Status:
COMPLETED
Effect of Neuromuscular Electrical Stimulation in Patients With Chronic Low Back Pain
Lead Sponsor:
Concordia University, Montreal
Collaborating Sponsors:
Mitacs
Conditions:
Low Back Pain
Paraspinal Muscles
Eligibility:
All Genders
18-60 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04891692
Start Date
February 22 2021
End Date
February 23 2024
Last Update
March 8 2024
Active Locations (1)
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1
PEFORM Centre
Montreal, Quebec, Canada, H4B1R6