Burst Spinal Cord Stimulation for Neuropathic Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sven Vanneste, University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT01486108
First received: September 21, 2011
Last updated: December 2, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Neuropathic Pain
Procedure: dorsal column stimulator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Burst, Tonic and Sham Spinal Cord Stimulation. A Verification of the Best Treatment Protocol

Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • Visual Analogue Scales for pain back, pain limb, pain general and paresthesia [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • VAS scores for pain now, worst pain, least pain and pain vigilance and awareness questionnaire [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: January 2011
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tonic
5 hz stimulation at an amplitude that the patient find bearable (+/- 1.5 mA)
Procedure: dorsal column stimulator
test different settings of stimulation
Other Name: IPG is used by ST Jude medical together with an 88 lamitrode lead
Experimental: Sham
no stimulation, patient receive a sham stimulation (actually the IPG is not running)
Procedure: dorsal column stimulator
test different settings of stimulation
Other Name: IPG is used by ST Jude medical together with an 88 lamitrode lead
Experimental: burst
500 hz burst at 5 hz stimulation
Procedure: dorsal column stimulator
test different settings of stimulation
Other Name: IPG is used by ST Jude medical together with an 88 lamitrode lead

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)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01486108

Locations
Belgium
University Hospital Antwerp
Edegem, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
Principal Investigator: Sven Vanneste, PhD Universiteit Antwerpen
  More Information

No publications provided

Responsible Party: Sven Vanneste, Principal investigator, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT01486108     History of Changes
Other Study ID Numbers: burst spinal cord stimulation
Study First Received: September 21, 2011
Last Updated: December 2, 2011
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Antwerp:
tonic, burst and placebo stimulation

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014