The purpose of this study is to investigate the effects of low-intensity and prolonged vibrotactile sensory stimulation on brain activity and functional connectivity in fibromyalgia patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
The active treatment will involve whole-body sensory stimulation with mechanical stimuli of vibrotactile (pallesthetic) type at a relatively high rate, low intensity and long duration administered at sleep time (a total daily duration of 3 h distributed within a period of 2 h at bedtime and 1 h prior to getting up). The intensity will be 30% of power at bedtime and 45% prior to getting up.
Hospital del Mar
Barcelona, Spain
Functional MRI measures of brain functional connectivity. A correlation scale ranging from 0 to 1 will be used.
Change on brain activity rated using functional MRI measures of functional connectivity
Time frame: 3 weeks
Functional MRI measures of brain activity. A functional MRI signal change scale ranging from 0 to 1 will be used.
Change on brain activity rated using functional MRI measures of brain activation in response to nociceptive stimulation
Time frame: 3 weeks
Functional MRI measures of sensory system activity. A functional MRI signal change scale ranging from 0 to 1 will be used.
Change on brain activity rated using functional MRI measures of brain activation in response to non-nociceptive stimulation
Time frame: 3 weeks
Measured fibromyalgia symptoms using a 101-point numerical rating scale.
Change on fibromyalgia symptoms (including pain, fatigue, cognitive symptoms, sleep disturbance, and general health rating). Rated using Numerical Rating 101-point Scales.
Time frame: 3 weeks
Tolerability rated using a numerical rating scale ranging from 0 to 100 points.
Tolerability index (0-100).
Time frame: 3 weeks
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