Mollii Suit and Fibromyalgia (EXOFIB 2)

Launched by SHEIKH SHAKHBOUT MEDICAL CITY · Jan 17, 2024

Keywords

ClinConnect Summary

The clinical trial titled "Mollii Suit and Fibromyalgia (EXOFIB 2)" is studying how a special wearable device called the Exopulse Mollii suit can help improve symptoms in adults with fibromyalgia, a condition that causes widespread pain, fatigue, and mood issues. The trial compares the effects of the active suit to a "sham" or inactive version to see if it can reduce pain, improve quality of life, and enhance overall well-being. Participants will first take part in a 2-week phase where they will use either the active suit or the sham suit, followed by a second phase where everyone will use the active suit for four weeks to understand its benefits.

To join the study, participants must be between 18 and 75 years old and have a confirmed diagnosis of fibromyalgia for at least one month. They should be able to follow simple verbal instructions. However, those with certain medical conditions or who are currently involved in other research studies may not be eligible. If you decide to participate, you can expect to help researchers learn more about this promising treatment while potentially experiencing improvements in your symptoms.

Gender

ALL

Eligibility criteria

• 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