Exopulse Mollii Suit and Fibromyalgia

Not Applicable

Completed

• Conditions: Fibromyalgia, Primary
• Interventions: Device: Exopulse Mollii suit (sham); Device: Exoplulse Mollii suit

• Registration Number: NCT05361577
• Lead Sponsor: Institut De La Colonne Vertebrale Et Des Neurosciences

Brief Summary

Fibromyalgia is a debilitating pain condition that is characterized by the chronic occurrence of pain affecting the musculoskeletal system, a sensitivity to pressure stimuli, and a low threshold to noxious stimuli. The topography of pain is widespread, although it could be more pronounced in some bodily regions. Besides pain, patients suffer from a wide range of symptoms, including fatigue, anxiety and depression manifestations, and altered quality of life. Facing these debilitating symptoms, the available therapeutic strategies for treating pain and associated manifestations are usually faced with limited efficacy and numerous side effects. For these reasons, non-invasive stimulation techniques, namely transcutaneous stimulation by means of Exopulse Mollii suit, might be of help in this context.

The investigators 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-24
• Study Start: 2022-03-01
• Study First Submitted QC: 2022-05-01
• Study First Posted: 2022-05-04
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 French speakers, able to understand verbal instructions, and affiliated to the national health insurance

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 (" mesure de protection judiciare : tutelle, curatelle, sauvegarde de justice ")

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham stimulation	Exopulse Mollii suit (sham)	In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.
Active astimulation	Exoplulse Mollii suit	Active sessions will last 1 hour each. The following parameters will be used for electric stimulation: low frequency (20 Hz), low current intensity (2 mA), with a small pulse width of 25-170 microseconds.

Primary Outcome Measures

Name	Time	Method
Change in the Visual Analogue Scale for Pain	This be assessed at baseline (before intervention) then at 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks later	VAS consists of rating the symptom on a 10 cm horizontal line going from "no pain" to "worst pain imaginable".

Secondary Outcome Measures

Name	Time	Method
Pain Catastrophizing Scale (PCS)	This be assessed at baseline (before intervention) then at 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks later	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)
Hospital Anxiety and Depression Scale (HADS)	This be assessed at baseline (before intervention) then at 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks later	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
Short Form 36 Health Survey (SF-36)	This be assessed at baseline (before intervention) then at 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks later	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.
Visual Analogue Scale (VAS) for fatigue	This be assessed at baseline (before intervention) then at 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks later	Like pain, fatigue will be assessed using VAS which consists of rating the symptom on a 10 cm horizontal line going from "no fatigue" to "worst fatigue imaginable".
Brief Pain Inventory	This be assessed at baseline (before intervention) then at 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks later	The validated French version of the 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).
Fibromyalgia Impact Questionnaire (FIQ)	This be assessed at baseline (before intervention) then at 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks later	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)

Trial Locations

Locations (1)

Hopital Henri Mondor; 🇫🇷 Créteil, France