Clinical trial NCT04891692: Effect of Neuromuscular Electrical Stimulation in Patients With Chronic Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Paraspinal Muscles
Keywords: Diagnostic Imaging
Electrical Stimulation Therapy
Low Back Pain
Paraspinal Muscles
Lead sponsor: Concordia University, Montreal
Sponsor class: OTHER
Collaborators: name: Mitacs
First posted: 2021-05-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in multifidus muscle size (cross-sectional area)
timeFrame: Baseline, after 10 weeks
measure: Change in multifidus muscle fat infiltration
timeFrame: Baseline, after 10 weeks
measure: Change in multifidus muscle function (% thickness change)
timeFrame: Baseline, after 10 weeks
measure: Change in multifidus muscle stiffness
timeFrame: Baseline, after 10 weeks
measure: Change in multifidus muscle stiffness
timeFrame: Before and 15 minutes after 3rd treatment
Secondary outcomes:
measure: Change in the Numerical Pain Rating Scale (NPRS) for low back pain intensity at present
timeFrame: Baseline, before and after each treatment, after 10 weeks
measure: Change in the Numerical Pain Rating Scale (NPRS) for low back pain intensity (best and worst pain over previous week)
timeFrame: Baseline, prior to 11th treatment, after 10 weeks
measure: Change in the Numerical Pain Rating Scale (NPRS) for low back pain intensity (sitting and with movement over past 24h)
timeFrame: Baseline, prior to 11th treatment, after 10 weeks
measure: Change in the Numerical Pain Rating Scale (NPRS) for overall leg pain intensity in the past week
timeFrame: Baseline, prior to 11th treatment, after 10 weeks
measure: Change in the Oswestry Disability Index (ODI)
timeFrame: Baseline, prior to 11th treatment, after 10 weeks
measure: Change in the Pain Catastrophizing Scale (PCS)
timeFrame: Baseline, prior to 11th treatment, after 10 weeks
measure: Change in the Brief Pain Inventory - Interference (BPI)
timeFrame: Baseline, prior to 11th treatment, after 10 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: PEFORM Centre
state: Quebec
Study officials:
References:
citation: Fortin M, Wolfe D, Dover G, Boily M. The effect of phasic versus combined neuromuscular electrical stimulation using the StimaWELL 120MTRS system on multifidus muscle morphology and function in patients with chronic low back pain: a randomized controlled trial protocol. BMC Musculoskelet Disord. 2022 Jul 1;23(1):627. doi: 10.1186/s12891-022-05578-1.