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:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT04502251
Eligibility Criteria:
Inclusion Criteria:
* signed the consent form
* women from 18 to 65 years
* confirmed diagnosis of fibromyalgia according 2016 American College of Rheumatology criteria
* read and write
* pain higher than 6 in the Visual Analogue Scale (VAS), in the last 3 months
* chronic stable treatment in the last 3 months.
Exclusion Criteria:
* in use of opioid drugs;
* pregnancy or not using anticontraceptive
* history of alcohol or drug abuse in the last 6 months
* history of neurological pathologies
* history of arrhythmia
* history of use of drugs that might change vascular response
* history of head trauma
* history of neurosurgery
* decompensated systemic diseases or chronic inflammatory diseases (lupus, rheumatoid arthritis, Sjogren syndrome, Reiter syndrome)
* history of non-compensated hypothyroidism
* personal history of cancer.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
8 Years
Maximum Age:
65 Years
Study:
NCT04502251
Study Brief:
Protocol Section:
NCT04502251