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Enrolling by Invitation

NCT Number: NCT07301944

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Tlalpan, Mexico City, 14080, Mexico

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 informed consent 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:

Treatment and study plan

Primary outcomes

  1. Newly Diagnosed Fibromyalgia

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

    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.

Sponsors and collaborators

Lead sponsor

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 24, 2025
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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