CompletedNot Applicable

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

Canada30 participantsStarted 2021-02-22

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 pi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in multifidus muscle size (cross-sectional area)

Timeframe: Baseline, after 10 weeks

Change in multifidus muscle fat infiltration

Timeframe: Baseline, after 10 weeks

Change in multifidus muscle function (% thickness change)

Timeframe: Baseline, after 10 weeks

Change in multifidus muscle stiffness

Timeframe: Baseline, after 10 weeks

Change in multifidus muscle stiffness

Timeframe: Before and 15 minutes after 3rd treatment

Trial details

NCT IDNCT04891692

SponsorConcordia University, Montreal

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-23

View on ClinicalTrials.gov More Low Back Pain trials

Plain-language summary

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in multifidus muscle size (cross-sectional area)

Timeframe: Baseline, after 10 weeks

Change in multifidus muscle fat infiltration

Timeframe: Baseline, after 10 weeks

Change in multifidus muscle function (% thickness change)

Timeframe: Baseline, after 10 weeks

Change in multifidus muscle stiffness

Timeframe: Baseline, after 10 weeks

Change in multifidus muscle stiffness

Timeframe: Before and 15 minutes after 3rd treatment