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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.
Full description
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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Inclusion and exclusion 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:
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
Primary purpose
Allocation
Interventional model
Masking
42 participants in 2 patient groups
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Central trial contact
BUFFENOIR Kevin, Professor
Data sourced from clinicaltrials.gov
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