NCT06702189 The Effects of EXOPULSE Mollii Suit on Low Back Pain
| NCT ID | NCT06702189 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut De La Colonne Vertebrale Et Des Neurosciences |
| Condition | Low Back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-05-07 |
| Primary Completion | 2027-09-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-05-07 with a primary completion date of 2027-09-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Samar S Ayache, MD, PhD, HDR
PRINCIPAL INVESTIGATOR
Hopital Henri Mondor, Assistance Publique - Hôpitaux de Paris, Créteil, France
Frequently Asked Questions
Who can join the NCT06702189 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Low Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06702189 currently recruiting?
Yes, NCT06702189 is actively recruiting participants. Contact the research team at samarayache@gmail.com for enrollment information.
Where is the NCT06702189 trial being conducted?
This trial is being conducted at Créteil, France.
Who is sponsoring the NCT06702189 clinical trial?
NCT06702189 is sponsored by Institut De La Colonne Vertebrale Et Des Neurosciences. The principal investigator is Samar S Ayache, MD, PhD, HDR at Hopital Henri Mondor, Assistance Publique - Hôpitaux de Paris, Créteil, France. The trial plans to enroll 30 participants.