Functional MRI Study of Vibrotactile Stimulation Effects in Fibromyalgia

Neurovoxel SLP

Status: Completed

Conditions: Fibromyalgia

Treatments: Device: Vibrotactile stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03785535

PSI2017-83777-P

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Actual treatment

Experimental group

Description:

Vibrotactile sensory stimulation will consist on whole-body stimulation with mechanical stimuli of pallesthetic type at high rate (2-90 Hz), low intensity and long daily duration (3h).

Treatment:

Device: Vibrotactile stimulation

Sham

Sham Comparator group

Description:

Sham treatment will be applied using identical instruments and with power and duration programmed identically. However, in this case, the output will not be the signal activating the vibration motors, but rather an electrical signal turning on an incorporated pilot light indicating that the (simulated) treatment was operating

Treatment:

Device: Vibrotactile stimulation