Trial record 11 of 126 for:    fibromyalgia | Open Studies | Interventional Studies

A Study of the Effect of Rhythmic Sensory Stimulation and Music on Fibromyalgia

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2015 by Mount Sinai Hospital, Canada
Sponsor:
Collaborator:
University of Toronto
Information provided by (Responsible Party):
Allan Gordon, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT02493348
First received: July 2, 2015
Last updated: July 8, 2015
Last verified: July 2015
  Purpose

Fibromyalgia is a chronic pain disorder associated with widespread pain that dramatically impacts patient's quality of life. Its exact cause has not yet been identified, however recent studies have indicated that fibromyalgia is associated with significant imbalance of the connectivity within brain networks associated with pain, decreased functional connectivity in the descending pain-modulating system, and increased activity in the pain matrix related to central sensitization. It has been suggested, therefore, that treatments that induce coherent neuronal activity, and/or stimulate synchronization of dysregulated brain circuitry, have significant benefits, improving pain management and enhancing patient's quality of life. Rhythmic Sensory Stimulation (RSS) is an example of a non-invasive treatment that is thought to indirectly stimulate neuronal coherence. The present research proposal aims to determine the effectiveness of Rhythmic Sensory Stimulation with 40 Hz sound on the treatment of fibromyalgia. The proposed treatment involves 30 minutes of daily rhythmic vibroacoustic stimulation at 40 Hz, 5 days per week, for 5 weeks. The treatment is self-administered by the patients at home with the Sound Oasis Vibroacoustic Therapy System (VTS) 1000 portable device. 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.


Condition Intervention
Fibromyalgia
Device: Rhythmic Sensory Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Study of the Effect of Rhythmic Sensory Stimulation and Music on Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:
  • Change of Fibromyalgia symptoms and severity from baseline assessed by the Revised Fibromyalgia Impact Questionnaire (FIQ) at 6 weeks [ Time Frame: Assessed at Week 0 (pre-intervention) and Week 6 (post-intervention) ] [ Designated as safety issue: No ]
    The FIQ is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes, based on a 10 point scale.

  • Change of pain severity from baseline assessed by Brief Pain Inventory - short form (BPI-SF) at 6 weeks [ Time Frame: Assessed at Week 0 (pre-intervention) and Week 6 (post-intervention) ] [ Designated as safety issue: No ]
    BPI-SF is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning based on a 10 point scale.


Secondary Outcome Measures:
  • Change of sleep quality from baseline assessed by the Pittsburgh Sleep Quality Index (PSQI) at 6 weeks [ Time Frame: Assessed at Week 0 (pre-intervention) and Week 6 (post-intervention) ] [ Designated as safety issue: No ]
    The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time.

  • Change of depression severity from baseline assessed by the Patient Health Questionnaire-9 (PHQ-9) at 6 weeks [ Time Frame: Assessed at Week 0 (pre-intervention) and Week 6 (post-intervention) ] [ Designated as safety issue: No ]
    The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module.

  • Change in general quality of life from baseline assessed by the Quality of Life Enjoyment and Satisfaction questionnaire (Q-LES-Q-SF) at 6 weeks [ Time Frame: Assessed at Week 0 (pre-intervention) and Week 6 (post-intervention) ] [ Designated as safety issue: No ]
    The Quality of Life Enjoyment and Satisfaction questionnaire is a generic, self-reported quality of life measure assessing the physical health, subjective feelings, leisure activities, social relationships, general activities, satisfaction with medications and life-satisfaction domains.


Other Outcome Measures:
  • Patient Global Improvement Impression (PGI-I) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    PGI-I is a global index that may be used to rate the response of a condition to a therapy.

  • Perceived treatment satisfaction assessed by a Modified version of the Glasgow Benefit Inventory [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The Glasgow Benefit Inventory is a subjective post-interventional questionnaire especially developed to evaluate patient's perceived satisfaction with the treatment.


