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

NCT ID: NCT07301944

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 534 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-28
• Study Completion Date: 2027-01-28

Brief 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.

Conditions

Fibromyalgia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with rheumatologic diseases

No interventions assigned to this group

Healthy controls

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

OTHER

Sponsor Role: lead

Responsible Party

Virginia Pascual Ramos

MD, MSc, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Tlalpan, Mexico City, Mexico

Countries

Mexico

Other Identifiers

IRE-5559-25-27-1

Identifier Type: REGISTRY

Identifier Source: secondary_id

IRE-5559-25-27-1

Identifier Type: -

Identifier Source: org_study_id