Functional MRI Study of Vibrotactile Stimulation Effects in Fibromyalgia
NCT ID: NCT03785535
Last Updated: 2021-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2019-01-15
2021-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Actual treatment
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).
Vibrotactile stimulation
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.
Sham
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
Vibrotactile stimulation
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.
Interventions
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Vibrotactile stimulation
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.
Eligibility Criteria
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Inclusion Criteria
2. Clinical symptoms are not a consequence of other medical disorder (although the presence of other disorders is not an exclusion criterion)
3. Diagnoses established by an expert on fibromyalgia.
4. Stable treatment of chronic use.
5. Subject demonstrates an understanding of the study and a willingness to participate as evidenced by voluntary written informed consent.
Exclusion Criteria
2. Severe, non-stable medical, endocrinological or neurological disorder.
3. Psychotic disorder or drug abuse.
18 Years
65 Years
FEMALE
No
Sponsors
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Neurovoxel SLP
OTHER
Responsible Party
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Jesus Pujol
Principal Investigator
Locations
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Hospital del Mar
Barcelona, , Spain
Countries
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Other Identifiers
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PSI2017-83777-P
Identifier Type: -
Identifier Source: org_study_id
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