FibromyalgiaNCT07301944
Adversity as a Factor Associated With the Development of Fibromyalgia in Patients With Rheumatologic Diseases and Healthy Controls
An observational study of Fibromyalgia, run by National Institute of Medical Sciences and Nutrition, Salvador Zubiran at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- How many people
- 534 participants
- Where
- 1 siteMexico
- Study dates
- 28 Jul 2025to 28 Jan 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Tlalpan, Mexico City, 14080
About this study
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.
Read more
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
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with rheumatologic diseases | Not described | |
| Healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of the study at 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start28 Jul 2025
- Primary completion28 Jan 2026 (estimated)
- Study completion28 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 534 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- National Institute of Medical Sciences and Nutrition, Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virginia Pascual Ramos, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301944
- Sponsor's protocol ID
- IRE-5559-25-27-1
- Other IDs
- IRE-5559-25-27-1
- Status last verified
- Jan 2026
- First submitted
- 11 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adversity as a Factor Associated With the Development of Fibromyalgia in Patients With Rheumatologic Diseases and Healthy Controls
- ClinicalTrials.gov ID
- NCT07301944
- Acronym / sponsor ID
- IRE-5559-25-27-1
- Conditions
- Fibromyalgia
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 534 participants (estimated)
- Lead sponsor
- National Institute of Medical Sciences and Nutrition, Salvador ZubiranUniversity, hospital or other
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 28 Jan 2026 (estimated)
- Study completion
- 28 Jan 2027 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with rheumatologic diseases | – | – |
| Healthy controls | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by National Institute of Medical Sciences and Nutrition, Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Newly Diagnosed Fibromyalgia (time frame: From enrollment to the end of the study at 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.