Mollii Suit and Fibromyalgia (EXOFIB 2)

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06226376
• Other study ID #: EXOFIB2
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: April 2024
• Source: Sheikh Shakhbout Medical City
• Contact: Naji J Riachi, MD
• Phone: +97123144444
• Email: nriachi[@]ssmc.ae
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: July 1, 2025
• Est. primary completion date: April 2, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Collagen Diseases
• Fibromyalgia
• Muscular Diseases
• Myofascial Pain Syndromes
• Nervous System Diseases
• Neuromuscular Diseases
• Rheumatic Diseases

Intervention

Device:
• EXOPULSE Mollii Suit Stimulation
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.

Locations

Country	Name	City	State
United Arab Emirates	SSMC	Abu Dhabi

Sponsors (1)

Lead Sponsor	Collaborator
Sheikh Shakhbout Medical City

Country where clinical trial is conducted

United Arab Emirates, 

References & Publications (40)

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* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.