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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Medium-frequency electrotherapy device that delivers current via up to 12 channels. The device also provides heat therapy up to 40°C.
PEFORM Centre
Montreal, Quebec, Canada
Change in multifidus muscle size (cross-sectional area)
Multifidus muscle cross-sectional area measurements will be obtained from magnetic resonance imaging (MRI) at L4-L5 and L5-SI spinal levels.
Time frame: Baseline, after 10 weeks
Change in multifidus muscle fat infiltration
Multifidus muscle fatty infiltration (composition) measurements will be obtained from magnetic resonance imaging (MRI) at L4-L5 and L5-S1 spinal levels
Time frame: Baseline, after 10 weeks
Change in multifidus muscle function (% thickness change)
Multifidus muscle function, expressed as the % thickness change from a rested to contracted position via prone contralateral arm lifts will be assessed by ultrasound.
Time frame: Baseline, after 10 weeks
Change in multifidus muscle stiffness
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)
Time frame: Baseline, after 10 weeks
Change in multifidus muscle stiffness
Multifidus muscle stiffness, obtained at rest in a prone position, and in a standing position, will be assessed by ultrasound (shear-wave elastography)
Time frame: Before and 15 minutes after 3rd treatment
Change in the Numerical Pain Rating Scale (NPRS) for low back pain intensity at present
The NPRS measures pain intensity on a scale of 0 - 10, with 0 being no pain, and 10 being the worst pain imaginable
Time frame: Baseline, before and after each treatment, after 10 weeks
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Change in the Numerical Pain Rating Scale (NPRS) for low back pain intensity (best and worst pain over previous week)
The NPRS measures pain intensity on a scale of 0 - 10, with 0 being no pain, and 10 being the worst pain imaginable
Time frame: 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)
The NPRS measures pain intensity on a scale of 0 - 10, with 0 being no pain, and 10 being the worst pain imaginable
Time frame: Baseline, prior to 11th treatment, after 10 weeks
Change in the Numerical Pain Rating Scale (NPRS) for overall leg pain intensity in the past week
The NPRS measures pain intensity on a scale of 0 - 10, with 0 being no pain, and 10 being the worst pain imaginable
Time frame: Baseline, prior to 11th treatment, after 10 weeks
Change in the Oswestry Disability Index (ODI)
The ODI is used to measure the participant's level of disability in relation to LBP. It is a 10-item scale in which each item is rated from 0-6. Higher scores indicate greater disability.
Time frame: Baseline, prior to 11th treatment, after 10 weeks
Change in the Pain Catastrophizing Scale (PCS)
The PCS is a 13-item questionnaire that assesses the participant's level of catastrophizing. Each item is rated from 0-4 for a possible total of 52. Higher scores indicate greater catastrophizing.
Time frame: Baseline, prior to 11th treatment, after 10 weeks
Change in the Brief Pain Inventory - Interference (BPI)
The BPI-I is a 7-item questionnaire that measures how pain interferes with activities of daily living. Each item is rated from 0-10. Higher scores indicative greater interference.
Time frame: Baseline, prior to 11th treatment, after 10 weeks