42
Participants
Start Date
September 30, 2015
Primary Completion Date
October 11, 2023
Study Completion Date
October 11, 2023
CMS group
"Conus medullaris stimulation with pentapolar surgical lead includes:~* Pentapolar surgical lead implant ((TM)Penta lead from St Judes Medical ANS which is the medical device under study)~* Test phase of 10 days according to HAS(Haute Autorité de Santé) recommendation~* If test phase positive, the lead is kept and subcutaneous rechargeable generator is implanted.~* If test phase negative, the lead is removed.~Optimal medical management : Similarly to patients randomized in active comparator group, patients randomized in experimental group will also be prescribed optimized medical management (treatment for pain relief) under algologist control.~(A decrease of the consumption of pain treatment should be observed if conus medullaris stimulation has a positive effect)."
OMM group
"Optimal Medical Management (treatment for pain relief) includes analgesics and/or antidepressant and/or antiepileptics.Usually, drugs for neuropathic pain are prescribed as follows:~* at effective dose, and minimal effective dose on the basis of adverse events and contraindications~* as alone treatment in first and second line, then combination treatment. All this depends on the patient, on her/his pain, on her/his previous treatment.~Medical treatment prescription will reviewed by algologist at each clinical visit. It is not possible in this indication to establish a standardized treatment.~Non drugs therapies (physiotherapy, psychobehavioral approaches…) will not be forbidden or contra-indicated."
Bordeaux University Hospital, Bordeaux
Nantes Hospital, Nantes
Clinic Catherine de Sienne, Nantes
Lille University Hospital, Lille
Colmar Hospital, Colmar
Lyon University Hospital, Lyon
Hôpital Foch, Suresnes
Nantes University Hospital
OTHER