Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT05017220
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of fibromyalgia syndrome (ACR criteria 2016).
* Chronic widespread musculoskeletal pain symptoms (\>1 location using the Widespread Pain Index).
* High-intensity pain (VAS ≥ 4), at least 3 days a week for the previous 3 months.
* If currently taking analgesic or psychotropic medications, they had to be stabilised for four or more weeks before the study enrolment
* Over 18 and less than 65 years old (labour active).
* Ability to speak and understand English or Spanish.
Exclusion Criteria:
* Acute or temporal pain
* Severe cognitive impairment, detected by the Mini-Mental State Examination (score \<24 out of 30 points)
* Severe mental disorders in acute phase or symptomatic phase
* Behavioural alterations as this may interfere in their participation
* Severe intellectual disability
* Other severe or medically unstable diseases interfering with the project participation
* Co-occurrence of neuropathic pain
* Other disorders that may cause pain
* Pregnant or breast-feeding
* Drug abuse within the past year.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05017220
Study Brief:
Protocol Section:
NCT05017220