RecruitingNAINTERVENTIONAL

The Effects of EXOPULSE Mollii Suit on Low Back Pain

This study is investigating a new approach to managing persistent lower back pain, a very common problem that can make daily activities difficult and sometimes lead to anxiety or depression. Many current treatments for back pain have limited success or side effects. This research explores whether a device called the EXOPULSE Mollii Suit can offer relief. The suit uses gentle electrical stimulation to target multiple muscles at the same time, which is different from some other electrical pain relief methods that only focus on small areas. The study wants to understand if this suit can effectively lessen pain and improve overall well-being for those living with long-term lower back discomfort.

At a glance

Status

Recruiting

Phase

Sponsor

Institut De La Colonne Vertebrale Et Des Neurosciences

Enrolment target

Start

07 May 2024

Estimated completion

01 Nov 2027

Low Back Pain

What is this study about?

Imagine living with a constant ache in your lower back. This is what happens with chronic low back pain, which means the pain has lasted for more than three months. It's a really common issue, affecting many people's ability to do daily tasks, go to work, and generally enjoy life. It can even take a toll on your mental health, sometimes leading to feelings of anxiety or depression.

Current treatments for long-term back pain, like certain medications, don't always work perfectly and can sometimes have unwanted side effects. Also, many existing methods only address a small part of the problem. Because back pain can be quite complex, doctors are looking for new ways to help that can tackle more aspects of the pain simultaneously.

This study is looking at a new device called the EXOPULSE Mollii Suit. This suit uses a gentle electrical stimulation method, similar in principle to something called TENS (Transcutaneous Electrical Nerve Stimulation), which has been shown to help with pain. However, unlike traditional TENS that often targets just a few muscles, the Mollii Suit is designed to stimulate many muscle groups at once. The researchers want to find out if this broader approach can be more effective at reducing pain and improving daily life for people with ongoing lower back pain.

Key takeaways

The study explores a new electrical stimulation suit for long-term lower back pain.
It aims to see if stimulating many muscles at once can reduce pain.
Participants must have had back pain for at least 3 months and not require surgery.
The study compares an 'active' suit to a 'sham' suit.
You can withdraw from the study at any time.
It's for people in France, who speak French and are covered by national health insurance.

Who may be eligible?

To be able to take part in this study, you need to be an adult between 18 and 75 years old. You must have been diagnosed with lower back pain that has lasted for at least three months, and doctors should have confirmed that you don't need surgery for your back pain at this time. If you're already taking medication for your back pain, that's fine, as long as your dose hasn't changed in the last three months. You also need to speak French, be able to understand instructions, and be covered by the national health insurance in France.

There are several reasons why someone might not be able to join the study. For example, if your pain is very mild (doctors would measure this using a scale where you need to score at least 4 out of 10), or if you have specific conditions like a spinal infection, certain types of tumors, or problems from previous back surgery, then this study might not be right for you. Also, if your back pain is caused by things like pregnancy or women's health issues, or if you have certain heart conditions or other serious health problems, you wouldn't be able to participate.

Finally, you can't be pregnant, have a very high body mass index (over 35), or be taking part in another medical study at the same time. If you have medical devices implanted, like a pacemaker, or if you're under legal protection or are a prisoner, you also wouldn't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 75 years old?
Has your lower back pain lasted for at least 3 months?
Has a doctor told you that you don't need back surgery?
Have you been on the same back pain medication dose for the last 3 months?
Do you not have a pacemaker or other implanted medical devices?
Are you not pregnant and do not have a very high BMI (over 35)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be trying out the EXOPULSE Mollii Suit. Some participants will receive the active suit, which delivers the electrical stimulation, while others will receive a 'sham' suit, which looks the same but doesn't deliver the stimulation. This helps the researchers accurately compare the effects. You would use the suit as instructed, and the research team would regularly check in with you to see how you're feeling and how your back pain is responding. They would ask you questions about your pain levels and how it affects your daily activities. The exact number of visits and the full length of your participation would be explained in detail before you agree to join. You would also need to keep your current medications for back pain stable throughout the study period.

Potential risks and benefits

By taking part, you might find that the Mollii Suit helps to reduce your lower back pain and improve your overall comfort and ability to do daily activities. However, there's also a chance that the suit may not help, or that you might experience some mild side effects from the electrical stimulation, such as skin irritation, although this is usually temporary. As with any medical study, there are no guarantees of benefit. It's very important to remember that you are free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Clinical Neurophysiology department, Henri Mondor Hospital, Créteil, France
Verified postcode
Créteil, France· Recruiting

Common questions

What is chronic lower back pain?

Chronic lower back pain means your back pain has lasted for more than three months. It's a common condition that can really impact your daily life.

What is the EXOPULSE Mollii Suit?

It's a special suit that uses gentle electrical stimulation on many muscles at once. This study is testing if it can help reduce lower back pain.

Will I definitely get the 'active' suit?

Participants are randomly assigned to either the active suit (with stimulation) or a 'sham' suit (without stimulation) to ensure fair testing. You won't know which one you have.

Can I continue my regular pain medication during the study?

Yes, but you must have been on a stable dose of your medication for the last three months and continue to keep it stable throughout the study.

What if I decide I don't want to continue with the study?

You are completely free to leave the study at any point, and it will not affect your usual medical care.

How to find out more

Samar S AYACHE, MD, PhD

samarayache@gmail.com +33 149814662 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.