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Enrolling by invitationNCT07301944Updated Jan 6, 2026

Adversity as a Factor Associated With the Development of Fibromyalgia in Patients With Rheumatologic Diseases and Healthy Controls

An observational study in Fibromyalgia, sponsored by National Institute of Medical Sciences and Nutrition, Salvador Zubiran. Enrolling by invitation at 1 site in Mexico. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-06.

Sponsored by National Institute of Medical Sciences and Nutrition, Salvador Zubiran · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
534
Ages
18 Years and older
Sex
All
01

Study summary

Adverse experiences, such as exposure to stressful or traumatic events, have been consistently associated with immune system dysfunction, accelerated inflammatory processes, and an increased risk of developing musculoskeletal symptoms, as well as autoimmune and rheumatologic diseases. The etiopathogenesis of this broad group of conditions is highly complex, involving the interaction of genetic, environmental, hormonal, and immunological factors. Although in many cases no clear external trigger can be identified, scientific evidence has shown that adverse experiences-particularly those occurring during childhood-can induce both acute and chronic stress responses that, over time, disrupt the normal function of the hypothalamic-pituitary-adrenal (HPA) axis. This alteration has been proposed as one of the possible biological explanations for the association described between adversity and the onset of rheumatologic and musculoskeletal disorders.

The primary objective of the present proposal is to evaluate the risk of developing fibromyalgia in relation to the presence of adverse experiences, both in patients already diagnosed with rheumatologic diseases and in healthy individuals. To achieve this objective, a longitudinal follow-up study is proposed in which two cohorts will be systematically evaluated: the first cohort will consist of patients with a confirmed diagnosis of rheumatologic conditions, while the second cohort will consist of healthy individuals, carefully matched to the patient group by age and sex in order to minimize potential confounding factors.

The study will begin with a defined selection period, during which eligibility will be verified according to rigorous inclusion and exclusion criteria. Only those individuals who meet all requirements will be enrolled. After enrollment, comprehensive sociodemographic and clinical data will be collected. Standardized and validated questionnaires will then be administered to explore participants' exposure to adverse experiences, considering both childhood and adulthood events. Additionally, these instruments will be used to assess factors closely linked to overall health outcomes, including quality of life, physical health, and mental health.

Data collection will be performed at multiple time points to capture both baseline and longitudinal information. Specifically, measurements will be obtained at baseline (upon enrollment) and during follow-up assessments at 3, 6, and 12 months. This approach will make it possible to evaluate not only cross-sectional associations but also temporal relationships and dynamic changes over time, thereby providing a more robust understanding of the impact of adverse experiences on the potential development of fibromyalgia.

By integrating clinical and psychosocial data across different time points, the study seeks to clarify the multifactorial mechanisms through which adverse experiences may influence the risk of fibromyalgia among individuals with rheumatologic conditions as well as among healthy participants. Ultimately, the findings may contribute to advancing knowledge about disease risk and progression, with the potential to inform preventive strategies and guide future therapeutic approaches.

02

Conditions studied

  • Fibromyalgia

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03

In context

Fibromyalgia

1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.

This study's planned enrollment of 534 is above the median of 100 across 279 observational studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

National Institute of Medical Sciences and Nutrition, Salvador Zubiran is the lead sponsor of 16 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Cohort 1: Patients who are beneficiaries of institutional care, Age $\geq 18$ years, with a diagnosis of a rheumatological disease, who will be followed for 12 months. Questionnaires will be answered on paper or through a digital platform, according to the participant's preference. Cohort 2: Healthy individuals matched for age and sex with patients diagnosed with a rheumatological disease, who will be followed for 12 months. Questionnaires will be answered on paper or through a digital platform, according to the participant's preference.

Eligibility criteria

Inclusion Criteria Cohort 1:

  • Patient who is a beneficiary of institutional care.
  • Confirmed diagnosis of rheumatological disease according to the treating physician's criteria.
  • Onset of the rheumatological disease in adulthood (>18 years).
  • Must have signed the form to participate in the research study.

Exclusion Criteria Cohort 1:

  • Concomitant diagnosis of severe disease that compromises the person's short-to-medium-term survival.
  • Diagnosis of fibromyalgia self-reported or confirmed during the selection process.
  • Lack of availability for follow-up.

Inclusion Criteria Cohort 2:

Exclusion Criteria Cohort 2:

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
534 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • Patients with rheumatologic diseases
  • Healthy controls
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What researchers measure

Primary outcomes

  1. Newly Diagnosed Fibromyalgia

    A diagnosis of fibromyalgia will be established for all participants who, over the 12 months of the study, obtain a Widespread Pain Index (WPI) score ≥7 plus a Symptom Severity (SS) Scale score ≥5, OR a WPI score between 3 and 6 plus an SS Scale score ≥9.

    Time frame: From enrollment to the end of the study at 12 months.

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2025 (actual). Primary completion is estimated for Jan 2026, 6 months after the start.

Of 81 non-industry observational studies under Fibromyalgia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 109. This study's planned 6 months is below that.

Counting every sponsor, half of 88 studies reached it within 27 months; a quarter within 8 and three quarters within 91.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 11, 2025
First posted
Dec 24, 2025
StartActual
Jul 28, 2025
Primary completionEst.
Jan 28, 2026
CompletionEst.
Jan 28, 2027
Last update
Jan 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07301944
Lead sponsor
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Responsible party
Virginia Pascual Ramos (Principal Investigator, National Institute of Medical Sciences and Nutrition, Salvador Zubiran) — Principal investigator
First posted
Dec 24, 2025
Start date
Jul 28, 2025
Primary completion
Jan 28, 2026 (estimated)
Completion
Jan 28, 2027 (estimated)
Last update
Jan 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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