Pudendal neuralgia is a frequent diagnosis in pain clinics. This perineal pain has devastating effects on patient's quality of life. Today, 30% of patients are refractory to pain management and surgical procedure. The neuropathic characteristics of the pain in these patients lead us to test the efficiency of spinal cord stimulation at conus medullaris level. In our published preliminary study involving 27 patients with refractory pudendal neuralgia, we demonstrated that 74% of patients implanted with stimulation electrodes at the conus medullaris responded to stimulation. The primary objective of the present trial is to assess through a randomized, parallel group design, the effectiveness of spinal cord stimulation at the conus medullaris using pentapolar surgical lead ((TM)Penta, St Jude medical ANS) versus medical treatment alone on sitting time in refractory pudendal neuralgia.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
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).
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.
Nantes Hospital
Nantes, Pays de la Loire Region, France
Bordeaux University Hospital
Bordeaux, France
Colmar Hospital
Colmar, France
Lille University Hospital
Lille, France
Lyon University Hospital
Lyon, France
Clinic Catherine de Sienne
Nantes, France
Hôpital Foch
Suresnes, France
Improvement of the sitting time from baseline to 6 months of follow-up
Sitting time is measured by a sitting time diary (in minutes) which patients will record during a daily activity, two times per day, once in the morning and once in the evening during one week before clinical visit.
Time frame: At 6 months of follow-up
Improvement of the sitting time, as measured from baseline to 12 months of follow-up.
Sitting time is measured by a sitting time diary (in minutes) which patients will record during a daily activity, two times per day, once in the morning and once in the evening during one week before clinical visit.
Time frame: 12 months
Improvement of the sitting time, as measured from baseline to 3 months of follow-up.
Sitting time is measured by a sitting time diary (in minutes) which patients will record during a daily activity, two times per day, once in the morning and once in the evening during one week before clinical visit.
Time frame: 3 months
Improvement of the sitting time, as measured from baseline to 1 month of follow-up.
Sitting time is measured by a sitting time diary (in minutes) which patients will record during a daily activity, two times per day, once in the morning and once in the evening during one week before clinical visit.
Time frame: 1 month
Pain relief (visual analogic scale), as measured from baseline to 12 months of follow-up.
Visual analogic scale is recorded in a diary, which patient will complete two times per day, once in the morning and once in the evening during one week before clinical visit.
Time frame: 12 months
Pain relief (visual analogic scale), as measured from baseline to 6 months of follow-up.
Visual analogic scale is recorded in a diary, which patient will complete two times per day, once in the morning and once in the evening during one week before clinical visit.
Time frame: 6 months
Pain relief (visual analogic scale), as measured from baseline to 3 months of follow-up.
Visual analogic scale is recorded in a diary, which patient will complete two times per day, once in the morning and once in the evening during one week before clinical visit.
Time frame: 3 months
Pain relief (visual analogic scale), as measured from baseline to 1 month of follow-up.
Visual analogic scale is recorded in a diary, which patient will complete two times per day, once in the morning and once in the evening during one week before clinical visit.
Time frame: 1 month
Euro Quality of Life-5 Dimension Health questionnaire, as measured from baseline to 12 months of follow-up.
health-related quality of life
Time frame: 12 months
Use of pain treatment
Use of antiepileptics and of antidepressants and of analgesics OMS level I, II or III will be recorded and percentage of their variation between visits analysed. Use of non drugs therapies will be reported for descripton only.
Time frame: 12 months
Use of pain treatment
Use of antiepileptics and of antidepressants and of analgesics OMS level I, II or III will be recorded and percentage of their variation between visits analysed. Use of non drugs therapies will be reported for descripton only.
Time frame: 6 months
Use of pain treatment
Use of antiepileptics and of antidepressants and of analgesics OMS level I, II or III will be recorded and percentage of their variation between visits analysed. Use of non drugs therapies will be reported for descripton only.
Time frame: 3 months
Use of pain treatment
Use of antiepileptics and of antidepressants and of analgesics OMS level I, II or III will be recorded and percentage of their variation between visits analysed. Use of non drugs therapies will be reported for descripton only.
Time frame: 1 month
Euro Quality of Life-5 Dimension Health questionnaire, as measured from baseline to 6 months of follow-up
health-related quality of life
Time frame: 6 months
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