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

NCT ID: NCT02564172

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2023-10-11

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.

Conditions

Pudendal Neuralgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CMS group

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

Group Type: EXPERIMENTAL

CMS group

Intervention Type: DEVICE

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).

OMM group

Optimal medical management alone.

Group Type: ACTIVE_COMPARATOR

OMM group

Intervention Type: OTHER

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.

Interventions

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).

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

Conus medullaris stimulation with pentapolar lead plus optimal medical management.; Optimal Medical Management alone.

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

BUFFENOIR Kevin, Professor

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

Nantes Hospital

Nantes, Pays de la Loire Region, France

Bordeaux University Hospital

Bordeaux, , France

Colmar Hospital

Colmar, , France

Lille University Hospital

Lille, , France

Lyon University Hospital

Lyon, , France

Clinic Catherine de Sienne

Nantes, , France

Hôpital Foch

Suresnes, , France

Countries

France

Other Identifiers

RC15_0075

Identifier Type: -

Identifier Source: org_study_id