The Effects of EXOPULSE Mollii Suit on Low Back Pain

ConditionLow Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInstitut De La Colonne Vertebrale Et Des Neurosciences

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • EXOPULSE MOLLII SUIT (active)
  • EXOPULSE MOLLII SUIT (sham)

Treatment groups

30 Participants
are divided into 2 treatment groups