RecruitingNAINTERVENTIONAL

"Using a Multisite TENS SysteM to Improve Fibromyalgia-related Symptoms.

This research is investigating whether a special suit, called the Exopulse Mollii suit, can help people living in France with fibromyalgia. Fibromyalgia is a long-term condition that causes widespread body pain, tiredness, and can affect mood and overall well-being. Previous small studies showed the suit might help reduce pain and fatigue, and improve quality of life. This new study wants to see if wearing the suit for a longer period, specifically six months, leads to even better results. They are looking for ways to improve treatment because current options often have limited success and side effects. Participants will either wear the active suit or a 'sham' (inactive) version to fairly test its effects.

At a glance

Status

Recruiting

Phase

Sponsor

Institut De La Colonne Vertebrale Et Des Neurosciences

Enrolment target

Start

01 Mar 2024

Estimated completion

30 Jun 2026

Fibromyalgia, Pain

What is this study about?

Fibromyalgia is a condition that causes ongoing, widespread body pain, often described as a deep ache or throbbing. People with fibromyalgia also frequently experience extreme tiredness, trouble sleeping, and sometimes anxiety or depression. These symptoms can make everyday life quite challenging and impact overall well-being. Current treatments for fibromyalgia pain and other symptoms don't always work well for everyone and can sometimes have unwanted side effects.

This study is looking into a new approach using a special suit called the Exopulse Mollii suit. Previous research with this suit showed some promising results, helping to ease pain, reduce tiredness, and improve how people felt about their lives. However, those improvements were considered moderate. The researchers believe that using the suit for a longer time might lead to greater benefits.

So, this study aims to find out if wearing the Exopulse Mollii suit for six months can make a bigger difference for people with fibromyalgia. By carefully studying its effects, they hope to discover a more effective way to manage the symptoms of this often difficult condition.

Key takeaways

The study explores a new suit to help fibromyalgia symptoms.
It aims to reduce pain, fatigue, and improve quality of life.
Participants will use either an active suit or a 'sham' suit for six months.
It's for French-speaking adults with confirmed fibromyalgia.
The goal is to find more effective treatments for fibromyalgia.
You have the right to leave the study at any time.

Who may be eligible?

To join this study, you need to be a French speaker between 18 and 75 years old and have a clear diagnosis of fibromyalgia for at least three months, confirmed by specific medical guidelines. You'll also need to be part of the French national health insurance scheme.

There are several reasons why someone might not be able to join. For example, if you're already in another research study, or if you have certain medical conditions that might make wearing the Exopulse Mollii suit unsafe, such as a heart pacemaker or if you're pregnant. People with a very high body weight (a BMI over 35) also can't take part. They also need to make sure you don't have other major health issues, apart from anxiety or depression, or any recent changes to your regular medications.

Finally, if your circumstances make it difficult to attend regular medical checks for the study, or if you're under legal protection that affects your ability to make decisions, you wouldn't be able to participate. This helps ensure everyone in the study is safe and can follow the study's plan.

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?
Do you have a clear diagnosis of fibromyalgia (for at least 3 months)?
Are you a French speaker and covered by French national health insurance?
Do you have conditions like a pacemaker, are you pregnant, or do you have a very high BMI (over 35)? (If yes to any, you might not be eligible).
Have you changed your fibromyalgia medication in the last three months?
Are you able to attend regular check-ups for the study?

Answer every question to see your result.

What does participation involve?

Information about how long you'd need to take part, how many visits, what assessments would be involved, and whether you'd receive medication or a device (and for how long), is not yet fully detailed in the provided summary. However, based on the study's aim to test the suit over six months, it's likely that wearing the Exopulse Mollii suit and attending regular check-ups for at least this period would be a key part of participating. You would be either using the active suit or a 'sham' (inactive) suit, and neither you nor the researchers would know which one you have received until the end of the study. This helps ensure the results are fair and unbiased. The main assessment would be to see how much your fibromyalgia symptoms, like pain and tiredness, change. You would have check-ups to monitor your progress and make sure you're doing well throughout the study.

Potential risks and benefits

Taking part in this study may offer potential benefits directly related to your fibromyalgia symptoms, as previous research suggests the Exopulse Mollii suit can help reduce pain and fatigue and improve quality of life. However, it's also possible you might receive the 'sham' suit, which wouldn't have any active treatment effects. As with any medical device, there could be risks or side effects, although these are not detailed in the summary. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

Common questions

What is fibromyalgia?

Fibromyalgia is a condition that causes long-lasting, widespread pain in your muscles and bones, along with other symptoms like tiredness, sleep problems, and sometimes anxiety or depression.

What is the Exopulse Mollii suit?

It's a special suit that uses gentle electrical pulses. The study is investigating if it can help people with fibromyalgia feel less pain and fatigue.

Will I definitely get the active suit?

No, you will either get the active suit or a 'sham' (inactive) suit. Neither you nor the study team will know which you have until the study finishes.

How long will the study last if I take part?

The study aims to have people use the suit for about six months to see if a longer period of treatment leads to better results.

What does a 'sham' suit mean?

A 'sham' suit looks and feels like the real one but doesn't deliver the active treatment. This helps researchers compare the real suit's effects against a placebo effect.

How to find out more

Samar S AYACHE, MD, PhD, HDR

samarayache@gmail.com +33 149814662 Official trial record

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