Could a simple questionnaire unmask Fibromyalgia's hidden emotional toll?
NCT ID NCT07677631
First seen Jul 01, 2026 · Last updated Sep 11, 2026 · Updated 2 times
Summary
This study evaluates a questionnaire called the Emotional Allodynia Questionnaire (AEQ), which measures how people with fibromyalgia react emotionally to everyday social cues. Researchers want to see if the tool can reliably identify fibromyalgia and tell it apart from other types of chronic pain. The study involves adults with fibromyalgia and those with other pain conditions, but does not test any treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this questionnaire could become a tool to help diagnose fibromyalgia and distinguish it from other chronic pain conditions.
- What could go wrong
- This is an observational study, not a treatment trial. The questionnaire may not prove accurate enough for widespread use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 425 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Anesthesia and Pain Therapy Unit, IRCCS AOSP di Bologna, Policlinico S. Orsola-Malpighi
NOT_YET_RECRUITINGBologna, 40138, Italy
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Department of Medical Sciences and Public Health, University of Cagliari
NOT_YET_RECRUITINGCagliari, Italy
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Department of Surgery, Dentistry, Pediatrics and Gynecology, University of Verona
NOT_YET_RECRUITINGVerona, Italy
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Department of Women, Child and General and Specialized Surgery, University of Campania Luigi Vanvitelli
NOT_YET_RECRUITINGNaples, Italy
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Pain Unit, Policlinico di Bari, University of Bari Aldo Moro (coordinating center)
RECRUITINGBari, 70124, Italy
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