Effect of Neuromuscular Electrical Stimulation in Patients With Chronic Low Back Pain
CompletedNot applicableNCT04891692
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Brief summary (from the registry)
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 details
- Official title
- Effect of Neuromuscular Electrical Stimulation Using the StimaWELL 120MTRS System on Multifidus Muscle Morphology and Function in Patients With Chronic Low Back Pain
- Conditions
- Low Back Pain
- Paraspinal Muscles
- Interventions
- Device: StimaWell 120MTRS system
- Sponsor
- Concordia University, Montreal
- Collaborators
- Mitacs
- Start date
- 2021-02-22
- Primary completion
- 2024-02-23
- Sex
- All
- Age range
- from 18 Years to 60 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Canadian sites (1)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04891692