A Study of the Effect of Rhythmic Sensory Stimulation on Fibromyalgia

NCT02493348 | Completed

• 1 other identifier: MSH REB 15-0140-E
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Fibromyalgia; Rhythmic Sensory Stimulation; Gamma Stimulation

Outcome Measures

Primary Outcomes (1)

• Change of Fibromyalgia symptoms and severity from baseline assessed by the Revised Fibromyalgia Impact Questionnaire (FIQ) at 6 weeks

  The FIQ is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes, based on a 10 point scale.

  Assessed at Week 0 (pre-intervention) and Week 6 (post-intervention)

Secondary Outcomes (4)

• Change of sleep quality from baseline assessed by the Pittsburgh Sleep Quality Index (PSQI) at 6 weeks

  Assessed at Week 0 (pre-intervention) and Week 6 (post-intervention)

• Change of depression severity from baseline assessed by the Patient Health Questionnaire-9 (PHQ-9) at 6 weeks

  Assessed at Week 0 (pre-intervention) and Week 6 (post-intervention)

• 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

  Assessed at Week 0 (pre-intervention) and Week 6 (post-intervention)

• Change of pain severity from baseline assessed by Brief Pain Inventory - short form (BPI-SF) at 6 weeks

  Assessed at Week 0 (pre-intervention) and Week 6 (post-intervention)

Other Outcomes (2)

• Patient Global Improvement Impression (PGI-I)

  6 weeks

• Perceived treatment satisfaction assessed by a Modified version of the Glasgow Benefit Inventory

  6 weeks

Study Arms (2)

Continuous 40 Hz Rhythmic Sensory Stimulation

EXPERIMENTAL

The intervention consists of Rhythmic Sensory Stimulation of a continuous sine wave single-frequency stimulation (40 Hz). 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

Intermittent Rhythmic Sensory Stimulation

ACTIVE COMPARATOR

The stimulation consists of random and intermittent complex wave gamma-range RSS with peaks at 45 Hz and 95 Hz, for 30 minutes daily stimulation, 5 days per week, for a total of five weeks of treatment.

Device: Rhythmic Sensory Stimulation

Interventions

Rhythmic Sensory Stimulation DEVICE

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.

Continuous 40 Hz Rhythmic Sensory Stimulation; Intermittent Rhythmic Sensory Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• University of Toronto: collaborator

Study Sites (1)

Wasser Pain Management Centre, Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Allan Gordon, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

• Lee Bartel, PhD

  University of Toronto

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Wasser Pain Management Centre

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: July 9, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 20, 2018

Record last verified: 2018-06

Locations

CA (1)