Effect of Neuromuscular Electrical Stimulation in Patients With Chronic Low Back Pain

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Neuromuscular Electrical Stimulation Using the StimaWELL 120MTRS System on Multifidus Muscle Morphology and Function in Patients With Chronic Low Back Pain

Conditions
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Low Back Pain, Paraspinal Muscles

Intervention / Treatment
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* Device: StimaWell 120MTRS system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic non-specific LBP (>3 months), defined as pain in the region between the lower ribs and gluteal folds, with or without leg pain. Aged between 18 to 60 years old. English or French speakers At least a 4/10 score on an 11-point Numerical Pain Rating Scale (NPRS) for pain intensity. The score will be the average of current pain, and best and worst pain over the previous week. At least a 'moderate' Modified Oswestry Disability Index (ODI) score. Able to undergo MRI exam. Exclusion Criteria: Currently undergoing or having received physical therapy treatment in the previous month Consistent motor control training for the low back and / or consistent weightlifting, power-lifting, bodybuilding, or strongman training in the previous 6 weeks History of lumbar surgery Presence of positive lumbosacral dermatomes or myotomes Presence of disease which could affect the stiffness of muscle tissue (collagen tissue disease, hemiplegia, multiple sclerosis, blood clots) Presence of systemic disease (cancer, metabolic syndrome) Presence of rheumatoid arthritis Presence of spinal stenosis, fracture, infection, or tumor Presence of lumbar scoliosis greater than 10 degrees Presence of cardiac arrhythmia Pregnant and breastfeeding women Individuals with epilepsy Individuals at risk for serious bleeding Individuals with pacemakers or metal implants Individuals with aneurysms or heart valve clips Individuals with tattoos or piercings in the lumbar spine Individuals who have taken prescribed muscle relaxants more than once a week over the past month BMI > 30

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phasic Treatment Group<br>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. | Device: StimaWell 120MTRS system<br>* Medium-frequency electrotherapy device that delivers current via up to 12 channels. The device also provides heat therapy up to 40°C.<br>|
| Experimental: Combined Treatment Group<br>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. | Device: StimaWell 120MTRS system<br>* Medium-frequency electrotherapy device that delivers current via up to 12 channels. The device also provides heat therapy up to 40°C.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnostic Imaging, Electrical Stimulation Therapy, Low Back Pain, Paraspinal Muscles