Pain, Emotional Allodynia, and Relational Load (PEARL): A Multicenter Validation Study of the Emotional Allodynia Questionnaire in Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 425
- 试验地点
- 5
- 主要终点
- Internal consistency of the Emotional Allodynia Questionnaire (AEQ) in fibromyalgia cases
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
Fibromyalgia cases
Adults with fibromyalgia diagnosed per the 2016 ACR criteria.
结局指标
主要结局
Internal consistency of the Emotional Allodynia Questionnaire (AEQ) in fibromyalgia cases
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- 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))
- Depression-stratified internal consistency and convergent validity of the AEQ(Baseline (T0))
研究者
Alberto Corriero, MD, PhD
Principal Investigator
University of Bari Aldo Moro