Clinical trial NCT06226376: Mollii Suit and Fibromyalgia (EXOFIB 2)
Official title: The Effects of EXOPULSE Mollii Suit on Fibromyalgia Syndrome in Patients With Fibromyalgia (EXOFIB 2): A Sham Controlled Randomized Double-Blind Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia
Rheumatic Diseases
Muscular Diseases
Neuromuscular Diseases
Nervous System Diseases
Lead sponsor: Sheikh Shakhbout Medical City
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to demonstrate the improvement of fibromyalgia syndrome obtained following active stimulation compared to sham, with diminished functional disability and improved health status using Exopulse Molli suit stimulation. The main questions it aims to answer are:

Evaluation of pain, fatigue, mood and quality of life changes observed after active stimulation in comparison to sham.

Improvement of fibromyalgia syndrome as per the Fibromyalgia Impact Questionnaire (FIQ)

Study subjects will participate in:

A randomized sham controlled double-blind trial to demonstrate the improvement of pain, quality of life, fatigue and mood in adult patients with fibromyalgia following a 2-week intervention of "active" versus "sham" Exopulse Mollii suit. A 2-week washout period should be enough to prevent a potential carry over effect. After this phase (phase 1), a second open label phase (phase 2) will be proposed for patients to understand the effects of Exopulse Mollii suit employed for 4 weeks (7 sessions per week) on the studied outcomes.


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

Primary outcomes:
measure: Visual Analogue Scale for Pain
timeFrame: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.
Secondary outcomes:
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.
measure: Brief Pain Inventory (BPI)
timeFrame: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.
measure: Pain Catastrophizing Scale (PCS)
timeFrame: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.
measure: Quality of life as per the Short Form 36 Health Survey (SF-36)
timeFrame: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.
measure: Visual Analogue Scale for Fatigue
timeFrame: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.
measure: Clinical Global Impression (CGI)
timeFrame: This to be assessed at week 2, week 6 and week 12.
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: SSMC
Study officials:
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