Sensory Stimulation in Fibromyalgia

Not Applicable

Completed

• Conditions: Fibromyalgia

• Registration Number: NCT03227952
• Lead Sponsor: Jesus Pujol

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-07-19
• Study First Posted: 2017-07-24
• Study Start: 2017-09-04
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-16
• Last Update Posted: 2018-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 77

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
101-point verbal rating scale (VRS)	3 weeks	Change on fibromyalgia key symptoms rated using 101-point verbal rating scale (combining pain, fatigue and subjective cognitive problems).

Secondary Outcome Measures

Name	Time	Method
Associated symptom improvement	3 weeks	Change on fibromyalgia secondary symptoms (including sleep disturbance, anxiety, mood, activity limitation, treatment reduction and general health rating).

Trial Locations

Locations (1)

Hospital del Mar; 🇪🇸 Barcelona, Spain