Depression Clinical Trial
Official title:
Transcranial Magnetic Stimulation (TMS) in the Treatment of Chronic Widespread Pain (CWP)
While acute pain after surgery or trauma comes on suddenly and lasts for a limited amount of time, chronic pain persists and can continue for months and even years. Repetitive transcranial magnetic stimulation (rTMS) uses a magnetic field to deliver a current to the brain and can affect brain activity. The purpose of this study is to determine the effectiveness of rTMS treatment in reducing chronic widespread pain in women.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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