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

March 7, 2024 updated by: Concordia University, Montreal

Effect of Neuromuscular Electrical Stimulation Using the StimaWELL 120MTRS System on Multifidus Muscle Morphology and Function 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4B1R6
        • PEFORM Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phasic Treatment Group
Muscle therapy for the lumbar spine at the StimaWell 120MTRS system's phasic setting. Treatment at 3 kHz, modulation 50 Hz. Supervised 10 week intervention, 2 times a week. Treatment time of 20 minutes for the first 3 weeks, 25 minutes for the second 3 weeks, and 30 minutes for the final 4 weeks. 120MTRS system recalibration every fifth treatment.
Device: StimaWell 120MTRS system
Medium-frequency electrotherapy device that delivers current via up to 12 channels. The device also provides heat therapy up to 40°C.
Experimental: Combined Treatment Group
Muscle therapy for the lumbar spine at the StimaWell 120MTRS system's combined (tonic and phasic) setting. Treatment at 3 kHz, modulation 4 Hz and 50 Hz. Supervised 10 week intervention, 2 times a week. Treatment time of 20 minutes for the first 3 weeks, 25 minutes for the second 3 weeks, and 30 minutes for the final 4 weeks. 120MTRS system recalibration every fifth treatment.
Device: StimaWell 120MTRS system
Medium-frequency electrotherapy device that delivers current via up to 12 channels. The device also provides heat therapy up to 40°C.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, after 10 weeks
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
Baseline, after 10 weeks
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.
Baseline, after 10 weeks
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)
Baseline, after 10 weeks
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)
Before and 15 minutes after 3rd treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, before and after each treatment, after 10 weeks
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
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)
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
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
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
Baseline, prior to 11th treatment, after 10 weeks
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.
Baseline, prior to 11th treatment, after 10 weeks
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.
Baseline, prior to 11th treatment, after 10 weeks
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.
Baseline, prior to 11th treatment, after 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Concordia University, Montreal

Collaborators

Mitacs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2021

Primary Completion (Actual)

February 23, 2024

Study Completion (Actual)

February 23, 2024

Study Registration Dates

First Submitted

May 13, 2021

First Submitted That Met QC Criteria

May 13, 2021

First Posted (Actual)

May 18, 2021

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCER 20-21-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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