Effect of Neuromuscular Electrical Stimulation Using the StimaWELL 120MTRS System on Multifidus Muscle Morphology and Function in Patients With Chronic Low Back Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in multifidus muscle fat infiltration
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Phasic Treatment Group
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.
Intervention: StimaWell 120MTRS system (Device)
Combined Treatment Group
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.
Intervention: StimaWell 120MTRS system (Device)
Outcomes
Primary Outcomes
Change in multifidus muscle fat infiltration
Time Frame: Baseline, after 10 weeks
Multifidus muscle fatty infiltration (composition) measurements will be obtained from magnetic resonance imaging (MRI) at L4-L5 and L5-S1 spinal levels
Change in multifidus muscle function (% thickness change)
Time Frame: Baseline, after 10 weeks
Multifidus muscle function, expressed as the % thickness change from a rested to contracted position via prone contralateral arm lifts will be assessed by ultrasound.
Change in multifidus muscle stiffness
Time Frame: Before and 15 minutes after 3rd treatment
Multifidus muscle stiffness, obtained at rest in a prone position, and in a standing position, will be assessed by ultrasound (shear-wave elastography)
Change in multifidus muscle size (cross-sectional area)
Time Frame: Baseline, after 10 weeks
Multifidus muscle cross-sectional area measurements will be obtained from magnetic resonance imaging (MRI) at L4-L5 and L5-SI spinal levels.
Change in multifidus muscle stiffness
Time Frame: Baseline, after 10 weeks
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)
Secondary Outcomes
- Change in the Numerical Pain Rating Scale (NPRS) for low back pain intensity (best and worst pain over previous week)(Baseline, prior to 11th treatment, after 10 weeks)
- Change in the Oswestry Disability Index (ODI)(Baseline, prior to 11th treatment, after 10 weeks)
- Change in the Numerical Pain Rating Scale (NPRS) for low back pain intensity at present(Baseline, before and after each treatment, after 10 weeks)
- Change in the Numerical Pain Rating Scale (NPRS) for overall leg pain intensity in the past week(Baseline, prior to 11th treatment, after 10 weeks)
- Change in the Pain Catastrophizing Scale (PCS)(Baseline, prior to 11th treatment, after 10 weeks)
- Change in the Brief Pain Inventory - Interference (BPI)(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)(Baseline, prior to 11th treatment, after 10 weeks)