do not meet the 2016 ACR criteria for fibromyalgia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults attending Italian tertiary pain outpatient services. Cases are identified from fibromyalgia services; controls are identified among patients attending the same services for chronic non-cancer pain of defined nociceptive or neuropathic origin. Consecutive eligible patients are considered for enrollment.
Key inclusion criteria (10 listed)
- Age 18 years or older
- Clinical diagnosis of fibromyalgia confirmed according to the 2016 revision of the ACR criteria
- Chronic non-cancer pain for at least 3 months
- Ability to understand and independently complete self-report questionnaires in Italian
- Willingness to provide written informed consent
Key exclusion criteria (11 listed)
- Active oncological disease or cancer-related pain
- Any current or past psychiatric diagnosis except Major Depressive Disorder and Panic Disorder (assessed by clinical history)
- Severe cognitive impairment precluding questionnaire completion
- Inability to understand or complete questionnaires in Italian
- CONTROLS (non-fibromyalgia chronic pain)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Internal consistency of the Emotional Allodynia Questionnaire (AEQ) in fibromyalgia cases
Time frame: Baseline (T0)
Internal consistency reliability of the AEQ, an 11-item self-report questionnaire (total score range 0-44), in fibromyalgia cases, assessed using Cronbach's alpha and McDonald's omega, each reported with 95% confidence intervals.
Factorial structure of the Emotional Allodynia Questionnaire (AEQ)
Time frame: Baseline (T0)
Latent factor structure of the 11-item AEQ self-report questionnaire, assessed by exploratory factor analysis and a single-factor confirmatory factor analysis (CFA). Reported as CFA model fit indices: comparative fit index (CFI), Tucker-Lewis index (TLI), root mean square error of approximation (RMSEA), and standardized root mean square residual (SRMR).
Known-groups discriminative accuracy of the AEQ (AUC)
Time frame: Baseline (T0)
Discriminative accuracy of the AEQ total score (11-item self-report questionnaire) in distinguishing fibromyalgia cases from non-fibromyalgia chronic pain controls, reported as the area under the receiver operating characteristic (ROC) curve (AUC, range 0-1) with 95% confidence interval, tested against a null value of 0.70.
6 secondary outcomes
Convergent validity of the Emotional Allodynia Questionnaire (AEQ)
Time frame: Baseline (T0)
Discriminant validity of the Emotional Allodynia Questionnaire (AEQ) versus the DERS
Time frame: Baseline (T0)
Test-retest reliability of the Emotional Allodynia Questionnaire (AEQ) total score
Time frame: Baseline (T0) and retest at approximately 40 days (plus or minus 10 days)
AEQ score distribution across AEQ-CSI median-split phenotypes
Time frame: Baseline (T0)
Floor and ceiling effects of the Emotional Allodynia Questionnaire (AEQ)
Time frame: Baseline (T0)
Depression-stratified internal consistency and convergent validity of the AEQ
Time frame: Baseline (T0)
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 11 Sep 2026.
- Background: PubMed 42261300Corriero A, Giglio M, Pilolla A, Galdini F, Mucci O, Vurro M, Fornarelli F, Di Venosa C, Trerotoli P, Puntillo F. The Emotional Allodynia Questionnaire: Preliminary Validation and Clinical Phenotyping in Fibromyalgia. J Pain Res. 2026 Jun 3;19:607309. doi: 10.2147/JPR.S607309. eCollection 2026.
- Derived from this study: PubMed 42796071Corriero A, Giglio M, Pilolla A, Trerotoli P, Schweiger V, Polati E, Pace MC, Passavanti MB, Finco G, Sardo S, Dekel BGS, Sorella MC, Di Venosa C, Costantino E, De Orsi D, Puntillo F. Pain, Emotional Allodynia, and Relational Load (PEARL): Protocol of a Multicenter Observational Case-Control Study Validating the Emotional Allodynia Questionnaire in Fibromyalgia. J Clin Med. 2026 Sep 19;15(18):7299. doi: 10.3390/jcm15187299.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly. Under Italian data protection regulations and the EU General Data Protection Regulation (GDPR), participant-level data from this study cannot be made publicly available. The working dataset is pseudonymized and held on secure institutional systems. De-identified data supporting the main findings may be made available from the corresponding author upon reasonable request, subject to a data-sharing agreement and compliance with applicable data-protection requirements.
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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.
Alberto Corriero, MD, PhD principal investigator
University of Bari Aldo Moro, Pain and ICU Section
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Chronic Pain, run by University of Bari at 5 sites 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 10 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Contact Alberto Corriero, MD, PhD (+39 3280072443, alberto.corriero@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal consistency of the Emotional Allodynia Questionnaire (AEQ) in fibromyalgia cases (time frame: Baseline (T0)). The study lists 3 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 NCT07677631, which also lists 2 linked publications.
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 11 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.