← Back to Search

Behavioural Intervention

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

N/A
Waitlist Available
Research Sponsored by Concordia University, Montreal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before and 15 minutes after 3rd treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a device called the StimaWELL 120MTRS, which uses electrical pulses to help back muscles. It aims to see if this device can improve muscle function and reduce stiffness in people with long-term low back pain. Participants will receive different types of muscle therapy using this device over several weeks.

Eligible Conditions
  • Low Back Pain
  • Lower Back Pain
  • Paraspinal Muscles

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and 15 minutes after 3rd treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and before and 15 minutes after 3rd treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in multifidus muscle fat infiltration
Change in multifidus muscle function (% thickness change)
Change in multifidus muscle size (cross-sectional area)
+1 more
Secondary study objectives
Pain
Change in the Numerical Pain Rating Scale (NPRS) for low back pain intensity (best and worst pain over previous week)
Change in the Numerical Pain Rating Scale (NPRS) for low back pain intensity (sitting and with movement over past 24h)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phasic Treatment GroupExperimental Treatment1 Intervention
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.
Group II: Combined Treatment GroupExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
StimaWell 120MTRS system
2021
N/A
~30

Find a Location

Who is running the clinical trial?

Concordia University, MontrealLead Sponsor
29 Previous Clinical Trials
5,221 Total Patients Enrolled
4 Trials studying Low Back Pain
277 Patients Enrolled for Low Back Pain
MitacsIndustry Sponsor
42 Previous Clinical Trials
4,501 Total Patients Enrolled
1 Trials studying Low Back Pain

Media Library

StimaWell 120MTRS system (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04891692 — N/A
Low Back Pain Research Study Groups: Combined Treatment Group, Phasic Treatment Group
Low Back Pain Clinical Trial 2023: StimaWell 120MTRS system Highlights & Side Effects. Trial Name: NCT04891692 — N/A
StimaWell 120MTRS system (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04891692 — N/A
~6 spots leftby Dec 2025