Sensory Stimulation in Fibromyalgia

Jesus Pujol77 enrolled

Overview

The purpose of this study is to investigate the effectiveness of low-intensity and prolonged vibrotactile sensory stimulation on symptom relieve in fibromyalgia patients.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Fibromyalgia

Interventions

Vibrotactile stimulationDEVICE

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

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital del Mar

Barcelona, Spain

Outcomes

Primary Outcomes

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).

Time frame: 3 weeks

Secondary Outcomes

Associated symptom improvement

Change on fibromyalgia secondary symptoms (including sleep disturbance, anxiety, mood, activity limitation, treatment reduction and general health rating).

Time frame: 3 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.