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

Overseen By Maryse Fortin, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Concordia University, Montreal

Must not be taking: Muscle relaxants

Disqualifiers: Lumbar surgery, Systemic disease, Rheumatoid arthritis, Spinal stenosis, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

Duration: 10 weeks

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you have been taking prescribed muscle relaxants more than once a week over the past month, you may not be eligible to participate.

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion 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.

English or French speakers.

Exclusion Criteria

Presence of rheumatoid arthritis.

Presence of cardiac arrhythmia.

You have epilepsy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive muscle therapy using the StimaWELL 120MTRS system for 10 weeks, with different settings for each group

10 weeks

20 sessions (in-person, 2 times a week)

Follow-up

Participants are monitored for changes in multifidus muscle stiffness, pain intensity, and disability

4 weeks

Treatment Details

Interventions

• StimaWell 120MTRS system

Participant Groups

Group I: Phasic Treatment Group Experimental Treatment 1 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 Group Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Concordia University, Montreal

Lead Sponsor

Trials

30

Recruited

5,200+

Mitacs

Industry Sponsor

Trials

46

Recruited

5,200+