Exopulse Mollii Suit and Fibromyalgia

NCT05361577 | Completed

• 1 other identifier: 2021-A01668-33
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia, Primary

Outcome Measures

Primary Outcomes (1)

• Change in the Visual Analogue Scale for Pain

  VAS consists of rating the symptom on a 10 cm horizontal line going from "no pain" to "worst pain imaginable".

  This be assessed at baseline (before intervention) then at 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks later

Secondary Outcomes (6)

• 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

• Brief Pain Inventory

  This be assessed at baseline (before intervention) then at 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks later

• 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

• 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

• 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

Study Arms (2)

Active astimulation

ACTIVE COMPARATOR

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.

Device: Exoplulse Mollii suit

Sham stimulation

SHAM COMPARATOR

In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.

Device: Exopulse Mollii suit (sham)

Interventions

Exoplulse Mollii suit DEVICE

Exopulse Mollii suits consists of a body Garments (Jacket and Pants) and a control unit. The body Garments (Jacket and Pants) is a suit with 58 embedded electrodes that can stimulate 40 groups of muscles, conductive wires and connectors to a detachable control unit, whose intended purpose is to transmit electric pulses from the control unit to key nerves and corresponding muscle groups throughout the body. The control unit is a battery powered electrical device which sends low intensity electric pulses through connectors to the Body Garments which in turn transmits the pulses from the connectors to key nerves and corresponding muscle groups throughout the body.

Active astimulation

Exopulse Mollii suit (sham) DEVICE

In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.

Sham stimulation

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

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

Sponsors & Collaborators

• Institut De La Colonne Vertebrale Et Des Neurosciences: lead

Study Sites (1)

Hopital Henri Mondor

Créteil, 94010, France

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Samar S. Ayache, MD, PhD

  Clinical Neurophysiology department, Henri Mondor Hospital, Creteil, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase 1: randomized sham controlled crossover study (active versus sham condition) Phase 2: Open label study (active condition)

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: May 4, 2022
• Study Start: March 1, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)