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:
NCT03236467
Eligibility Criteria:
Inclusion Criteria:
* Only Veteran and civilian participants in whom a physical examination and medical history indicate that the participant meets current diagnostic criteria for FM, as specified by the American College of Rheumatology, will be eligible for the study.
* Eligible participants who agree to a blood draw for measurement of biomarkers, must be free of medications and other substances (e.g., illicit drugs and alcohol) that may alter results for 2-6 weeks depending on the medication and frequency of use (which must be cleared by MD consultants).
* If on pain medications with short half-lives, participants must be off of them for 5 half-lives before testing, generally about 24 hours.
* Any FM participant with an ICD-10 chronic pain diagnosis of a musculoskeletal etiology, will also be eligible for inclusion in the study as many individuals with FM also have such conditions.
* Any participant with a confirmed psychiatric diagnosis of PTSD will be included in the study. Individuals in the PTSD group must meet diagnostic criteria for current chronic PTSD (\>3 months) as assessed by the CAPS-5, 1-Month Diagnostic Version.
Exclusion Criteria:
* Participants will be excluded from participation in the study if they have a life threatening or acute physical illness (e.g., cancer)
* Current schizophreniform illnesses (except for Psychosis NOS due to PTSD-related sensory hallucinations)
* Untreated bipolar disorder
* Or active suicidal or homicidal ideation requiring clinical intervention
* Individuals with current or past alcohol and/or substance dependence (less than three months from date of screening assessment) will be excluded
* Individuals seeking interventional pain treatment, such as surgical interventions or other pain clinic interventions, will also be excluded unless they agree to participate in the biomarker procedure prior to the start of their pain intervention.
* Finally, participants who have a neuropathic origin to their pain will be excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03236467
Study Brief:
Protocol Section:
NCT03236467