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A Study of the Effect of Rhythmic Sensory Stimulation on Fibromyalgia

NCT02493348 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-06-20

No results posted yet for this study

Summary

Fibromyalgia is a chronic pain disorder associated with widespread pain that dramatically impacts patient's quality of life. The present research aims to determine the effectiveness of Rhythmic Sensory Stimulation with rhythmic gamma-frequency (30 - 120 Hz) acoustic-driven stimulation of mechanoreceptors in the body on the treatment of fibromyalgia. The proposed treatment involves 30 minutes of daily rhythmic vibroacoustic stimulation at gamma range, 5 days per week, for 5 weeks. Measures of pain severity, fibromyalgia symptoms, sleep quality, and depression, will be compared before and after treatment between the treatment and control groups. The results of the present study will help to better understand the effectiveness of Rhythmic Sensory Stimulation to the treatment of chronic pain disorders, such as fibromyalgia, and contribute to the development of future studies to investigate the neural driving effects of therapies based on Rhythmic Sensory Stimulation.

Conditions

  • Fibromyalgia

Interventions

DEVICE

Rhythmic Sensory Stimulation

Rhythmic Sensory Stimulation (RSS) can be delivered through sound devices. In this study, the stimuli will be delivered with a portable consumer device called Sound Oasis Vibroacoustic Therapy System (VTS) 1000 unit, which is a low-voltage consumer product device that has two built-in mid to high-frequency speakers and one built in low frequency (subwoofer-type) speaker. The low frequency sounds played by the subwoofer speaker is experienced as vibrotactile vibration. Although the Intervention of Interest in this study is the gamma-frequency acoustic-driven rhythmic sensory stimulation, the efficacy of the Sound Oasis VTS-1000 device to deliver this sound will also be observed.

Sponsors & Collaborators

  • University of Toronto

    collaborator OTHER

  • Mount Sinai Hospital, Canada

    lead OTHER

Principal Investigators

  • Allan Gordon, MD · MOUNT SINAI HOSPITAL

  • Lee Bartel, PhD · University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02493348 on ClinicalTrials.gov