Rhythmic Sensory Stimulation on Fibromyalgia

Women's College Hospital

Status: Withdrawn

Conditions: Chronic Pain, Widespread

Treatments: Device: Vibroacoustic Therapy System - VTS 1000

Study type: Interventional

Funder types: Other

Identifiers

NCT06416826

FibroMusicTherapy

Details and patient eligibility

About

The aim of this project is to further examine the effectiveness of Rhythmic Sensory Stimulation (RSS) with low-frequency sounds and somatosensory stimulation as a complementary therapy for fibromyalgia, and to investigate potential mechanisms underlying the effects of RSS on chronic pain.

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients with clinical diagnosis of fibromyalgia
• able to read and write English adequately
• have satisfactory hearing bilaterally (self-reported)
• have the ability to operate the supplied device

Exclusion criteria

• acute and active inflammatory conditions (e.g., rheumatoid arthritis, osteoarthritis, autoimmune disease)
• medical or psychiatric illness
• history of psychosis, epilepsy, seizures
• pregnancy or breast feeding
• hemorrhaging or active bleeding
• thrombosis, angina pectoris
• heart disease, such as hypotension, arrhythmia, pacemaker
• substance abuse (harmful or hazardous use of psychoactive subtances, including alcohol and illicit drugs) in the last year
• suffering from a recently prolapsed vertebral disc
• recovering from a recent accident with back or neck injury.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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0 participants in 2 patient groups

control

No Intervention group

Description:

healthy controls n = 10

patients

Active Comparator group

Description:

patients with fibromyalgia n =20

Treatment:

Device: Vibroacoustic Therapy System - VTS 1000