Neuroimaging Approaches to Deconstructing Acupuncture for Chronic Pain

This study design has two components: 1) a cross sectional assessment of brain chemistry,
connectivity and response to pain in healthy controls and age- and sex-matched fibromyalgia
patients, and 2) a longitudinal assessment of the same outcomes in fibromyalgia patients
randomized to either electro-acupuncture or laser acupuncture.

The investigators will evaluate 80 fibromyalgia patients who will receive acupuncture
treatment twice a week for 4 weeks, for a total of 8 treatments. Baseline data from these
patients will be compared to results from 40 pain-free controls.

Participants will undergo experimental pain assessments as well as brain neuroimaging.

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.