The Effects of EXOPULSE Mollii Suit on Low Back Pain
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Low Back Pain
In brief
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.
Key facts
- Study ID
- NCT06702189
- Run by
- Institut De La Colonne Vertebrale Et Des Neurosciences
- People needed
- 30
- Starts
- 2024-05-07
- Expected to finish
- 2027-11-01
- Last updated by the study team
- 2026-02-18
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Clinical Neurophysiology department, Henri Mondor Hospital, Créteil, France — Créteil, VAL DE Marne, France (enrolling)
Full record on ClinicalTrials.gov
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