Burst, Tonic and Sham Spinal Cord Stimulation. A Verification of the Best Treatment Protocol
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neuropathic Pain
- Sponsor
- University Hospital, Antwerp
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Visual Analogue Scales for pain back, pain limb, pain general and paresthesia
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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)
Investigators
Sven Vanneste
Principal investigator
University Hospital, Antwerp
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Visual Analogue Scales for pain back, pain limb, pain general and paresthesia
Secondary Outcomes
- VAS scores for pain now, worst pain, least pain and pain vigilance and awareness questionnaire