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

  • STATUS
    Recruiting
  • End date
    Jun 23, 2023
  • participants needed
    42
  • sponsor
    Nantes University Hospital
Updated on 23 January 2021

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.

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.

Details
Condition Pudendal Neuralgia
Treatment CMS group, OMM group
Clinical Study IdentifierNCT02564172
SponsorNantes University Hospital
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Pudendal Neuralgia?
Do you have any of these conditions: Do you have Pudendal Neuralgia??
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
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