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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 : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Tracking Information
First Submitted Date  ICMJE September 25, 2015
First Posted Date  ICMJE September 30, 2015
Last Update Posted Date June 13, 2019
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2016)
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 Measures  ICMJE
 (submitted: September 28, 2015)
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.
Change History Complete list of historical versions of study NCT02564172 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • 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 ]
    health-related quality of life
  • 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 ]
    health-related quality of life
Original Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2015)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Conus Medullaris Stimulation With 5 Columns Lead Versus Medical Treatment in Refractory Pudendal Neuralgia
Official Title  ICMJE 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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pudendal Neuralgia
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: CMS group
    Conus medullaris stimulation with pentapolar surgical lead plus optimal medical management.
    Intervention: Device: CMS group
  • Active Comparator: OMM group
    Optimal medical management alone.
    Intervention: Other: OMM group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 28, 2015)
42
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BUFFENOIR Kevin, Professor +33240083758 kevin.buffenoir@chu-nantes.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02564172
Other Study ID Numbers  ICMJE RC15_0075
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nantes University Hospital
Study Sponsor  ICMJE Nantes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: BUFFENOIR Kevin, Professor Nantes University Hospital
PRS Account Nantes University Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP