Burst Spinal Cord Stimulation for Neuropathic Pain
December 2, 2011 updated by: Sven Vanneste, University Hospital, Antwerp
Burst, Tonic and Sham Spinal Cord Stimulation. A Verification of the Best Treatment Protocol
Recently a novel stimulation design was developed, called burst stimulation.
In a non-placebo controlled pilot study burst stimulation seemed superior to tonic stimulation over a period extending more than 2 years, and even though an incidental finding, this design seemed capable of suppressing pain without mandatory induction of paresthesias.
This permits for the first time to scientifically prove that spinal cord stimulation is better than placebo stimulation.
A study was therefore initiated to find out whether spinal cord stimulation is indeed capable of suppressing neuropathic limb pain in a placebo controlled way.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients receive three type of stimulation (burst, tonic and sham).
We want to compare these different stimulation protocol to verify which one is the one the patient prefer the most and have the least side-effects (paresthesia)
Study Type
Interventional
Enrollment (Actual)
15
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
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-
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Edegem, Belgium, 2650
- University Hospital Antwerp
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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 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
All patients were selected after multidisciplinary discussion with a specialized pain physician, a psychological and psychiatric evaluation was performed to rule out psychogenic pain as well as other psychiatric morbidity contraindicating an implant. After authorization by the psychologist and psychiatrist an implant was offered.
Inclusion Criteria
- Patients enrolled in this study must meet the following inclusion criteria:
- Patients able to provide informed consent to participate in the study;
- Patient is between the age of 18 and 75;
- Patient has Failed Back Surgery Syndrome;
- Patient has a simulator implanted at the dorsal column spinal cord powered by an EON/EON Mini® internal pulse generator.
- Patient medication has remained stable for at least 4 weeks prior to baseline data collection;
- Patient agrees not to add or increase medication throughout the randomization trial period of the study;
- Patient is willing to cooperate with the study requirements including compliance with the treatment regimen and completion of all office visits.
Exclusion Criteria
A patient will be excluded from participation in this study if they meet any one of the following criteria:
- Patient has current evidence of any psychiatric disorder, as documented by the DSM-IV-TR criteria with psychotic characteristics;
- Patient has a history of life-threatening severe illness or is suffering from severe chronic disease other than the indication for the study;
- Patient has history of substance abuse or substance dependency in the past 6 months prior to baseline data collection;
- Patient currently participating in another clinical study;
- Patient with demand-type cardiac pacemakers, an infusion pump or any other implantable neurostimulator device except for the spinal cord stimulator under study;
- Patient is not willing to maintain current medication regimen;
- Female candidates of child bearing potential who are pregnant (confirmed by positive urine/blood pregnancy test), not using adequate contraception as determined by the investigator, or nursing (lactating) a child.
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: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tonic
5 hz stimulation at an amplitude that the patient find bearable (+/- 1.5 mA)
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test different settings of stimulation
Other Names:
|
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Experimental: Sham
no stimulation, patient receive a sham stimulation (actually the IPG is not running)
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test different settings of stimulation
Other Names:
|
|
Experimental: burst
500 hz burst at 5 hz stimulation
|
test different settings of stimulation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Visual Analogue Scales for pain back, pain limb, pain general and paresthesia
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Secondary Outcome Measures
Outcome Measure |
|---|
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VAS scores for pain now, worst pain, least pain and pain vigilance and awareness questionnaire
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sven Vanneste, PhD, Universiteit Antwerpen
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.
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
January 1, 2011
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
September 21, 2011
First Submitted That Met QC Criteria
December 2, 2011
First Posted (Estimate)
December 6, 2011
Study Record Updates
Last Update Posted (Estimate)
December 6, 2011
Last Update Submitted That Met QC Criteria
December 2, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- burst spinal cord stimulation
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