Could a High-Tech suit soothe fibromyalgia pain?

NCT ID NCT06226376

Symptom relief Sponsor: Sheikh Shakhbout Medical City Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether a special suit called EXOPULSE Mollii can help adults with fibromyalgia feel less pain, fatigue, and depression. Twenty-eight participants wore either the active suit or a sham (fake) suit for two weeks, then had a washout period. After that, everyone could try the active suit for four more weeks. The goal was to see if the suit improves daily function and overall well-being.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: EXOPULSE Mollii suit (a wearable device that delivers electrical stimulation to muscles)
What this could lead to: If it works, this could offer a drug-free way to reduce pain, fatigue, and improve quality of life for people with fibromyalgia.
What could go wrong: This is a small, early-stage trial with only 28 participants. The results may not apply to everyone, and the device may not prove better than a sham (placebo) suit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

28 people

The number who actually took part.

Started

Jan 2024

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients aged between 18 and 75 years, with a definite diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) 2010 criteria, set for at least one month. * Patients should be able to understand verbal instructions. Exclusion Criteria: * Patient with VAS \< 4 * Patient included in another research protocol during the study period * Patient unable to undergo medical monitor for the study purposes due to geographical or social reasons * Patient with contraindication to wearing Exopulse Mollii suit (e.g., cardiac stimulator, a ventriculoperitoneal shunt, intrathecal baclofen pump, pregnancy, and/or body mass index above 35 kg/m2) * Patient with other somatic or psychiatric diagnoses other than anxiety and depression (e.g., arrhythmias, uncontrolled epilepsy, other diseases causing osteoarticular and muscular pain) * Any change in the pharmacological therapy in the last three months * Introduction of a medical device other than Exopulse Mollii suit during the study period * Patient under juridical protection

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Conditions

The condition(s) this trial relates to.

fibromyalgia muscle tissue disorder nervous system disorder neuromuscular disease rheumatic disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fibromyalgia Muscular diseases Nervous system diseases Neuromuscular diseases Rheumatic diseases

Could a High-Tech suit soothe fibromyalgia pain?

What the study statuses mean