Conus Medullaris Stimulation With 5 Columns Lead Versus Medical Treatment in Refractory Pudendal Neuralgia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pudendal Neuralgia

Intervention / Treatment
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* Device: CMS group
* Other: OMM group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CMS group<br>Conus medullaris stimulation with pentapolar surgical lead plus optimal medical management. | Device: CMS group<br>* 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).<br>* Other names: Conus medullaris stimulation with pentapolar lead plus optimal medical management.;|
| Active Comparator: OMM group<br>Optimal medical management alone. | Other: OMM group<br>* 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.<br>* Other names: Optimal Medical Management alone.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 6 months of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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. | 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. | 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. | 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. | 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 | 6 months |