Fibromyalgia
Conditions
Brief summary
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.
Interventions
DEVICEVibrotactile 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.
Sponsors
Neurovoxel SLP
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. A diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) (Arthritis Care Res 2010;62:600-10). 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
1. Generalized inflammatory articular or rheumatic disease. 2. Severe, non-stable medical, endocrinological or neurological disorder. 3. Psychotic disorder or drug abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional MRI measures of brain functional connectivity. A correlation scale ranging from 0 to 1 will be used. | 3 weeks | Change on brain activity rated using functional MRI measures of functional connectivity |
| Functional MRI measures of brain activity. A functional MRI signal change scale ranging from 0 to 1 will be used. | 3 weeks | Change on brain activity rated using functional MRI measures of brain activation in response to nociceptive stimulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional MRI measures of sensory system activity. A functional MRI signal change scale ranging from 0 to 1 will be used. | 3 weeks | Change on brain activity rated using functional MRI measures of brain activation in response to non-nociceptive stimulation |
| Measured fibromyalgia symptoms using a 101-point numerical rating scale. | 3 weeks | Change on fibromyalgia symptoms (including pain, fatigue, cognitive symptoms, sleep disturbance, and general health rating). Rated using Numerical Rating 101-point Scales. |
| Tolerability rated using a numerical rating scale ranging from 0 to 100 points. | 3 weeks | Tolerability index (0-100). |
Countries
Spain
Outcome results
None listed