Fibromyalgia Clinical Trial
Official title:
Efficacy of Extremely Low Magnetic Field (ELF) in Fibromyalgic Patients: Effect on Symptoms Severity, Sleep and Quality of Life.
This is a randomized double-blind crossover study. The investigators applied ELF with a device named "LIMFA Therapy®" to 48 fibromyalgic patients, assigned in two groups (true-sham and sham-true). Fibromyalgia severity was assessed with the Fibromyalgia Impact Questionnaire (FIQ), quality of sleep with the Pittsburgh Sleep Quality Index (PSQI) questionnaire and global quality of life with Short Form-12 of Physical and Mental Health Summary (SF-12) questionnaire.
In the first part of the protocol the group true-sham received 6 twice a week sessions of
true ELF therapy of 1 hour, following the antinflammatory, analgesic and biorhythm settings
of the device "LIMFA Therapy®". The sham-true group patients received 6 twice a week sessions
of sham therapy (no therapy).
During the second part of the protocol, the true-sham group received the sham therapy twice a
week for 3 weeks and the sham-true group received the actual true therapy twice a week for 3
weeks.
For the assessment of pain, sleep quality and global quality of life, a set of questionnaires
were administrated at specific stages of the protocol. Questionnaires were administrated
every three weeks: before the first therapy, after the first course of therapy, after the
washout period, after the second course of therapy, and 3 weeks after the end of treatment.
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