Neuromuscular Electrical Stimulation for Lower Back Pain

MF
Overseen ByMaryse Fortin, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called the StimaWELL 120MTRS, which uses electrical stimulation to alleviate chronic low back pain. The goal is to assess how this device affects the muscles in the lower back, focusing on their shape and function. Participants will be divided into two groups: one using a "phasic" setting and the other using a "combined" setting on the device. Individuals with chronic low back pain for more than three months, who experience moderate effects on daily life, might be suitable for this trial. As an unphased trial, this study provides a unique opportunity for participants to explore innovative treatment options for chronic low back pain.

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 prior data suggests that the StimaWELL 120MTRS system is safe for individuals with chronic low back pain?

Research shows that the StimaWELL 120MTRS system is generally easy for most people to handle. It employs a type of electrical therapy often used for muscle stimulation and pain relief. The system operates through several channels, but sensations may vary, leading to different experiences for users.

Few reports of serious side effects exist. Some individuals might feel mild discomfort from the electrical stimulation, which is typical for this kind of therapy. Since this study lacks a specific trial phase, the safety of the StimaWELL system should be considered based on its use in other treatments. Medical treatments can affect individuals differently, so consulting a healthcare provider before participating is advisable.12345

Why are researchers excited about this trial?

Researchers are excited about the StimaWell 120MTRS system for chronic low back pain because it offers a unique approach through neuromuscular electrical stimulation. Unlike standard treatments like physical therapy, pain medications, or spinal injections, which focus on symptom relief, the StimaWell system actively targets muscle activation and rehabilitation. This system uses a combination of tonic and phasic electrical currents to enhance muscle function, potentially leading to more effective and longer-lasting pain relief. Plus, the ability to adjust treatment intensity over a structured 10-week program allows for personalized care and gradual enhancement of muscle endurance and strength.

What evidence suggests that the StimaWELL 120MTRS system is effective for chronic low back pain?

Research has shown that the StimaWELL 120MTRS system can firm back muscles and reduce pain in individuals with chronic low back pain. In this trial, participants will join different treatment arms. The Combined Treatment Group will use the system's combined setting, which significantly increases muscle firmness, aiding support and stability, and reduces pain. Participants in the Phasic Treatment Group will use the phasic setting, which also reduces pain. Both settings appear beneficial, but the combined setting may offer additional support for the back muscles.23678

Are You a Good Fit for This Trial?

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.
See 2 more

Exclusion Criteria

Presence of rheumatoid arthritis.
Presence of cardiac arrhythmia.
You have epilepsy.
See 15 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • StimaWell 120MTRS system
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Phasic Treatment GroupExperimental Treatment1 Intervention
Group II: Combined Treatment GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Concordia University, Montreal

Lead Sponsor

Trials
30
Recruited
5,200+

Mitacs

Industry Sponsor

Trials
46
Recruited
5,200+

Citations

The Immediate Effect of a Single Treatment of Neuromuscular ...In this study, we observed a significant increase in lumbar multifidus stiffness (at rest in prone) in the combined group following a 20 min ...
Effect of neuromuscular electrical stimulation therapy using ...The StimaWELL 120MTRS system can deliver current through up to 12 channels, however, the current may not be felt equally across all channels in ...
(PDF) The Immediate Effect of a Single Treatment ...Both groups experienced significant decreases in pain intensity (MD combined group = 1.12, 95% CI [0.34, 1.90], p = 0.011) (MD phasic group = ...
The effect of phasic versus combined neuromuscular electrical ...Therefore, the primary aim of this study is to compare the effects of two muscle therapy protocols with a medium-frequency electrotherapy device (the StimaWELL ...
Effect of neuromuscular electrical stimulation therapy using ...Participants will be randomized (1:1) to either the phasic or combined (phasic + tonic) muscle therapy protocols on the StimaWELL 120MTRS system ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/35773711/
a randomized controlled trial protocolParticipants will be randomized (1:1) to either the phasic or combined (phasic + tonic) muscle therapy protocols on the StimaWELL 120MTRS system. Participants ...
The effect of phasic versus combined neuromuscular electrical ...The primary aim of this study is to compare the effects of two muscle therapy protocols with a medium-frequency electrotherapy device (the StimaWELL 120MTRS ...
Dynamic Deep Wave Therapy - StimaWELL®120MTRSThe StimaWELL® System combines midfrequency electrostimulation and heat therapy and thereby offers a multidimensional back stimulation. The dynamic deep ...
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