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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Actual treatment | Experimental | Vibrotactile sensory stimulation will consist on whole-body stimulation with mechanical stimuli of pallesthetic type at high rate (2-90 Hz), low intensity and long daily duration (3h). |
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| Sham | Sham Comparator | Sham treatment will be applied using identical instruments and with power and duration programmed identically. However, in this case, the output will not be the signal activating the vibration motors, but rather an electrical signal turning on an incorporated pilot light indicating that the (simulated) treatment was operating |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibrotactile stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 weeks |
| Measured fibromyalgia symptoms using a 101-point numerical rating scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Mar | Barcelona | 8003 | Spain |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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Change on fibromyalgia symptoms (including pain, fatigue, cognitive symptoms, sleep disturbance, and general health rating). Rated using Numerical Rating 101-point Scales. |
| 3 weeks |
| Tolerability rated using a numerical rating scale ranging from 0 to 100 points. | Tolerability index (0-100). | 3 weeks |
| D009422 |
| Nervous System Diseases |