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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMS group | Experimental | Conus medullaris stimulation with pentapolar surgical lead plus optimal medical management. |
|
| OMM group | Active Comparator | Optimal medical management alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMS group | Device | Conus medullaris stimulation with pentapolar surgical lead includes:
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). |
| 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 |
| 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 |
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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:
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:
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 :
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
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| Name | Affiliation | Role |
|---|---|---|
| BUFFENOIR Kevin, Professor | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantes Hospital | Nantes | Pays de la Loire Region | 44093 | France | ||
| Bordeaux University Hospital |
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| ID | Term |
|---|---|
| D060545 | Pudendal Neuralgia |
| ID | Term |
|---|---|
| D009408 | Nerve Compression Syndromes |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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|
| OMM group | Other | Optimal Medical Management (treatment for pain relief) includes analgesics and/or antidepressant and/or antiepileptics.Usually, drugs for neuropathic pain are prescribed as follows:
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. |
|
|
| 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 |
| Bordeaux |
| 33000 |
| France |
| Colmar Hospital | Colmar | 68024 | France |
| Lille University Hospital | Lille | 59037 | France |
| Lyon University Hospital | Lyon | 69003 | France |
| Clinic Catherine de Sienne | Nantes | 44200 | France |
| HĂ´pital Foch | Suresnes | 92151 | France |
| D009437 | Neuralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |