Transcranial Magnetic Stimulation for Treating Women With Chronic Widespread Pain

Chronic widespread pain is characterized by musculoskeletal pain that lasts for at least 3
months, pain above and below the waist, pain on both the right and left sides, and pain in
the head, neck, spine, or back. In addition to fatigue, chronic widespread pain is a
hallmark feature of fibromyalgia. Significant physical and emotional effects usually
accompany chronic widespread pain and fibromyalgia, making the development of effective
treatments a priority. rTMS involves a neurophysiologic technique that directs a current
into the brain by using a magnetic field to pass the scalp and skull safely and painlessly.
Stimuli are applied to the same brain area several times per second during several
consecutive seconds. rTMS has been found to be effective for treating certain types of
chronic pain. The purpose of this study is to determine the effectiveness of rTMS treatment
in reducing bodily pain associated with chronic widespread pain and/or fibromyalgia in
women.

Participants in this study will undergo a diagnostic interview, physical and neurological
exam, electrocardiogram, magnetic resonance imaging, and blood and urine collection for
screening purposes. Eligible participants will then be randomly assigned to receive either
rTMS treatment or sham rTMS treatment. One-hour daily treatment sessions will occur over 15
days. After every five treatment sessions, participants will be interviewed about their pain
and depression symptoms, and they will fill out questionnaires about pain, depression,
fatigue, sleep, and exercise. Participants will also undergo pain threshold and tolerance
testing of their right thumb. On a daily basis, participants will rate their level of pain
using a 0 to 20 scale. Follow-up evaluations will occur 1, 4, and 12 weeks after treatment
and will include a repeat interview and testing. After the follow-up evaluations, any
participants who did not respond to the sham treatment will be offered a series of 15 real
rTMS treatment sessions.

Inclusion Criteria:

- Diagnosis of chronic widespread pain as defined by the 1990 American College of
Rheumatology guidelines: chronic musculoskeletal pain for at least 3 months; pain
above and below the waist; pain on both right and left sides; pain at one axial site
(e.g., head, neck, spine, or back)

- Willing to remain on a stable medical regimen during the entire 6-week course of
Phase 1 treatment and 8 weeks prior to rTMS treatment

- Willing to undergo random assignment and able to attend treatment sessions

- Willing to remain on a stable psychotherapy regimen if currently receiving
psychotherapy that has been ongoing for at least 3 months prior to study entry

Exclusion Criteria:

- Unable to maintain treatment as usual at stable doses for any medical or psychiatric
conditions for 8 weeks prior to and during the study

- Another medical condition associated with significant pain (e.g., diabetic
neuropathy, systemic lupus erythematosus, Rheumatoid arthritis, severe degenerative
joint disease)

- Any condition that might increase the risk of seizures from TMS

- History of a seizure disorder or family history of a seizure disorder

- Previous use of TMS

- Involvement in litigation or disability that is related to fibromyalgia, chronic
widespread pain, or depression

- Current use of proconvulsant medications (e.g., bupropion)

- Metal in the body that would prevent magnetic resonance imaging (MRI) or TMS (e.g.,
aneurysm clips, pacemakers, neurostimulators)

- History of head injury associated with loss of consciousness for more than 15
minutes, brain surgery, or lithium toxicity

- History of bipolar disorder, schizophrenia, obsessive compulsive disorder, panic
disorder, or post-traumatic stress disorder

- Current substance abuse or dependence

- Active suicidal intent or plan

- Severe claustrophobia that would prevent MRI

- Major depression with psychotic features or a current major depressive episode
lasting longer than 5 years

- Pregnant