[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Institut De La Colonne Vertebrale Et Des Neurosciences\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100570049","the-effects-of-exopulse-mollii-suit-on-low-back-pain-100570049",false,"NCT06702189","The Effects of EXOPULSE Mollii Suit on Low Back Pain","The Effects of EXOPULSE Mollii Suit on Low Back Pain (EXOBACK)\" \u002F EXOPULSE Mollii Suit and Low Back Pain (EXOBACK)","EXOBACK","Inclusion Criteria:\n\n* 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.\n* Stable pharmacological treatment over the last three months\n* Residual back pain post-spinal surgery with no new surgical indication\n* Patients should be French speakers, able to understand verbal instructions, and affiliated to the national health insurance NHI.\n\nExclusion Criteria:\n\n* Patient with VAS \\\u003C 4\n* Presence of any surgical indication (i.e,. isthmic spondylolisthesis, herniated disc, Spinal canal stenosis, Vertebral fracture, Degenerative Spondylolisthesis, scoliosis)\n* Failed Back Surgery Syndrome (FBSS)\n* Presence of spinal infection\n* Presence of obstetrical or gynecological cause of the low back pain (ovarian torsion, ovarian cyst, endometriosis, menses)\n* Retroperitoneal tumors - Spinal tumors - Being included in another research protocol during the study period\n* Inability to undergo medical monitoring for the study purposes due to geographical or social reasons\n* Having a cardiac stimulator, a ventriculoperitoneal shunt, an intrathecal baclofen pump, or other contraindications to using EXOPULSE Mollii suit\n* Being pregnant\n* Having a change in their pharmacological therapy in the last three months.\n* Suffering from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain)\n* Having a body mass index above 35 Kg\u002Fm2\n* In case of the introduction of a medical device other than EXOPULSE Mollii suit during the study period\n* Patients under juridical protection (\" mesure de protection judiciaire : tutelle, curatelle, sauvegarde de justice \")\n* Prisoners","ALL","18 Years","75 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"NA","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\u002For 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.",[28],"Low Back Pain",[30],"EXOPULSE Mollii Suit and Low back pain","RECRUITING","2026-02-16",{"date":34,"type":35},"2026-02-18","ACTUAL",{"date":37,"type":35},"2024-05-07",{"date":39,"type":22},"2027-11-01",{"name":41,"class":42},"Institut De La Colonne Vertebrale Et Des Neurosciences","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":43},"100570048","using-a-multisite-tens-system-to-improve-fibromyalgia-related-symptoms-100570048","NCT06702176","\"Using a Multisite TENS SysteM to Improve Fibromyalgia-related Symptoms.","\"Using a Multisite TENS System (Transcutaneous Electrical Noninvasive Stimulation) to Improve Fibromyalgia-related Symptoms (EXOFIB 3)\"","EXOFIB3","Inclusion Criteria:\n\n* Patients aged between 18 and 75 years, with a definite diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) 2010 criteria, set for at least three months\n* Patients should be French speakers, able to understand verbal instructions, and affiliated with the National Health insurance\n\nExclusion Criteria:\n\n* Patient included in another research protocol during the study period\n* Patient unable to undergo medical monitoring for the study purposes due to geographical or social reasons\n* Patient with contraindication to wearing Exopulse Mollii suit (e.g., cardiac stimulator, a ventriculoperitoneal shunt, intrathecal baclofen pump, pregnancy, and\u002For body mass index above 35 kg\u002Fm2)\n* Patient with somatic or psychiatric diagnoses other than anxiety and depression (e.g., arrhythmias, uncontrolled epilepsy, other diseases causing osteoarticular and muscular pain)\n* Any change in the pharmacological therapy in the last three months\n* Introduction of a medical device other than Exopulse Mollii suit during the study period\n* Patient under juridical protection (\" mesure de protection judiciare : tutelle, curatelle, sauvegarde de justice \")",{"count":53,"type":22},40,[25],"Fibromyalgia is a debilitating pain condition that is characterized by the chronic occurrence of pain affecting the musculoskeletal system, a sensitivity to pressure stimuli, and a low threshold to noxious stimuli. The topography of pain is widespread, although it could be more pronounced in some bodily regions. Besides pain, patients suffer from a wide range of symptoms, including fatigue, anxiety and depression manifestations, and altered quality of life. Facing these debilitating symptoms, the available therapeutic strategies for treating pain and associated manifestations are usually faced with limited efficacy and numerous side effects. A previous pilot trial on fibromyalgia (EXOFIB-1 study) was conducted to evaluate the effects of Exopulse Mollii suit on fibromyalgia has showed beneficial and promising results. The intervention significantly alleviated pain, reduced fatigue, decreased physical and psychosocial impact of the disease, and improved the quality of life of patients with fibromyalgia. However, the observed effect sizes were small to medium. The investigators believe that a stimulation duration extended to six months would yield more positive outcomes and higher effect magnitude.",[57],"Fibromyalgia, Pain",[59],"Exopulse Mollii Suit, Fibromyalgia","2024-11-20",{"date":62,"type":35},"2024-11-22",{"date":64,"type":35},"2024-03-01",{"date":66,"type":22},"2026-06-30",{"name":41,"class":42},""]