Effectiveness and Cost Management of Multicolumn Spinal Cord Stimulation in Neuropathic Pain Patients With Failed Back Surgery Syndrome (ESTIMET)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Poitiers University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT01628237
First received: May 3, 2012
Last updated: June 22, 2012
Last verified: June 2012
  Purpose

Failed back surgery syndrome (FBSS) constitutes a frequent pathology, generates a severe handicap for patients and represents a considerable expense for healthcare system. Neurostimulation has currently not been validated in the treatment of back pain because of technological limitations in implantable spinal cord stimulation (SCS). The lack of a validated technique for back pain relief has prompted the development of newer devices, including leads with increased number of contacts (up to 16) and various geometric arrangements, the objective of which is to cover a larger area while attempting to extend, steer, or focus the electric field of the stimulation within the spinal cord regions. This led companies to design a new generation of multicolumn surgical leads that allow the activation of longitudinal and transverse electric fields (multicolumn spinal cord stimulation, MSCS) in order to provide bilateral paresthesia coverage of back pain.

The objective of this study is to compare the analgesic efficacy of MSCS (using longitudinal and transverse electric stimulation) versus mono-column spinal cord stimulation (CSCS, using axial stimulation, actually represented by quadripolar or octopolar lead) on the treatment of lumbar pain.

A total of 115 patients will be randomized to either CSCS or MSCS. Patients, between 18 and 80 years old suffering from refractory neuropathic pain of radicular origin with associated back pain will be included. Patients will be divided into two groups. One group with MSCS during the 12 months after the new generation electrode implantation and one group with CSCS during 6 months and MSCS between 6 and 12 months after the new generation electrode implantation.

The following parameters will be evaluated during this study: overall pain VAS, leg pain VAS, back pain VAS, Oswestry disability index, Montgomery and Asberg Depression Rating scale, Brief Anxiety Scale and the Euro Quality of Life-5 Dimension Health questionnaire and costing in relation to surgery and patient management.


Condition Intervention
Failed Back Surgery Syndrome
Device: comparison of spinal cord stimulation

Study Type: Interventional

Further study details as provided by Poitiers University Hospital:

Study Start Date: May 2012
Arms Assigned Interventions
Experimental: monocolumn spinal cord stimulation Device: comparison of spinal cord stimulation
Other Name: Specify(TM) 5-6-5 lead (Medtronic)
Experimental: multicolumn spinal cord stimulation Device: comparison of spinal cord stimulation
Other Name: Specify(TM) 5-6-5 lead (Medtronic)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged from 18 to 80 years
  • Presence of FBSS ≥ 3 months after one or several spine surgery
  • Presence of back and leg pain with documented neuropathic component (DN4)
  • Having failed well conducted conservative treatment
  • Meeting the criteria for a test of spinal cord stimulation as recommended by HAS (multidisciplinary consultation, psychological evaluation
  • Presence of uni-or bilateral radicular pain with severe intensity, VAS score greater than or equal to 50/100 (daily VAS mean on 5 consecutive days).
  • Presence of associated back pain, as related to type "bar" or "tender points"
  • Understanding and accepting the constraints of the study
  • Covered by a French Health Insurance plan or benefiting of such as a third party in agreement with the French law (Huriet law n°88.1138 and modifications) on biomedical research
  • Has given written consent to the study after receiving clear information.
  • Absence of psychosis or evolutionary history of severe psychosis requiring hospitalization.
  • Absence of progressive malignancy

Exclusion Criteria:

  • Age < 18 and > 80 years
  • Accessible because of back pain surgery 'mechanical' causal (discogenic back pain, spinal instability, spinal deformation)
  • Presence of surgery, anesthetic and psychiatric contraindication for spinal cord stimulation system implantation
  • Absence of informed consent signature
  • Women of childbearing without effective contraception (hormonal / mechanical: oral, injectable, transdermal, implantable, intrauterine device or surgical: tubal ligation, hysterectomy, oophorectomy total) or breastfeeding.
  • Subject not covered by a French Health Insurance plan or not benefiting of such as a third party
  • Subject receiving enhanced protection: minors, pregnant women, nursing women, persons deprived of liberty by a judicial or administrative decision, adults under legal protection, and finally patients in emergency situations.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01628237

Contacts
Contact: Philippe RIGOARD, MD +33(0)549443943 philippe.rigoard@chu-poitiers.fr

Locations
France
Poitiers University Hospital Recruiting
Poitiers, France, 86021
Principal Investigator: Philippe RIGOARD, MD         
Sponsors and Collaborators
Poitiers University Hospital
  More Information

No publications provided

Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT01628237     History of Changes
Other Study ID Numbers: 2011-A011695-36
Study First Received: May 3, 2012
Last Updated: June 22, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Syndrome
Failed Back Surgery Syndrome
Disease
Pathologic Processes
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications

ClinicalTrials.gov processed this record on October 16, 2014