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Behavioural Intervention
StimaWell 120MTRS system for 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 weeks3 visits
Treatment ~ Varies
Follow Up ~ before and 15 minutes after 3rd treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and 15 minutes after 3rd treatment
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 moreSecondary 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 moreAwards & 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
28 Previous Clinical Trials
5,179 Total Patients Enrolled
4 Trials studying Low Back Pain
265 Patients Enrolled for Low Back Pain
MitacsIndustry Sponsor
41 Previous Clinical Trials
4,401 Total Patients Enrolled
1 Trials studying Low Back Pain
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a pain score of at least 4 out of 10 on a scale that measures how much pain you are feeling. This score is based on your current pain as well as the worst and best pain you have experienced in the past week.You have a significant level of disability as measured by the Modified Oswestry Disability Index (ODI) score.You have epilepsy.You have a medical condition that could affect the stiffness of your muscles, such as collagen tissue disease, hemiplegia, multiple sclerosis, or blood clots.You have a condition in your spine such as narrowing, a fracture, infection, or tumor.Your spine is curved too much in your lower back (lumbar region).You have an aneurysm or have had heart valve clips placed.You have a body mass index (BMI) greater than 30, which means you are significantly overweight.You are currently receiving or have received physical therapy treatment in the last month.You have a serious illness like cancer or metabolic syndrome.You have a higher chance of experiencing severe bleeding.You have been regularly taking prescribed muscle relaxants more than once a week for the past month.You have signs of nerve or muscle damage in your lower back area.You have been regularly doing exercises that involve training your lower back or lifting heavy weights in the past 6 weeks.You have had lower back pain for more than 3 months, which means pain in the area between your lower ribs and buttocks, with or without pain in your legs.
Research Study Groups:
This trial has the following groups:- Group 1: Combined Treatment Group
- Group 2: Phasic Treatment Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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