Emotional Allodynia Questionnaire (AEQ) in Fibromyalgia (PEARL)

NCT07677631 | Recruiting

• 2 other identifiers: PEARL-MC-20262451/CEL
• Study Type: observational
• Target: 423
• Locations: 1 country
• Sites: 5

Brief 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. 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.

Conditions

Fibromyalgia; Chronic Pain; Nociplastic Pain

Keywords

Emotional Allodynia Questionnaire; Fibromyalgia; Nociplastic pain; Psychometric validation; Central sensitization; Emotion regulation

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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.

  Baseline (T0)

Secondary Outcomes (6)

• Convergent validity of the Emotional Allodynia Questionnaire (AEQ)

  Baseline (T0)

• Discriminant validity of the Emotional Allodynia Questionnaire (AEQ) versus the DERS

  Baseline (T0)

• Test-retest reliability of the Emotional Allodynia Questionnaire (AEQ) total score

  Baseline (T0) and retest at approximately 40 days (plus or minus 10 days)

• AEQ score distribution across AEQ-CSI median-split phenotypes

  Baseline (T0)

• Floor and ceiling effects of the Emotional Allodynia Questionnaire (AEQ)

  Baseline (T0)

Other Outcomes (1)

• Concordance between AEQ-CSI phenotypes and data-driven clusters

  Baseline (T0)

Study Arms (2)

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.

Eligibility Criteria

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

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.

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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
• 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

Sponsors & Collaborators

• University of Bari: lead
• Universita di Verona: collaborator
• University of Campania Luigi Vanvitelli: collaborator
• University of Cagliari: collaborator
• IRCCS Azienda Ospedaliero-Universitaria di Bologna: collaborator

Study Sites (5)

Pain Unit, Policlinico di Bari, University of Bari Aldo Moro (coordinating center)

Bari, 70124, Italy

RECRUITING

Anesthesia and Pain Therapy Unit, IRCCS AOSP di Bologna, Policlinico S. Orsola-Malpighi

Bologna, 40138, Italy

NOT YET RECRUITING

Department of Medical Sciences and Public Health, University of Cagliari

Cagliari, Italy

NOT YET RECRUITING

Department of Women, Child and General and Specialized Surgery, University of Campania Luigi Vanvitelli

Naples, Italy

NOT YET RECRUITING

Department of Surgery, Dentistry, Pediatrics and Gynecology, University of Verona

Verona, Italy

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 42261300 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain; Nociplastic Pain; Emotional Regulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Self-Control; Social Behavior; Behavior

Study Officials

• Alberto Corriero, MD, PhD

  University of Bari Aldo Moro, Pain and ICU Section

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto Corriero, MD, PhD

CONTACT

+39 3280072443; alberto.corriero@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 20, 2026
• First Posted: July 1, 2026
• Study Start: September 10, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5)