FibromyalgiaNCT02493348
A Study of the Effect of Rhythmic Sensory Stimulation on Fibromyalgia
A study testing Rhythmic Sensory Stimulation in people with Fibromyalgia, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Rhythmic Sensory Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Wasser Pain Management Centre, Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
About this study
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.
Read the 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 a 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 in 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 gamma-frequency sounds (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 gamma-frequency sound stimulation 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 gamma-frequency sound stimulation indirectly stimulates neuronal coherence.
Aim: The present study aims to examine the effects of gamma frequency rhythmic sensory stimulation on fibromyalgia symptoms. Treatment effectiveness will be assessed by examining whether sensory stimulation will produce clinically meaningful changes in fibromyalgia symptom severity and whether treatment response will differ between the two treatment parameters.
Intervention: Fifty patients with a formal diagnosis of fibromyalgia were randomly assigned to two test groups. One group received vibrotactile stimulation from a continuous sine wave single-frequency stimulation (40 Hz) for 30 minutes, five days per week, over five weeks, concomitant with usual care. The second group completed the same treatment protocol but received different stimulation consisting of random and intermittent complex wave gamma-range vibrotactile stimulation. Measures of pain severity, fibromyalgia symptoms, sleep quality, and depression will be compared before and after treatment between the two groups.
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 mechanisms underlying clinical responses to rhythmic sensory stimulation.
- Conditions
- Fibromyalgia
- Being tested
- Rhythmic Sensory Stimulation
- Keywords
- Fibromyalgia, Rhythmic Sensory Stimulation, Gamma Stimulation
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmic Sensory StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Rhythmic Sensory Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Assessed at Week 0 (pre-intervention) and Week 6 (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Principal investigator, Allan Gordon, Mount Sinai Hospital, Canada
- Investigators
- Allan Gordon, MD, Principal investigator, MOUNT SINAI HOSPITALLee Bartel, PhD, Study director, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493348
- Sponsor's protocol ID
- MSH REB 15-0140-E
- Status last verified
- Jun 2018
- First submitted
- 2 Jul 2015
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effect of Rhythmic Sensory Stimulation on Fibromyalgia
- ClinicalTrials.gov ID
- NCT02493348
- Acronym / sponsor ID
- MSH REB 15-0140-E
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Rhythmic Sensory Stimulation, Gamma Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- Oct 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 a 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 in 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 gamma-frequency sounds (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 gamma-frequency sound stimulation 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 gamma-frequency sound stimulation indirectly stimulates neuronal coherence.
Aim: The present study aims to examine the effects of gamma frequency rhythmic sensory stimulation on fibromyalgia symptoms. Treatment effectiveness will be assessed by examining whether sensory stimulation will produce clinically meaningful changes in fibromyalgia symptom severity and whether treatment response will differ between the two treatment parameters.
Intervention: Fifty patients with a formal diagnosis of fibromyalgia were randomly assigned to two test groups. One group received vibrotactile stimulation from a continuous sine wave single-frequency stimulation (40 Hz) for 30 minutes, five days per week, over five weeks, concomitant with usual care. The second group completed the same treatment protocol but received different stimulation consisting of random and intermittent complex wave gamma-range vibrotactile stimulation. Measures of pain severity, fibromyalgia symptoms, sleep quality, and depression will be compared before and after treatment between the two groups.
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 mechanisms underlying clinical responses to rhythmic sensory stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous 40 Hz Rhythmic Sensory Stimulation | Experimental | Device: Rhythmic Sensory StimulationThe 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. |
| Intermittent Rhythmic Sensory Stimulation | Active comparator | Device: Rhythmic Sensory StimulationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhythmic Sensory StimulationRhythmic 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. | Device | Continuous 40 Hz Rhythmic Sensory Stimulation, Intermittent Rhythmic Sensory Stimulation |
Primary outcome
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)
The FIQ is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes, based on a 10 point scale.
4 secondary outcomes
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan Gordon, MD principal investigator
MOUNT SINAI HOSPITAL
Lee Bartel, PhD study director
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhythmic Sensory Stimulation in people with Fibromyalgia, run by Mount Sinai Hospital, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2018.