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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT03882567
Eligibility Criteria:
Inclusion Criteria:
1. . American College of Rheumatology classification criteria for Fibromyalgia.
2. . reported average pain intensity ≥ 4 on a 0 to 10 cm visual analogue scale based on 1 week of daily pain diaries;
3. on stable doses of medications for FM ≥ 4 weeks.
Exclusion Criteria:
* Patients will be excluded from enrolment if: (1) they suffer from an inflammatory rheumatic conditions; (2) have a planned elective surgery during the study period; (3) have ongoing unresolved disability claims; (4) experience symptoms of bipolar disorder, major depressive disorder, panic disorder, or psychosis; (5) do not speak Spanish fluently.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03882567
Study Brief:
Protocol Section:
NCT03882567