Burst Spinal Cord Stimulation for Neuropathic Pain

Not Applicable

Completed

• Conditions: Neuropathic Pain
• Interventions: Procedure: dorsal column stimulator

• Registration Number: NCT01486108
• Lead Sponsor: University Hospital, Antwerp

Brief Summary

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.

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 Timeline

• Study Start: 2011-01
• Primary Completion: 2011-08
• Study Completion: 2011-09
• Study First Submitted: 2011-09-21
• Status Verified: 2011-12
• Study First Submitted QC: 2011-12-02
• Last Update Submitted: 2011-12-02
• Study First Posted: 2011-12-06
• Last Update Posted: 2011-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Tonic	dorsal column stimulator	5 hz stimulation at an amplitude that the patient find bearable (+/- 1.5 mA)
Sham	dorsal column stimulator	no stimulation, patient receive a sham stimulation (actually the IPG is not running)
burst	dorsal column stimulator	500 hz burst at 5 hz stimulation

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scales for pain back, pain limb, pain general and paresthesia

Secondary Outcome Measures

Name	Time	Method
VAS scores for pain now, worst pain, least pain and pain vigilance and awareness questionnaire

Trial Locations

Locations (1)

University Hospital Antwerp; 🇧🇪 Edegem, Belgium