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:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
NCT ID:
NCT01397006
Eligibility Criteria:
Inclusion Criteria:
* • Meet the 2010 ACR criteria for diagnosis of fibromyalgia (See Appendix)
* Meet the 1990 ACR criteria for the classification of fibromyalgia (See Appendix)
* Patients have a pain VAS \> 4
* Patients are able to understand and sign informed consent
* Patients are able to understand and complete study questionnaires
* Patients are prepared to discontinue all pain medications including non-steroidal anti-inflammatory drugs (NSAIDs), and medications for sleep or mood disturbances two weeks prior to beginning the study. Acetaminophen, up to 2 extra-strength, three times daily, will be allowed for break-through pain. Medication use will be surveyed at each visit (See Appendix).
* Age - \> 18
* Females with no documented evidence of current pregnancy, and willingness to take the necessary precautions to prevent pregnancy for the duration of the study period
Exclusion Criteria:
* • Patients with a significant musculoskeletal or rheumatic disorder that may confuse the diagnosis
* Any subject with suicidal thoughts in the past or currently
* Patient with a history of renal disease, heart disease, bleeding problems or low platelet counts
* Women who are breast feeding
* Men or women who plan to have children during the course of the study
* Unable to discontinue any medications prescribed for pain, other than acetaminophen, or any medications for sleep or mood disturbances for at least 2 weeks before the study
* Unable to discontinue any mediations used for sleep disturbances
* Patients currently being treated for any psychiatric illness including depression or anxiety disorder
* Patients currently taking antidepressant, anti-anxiety, or antipsychotic medications.
* Inability to understand and sign informed consent and complete questionnaires.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01397006
Study Brief:
Protocol Section:
NCT01397006