Fibromyalgia
Conditions
Brief summary
The purpose of this study is to investigate the effectiveness of low-intensity and prolonged vibrotactile sensory stimulation on symptom relieve in fibromyalgia patients.
Detailed description
The trial will last up to 8 weeks for each subject and includes: 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.
Interventions
DEVICEVibrotactile 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).
Sponsors
Jesus Pujol
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
a sham device identical to the active device
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* A diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) (Arthritis Rheum, 1990;33:160-172) * 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
* Generalized inflammatory articular or rheumatic disease. * Heavily exercise for 12 hours prior to fMRI assessment * Severe, non-stable medical, endocrinological or neurological disorder. * Psychotic disorder or drug abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 101-point verbal rating scale (VRS) | 3 weeks | Change on fibromyalgia key symptoms rated using 101-point verbal rating scale (combining pain, fatigue and subjective cognitive problems). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Associated symptom improvement | 3 weeks | Change on fibromyalgia secondary symptoms (including sleep disturbance, anxiety, mood, activity limitation, treatment reduction and general health rating). |
Countries
Spain
Outcome results
None listed