At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Direct Comparison of Spinal Cord Stimulator Parameter Settings
In Brief
A clinical study evaluating High-frequency stimulation and Sham Stimulation for Spinal Cord Stimulation and 2 related conditions. Completed, enrolled 4 participants across 1 site.
Detailed Summary
(Primary) 1. To compare the clinical effects and side effects of two different stimulation strategies that do not produce any sensory percept (1000 Hz and placebo) on clinical benefit for electrodes implanted for chronic pain as measured by the Visual Analog Pain Scale for back and leg pain, the Brief Pain Inventory, the 36-Item Short Form Survey (SF-36), and the Pain Vigilance and Awareness Questionnaire. (Secondary) 2. To compare the clinical effects of the subthreshold (paresthesia-free) stimulation patterns with conventional (paresthesia-producing) stimulation patterns to evaluate the necessity of paresthesias and current amplitudes on clinical benefit for pain. 3. To identify the ability of subthreshold high-frequency to improve axial pain or the affective component of pain.
Study Details
Timeline
Interventions
Patients in this group will receive sub-threshold high-frequency (aka 1200Hz) spinal cord stimulation for 2 weeks.
Patients in this group will receive receive sham spinal cord stimulation (aka no stimulation) for 2 weeks.