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

Primary Purpose

Low Back Pain, Paraspinal Muscles

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
StimaWell 120MTRS system
Sponsored by
Concordia University, Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Diagnostic Imaging, Electrical Stimulation Therapy, Low Back Pain, Paraspinal Muscles

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • PEFORM CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Phasic Treatment Group

Combined Treatment Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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
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.
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)
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)

Secondary Outcome Measures

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
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
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
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
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.
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.
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.

Full Information

First Posted
May 13, 2021
Last Updated
September 5, 2023
Sponsor
Concordia University, Montreal
Collaborators
Mitacs
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1. Study Identification

Unique Protocol Identification Number
NCT04891692
Brief Title
Effect of Neuromuscular Electrical Stimulation in Patients With Chronic Low Back Pain
Official Title
Effect of Neuromuscular Electrical Stimulation Using the StimaWELL 120MTRS System on Multifidus Muscle Morphology and Function in Patients With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Concordia University, Montreal
Collaborators
Mitacs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Paraspinal Muscles
Keywords
Diagnostic Imaging, Electrical Stimulation Therapy, Low Back Pain, Paraspinal Muscles

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phasic Treatment Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Combined Treatment Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
StimaWell 120MTRS system
Intervention Description
Medium-frequency electrotherapy device that delivers current via up to 12 channels. The device also provides heat therapy up to 40°C.
Primary Outcome Measure Information:
Title
Change in multifidus muscle size (cross-sectional area)
Description
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
Title
Change in multifidus muscle fat infiltration
Description
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
Title
Change in multifidus muscle function (% thickness change)
Description
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
Title
Change in multifidus muscle stiffness
Description
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
Title
Change in multifidus muscle stiffness
Description
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
Secondary Outcome Measure Information:
Title
Change in the Numerical Pain Rating Scale (NPRS) for low back pain intensity at present
Description
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
Title
Change in the Numerical Pain Rating Scale (NPRS) for low back pain intensity (best and worst pain over previous week)
Description
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
Title
Change in the Numerical Pain Rating Scale (NPRS) for low back pain intensity (sitting and with movement over past 24h)
Description
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
Title
Change in the Numerical Pain Rating Scale (NPRS) for overall leg pain intensity in the past week
Description
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
Title
Change in the Oswestry Disability Index (ODI)
Description
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
Title
Change in the Pain Catastrophizing Scale (PCS)
Description
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
Title
Change in the Brief Pain Inventory - Interference (BPI)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maryse Fortin, PhD
Phone
514-848-242
Ext
8642
Email
maryse.fortin@concordia.ca
Facility Information:
Facility Name
PEFORM Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4B1R6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Wolfe, BSc
Phone
5148057266
Email
lbpstudy.concordia@gmail.com
First Name & Middle Initial & Last Name & Degree
Daniel Wolfe, BSc

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35773711
Citation
Fortin M, Wolfe D, Dover G, Boily M. The effect of phasic versus combined neuromuscular electrical stimulation using the StimaWELL 120MTRS system on multifidus muscle morphology and function in patients with chronic low back pain: a randomized controlled trial protocol. BMC Musculoskelet Disord. 2022 Jul 1;23(1):627. doi: 10.1186/s12891-022-05578-1.
Results Reference
derived

Learn more about this trial

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

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