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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.


Detailed Summary:

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.


Sponsor: Nantes University Hospital

Current Primary Outcome: Improvement of the sitting time from baseline to 6 months of follow-up [ Time Frame: At 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.


Original Primary Outcome: Improvement of the sitting time from baseline to 12 months of follow-up [ Time Frame: At 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.


Current Secondary Outcome:

  • Improvement of the sitting time, as measured from baseline to 12 months of follow-up. [ Time Frame: 12 months ]
    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.
  • Improvement of the sitting time, as measured from baseline to 3 months of follow-up. [ Time Frame: 3 months ]
    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.
  • Improvement of the sitting time, as measured from baseline to 1 month of follow-up. [ Time Frame: 1 month ]
    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.
  • Pain relief (visual analogic scale), as measured from baseline to 12 months of follow-up. [ Time Frame: 12 months ]
    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.
  • Pain relief (visual analogic scale), as measured from baseline to 6 months of follow-up. [ Time Frame: 6 months ]
    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.
  • Pain relief (visual analogic scale), as measured from baseline to 3 months of follow-up. [ Time Frame: 3 months ]
    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.
  • Pain relief (visual analogic scale), as measured from baseline to 1 month of follow-up. [ Time Frame: 1 month ]
    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.
  • Euro Quality of Life-5 Dimension Health questionnaire, as measured from baseline to 12 months of follow-up. [ Time Frame: 12 months ]
  • Use of pain treatment [ Time Frame: 12 months ]

    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.

  • Use of pain treatment [ Time Frame: 6 months ]

    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.

  • Use of pain treatment [ Time Frame: 3 months ]

    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.

  • Use of pain treatment [ Time Frame: 1 month ]

    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.

  • Euro Quality of Life-5 Dimension Health questionnaire, as measured from baseline to 6 months of follow-up [ Time Frame: 6 months ]


Original Secondary Outcome:

  • Improvement of the sitting time, as measured from baseline to 6 months of follow-up. [ Time Frame: 6 months ]
    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.
  • Improvement of the sitting time, as measured from baseline to 3 months of follow-up. [ Time Frame: 3 months ]
    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.
  • Improvement of the sitting time, as measured from baseline to 1 month of follow-up. [ Time Frame: 1 month ]
    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.
  • Pain relief (visual analogic scale), as measured from baseline to 12 months of follow-up. [ Time Frame: 12 months ]
    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.
  • Pain relief (visual analogic scale), as measured from baseline to 6 months of follow-up. [ Time Frame: 6 months ]
    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.
  • Pain relief (visual analogic scale), as measured from baseline to 3 months of follow-up. [ Time Frame: 3 months ]
    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.
  • Pain relief (visual analogic scale), as measured from baseline to 1 month of follow-up. [ Time Frame: 1 month ]
    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.
  • Euro Quality of Life-5 Dimension Health questionnaire, as measured from baseline to 12 months of follow-up. [ Time Frame: 12 months ]
  • Use of pain treatment [ Time Frame: 12 months ]

    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.

  • Use of pain treatment [ Time Frame: 6 months ]

    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.

  • Use of pain treatment [ Time Frame: 3 months ]

    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.

  • Use of pain treatment [ Time Frame: 1 month ]

    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.



Information By: Nantes University Hospital

Dates:
Date Received: September 25, 2015
Date Started: September 2015
Date Completion: October 2020
Last Updated: December 20, 2016
Last Verified: December 2016