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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXOPULSE Mollii Suit Stimulation Active. | Active Comparator | This will be the EXOPULSE Mollii Suit Active Stimulation. Stimulation will go on for 60 minutes while control unit is on for 60 minutes. |
|
| EXOPULSE Mollii Suit Stimulation Sham. | Sham Comparator | This will be the EXOPULSE Mollii Suit Sham Stimulation. Stimulation will go on for 1 minute then it turns off while the control unit will remain on for total of 60 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fibromyalgia Impact Questionnaire (FIQ) | 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) | This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory (BPI) | 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). | This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SSMC | Abu Dhabi | United Arab Emirates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19663526 | Background | Annemans L, Le Lay K, Taieb C. Societal and patient burden of fibromyalgia syndrome. Pharmacoeconomics. 2009;27(7):547-59. doi: 10.2165/11313650-000000000-00000. | |
| 2691674 | Background | Bengtsson A, Henriksson KG. The muscle in fibromyalgia--a review of Swedish studies. J Rheumatol Suppl. 1989 Nov;19:144-9. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D012216 | Rheumatic Diseases |
| D009135 | Muscular Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Pain Catastrophizing Scale (PCS) | 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) | This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12. |
| Quality of life as per the Short Form 36 Health Survey (SF-36) | 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. | This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12. |
| Visual Analogue Scale for Pain | Pain will be measured using a visual analog score from 0 to 10, 0 being no pain, to 10 being the worst possible pain. | This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12. |
| Visual Analogue Scale for Fatigue | Fatigue will be measured using a visual analog score from 0 to 10, 0 being no fatigue, to 10 being the worst possible fatigue | This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12. |
| Hospital Anxiety and Depression Scale (HADS) | 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. | This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12. |
| Clinical Global Impression (CGI) | 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. | This to be assessed at week 2, week 6 and week 12. |
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