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

Primary Purpose

Pudendal Neuralgia

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CMS group
OMM group
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pudendal Neuralgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nantes HospitalRecruiting
  • Bordeaux University Hospital
  • Colmar HospitalRecruiting
  • Lille University HospitalRecruiting
  • Lyon University HospitalRecruiting
  • Clinic Catherine de SienneRecruiting
  • Hôpital FochRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CMS group

OMM group

Arm Description

Conus medullaris stimulation with pentapolar surgical lead plus optimal medical management.

Optimal medical management alone.

Outcomes

Primary Outcome Measures

Improvement of the sitting time from baseline to 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

Improvement of the sitting time, as measured from baseline to 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.
Improvement of the sitting time, as measured from baseline to 3 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.
Improvement of the sitting time, as measured from baseline to 1 month 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.
Pain relief (visual analogic scale), as measured from baseline to 12 months of follow-up.
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.
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.
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.
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.
health-related quality of life
Use of pain treatment
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
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
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
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
health-related quality of life

Full Information

First Posted
September 25, 2015
Last Updated
January 27, 2020
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02564172
Brief Title
Conus Medullaris Stimulation With 5 Columns Lead Versus Medical Treatment in Refractory Pudendal Neuralgia
Acronym
STIMCONE
Official Title
Conus Medullaris Stimulation With 5 Columns Lead Versus Medical Treatment in Refractory Pudendal Neuralgia: a Randomized, Open, Controlled, Multicenter Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pudendal Neuralgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CMS group
Arm Type
Experimental
Arm Description
Conus medullaris stimulation with pentapolar surgical lead plus optimal medical management.
Arm Title
OMM group
Arm Type
Active Comparator
Arm Description
Optimal medical management alone.
Intervention Type
Device
Intervention Name(s)
CMS group
Other Intervention Name(s)
Conus medullaris stimulation with pentapolar lead plus optimal medical management.
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
OMM group
Other Intervention Name(s)
Optimal Medical Management alone.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement of the sitting time from baseline to 6 months of follow-up
Description
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.
Time Frame
At 6 months of follow-up
Secondary Outcome Measure Information:
Title
Improvement of the sitting time, as measured from baseline to 12 months of follow-up.
Description
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.
Time Frame
12 months
Title
Improvement of the sitting time, as measured from baseline to 3 months of follow-up.
Description
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.
Time Frame
3 months
Title
Improvement of the sitting time, as measured from baseline to 1 month of follow-up.
Description
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.
Time Frame
1 month
Title
Pain relief (visual analogic scale), as measured from baseline to 12 months of follow-up.
Description
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.
Time Frame
12 months
Title
Pain relief (visual analogic scale), as measured from baseline to 6 months of follow-up.
Description
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.
Time Frame
6 months
Title
Pain relief (visual analogic scale), as measured from baseline to 3 months of follow-up.
Description
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.
Time Frame
3 months
Title
Pain relief (visual analogic scale), as measured from baseline to 1 month of follow-up.
Description
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.
Time Frame
1 month
Title
Euro Quality of Life-5 Dimension Health questionnaire, as measured from baseline to 12 months of follow-up.
Description
health-related quality of life
Time Frame
12 months
Title
Use of pain treatment
Description
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.
Time Frame
12 months
Title
Use of pain treatment
Description
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.
Time Frame
6 months
Title
Use of pain treatment
Description
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.
Time Frame
3 months
Title
Use of pain treatment
Description
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.
Time Frame
1 month
Title
Euro Quality of Life-5 Dimension Health questionnaire, as measured from baseline to 6 months of follow-up
Description
health-related quality of life
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BUFFENOIR Kevin, Professor
Phone
+33240083758
Email
kevin.buffenoir@chu-nantes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BUFFENOIR Kevin, Professor
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantes Hospital
City
Nantes
State/Province
Pays De La Loire
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin BUFFENOIR, Professor
Phone
+33240083758
Email
kevin.buffenoir@chu-nantes.fr
First Name & Middle Initial & Last Name & Degree
BUFFENOIR Kevin
Facility Name
Bordeaux University Hospital
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CUNY Emmanuel, Professor
Phone
+33556795518
Email
emmanuel.cuny@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
CUNY Emmanuel
Facility Name
Colmar Hospital
City
Colmar
ZIP/Postal Code
68024
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VOIRIN Jimmy, Doctor
Phone
+3389124207
Email
jimmy.voirin@ch-colmar.fr
First Name & Middle Initial & Last Name & Degree
VOIRIN Jimmy
Facility Name
Lille University Hospital
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BLOND Serge, Professor
Phone
+3320445962
Email
serge.blond@chru-lille.fr
First Name & Middle Initial & Last Name & Degree
BLOND Serge
Facility Name
Lyon University Hospital
City
Lyon
ZIP/Postal Code
69003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MERTENS Patrick, Professor
Phone
+33472118903
Email
patrick.mertens@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
MERTENS Patrick
Facility Name
Clinic Catherine de Sienne
City
Nantes
ZIP/Postal Code
44200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RIOULT Bruno, Doctor
Phone
+33228272315
Email
rioult.bruno@catherinedesienne.fr
First Name & Middle Initial & Last Name & Degree
RIOULT Bruno
Facility Name
Hôpital Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JARRAYA Bechir, Professor
Phone
+33146252966
Email
b.jarraya@hopital-foch.org
First Name & Middle Initial & Last Name & Degree
JARRAYA Bechir

12. IPD Sharing Statement

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

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