Rhythmic Sensory Stimulation on Fibromyalgia

An Investigation of the Effects of Rhythmic Sensory Stimulation on Fibromyalgia

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06416826

Enrollment

Registered

2024-05-16

Start date

2019-04-01

Completion date

2020-03-01

Last updated

2024-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Widespread

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.

Interventions

DEVICEVibroacoustic 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).

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026