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NCT Number: NCT04891692

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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Paraspinal Muscles Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PEFORM Centre

Montreal, Quebec, H4B1R6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

StimaWell 120MTRS system

Device

Medium-frequency electrotherapy device that delivers current via up to 12 channels. The device also provides heat therapy up to 40°C.

Primary outcomes

  1. Change in multifidus muscle size (cross-sectional area)

    Time frame: Baseline, after 10 weeks

    Multifidus muscle cross-sectional area measurements will be obtained from magnetic resonance imaging (MRI) at L4-L5 and L5-SI spinal levels.

  2. Change in multifidus muscle fat infiltration

    Time frame: Baseline, after 10 weeks

    Multifidus muscle fatty infiltration (composition) measurements will be obtained from magnetic resonance imaging (MRI) at L4-L5 and L5-S1 spinal levels

  3. Change in multifidus muscle function (% thickness change)

    Time frame: Baseline, after 10 weeks

    Multifidus muscle function, expressed as the % thickness change from a rested to contracted position via prone contralateral arm lifts will be assessed by ultrasound.

  4. Change in multifidus muscle stiffness

    Time frame: Baseline, after 10 weeks

    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)

  5. Change in multifidus muscle stiffness

    Time frame: Before and 15 minutes after 3rd treatment

    Multifidus muscle stiffness, obtained at rest in a prone position, and in a standing position, will be assessed by ultrasound (shear-wave elastography)

Secondary outcomes

  1. Change in the Numerical Pain Rating Scale (NPRS) for low back pain intensity at present

    Time frame: Baseline, before and after each treatment, after 10 weeks

    The NPRS measures pain intensity on a scale of 0 - 10, with 0 being no pain, and 10 being the worst pain imaginable

  2. Change in the Numerical Pain Rating Scale (NPRS) for low back pain intensity (best and worst pain over previous week)

    Time frame: Baseline, prior to 11th treatment, after 10 weeks

    The NPRS measures pain intensity on a scale of 0 - 10, with 0 being no pain, and 10 being the worst pain imaginable

  3. Change in the Numerical Pain Rating Scale (NPRS) for low back pain intensity (sitting and with movement over past 24h)

    Time frame: Baseline, prior to 11th treatment, after 10 weeks

    The NPRS measures pain intensity on a scale of 0 - 10, with 0 being no pain, and 10 being the worst pain imaginable

  4. Change in the Numerical Pain Rating Scale (NPRS) for overall leg pain intensity in the past week

    Time frame: Baseline, prior to 11th treatment, after 10 weeks

    The NPRS measures pain intensity on a scale of 0 - 10, with 0 being no pain, and 10 being the worst pain imaginable

  5. Change in the Oswestry Disability Index (ODI)

    Time frame: Baseline, prior to 11th treatment, after 10 weeks

    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.

  6. Change in the Pain Catastrophizing Scale (PCS)

    Time frame: Baseline, prior to 11th treatment, after 10 weeks

    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.

  7. Change in the Brief Pain Inventory - Interference (BPI)

    Time frame: Baseline, prior to 11th treatment, after 10 weeks

    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.

Sponsors and collaborators

Lead sponsor

Concordia University, Montreal

Other

Collaborators

  • Mitacs

Registry information

Official study title

Effect of Neuromuscular Electrical Stimulation Using the StimaWELL 120MTRS System on Multifidus Muscle Morphology and Function in Patients With Chronic Low Back Pain

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 18, 2021
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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