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
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.
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 →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.
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.
Inclusion Criteria Cohort 1:
Exclusion Criteria Cohort 1:
Inclusion Criteria Cohort 2:
Exclusion Criteria Cohort 2:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Plan to share: Undecided
No publications or documents are linked to this record.
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.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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National Institute of Medical Sciences and Nutrition, Salvador Zubiran