Sensory Stimulation in Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Study of the Effectiveness of Vibrotactile Sensory Stimulation in Fibromyalgia Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03227952
• Other study ID #: MOT6932
• Status: Completed
• Phase: N/A
• Start date: September 4, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: October 2018
• Source: Neurovoxel SLP
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• Vibrotactile stimulation
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).

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Jesus Pujol

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Associated symptom improvement	Change on fibromyalgia secondary symptoms (including sleep disturbance, anxiety, mood, activity limitation, treatment reduction and general health rating).	3 weeks