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Emotional Allodynia Questionnaire (AEQ) in Fibromyalgia (PEARL) (PEARL)

24 giugno 2026 aggiornato da: Alberto Corriero, MD, PhD, University of Bari

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

423

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Italia
      • Bari, Italia, 70124
        • Reclutamento
        • Pain Unit, Policlinico di Bari, University of Bari Aldo Moro (coordinating center)
        • Investigatore principale:
          • Mariateresa Giglio, MD
        • Investigatore principale:
          • Filomena Puntillo, MD
        • Investigatore principale:
          • Alberto Corriero, MD, PhD
      • Bologna, Italia, 40138
        • Non ancora reclutamento
        • Anesthesia and Pain Therapy Unit, IRCCS AOSP di Bologna, Policlinico S. Orsola-Malpighi
        • Investigatore principale:
          • Samolsky Dekel Boaz, MD
      • Cagliari, Italia
        • Non ancora reclutamento
        • Department of Medical Sciences and Public Health, University of Cagliari
        • Investigatore principale:
          • Gabriele Finco, MD
      • Naples, Italia
        • Non ancora reclutamento
        • Department of Women, Child and General and Specialized Surgery, University of Campania Luigi Vanvitelli
        • Investigatore principale:
          • Maria Caterina Pace, MD
      • Verona, Italia
        • Non ancora reclutamento
        • Department of Surgery, Dentistry, Pediatrics and Gynecology, University of Verona
        • Investigatore principale:
          • Vittorio Schweiger, MD, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

CASES (fibromyalgia)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Inclusion Criteria:

  • Age 18 years or older
  • 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

Exclusion Criteria (parallel to cases):

  • Diagnosis of fibromyalgia or another recognized nociplastic primary pain condition (e.g., primary chronic widespread pain)
  • 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Internal consistency of the Emotional Allodynia Questionnaire (AEQ) in fibromyalgia cases
Lasso di tempo: 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.
Baseline (T0)
Factorial structure of the Emotional Allodynia Questionnaire (AEQ)
Lasso di tempo: 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).
Baseline (T0)
Known-groups discriminative accuracy of the AEQ (AUC)
Lasso di tempo: 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.
Baseline (T0)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Convergent validity of the Emotional Allodynia Questionnaire (AEQ)
Lasso di tempo: Baseline (T0)
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).
Baseline (T0)
Discriminant validity of the Emotional Allodynia Questionnaire (AEQ) versus the DERS
Lasso di tempo: Baseline (T0)
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).
Baseline (T0)
Test-retest reliability of the Emotional Allodynia Questionnaire (AEQ) total score
Lasso di tempo: Baseline (T0) and retest at approximately 40 days (plus or minus 10 days)
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.
Baseline (T0) and retest at approximately 40 days (plus or minus 10 days)
AEQ score distribution across AEQ-CSI median-split phenotypes
Lasso di tempo: Baseline (T0)
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)
Baseline (T0)
Floor and ceiling effects of the Emotional Allodynia Questionnaire (AEQ)
Lasso di tempo: Baseline (T0)
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).
Baseline (T0)
Depression-stratified internal consistency and convergent validity of the AEQ
Lasso di tempo: Baseline (T0)
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.
Baseline (T0)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Concordance between AEQ-CSI phenotypes and data-driven clusters
Lasso di tempo: Baseline (T0)
Agreement between the theory-driven AEQ-CSI median-split phenotypes (Resilient, Emotional Allodynia, Central Sensitization, Mixed) and data-driven clusters from k-means, hierarchical clustering (Ward's method), and latent class analysis (LCA), reported as the Adjusted Rand Index (range -1 to 1).
Baseline (T0)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Bari

Collaboratori

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Universita di Verona
University of Cagliari
University of Campania Luigi Vanvitelli

Investigatori

  • Investigatore principale: Alberto Corriero, MD, PhD, University of Bari Aldo Moro, Pain and ICU Section

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 settembre 2025

Completamento primario (Stimato)

1 giugno 2027

Completamento dello studio (Stimato)

1 agosto 2027

Date di iscrizione allo studio

Primo inviato

20 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 giugno 2026

Primo Inserito (Effettivo)

1 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PEARL-MC-2026
  • 2451/CEL (Altro identificatore: Ethics Committee protocol number (preliminary single-center phase))

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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