Conus Medullaris Stimulation With 5 Columns Lead Versus Medical Treatment in Refractory Pudendal … (NCT02564172) | Clinical Trial Compass
CompletedNot Applicable
Conus Medullaris Stimulation With 5 Columns Lead Versus Medical Treatment in Refractory Pudendal Neuralgia
France42 participantsStarted 2015-09-30
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 truste…
What they're measuring
1
Improvement of the sitting time from baseline to 6 months of follow-up