STIMCONEConus Medullaris Stimulation With 5 Columns Lead Versus Medical Treatment in Refractory Pudendal Neuralgia: a Randomized, Open, Controlled, Multicenter Trial.

Fecha de inicio: 30 de septiembre de 2015

PRE-SCREENING CRITERIA: * Male or female aged 18 years or over * Pudendal neuralgia according published Nantes criteria * History of failure medical management : defined by HAS such as intractable pain after failure (by side effect, ineffective, or contraindication) at effective dose and combination of following treatment: * Pain treatment OMS analgesics Level I or II * Tricyclicantidepressant * Antiepileptics * Nerve block * Muscle relaxants * Physiotherapy * TENS (Transcutaneus electric nerve stimulation) * Psychobehavioral approach * Failure of pudendal nerve decompression surgery performed more than 12 months ago * Neuropathic pain according to criteria of the Neuropathic Pain Diagnostic Questionnaire (DN4). * Subjects able of giving informed consent * Affiliation with French social security system. * Average or maximum pain experienced greater than or equal to 5/10 on a visual analogue scale INCLUSION CRITERIA: * Average or maximum pain experienced greater than or equal to 50/100 on a visual analogue scale (average of data collected 7 days prior to the inclusion visit and recorded by the patient on the clinical diary) * Evaluation by multidisciplinary team including neuro-surgeons, algologists and psychologists performed, (if not already done in the previous year for algologists and psychologists) * Given informed consent. EXCLUSION CRITERIA: * Pregnant, or planning to become pregnant during the study (12months) * Adults under guardianship or trusteeship * Being treated or has been treated with spinal cord stimulation, subcutaneous or peripheral nerve stimulation, intrathecal drug delivery system. * Had pudendal nerve decompression surgery less than 12 months ago * Is suspected of substance abuse * Has unresolved major issues of secondary gain * Exhibits major psychiatric morbidity * Has life expectancy inferior to 5 years * Implant spinal cord stimulation surgery contraindication : * Magnetic resonnance imaging contraindication * History of coagulation disorder * Severe immunodepression, systemic, due to medicine drug intake or not (AIDS, transplanted, under anti TNF alpha treatment, …) * Current infection * Would be unable to operate the spinal cord stimulation equipment, undergo the study assessments or complete questionnaires or clinical diary, based on the opinion of the investigator * Unwilling to be treated with spinal cord stimulation, comply with study requirements. * Suffering from another neuropathic pain, or chronic pain, cancer, diabetic neuropathy * Patient with cardiac sentry stimulator or planned to be implanted with one