STIMCONEConus Medullaris Stimulation With 5 Columns Lead Versus Medical Treatment in Refractory Pudendal Neuralgia: a Randomized, Open, Controlled, Multicenter Trial.
CMS group
+ OMM group
Nerve Compression Syndromes+7
+ Nervous System Diseases
+ Neuralgia
Treatment Study
Summary
Study start date: September 30, 2015
Actual date on which the first participant was enrolled.In this national multicenter prospective open label trial, patients will be randomized 1:1 to experimental group (CMS group : Conus Medullaris Stimulation using pentapolar surgical lead, plus optimal medical management) or to control group (OMM group : optimal medical management alone) and followed for 12 months, in intention to treat. 42 patients suffering of refractory pudendal neuralgia will be included. Optimal medical management will be prescribed by algologists in both groups according to patient pain relief.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.42 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 7 locations
Clinic Catherine de Sienne
Nantes, FranceHôpital Foch
Suresnes, FranceLille University Hospital
Lille, France