Rhythmic Sensory Stimulation on Fibromyalgia

May 10, 2024 updated by: Women's College Hospital

An Investigation of the Effects of Rhythmic Sensory Stimulation on Fibromyalgia

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control

healthy controls

n = 10
Active Comparator: patients

patients with fibromyalgia

n =20
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).
Other Names:
  • Rhythmic Sensory Stimulation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women's College Hospital

Collaborators

University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2019

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

April 8, 2019

First Submitted That Met QC Criteria

May 10, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FibroMusicTherapy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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