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StimaWell 120MTRS system for Lower Back Pain
Study Summary
This trial will study the effects of a 10-week intervention using the StimaWELL 120MTRS device on the muscle structure and function of people with chronic low back pain. The study will also look at the acute effect of a single treatment with the StimaWELL 120MTRS on the stiffness of the multifidus muscle in people with chronic low back pain.
- Lower Back Pain
- Paraspinal Muscles
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Combined Treatment Group
- Group 2: Phasic Treatment Group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Does this protocol accept participants aged 30 or older?
"This clinical trial is available to those aged 18 - 60. For younger and older patients, there are 11 trials for minors and 263 studies open to senior citizens."
Who is the ideal participant for this research project?
"This medical trial seeks 30 participants aged 18 to 60 who suffer from chronic lower back agony. Qualified individuals must also fulfill the following prerequisites: score a minimum of 4/10 on an 11-point Numerical Pain Rating Scale (NPRS) for pain intensity, experience 'moderate' Modified Oswestry Disability Index (ODI), and be able to undergo MRI exam; furthermore, they need to speak either English or French. The selection criteria will take into account current pain as well as best and worst experiences over the preceding seven days."
What goals are being sought after in this experiment?
"This trial has the primary goal of measuring changes in multifidus muscle stiffness over a 10 week baseline. Secondary objectives include gauging alterations to participants' Numerical Pain Rating Scale (NPRS) for present and past-week low back pain intensity, as well as assessing fluctuations on their Pain Catastrophizing Scale (PCS). The NPRS utilises a 0 - 10 scale, with zero representing no pain and ten being unbearable anguish; while PCS is scored from 0 - 4 per item, totalling 52 points – higher scores indicate more pessimism about one's condition."
Is there any capacity for additional participants in this research?
"Affirmative. The clinicaltrial.gov website reports that this medical trial is actively recruiting participants, with the initial posting on February 22nd 2021 and most recent update on July 26th 2022. 30 individuals need to be enrolled at one particular location."
What is the total number of participants enrolled in this experiment?
"Affirmative. Clinicaltrials.gov reports that, since its inception on February 22nd 2021, this clinical trial has been actively recruiting participants from one location with a goal of enrolling 30 patients."
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