NCT06416826

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2019

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
4.2 years until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

11 months

First QC Date

April 8, 2019

Last Update Submit

May 10, 2024

Conditions

Chronic Pain, Widespread

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • change in pain severity

    baseline, 1 month, 2 months

  • change in EEG brain activity

    baseline, 1 month, 2 months

Study Arms (2)

control

NO INTERVENTION

healthy controls n = 10

patients

ACTIVE COMPARATOR

patients with fibromyalgia n =20

Device: Vibroacoustic Therapy System - VTS 1000

Interventions

Vibroacoustic Therapy System - VTS 1000DEVICE

Participants will undertake 15 self-administered sessions of RSS 40Hz low frequency sound stimulation, 30 minutes daily, over 3 weeks (5 days/week).

Also known as: Rhythmic Sensory Stimulation
patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2019

First Posted

May 16, 2024

Study Start

April 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

May 16, 2024

Record last verified: 2024-05