Functional MRI Study of Vibrotactile Stimulation Effects in Fibromyalgia

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Device: Vibrotactile stimulation

• Registration Number: NCT03785535
• Lead Sponsor: Neurovoxel SLP

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2018-12-21
• Study First Posted: 2018-12-24
• Study Start: 2019-01-15
• Primary Completion: 2021-02-28
• Study Completion: 2021-02-28
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Actual treatment	Vibrotactile stimulation	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).
Sham	Vibrotactile stimulation	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

Primary Outcome Measures

Name	Time	Method
Functional MRI measures of brain functional connectivity. A correlation scale ranging from 0 to 1 will be used.	3 weeks	Change on brain activity rated using functional MRI measures of functional connectivity
Functional MRI measures of brain activity. A functional MRI signal change scale ranging from 0 to 1 will be used.	3 weeks	Change on brain activity rated using functional MRI measures of brain activation in response to nociceptive stimulation

Secondary Outcome Measures

Name	Time	Method
Tolerability rated using a numerical rating scale ranging from 0 to 100 points.	3 weeks	Tolerability index (0-100).
Functional MRI measures of sensory system activity. A functional MRI signal change scale ranging from 0 to 1 will be used.	3 weeks	Change on brain activity rated using functional MRI measures of brain activation in response to non-nociceptive stimulation
Measured fibromyalgia symptoms using a 101-point numerical rating scale.	3 weeks	Change on fibromyalgia symptoms (including pain, fatigue, cognitive symptoms, sleep disturbance, and general health rating). Rated using Numerical Rating 101-point Scales.

Trial Locations

Locations (1)

Hospital del Mar; 🇪🇸 Barcelona, Spain