Mollii Suit and Fibromyalgia (EXOFIB 2)

NCT06226376 | Completed DMC

• 1 other identifier: EXOFIB2
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Brief Pain Inventory (BPI)

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

• Pain Catastrophizing Scale (PCS)

  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)

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

• Visual Analogue Scale for 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

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

Study Arms (2)

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.

Device: EXOPULSE Mollii Suit Stimulation

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

Device: EXOPULSE Mollii Suit Stimulation

Interventions

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.

EXOPULSE Mollii Suit Stimulation Active.; EXOPULSE Mollii Suit Stimulation Sham.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheikh Shakhbout Medical City: lead

Study Sites (1)

SSMC

Abu Dhabi, United Arab Emirates

Location

Related Publications (40)

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MeSH Terms

Conditions

Fibromyalgia; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 26, 2024
• Study Start: January 8, 2024
• Primary Completion: March 24, 2025
• Study Completion: May 24, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)