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Completed

NCT Number: NCT06226376

Mollii Suit and Fibromyalgia (EXOFIB 2)

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.

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Key information

Conditions

Fibromyalgia Connective Tissue Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SSMC

Abu Dhabi, United Arab Emirates

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EXOPULSE Mollii Suit Stimulation

Device

We designed 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.

Primary outcomes

  1. Fibromyalgia Impact Questionnaire (FIQ)

    Time frame: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.

    It is an 11-item scale that assesses health status and functional disability by exploring the impact of fibromyalgia on work, wellbeing, fatigue, sleep, stiffness, anxiety, and depression. FIQ scores can range from 0 to 100, with higher scores reflecting worse health status. Scores could be used to classify fibromyalgia as mild (scores: 0-38), moderate (scores: 39-58), and severe (scores: 59-100)

Secondary outcomes

  1. Brief Pain Inventory (BPI)

    Time frame: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.

    will be used to assess pain severity (4 items) and pain interference (7 items). BPI items are rated on a 10-point scale running from 0 (no pain/does not interfere) to 10 (pain as bad as the participant can imagine/interferes completely).

  2. Pain Catastrophizing Scale (PCS)

    Time frame: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.

    Pain Catastrophizing Scale (PCS) will be employed, which is a valid and reliable scale that includes 13 items assessing the presence and severity of feelings or thoughts that emerge when experiencing pain. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time). It is possible to calculate a total and three subscale scores (i.e., helplessness, magnification, and rumination)

  3. Quality of life as per the Short Form 36 Health Survey (SF-36)

    Time frame: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.

    It is a generic survey that contains 36 items which assess the quality of life and yield eight dimensions: physical functioning, physical role, emotional role, bodily pain, general health, vitality, social functioning, and mental health. The score of each dimension ranges from 0 to 100, with higher scales implying better health status.

  4. Visual Analogue Scale for Pain

    Time frame: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.

    Pain will be measured using a visual analog score from 0 to 10, 0 being no pain, to 10 being the worst possible pain.

  5. Visual Analogue Scale for Fatigue

    Time frame: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.

    Fatigue will be measured using a visual analog score from 0 to 10, 0 being no fatigue, to 10 being the worst possible fatigue

  6. Hospital Anxiety and Depression Scale (HADS)

    Time frame: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.

    It is a 14-item generic scale with good psychometric properties and consists of seven items assessing anxiety and seven others assessing depression. Scores can range from 0 to 21 on each subscale, with higher scores indicating worse symptomatology.

  7. Clinical Global Impression (CGI)

    Time frame: This to be assessed at week 2, week 6 and week 12.

    Evaluation of overall Clinical improvement will be done using the 7-point Clinical Global Impression (CGI). Patient will fill a questionnaire that will address their clinical situation as follows:

    Very much improved. Much improved. Slightly improved. No change. Slightly worse Much worse. Very much worse The score will range from 1-7, 1 being the best clinical outcome and 7 the worst.

Sponsors and collaborators

Lead sponsor

Sheikh Shakhbout Medical City

Other

Registry information

Official study title

The Effects of EXOPULSE Mollii Suit on Fibromyalgia Syndrome in Patients With Fibromyalgia (EXOFIB 2): A Sham Controlled Randomized Double-Blind Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 26, 2024
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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