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 @ 4:12 PM
Ignite Modification Date:
2025-12-24 @ 4:12 PM
NCT ID:
NCT01333566
Eligibility Criteria:
Inclusion Criteria:
* Patients with a diagnosis of primary FM, based on the 1990 American College of Rheumatology criteria (Wolfe et al, 1990),
* between the ages of 18 and 70 years;
* willing to withdraw from CNS-active therapies commonly used to treat FM; willing to discontinue treatment with transcutaneous electrical nerve stimulation, biofeedback, tender- and trigger-point injections, acupuncture, and anesthetic or narcotic patches;
* with a raw score \> 4 on the physical function component of the Fibromyalgia Impact Questionnaire (FIQ) (Burckhardt et al, 1991);
* and a mean visual analog scale (VAS) pain score \> 40 on a scale from 0 to 100.
Exclusion Criteria:
* severe psychiatric illness;
* a current major depressive episode (as determined by a Beck Depression Inventory (Beck et al, 1961) score \>25);
* significant suicide risk;
* abuse of alcohol, benzodiazepines, or other drugs; a history of behavior that would prohibit compliance for the duration of the study;
* active cardiovascular, pulmonary, hepatic, renal, gastrointestinal, or autoimmune disease (except Hashimoto's or Graves' disease that had been stable for 3 months before screening);
* current systemic infection; active cancer (except basal cell carcinoma); unstable endocrine disease; severe sleep apnea;
* prostate enlargement or other genitourinary disorder (male patients);
* or pregnancy or breastfeeding (female patients).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01333566
Study Brief:
Protocol Section:
NCT01333566