Fibromyalgia affects up to an estimate 10 percent of the population, primarily women. The syndrome is characterized as both a musculoskeletal and a subtle neurological disorder, and is associated with widespread muscle pain and tender points, along with fatigue, muscle weakness, and stiffness. Conventional medical approaches have limited success in treating fibromyalgia, leading patients to seek complementary therapies, including the use of magnetic therapies, in the hope of finding more effective pain relief. However, the efficacy and safety of magnetic therapy has not been definitively established through rigorously controlled trials. This double-blind randomized placebo-controlled study is the second in a series investigating the efficacy of static magnetic field (SMF) therapies in alleviating symptoms associated with fibromyalgia. Chronic conditions are frequently associated with poor quality of life; and fibromyalgia is associated with even poorer quality of life than a variety of other chronic conditions such as rheumatoid arthritis, osteoarthritis, permanent ostomies, chronic obstructive pulmonary disease, and insulin dependent diabetes. Successful management of pain, the primary symptom of fibromyalgia, may result in improved quality of life. The study tests the primary hypotheses that locally applied quadripolar SMF devices, which have been shown to suppress the firing of action potentials of sensory neurons, will provide pain reduction and other therapeutic benefits. It is further proposed that treatment with SMF devices will lead to improved functional status and improved quality of life.
The specific aims of the research are to compare the effects of quadripolar SMF devices externally applied to tender points and the effects of magnetic placebo devices. The proposed study will include a 6-month treatment period and a 9 month follow-up assessment to determine long-term effectiveness.
