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

Last updated: March 7, 2024
Sponsor: Concordia University, Montreal
Overall Status: Completed

Phase

N/A

Condition

Chronic Pain

Treatment

StimaWell 120MTRS system

Clinical Study ID

NCT04891692
CCER 20-21-07
  • Ages 18-60
  • All Genders

Study 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

Inclusion Criteria:

  • Chronic non-specific LBP (>3 months), defined as pain in the region between the lowerribs 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 painintensity. The score will be the average of current pain, and best and worst pain over the previousweek.
  • At least a 'moderate' Modified Oswestry Disability Index (ODI) score.
  • Able to undergo MRI exam.

Exclusion

Exclusion Criteria:

  • Currently undergoing or having received physical therapy treatment in the previousmonth
  • 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 tissuedisease, 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 thepast month
  • BMI > 30

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: StimaWell 120MTRS system
Phase:
Study Start date:
February 22, 2021
Estimated Completion Date:
February 23, 2024

Connect with a study center

  • PEFORM Centre

    Montreal, Quebec H4B1R6
    Canada

    Site Not Available

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