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

Concordia University, Montreal

Status: Completed

Conditions: Paraspinal Muscles; Low Back Pain

Treatments: Device: StimaWell 120MTRS system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04891692

CCER 20-21-07

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Phasic Treatment Group

Experimental group

Description:

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.

Treatment:

Device: StimaWell 120MTRS system

Combined Treatment Group

Experimental group

Description:

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.

Treatment:

Device: StimaWell 120MTRS system