Emotional Allodynia Questionnaire (AEQ) in Fibromyalgia (PEARL)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Bari
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
425 Participants
are grouped into 2 trial groupsGroup A: Fibromyalgia cases
Group B: Non-fibromyalgia chronic pain controls
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (T0)2
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).
Time frame
Baseline (T0)3
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.
Time frame
Baseline (T0)Secondary outcomes
1
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).
Time frame
Baseline (T0)2
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).
Time frame
Baseline (T0)3
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.
Time frame
Baseline (T0) and retest at approximately 40 days (plus or minus 10 days)4
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)
Time frame
Baseline (T0)Other outcomes
1
Concordance between AEQ-CSI phenotypes and data-driven clusters
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).
Time frame
Baseline (T0)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Bari
Lead sponsor
University of Bari Aldo Moro
Sponsor institution
Universita di Verona
Collaborator
University of Campania Luigi Vanvitelli
Collaborator
University of Cagliari
Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborator
Source ClinicalTrials.gov