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 @ 7:14 PM
Ignite Modification Date:
2025-12-24 @ 7:14 PM
NCT ID:
NCT01745003
Eligibility Criteria:
The inclusion criteria are:
1. Women who have met American College of Rheumatology (1990) criteria for the diagnosis of FM (Wolfe, Smythe et al. 1990) for at least 1 year. To fulfill the criteria for FM established by the American College of Rheumatology in 1990, an individual must have both chronic widespread pain involving all four quadrants of the body (and the axial skeleton), and the presence of 11 of 18 pre-defined "tender points" on examination. A positive tender point is identified when an individual complains of pain when approximately four kilograms of pressure is applied to one of these points by an examiner
2. Continued presence of pain more than 50% of days
3. Willingness to limit the introduction of any new medications or treatment modalities for control of FM symptoms during the study
4. Being over 18 and under 65 years of age
5. BMI of 36 or less (because we use the MRI machine)
6. Capability of giving written informed consent
The exclusion criteria are:
1. Presence of concurrent autoimmune or inflammatory disease; such as, rheumatoid arthritis, systemic lupus erythematous, inflammatory bowel disease, etc. that causes pain
2. Routine daily use of narcotic analgesics or history of substance abuse
3. Concurrent participation in other therapeutic trials
4. Pregnant and nursing mothers (verification of pregnancy status will be determined via a urine test)
5. Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, substance abuse within two years)
6. Contraindications to fMRI, or H-MRS methods
7. Any impairment, activity or situation that in the judgment of the Study Coordinator or PI would prevent satisfactory completion of the study protocol
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01745003
Study Brief:
Protocol Section:
NCT01745003