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

February 13, 2015 updated by: Poitiers University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Poitiers, France, 86021
        • Poitiers university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Monocolumn spinal cord stimulation
Specify 5-6-5 Lead (only one column)
Device: comparison of spinal cord stimulation
Other Names:
  • Specify(TM) 5-6-5 lead (Medtronic)
EXPERIMENTAL: Multicolumn spinal cord stimulation
Specify 5-6-5 Lead
Device: comparison of spinal cord stimulation
Other Names:
  • Specify(TM) 5-6-5 lead (Medtronic)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual Analogic Scale Low Back pain
Time Frame: Month 6
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

May 3, 2012

First Submitted That Met QC Criteria

June 22, 2012

First Posted (ESTIMATE)

June 26, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 16, 2015

Last Update Submitted That Met QC Criteria

February 13, 2015

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-A011695-36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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