Sensory Stimulation in Fibromyalgia

Jesus Pujol

Status: Completed

Conditions: Fibromyalgia

Treatments: Device: Vibrotactile stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03227952

MOT6932

Details and patient eligibility

About

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

Full 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.

Enrollment: 77 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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77 participants in 2 patient groups

Active treatment

Active Comparator group

Description:

Vibrotactile sensory stimulation

Treatment:

Device: Vibrotactile stimulation

Sham

Sham Comparator group

Description:

Identical device. No vibration

Treatment:

Device: Vibrotactile stimulation