Estimated Enrollment: 50
Study Start Date: July 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 40 Hz Rhythmic Sensory Stimulation
Intervention consists of Rhythmic Sensory Stimulation of a sustained single pitch of 40 Hz sound of regular temporal intervals. The treatment prescription is 30 minutes daily 40 Hz Rhythmic Sensory Stimulation, 5 days per week, for five weeks of treatment, for a total of 25 sessions.
Device: Rhythmic Sensory Stimulation
Rhythmic Sensory Stimulation (RSS) uses rhythmic sensory cues to induce brain entrainment based on the premise that the spontaneous electrical activity of the brain can synchronize to external periodic auditory, visual, or somatosensory stimuli. RSS can be delivered through sound devices. In this study, the stimuli will be delivered with a portable sound 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 sound (40 Hz RSS), the efficacy of the Sound Oasis VTS-1000 device to deliver this sound will also be observed.
Other Name: Sound Oasis Vibroacoustic Therapy System (VTS) 1000 device
Sham Comparator: Non-specific Rhythmic Sensory Stimulation
Sham Rhythmic Sensory Stimulation of non-specific pitch in the 30-100 Hz frequency and irregular temporal interval, for 30 minutes daily stimulation, 5 days per week, for a total of five weeks of treatment.
Device: Rhythmic Sensory Stimulation
Rhythmic Sensory Stimulation (RSS) uses rhythmic sensory cues to induce brain entrainment based on the premise that the spontaneous electrical activity of the brain can synchronize to external periodic auditory, visual, or somatosensory stimuli. RSS can be delivered through sound devices. In this study, the stimuli will be delivered with a portable sound 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 sound (40 Hz RSS), the efficacy of the Sound Oasis VTS-1000 device to deliver this sound will also be observed.
Other Name: Sound Oasis Vibroacoustic Therapy System (VTS) 1000 device

Detailed Description:

Fibromyalgia is a chronic pain disorder associated with widespread pain that dramatically impacts patients' quality of life. Its exact cause has not yet been identified, however, recent studies indicate that fibromyalgia is associated with significant imbalance of the connectivity within brain networks associated with pain, decreased functional connectivity in the descending pain-modulating system, and increased activity in the pain matrix related to central sensitization. It has been suggested that treatments that stimulate or induce coherent neuronal activity, and synchronize dysregulated brain circuitry, have significant benefits improving pain management and enhancing patients' quality of life.

An example of a non-invasive treatment that is thought to indirectly stimulate neuronal coherence is Rhythmic Sensory Stimulation (RSS) in gamma frequencies. RSS stimulates the mechanoreceptors in the body using low-frequency sound (e.g., 40 Hz) by means of speakers in a chair. Previous research demonstrates significantly improved pain management in several pain conditions (e.g., rheumatoid arthritis, low-back pain, sports injuries); however, little is known about the effect of RSS with low-frequency sound on fibromyalgia. The use of RSS to treat fibromyalgia was first explored very recently and findings indicate that this treatment could be effective for individuals with fibromyalgia given that 40 Hz low-frequency sound stimulation indirectly stimulates neuronal coherence. The present research aims to determine the effectiveness of RSS with 40 Hz sound for treating individuals with fibromyalgia.

Aim: The present study aims to examine and determine the effectiveness of RSS at 40 Hz with sound in improving pain management and quality of life among patients with fibromyalgia.

Intervention: The proposed treatment involves 30 minutes of daily rhythmic vibroacoustic stimulation at 40 Hz, 5 days per week, for 5 weeks. The treatment is self-administered by the patients at home with the Sound Oasis Vibroacoustic Therapy System (VTS) 1000 portable device. Measures of pain severity, fibromyalgia symptoms, sleep quality, and depression will be compared before and after treatment between the treatment and control groups.

Outcomes: It is expected that patients undergoing RSS at 40 Hz will have significantly different scores after treatment on all outcome measures examined in comparison to the control group. The results of the present study will help to better understand the effectiveness of RSS for 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 RSS.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of fibromyalgia conducted by the medical staff at Wasser Pain Management Centre;
  • Ability 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);
  • Unstable medical or psychiatric illness;
  • History of psychosis, epilepsy, seizures;
  • Pregnancy or breast feeding;
  • Hemorrhaging or active bleeding;
  • Thrombosis, angina pectoris;
  • Heart diseases, such as hypotension, arrhythmia, pacemaker;
  • Substance abuse in the last year;
  • Recently prolapsed vertebral disc;
  • Recovering from a recent accident with back or neck injury.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02493348

Contacts
Contact: Denise Paneduro, MA 416-586-4800 ext 2082 DPaneduro@mtsinai.on.ca
Contact: Thenille Braun Janzen, PhD thenille.braunjanzen@utoronto.ca

Sponsors and Collaborators
Mount Sinai Hospital, Canada
University of Toronto
Investigators
Principal Investigator: Allan Gordon, MD Mount Sinai Hospital, New York
Study Director: Lee Bartel, PhD University of Toronto
  More Information

Publications:
Responsible Party: Allan Gordon, Director of Wasser Pain Management Centre, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT02493348     History of Changes
Other Study ID Numbers: MSH REB 15-0140-E
Study First Received: July 2, 2015
Last Updated: July 8, 2015
Health Authority: Canada: Institutional Review Board

Keywords provided by Mount Sinai Hospital, Canada:
Fibromyalgia
Rhythmic Sensory Stimulation
Gamma Stimulation

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 02, 2015