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

8. september 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

425

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Internal consistency of the Emotional Allodynia Questionnaire (AEQ) in fibromyalgia cases
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Convergent validity of the Emotional Allodynia Questionnaire (AEQ)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Concordance between AEQ-CSI phenotypes and data-driven clusters
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Bari

Samarbeidspartnere

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

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

10. september 2025

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. august 2027

Datoer for studieregistrering

Først innsendt

20. juni 2026

Først innsendt som oppfylte QC-kriteriene

24. juni 2026

Først lagt ut (Faktiske)

1. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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