Direct Comparison of Spinal Cord Stimulator Parameter Settings
Completed · Not applicable · Has a placebo group
Conditions studied: Spinal Cord Stimulation, High-frequency Stimulation, High-density Stimulation
In brief
(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.
Key facts
- Study ID
- NCT05283863
- Run by
- Case Western Reserve University
- People needed
- 4
- Starts
- 2015-06-01
- Expected to finish
- 2015-08-01
- Last updated by the study team
- 2024-05-21
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18-75 years
- Diagnosis of chronic neuropathic pain for which placement of electrodes into the spinal column is planned for clinical indications (failed back surgery syndrome, peripheral neuropathy or complex regional pain syndrome)
- History of implantation of spinal cord stimulation system with rechargeable implanted neurostimulator
You may not qualify if…
- Significant dementia or other condition preventing informed consent by the patient.
- Current drug or alcohol abuse or dependence.
- Uncontrolled depression or anxiety or failure to pass psychological screening for spinal cord stimulation.
- Inability or unwillingness to cooperate with clinical testing.
Where it is running
- University Hospitals Case Medical Center — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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