Mollii Suit and Fibromyalgia (EXOFIB 2)

September 1, 2025 updated by: Naji Joseph Riachi, Sheikh Shakhbout Medical City

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EXOPULSE Mollii Suit Stimulation Active.
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
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.
Sham Comparator: EXOPULSE Mollii Suit Stimulation Sham.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.
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).
This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.
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)
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)
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.
This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.
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
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)
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.
This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.
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.
This to be assessed at week 2, week 6 and week 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheikh Shakhbout Medical City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2024

Primary Completion (Actual)

March 24, 2025

Study Completion (Actual)

May 24, 2025

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

January 17, 2024

First Posted (Actual)

January 26, 2024

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

September 1, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXOFIB2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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