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

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ClinicalTrials.gov Identifier: NCT02564172
Recruitment Status : Recruiting
First Posted : September 30, 2015
Last Update Posted : December 22, 2016
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.


Condition or disease Intervention/treatment Phase
Pudendal Neuralgia Device: CMS group Other: OMM group Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Conus Medullaris Stimulation With 5 Columns Lead Versus Medical Treatment in Refractory Pudendal Neuralgia: a Randomized, Open, Controlled, Multicenter Trial.
Study Start Date : September 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 2020


Arm Intervention/treatment
Experimental: CMS group
Conus medullaris stimulation with pentapolar surgical lead plus optimal medical management.
Device: CMS group

Conus medullaris stimulation with pentapolar surgical lead includes:

  • Pentapolar surgical lead implant ((TM)Penta lead from St Judes Medical ANS which is the medical device under study)
  • Test phase of 10 days according to HAS("Haute Autorité de Santé") recommendation
  • If test phase positive, the lead is kept and subcutaneous rechargeable generator is implanted.
  • If test phase negative, the lead is removed.

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).

Other Name: Conus medullaris stimulation with pentapolar lead plus optimal medical management.

Active Comparator: OMM group
Optimal medical management alone.
Other: OMM group

Optimal Medical Management (treatment for pain relief) includes analgesics and/or antidepressant and/or antiepileptics.Usually, drugs for neuropathic pain are prescribed as follows:

  • at effective dose, and minimal effective dose on the basis of adverse events and contraindications
  • as alone treatment in first and second line, then combination treatment. All this depends on the patient, on her/his pain, on her/his previous treatment.

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.

Other Name: Optimal Medical Management alone.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Euro Quality of Life-5 Dimension Health questionnaire, as measured from baseline to 12 months of follow-up. [ Time Frame: 12 months ]
  9. 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.


  10. 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.


  11. 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.


  12. 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.


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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    • 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02564172


Contacts
Contact: BUFFENOIR Kevin, Professor +33240083758 kevin.buffenoir@chu-nantes.fr
Contact: MOLES Alexis, Dr alexis.moles@chu-nantes.fr

Locations
France
Nantes Hospital Recruiting
Nantes, Pays de la Loire, France, 44093
Contact: Kevin BUFFENOIR, Professor    +33240083758    kevin.buffenoir@chu-nantes.fr   
Principal Investigator: BUFFENOIR Kevin         
Bordeaux University Hospital Not yet recruiting
Bordeaux, France, 33000
Contact: CUNY Emmanuel, Professor    +33556795518    emmanuel.cuny@chu-bordeaux.fr   
Principal Investigator: CUNY Emmanuel         
Colmar Hospital Recruiting
Colmar, France, 68024
Contact: VOIRIN Jimmy, Doctor    +3389124207    jimmy.voirin@ch-colmar.fr   
Principal Investigator: VOIRIN Jimmy         
Lille University Hospital Recruiting
Lille, France, 59037
Contact: BLOND Serge, Professor    +3320445962    serge.blond@chru-lille.fr   
Principal Investigator: BLOND Serge         
Lyon University Hospital Recruiting
Lyon, France, 69003
Contact: MERTENS Patrick, Professor    +33472118903    patrick.mertens@chu-lyon.fr   
Principal Investigator: MERTENS Patrick         
Clinic Catherine de Sienne Recruiting
Nantes, France, 44200
Contact: RIOULT Bruno, Doctor    +33228272315    rioult.bruno@catherinedesienne.fr   
Principal Investigator: RIOULT Bruno         
Hôpital Foch Recruiting
Suresnes, France, 92151
Contact: JARRAYA Bechir, Professor    +33146252966    b.jarraya@hopital-foch.org   
Principal Investigator: JARRAYA Bechir         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: BUFFENOIR Kevin, Professor Nantes University Hospital

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02564172     History of Changes
Other Study ID Numbers: RC15_0075
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Neuralgia
Pudendal Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Nerve Compression Syndromes