Rhythmic Sensory Stimulation on Fibromyalgia

Chronic Pain, Widespread Clinical Trial

Official title:

An Investigation of the Effects of Rhythmic Sensory Stimulation on Fibromyalgia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT06416826
• Other study ID #: FibroMusicTherapy
• Status: Withdrawn
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: May 2024
• Source: Women's College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain, Widespread
• Fibromyalgia

Intervention

Device:
• Vibroacoustic Therapy System - VTS 1000
Participants will undertake 15 self-administered sessions of RSS 40Hz low frequency sound stimulation, 30 minutes daily, over 3 weeks (5 days/week).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Women's College Hospital	University of Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in inflammatory cytokine levels	The investigator will use a multiplex enzyme-linked immunosorbent assay (ELISA) to asses inflammatory cytokines in fibromyalgia.	baseline, 1 month, 2 months
Secondary	change in pain severity	Patients will rate their pain severity on a scale from 0 (no pain) to 10 (extreme pain)	baseline, 1 month, 2 months
Secondary	change in EEG brain activity	The investigators will measure EEG dynamics to quantify dysfunctional activity in brain areas that are affected by fibromyalgia	baseline, 1 month, 2 months