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| Name | Class |
|---|---|
| Mitacs | INDUSTRY |
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This study evaluates the effect of a 10-week long intervention with the StimaWELL 120MTRS system on multifidus morphology and function in individuals with chronic low back pain. Half the participants will receive muscle therapy at the device's phasic setting, while half will receive muscle therapy at the device's combined setting. This study also evaluates the acute effect of a single treatment with the StimaWELL 120MTRS on multifidus stiffness in individuals with chronic low back pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phasic Treatment Group | Experimental | Muscle therapy for the lumbar spine at the StimaWell 120MTRS system's phasic setting. Treatment at 3 kHz, modulation 50 Hz. Supervised 10 week intervention, 2 times a week. Treatment time of 20 minutes for the first 3 weeks, 25 minutes for the second 3 weeks, and 30 minutes for the final 4 weeks. 120MTRS system recalibration every fifth treatment. |
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| Combined Treatment Group | Experimental | Muscle therapy for the lumbar spine at the StimaWell 120MTRS system's combined (tonic and phasic) setting. Treatment at 3 kHz, modulation 4 Hz and 50 Hz. Supervised 10 week intervention, 2 times a week. Treatment time of 20 minutes for the first 3 weeks, 25 minutes for the second 3 weeks, and 30 minutes for the final 4 weeks. 120MTRS system recalibration every fifth treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| StimaWell 120MTRS system | Device | Medium-frequency electrotherapy device that delivers current via up to 12 channels. The device also provides heat therapy up to 40°C. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in multifidus muscle size (cross-sectional area) | Multifidus muscle cross-sectional area measurements will be obtained from magnetic resonance imaging (MRI) at L4-L5 and L5-SI spinal levels. | Baseline, after 10 weeks |
| Change in multifidus muscle fat infiltration | Multifidus muscle fatty infiltration (composition) measurements will be obtained from magnetic resonance imaging (MRI) at L4-L5 and L5-S1 spinal levels | Baseline, after 10 weeks |
| Change in multifidus muscle function (% thickness change) | Multifidus muscle function, expressed as the % thickness change from a rested to contracted position via prone contralateral arm lifts will be assessed by ultrasound. | Baseline, after 10 weeks |
| Change in multifidus muscle stiffness | Multifidus muscle stiffness, obtained at rest in a prone position, with prone contralateral arm lifts, and in a standing position, will be assessed by ultrasound (shear-wave elastography) | Baseline, after 10 weeks |
| Change in multifidus muscle stiffness | Multifidus muscle stiffness, obtained at rest in a prone position, and in a standing position, will be assessed by ultrasound (shear-wave elastography) | Before and 15 minutes after 3rd treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Numerical Pain Rating Scale (NPRS) for low back pain intensity at present | The NPRS measures pain intensity on a scale of 0 - 10, with 0 being no pain, and 10 being the worst pain imaginable | Baseline, before and after each treatment, after 10 weeks |
| Change in the Numerical Pain Rating Scale (NPRS) for low back pain intensity (best and worst pain over previous week) |
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Inclusion Criteria:
The score will be the average of current pain, and best and worst pain over the previous week.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PEFORM Centre | Montreal | Quebec | H4B1R6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35773711 | Derived | Fortin M, Wolfe D, Dover G, Boily M. The effect of phasic versus combined neuromuscular electrical stimulation using the StimaWELL 120MTRS system on multifidus muscle morphology and function in patients with chronic low back pain: a randomized controlled trial protocol. BMC Musculoskelet Disord. 2022 Jul 1;23(1):627. doi: 10.1186/s12891-022-05578-1. |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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The NPRS measures pain intensity on a scale of 0 - 10, with 0 being no pain, and 10 being the worst pain imaginable |
| Baseline, prior to 11th treatment, after 10 weeks |
| Change in the Numerical Pain Rating Scale (NPRS) for low back pain intensity (sitting and with movement over past 24h) | The NPRS measures pain intensity on a scale of 0 - 10, with 0 being no pain, and 10 being the worst pain imaginable | Baseline, prior to 11th treatment, after 10 weeks |
| Change in the Numerical Pain Rating Scale (NPRS) for overall leg pain intensity in the past week | The NPRS measures pain intensity on a scale of 0 - 10, with 0 being no pain, and 10 being the worst pain imaginable | Baseline, prior to 11th treatment, after 10 weeks |
| Change in the Oswestry Disability Index (ODI) | The ODI is used to measure the participant's level of disability in relation to LBP. It is a 10-item scale in which each item is rated from 0-6. Higher scores indicate greater disability. | Baseline, prior to 11th treatment, after 10 weeks |
| Change in the Pain Catastrophizing Scale (PCS) | The PCS is a 13-item questionnaire that assesses the participant's level of catastrophizing. Each item is rated from 0-4 for a possible total of 52. Higher scores indicate greater catastrophizing. | Baseline, prior to 11th treatment, after 10 weeks |
| Change in the Brief Pain Inventory - Interference (BPI) | The BPI-I is a 7-item questionnaire that measures how pain interferes with activities of daily living. Each item is rated from 0-10. Higher scores indicative greater interference. | Baseline, prior to 11th treatment, after 10 weeks |
| D013568 |
| Pathological Conditions, Signs and Symptoms |