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 @ 12:05 PM
Ignite Modification Date:
2025-12-24 @ 12:05 PM
NCT ID:
NCT00932061
Eligibility Criteria:
Inclusion Criteria:
Inclusion Criteria for Fibromyalgia Volunteers:
* Has met American College of Rheumatology (1990) criteria for the diagnosis of fibromyalgia for at least 1 year
* Chronic pain more than 50% of days
* Willing to limit introduction of any new medications or treatments for fibromyalgia during the study
* Able to attend study visits up to three times weekly
* Right-handed
* Be capable of giving written informed consent
Inclusion Criteria for Healthy Volunteers:
* Willing to refrain from alcohol intake for 48 hours prior to brain scans
* Be right handed
* Be capable of giving written informed consent
PET Inclusion Criteria:
* Willing to refrain from alcohol intake 48 hours prior to brain scans
* Capable of giving written consent
Exclusion Criteria:
Exclusion Criteria for Fibromyalgia Volunteers:
* Knowledge that could prevent "blinding" of the participant to the study interventions (including previous acupuncture treatment)
* Presence of a known coagulation abnormality, thrombocytopenia, or bleeding diathesis that may preclude the safe use of acupuncture
* Autoimmune or inflammatory disease (in addition to fibromyalgia) that causes pain (e.g., rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease)
* Daily use of narcotic pain-relievers
* History of substance abuse
* Simultaneous participation in other therapeutic trials
* Pregnant or breastfeeding
* Current severe psychiatric illness (e.g., schizophrenia, major depression with suicidal ideation)
* Condition that may make exposure to fMRI medically inadvisable
* Any condition that may prevent satisfactory completion of the study protocol
Exclusion for Healthy Volunteers:
* Autoimmune or inflammatory disease (in addition to fibromyalgia) that causes pain (e.g., rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease)
* Having met the ACR criteria for FM
* Simultaneous participation in other therapeutic trials
* Pregnant or breastfeeding
* Current severe psychiatric illness (e.g., schizophrenia, major depression with suicidal ideation)
* Condition that may make exposure to fMRI medically inadvisable
* Any condition that may prevent satisfactory completion of the study protocol
PET Exclusion Criteria:
* Meets any of the fMRI exclusion criteria
* Current major depression
* Condition that may make exposure to PET medically inadvisable
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00932061
Study Brief:
Protocol Section:
NCT00932061