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 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
NCT ID:
NCT07048366
Eligibility Criteria:
Inclusion Criteria:
* Female patients
* Diagnosis of Fibromyalgia Syndrome according to 2016 criteria
* Muscle pain Visual Analogue Scale (VAS) score greater than 5 in the last month
* Age between 18 and 60 years
* Absence of other chronic, widespread, or localized painful conditions
* Absence of any other condition that might affect pain perception (e.g., diabetes)
* Absence of neurological or psychiatric conditions that might affect study participation
* Absence of current or past oncological diseases in the last 5 years
* Absence of corticosteroid therapy in the last 30 days
* Absence of NSAID (Non-Steroidal Anti-Inflammatory Drugs) and analgesic therapy in the last 4 days
* Absence of pregnancy and breastfeeding for the entire duration of observation
* Signed informed consent
Exclusion Criteria:
* Presence of severe scoliosis or kyphoscoliosis
* Previous spinal surgeries or sequelae of vertebral fractures
* Presence of lumbosciatalgia (sciatica-like pain in the lower back) at the time of the visit
* Presence of osteoporosis
* Presence of neurological or psychiatric conditions
* Current therapy with corticosteroids and/or NSAIDs and/or analgesics
* Pregnancy or breastfeeding
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT07048366
Study Brief:
Protocol Section:
NCT07048366