N/A N=4 Randomized Triple-blind Treatment

Direct Comparison of Spinal Cord Stimulator Parameter Settings

Spinal Cord Stimulation · High-frequency Stimulation · High-density Stimulation

Bottom Line

View on ClinicalTrials.gov: NCT05283863 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2024

Primary outcome: Primary: Visual Analog Pain Scale — 2.29; 6.31 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: High-frequency stimulation (Device); Sham Stimulation (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Case Western Reserve University
Primary completion: Aug 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Visual Analog Pain Scale	2.29; 6.31	—
SECONDARY Change in Brief Pain Inventory (BPI)	-2.0625; 1.21875	—
SECONDARY Change in SF-36	-28.125; 23.125	—
SECONDARY Pain Vigilance and Awareness Questionnaire (PVAQ)	46.8; 51.5	—
SECONDARY Number of Patients With Side Effects of Stimulation	2; 2	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT05283863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.