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The Effects of EXOPULSE Mollii Suit on Low Back Pain

RecruitingNAAges 18 Years - 75 YearsAllInstitut De La Colonne Vertebrale Et Des Neurosci…
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In plain words

What the trial is, and whether it could suit you

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 s

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📋 Eligibility rules (as published)
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
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What it tests

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

1 site
Clinical Neurophysiology department, Henri Mondor Hospital, Créteil, France
Créteil, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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