The Effects of EXOPULSE Mollii Suit on Low Back Pain (EXOBACK)

Institut De La Colonne Vertebrale Et Des Neurosciences

Status: Enrolling

Conditions: Low Back Pain

Treatments: Device: EXOPULSE MOLLII SUIT (sham); Device: EXOPULSE MOLLII SUIT (active)

Study type: Interventional

Funder types: Other

Identifiers

NCT06702189

2024-A00020-47

Details and patient eligibility

About

Low back pain is a common musculoskeletal problem. It is the main cause of activity limitation and work absence and carries a huge medical burden and economic cost. Low back pain is considered "chronic" when it persists for more than 3 months. Chronic low back pain affects daily activities and constitutes a psychological burden, which could lead to anxiety and/or depression. Prevention of low back pain is recognized as a pivotal challenge in high-risk populations to help tackle high healthcare costs related to therapy and rehabilitation. Current pharmacological drugs, namely anti-inflammatory and narcotics medications, have limited efficacy and numerous side effects. In addition, most available treatment options only address single, targeted causes; however, given the complexity of low back pain, a multi-modal interdisciplinary approach is highly needed. Transcutaneous electrical nerve stimulation (TENS) is a safe alternative to current treatments. Many studies have shown its efficacy and benefit in reducing pain. However, it only targets a limited number of muscles. For this reason, transcutaneous stimulation using the EXOPULSE Mollii suit might help reduce pain and related outcomes in this context since it simultaneously targets several muscle groups.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged between 18 and 75 years, with a definite diagnosis of Low Back Pain for at least 3 months, with absence of any surgical indication.
• Stable pharmacological treatment over the last three months
• Residual back pain post-spinal surgery with no new surgical indication
• Patients should be French speakers, able to understand verbal instructions, and affiliated to the national health insurance NHI.

Exclusion criteria

• Patient with VAS < 4
• Presence of any surgical indication (i.e,. isthmic spondylolisthesis, herniated disc, Spinal canal stenosis, Vertebral fracture, Degenerative Spondylolisthesis, scoliosis)
• Failed Back Surgery Syndrome (FBSS)
• Presence of spinal infection
• Presence of obstetrical or gynecological cause of the low back pain (ovarian torsion, ovarian cyst, endometriosis, menses)
• Retroperitoneal tumors - Spinal tumors - Being included in another research protocol during the study period
• Inability to undergo medical monitoring for the study purposes due to geographical or social reasons
• Having a cardiac stimulator, a ventriculoperitoneal shunt, an intrathecal baclofen pump, or other contraindications to using EXOPULSE Mollii suit
• Being pregnant
• Having a change in their pharmacological therapy in the last three months.
• Suffering from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain)
• Having a body mass index above 35 Kg/m2
• In case of the introduction of a medical device other than EXOPULSE Mollii suit during the study period
• Patients under juridical protection (" mesure de protection judiciaire : tutelle, curatelle, sauvegarde de justice ")
• Prisoners

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Experimental Condition

Active Comparator group

Description:

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. These parameters were previously found to be safe in human studies. Based on the clinical exam of each patient, the spastic muscles will be targeted.

Treatment:

Device: EXOPULSE MOLLII SUIT (active)

Control Condition

Sham Comparator group

Description:

The control arm will be a sham intervention. The patients will receive a sham stimulation, for which the same EXOPULSE Mollii suit will be used but the suit control unit will be programmed to start stimulating for 1 minute then it will shut off which could enable cutaneous sensations that mimic the active condition, aiming to achieve an effective blinding integrity. There is no risk related to the sham intervention since 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).

Treatment:

Device: EXOPULSE MOLLII SUIT (sham)