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Could a simple questionnaire unmask Fibromyalgia's hidden emotional toll?

NCT ID NCT07677631

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 425 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

Chronic Pain chronic pain syndrome Emotional Regulation fibromyalgia Nociplastic Pain

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.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

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

    NOT_YET_RECRUITING

    Bologna, 40138, Italy

  • Department of Medical Sciences and Public Health, University of Cagliari

    NOT_YET_RECRUITING

    Cagliari, Italy

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

    NOT_YET_RECRUITING

    Verona, Italy

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

    NOT_YET_RECRUITING

    Naples, Italy

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

    RECRUITING

    Bari, 70124, Italy

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