The Effects of EXOPULSE Mollii Suit on Low Back Pain

NARecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 1, 2024

Primary Completion Date

December 30, 2025

Study Completion Date

January 31, 2026

Conditions
Low Back Pain
Interventions
DEVICE

EXOPULSE MOLLII SUIT (active)

"Exopulse Mollii suit is a new assistive device that has been developed by Exoneural Network (initially Inerventions AB), a Swedish med-tech company.~Exopulse Mollii suit is a full-body garment with integrated 58 electrodes that can transcutaneously stimulate several groups of muscles. The device is CE labelled and is intended to use for reducing spasticity and improving blood circulation. The outfit is very easy to put on, it can be used for one hour every day and the analgesic effects last 24 hours or more. EXOPULSE Mollii suit consists of transcutaneous stimulation of several muscles by means of a feeble electric current (i.e., low frequency \~20 Hz, low-intensity 2mA), aiming to reduce pain.~This treatment method theoretical background primarily refers to the theory of gate control. Based on this theory, the stimulation of large proprioceptive fibers would inhibit the nociceptive information transmitted by small fibers."

DEVICE

EXOPULSE MOLLII SUIT (sham)

It consists of applying the same parameters used for the active session (low frequency: 20 Hz; current intensity: 2 mA; pulse width ranging from 25 to 175 µs) but for a shorter duration of time (1 minute).

Trial Locations (1)

94000

RECRUITING

Clinical Neurophysiology department, Henri Mondor Hospital, Créteil, France, Créteil

All Listed Sponsors
lead

Institut De La Colonne Vertebrale Et Des Neurosciences

OTHER