Rhythmic Sensory Stimulation on Fibromyalgia

Not Applicable

Withdrawn

• Conditions: Chronic Pain, Widespread
• Interventions: Device: Vibroacoustic Therapy System - VTS 1000

• Registration Number: NCT06416826
• Lead Sponsor: Women's College Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-04-08
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-10
• Last Update Submitted: 2024-05-10
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients	Vibroacoustic Therapy System - VTS 1000	patients with fibromyalgia n =20

Primary Outcome Measures

Name	Time	Method
change in inflammatory cytokine levels	baseline, 1 month, 2 months	The investigator will use a multiplex enzyme-linked immunosorbent assay (ELISA) to asses inflammatory cytokines in fibromyalgia.

Secondary Outcome Measures

Name	Time	Method
change in EEG brain activity	baseline, 1 month, 2 months	The investigators will measure EEG dynamics to quantify dysfunctional activity in brain areas that are affected by fibromyalgia
change in pain severity	baseline, 1 month, 2 months	Patients will rate their pain severity on a scale from 0 (no pain) to 10 (extreme pain)