NCT05361577

Exopulse Mollii Suit and Fibromyalgia

Using a TENS System (Transcutaneous Electrical Noninvasive Stimulation) to Improve Pain Related to Fibromyalgia (EXOFIB)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Institut De La Colonne Vertebrale Et Des Neurosciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Exoplulse Mollii suit	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.
DEVICE	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.

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2022-05-04
• Last updated: 2023-12-13

Locations

1 site across 1 country: France