Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
unforeseen circumstances
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Toronto | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention | healthy controls n = 10 | |
| patients | Active Comparator | patients with fibromyalgia n =20 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibroacoustic Therapy System - VTS 1000 | Device | Participants will undertake 15 self-administered sessions of RSS 40Hz low frequency sound stimulation, 30 minutes daily, over 3 weeks (5 days/week). |
| Measure | Description | Time Frame |
|---|---|---|
| change in inflammatory cytokine levels | The investigator will use a multiplex enzyme-linked immunosorbent assay (ELISA) to asses inflammatory cytokines in fibromyalgia. | baseline, 1 month, 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| change in pain severity | Patients will rate their pain severity on a scale from 0 (no pain) to 10 (extreme pain) | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| baseline, 1 month, 2 months |