Neuroimaging Approaches to Deconstructing Acupuncture for Chronic Pain

This is an interventional diagnostic trial for Fibromyalgia focused on measuring Fibromyalgia Chronic Pain Read More

Inclusion Criteria for Fibromyalgia Participants

• Have self-reported FM symptoms for at least one year and also meet the Wolfe et al 2011 criteria for Fibromyalgia.
• Continued presence of pain more than 50% of days.
• Pain greater than a certain threshold on the Visual Analog Scale (VAS) for pain; 7-day recall; [Note: The VAS is widely used in clinical pain research and as such we chose to use it for inclusion criteria and for clinical pain assessment below. Within our group numerical ratings scales 0-100 are more commonly used in quantitative sensory assessment, and as such we chose to use NRS scales for evoked pain assessments below.]
• Willing to limit the introduction of any new medications or treatment modalities for control of FM symptoms during the study.
• Able to travel to the study site to receive acupuncture treatments up to two times weekly.
• Over 18 and under 65 years of age.
• Right-handed.
• Female.
• Capable of giving written informed consent.

Inclusion Criteria for Healthy Control Participants

• Over 18 and under 65 years of age.
• Female.
• Right-handed.
• Do not have fibromyalgia or an associated pain disorder, including: migraine, temporomandibular joint disorder (TMJ), chronic pelvic pain (CPP), or chronic fatigue syndrome (CFS).
• Pain less than a certain threshold on the Visual Analog Scale (VAS) for pain; 7-day recall
• Willing to complete all study procedures.
• Capable of giving written informed consent.

Exclusion Criteria for Fibromyalgia Participants:

• Acupuncture within last 6-months.
• Presence of a known coagulation abnormality, thrombocytopenia, or bleeding diathesis that may preclude the safe use of acupuncture.
• Presence of a concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc., or any other chronic pain condition with pain greater than fibromyalgia pain.
• Peripheral neuropathy of know cause that interferes with activities of daily living.
• History of vascular surgery in lower limbs or current lower limb vascular dysfunction.
• History of head injury with substantial loss of consciousness.
• Routine daily use of narcotic analgesics, marijuana or have a history of substance abuse in the past 24 months as determine by subject self-report.
• Stimulant medications, such as those used to treat ADD/ADHD (e.g., amphetamine/ dextroamphetamine [Adderall®], methylphenidate, dextroamphetamine), or the fatigue associated with sleep apnea or shift work (e.g., modafinil), are excluded.
• Concurrent participation in other therapeutic trials.
• Pregnant or nursing.
• Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, substance abuse within two years).
• Contraindications to fcMRI, fMRI, or 1H-MRS methods. These may include but are not limited to: surgical clips, surgical staples, metal implants, and certain metallic dental material. [Note: a more formal description of contraindications for MRI is present in our DSM Plan].
• Use of over the counter pain medications (NSAIDs, etc.) on the day of MRI scan.
• Use of as needed narcotic pain medication 48 hours prior to MRI scan.
• Current, habitual, or previous use within the last 12 months of artificial nails, nail enhancements, or nail extensions that cover any portion of either thumbnail. Exceptions, including brief and/or occasional use, may be permissible at the discretion of the principle investigator.
• Any impairment, activity or situation that in the judgment of the Study Coordinator or Principal Investigator that would prevent satisfactory completion of the study protocol.
• Contraindications to the Electrostimulator device: Participants with electrical implants (i.e. pacemakers, defibrillators), cardiac rhythmic disorders, seizure disorders, any skin disorder in the vicinity of the electrode or an malignant diseases in the region of application. (Fibromyalgia participants only)

Exclusion Criteria for Healthy Control Participants:

• Have a diagnosis of fibromyalgia or meet the Wolfe et al 2011 criteria for Fibromyalgia.
• Presence of a concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc. that causes pain.
• Routine daily use of narcotic analgesics, marijuana or have a history of substance abuse in the past 24 months as determine by subject self-report.
• Stimulant medications, such as those used to treat ADD/ADHD (e.g., amphetamine/ dextroamphetamine [Adderall®], methylphenidate, dextroamphetamine), or the fatigue associated with sleep apnea or shift work (e.g., modafinil), are excluded.
• Concurrent participation in other therapeutic trials.
• Pregnant or nursing.
• Peripheral neuropathy of know cause that interferes with activities of daily living.
• History of vascular surgery in lower limbs or current lower limb vascular dysfunction.
• History of head injury with substantial loss of consciousness.
• Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, substance abuse within two years).
• Contraindications to fcMRI, fMRI, or 1H-MRS methods. (see above section)
• Use of over the counter pain medications (NSAIDs, etc.) on the day of MRI scan.
• Use of as needed narcotic pain medication 48 hours prior to MRI scan.
• Current, habitual, or previous use within the last 12 months of artificial nails, nail enhancements, or nail extensions that cover any portion of either thumbnail. Exceptions, including brief and/or occasional use, may be permissible at the discretion of the principle investigator.
• Any impairment, activity or situation that in the judgment of the Study Coordinator or Principal Investigator that would prevent satisfactory completion of the study protocol.