Sensory Stimulation in Fibromyalgia

Study Overview
=================
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.

Official Title
-----------------
Study of the Effectiveness of Vibrotactile Sensory Stimulation in Fibromyalgia Patients

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Device: Vibrotactile stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active treatment<br>Vibrotactile sensory stimulation | Device: Vibrotactile stimulation<br>* 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).<br>|
| Sham Comparator: Sham<br>Identical device. No vibration | Device: Vibrotactile stimulation<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 101-point verbal rating scale (VRS) | Change on fibromyalgia key symptoms rated using 101-point verbal rating scale (combining pain, fatigue and subjective cognitive problems). | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Associated symptom improvement | Change on fibromyalgia secondary symptoms (including sleep disturbance, anxiety, mood, activity limitation, treatment reduction and general health rating). | 3 weeks |