NCT04891692

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2024

Completed
Last Updated

March 8, 2024

Status Verified

August 1, 2023

Enrollment Period

3 years

First QC Date

May 13, 2021

Last Update Submit

March 7, 2024

Conditions

Low Back PainParaspinal Muscles

Keywords

Diagnostic ImagingElectrical Stimulation TherapyLow Back PainParaspinal Muscles

Outcome Measures

Primary Outcomes (5)

  • 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.

    Baseline, after 10 weeks

  • 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

    Baseline, after 10 weeks

  • 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.

    Baseline, after 10 weeks

  • 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)

    Baseline, after 10 weeks

  • 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)

    Before and 15 minutes after 3rd treatment

Secondary Outcomes (7)

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

    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)

    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)

    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

    Baseline, prior to 11th treatment, after 10 weeks

  • Change in the Oswestry Disability Index (ODI)

    Baseline, prior to 11th treatment, after 10 weeks

  • +2 more secondary outcomes

Study Arms (2)

Phasic Treatment Group

EXPERIMENTAL

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

Combined Treatment Group

EXPERIMENTAL

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

Interventions

StimaWell 120MTRS systemDEVICE

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

Combined Treatment GroupPhasic Treatment Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PEFORM Centre

Montreal, Quebec, H4B1R6, Canada

Location

Related Publications (1)

  • 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.

    PMID: 35773711DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2021

First Posted

May 18, 2021

Study Start

February 22, 2021

Primary Completion

February 23, 2024

Study Completion

February 23, 2024

Last Updated

March 8, 2024

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)