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
77 participants
INTERVENTIONAL
2017-09-04
2018-05-31
Brief Summary
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Detailed Description
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Three weeks treatment 1 (sham or actual) Two week washout Three weeks treatment 2 (sham or actual) Vibrotactile sensory stimulation will consist on whole-body stimulation with mechanical stimuli of pallesthetic type at high rate, low intensity and long daily duration.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Active treatment
Vibrotactile sensory stimulation
Vibrotactile stimulation
Vibrotactile sensory stimulation will consist on whole-body stimulation with mechanical stimuli of pallesthetic type at high rate (20-90 Hz), low intensity and long daily duration (3h).
Sham
Identical device. No vibration
Vibrotactile stimulation
Vibrotactile sensory stimulation will consist on whole-body stimulation with mechanical stimuli of pallesthetic type at high rate (20-90 Hz), low intensity and long daily duration (3h).
Interventions
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Vibrotactile stimulation
Vibrotactile sensory stimulation will consist on whole-body stimulation with mechanical stimuli of pallesthetic type at high rate (20-90 Hz), low intensity and long daily duration (3h).
Eligibility Criteria
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Inclusion Criteria
* Clinical symptoms are not a consequence of other medical disorder (although the presence of other disorders is not an exclusion criterion)
* Diagnoses established by an expert on fibromyalgia.
* Stable treatment of chronic use.
* Subject demonstrates an understanding of the study and a willingness to participate as evidenced by voluntary written informed consent.
Exclusion Criteria
* Heavily exercise for 12 hours prior to fMRI assessment
* Severe, non-stable medical, endocrinological or neurological disorder.
* Psychotic disorder or drug abuse.
18 Years
65 Years
FEMALE
No
Sponsors
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Jesus Pujol
OTHER
Responsible Party
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Jesus Pujol
Principal Investigator
Principal Investigators
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Jesus Pujol, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital del Mar
Locations
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Hospital del Mar
Barcelona, , Spain
Countries
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References
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Pujol J, Ramos-Lopez D, Blanco-Hinojo L, Pujol G, Ortiz H, Martinez-Vilavella G, Blanch J, Monfort J, Deus J. Testing the effects of gentle vibrotactile stimulation on symptom relief in fibromyalgia. Arthritis Res Ther. 2019 Jun 14;21(1):148. doi: 10.1186/s13075-019-1932-9.
Other Identifiers
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MOT6932
Identifier Type: -
Identifier Source: org_study_id
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