Chronic Pain, WidespreadNCT06416826
Rhythmic Sensory Stimulation on Fibromyalgia
A study testing Vibroacoustic Therapy System - VTS 1000 in people with Chronic Pain, Widespread, run by Women's College Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Widespread
- What is being tested?
- Vibroacoustic Therapy System - VTS 1000
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 1 Mar 2020
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
About this study
Official title: An Investigation of the Effects of Rhythmic Sensory Stimulation on Fibromyalgia
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.
- Conditions
- Chronic Pain, Widespread
- Being tested
- Vibroacoustic Therapy System - VTS 1000
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibroacoustic Therapy System - VTS 1000Device
Also called Rhythmic Sensory Stimulation
Participants will undertake 15 self-administered sessions of RSS 40Hz low frequency sound stimulation, 30 minutes daily, over 3 weeks (5 days/week).
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | healthy controls n = 10 |
| patients | Active comparator | patients with fibromyalgia
n =20 Receives: Device: Vibroacoustic Therapy System - VTS 1000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in inflammatory cytokine levels
The investigator will use a multiplex enzyme-linked immunosorbent assay (ELISA) to asses inflammatory cytokines in fibromyalgia.
Measured: baseline, 1 month, 2 months
Secondary outcomes (2)
change in pain severity
Patients will rate their pain severity on a scale from 0 (no pain) to 10 (extreme pain)
Measured: baseline, 1 month, 2 months
change in EEG brain activity
The investigators will measure EEG dynamics to quantify dysfunctional activity in brain areas that are affected by fibromyalgia
Measured: baseline, 1 month, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Apr 2019 (estimated)
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Why it stopped: unforeseen circumstances
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pain, WidespreadStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416826
- Sponsor's protocol ID
- FibroMusicTherapy
- Status last verified
- May 2024
- First submitted
- 8 Apr 2019
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Effects of Rhythmic Sensory Stimulation on Fibromyalgia
- ClinicalTrials.gov ID
- NCT06416826
- Acronym / sponsor ID
- FibroMusicTherapy
- Conditions
- Chronic Pain, Widespread
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unforeseen circumstances
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 16 May 2024 (actual)
- 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –healthy controls n = 10 |
| patients | Active comparator | Device: Vibroacoustic Therapy System - VTS 1000patients with fibromyalgia n =20 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Vibroacoustic Therapy System - VTS 1000Also: Rhythmic Sensory StimulationParticipants will undertake 15 self-administered sessions of RSS 40Hz low frequency sound stimulation, 30 minutes daily, over 3 weeks (5 days/week). | Device | patients |
Primary outcome
change in inflammatory cytokine levels
Time frame: baseline, 1 month, 2 months
The investigator will use a multiplex enzyme-linked immunosorbent assay (ELISA) to asses inflammatory cytokines in fibromyalgia.
2 secondary outcomes
change in pain severity
Time frame: baseline, 1 month, 2 months
change in EEG brain activity
Time frame: baseline, 1 month, 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Pain, Widespread
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
RecruitingObservational study
Overlapping Pain Trajectory Study
Migraine, Musculoskeletal Pain
Not yet recruiting
Hyperthermia in Patients With Chronic Primary Pain - Effects on Thermoregulation, Somatosensory System and Movement Evoked Pain
Hyperthermia, Chronic Primary Pain
Recruiting
Shiatsu for Chronic Non-Inflammatory Pain in Children and Adolescents
Chronic Pain, Chronic Pain Syndrome
RecruitingObservational study
Thoracolumbar Fascia Thickness in Women With Fibromyalgia
Fibromyalgia
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Vibroacoustic Therapy System - VTS 1000 in people with Chronic Pain, Widespread, run by Women's College Hospital.
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: withdrawn, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 in inflammatory cytokine levels (time frame: baseline, 1 month, 2 months). 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 16 May 2024.