Researchers at the University of Washington in Seattle are recruiting women with chronic widespread pain – considered “a hallmark feature of Fibromyalgia.” The trial involves a painless interventional treatment using repetitive Transcranial Magnetic Stimulation (rTMS) in 15 sessions over 15 days, with follow-up visits at 1, 4, and 12 weeks.
This trial (ClinicalTrials.gov identifier NCT00524420) is sponsored by the National Institute of Arthritis and Musculoskeletal & Skin Diseases (NIAMS) and will measure pain intensity as a primary outcome – as well as a number of secondary outcomes such as depression, fatigue, sleep, and exercise.
According to the ClinicalTrials.gov trial description:
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.
For more information about the trial and about rTMS, click here.
Contacts, if you might be interested in participating: