Direct Comparison of Spinal Cord Stimulator Parameter Settings

Spinal Cord Stimulation Clinical Trial

Official title:

Direct Comparison of Spinal Cord Stimulator Parameter Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05283863
• Other study ID #: 10-13-29
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: August 2015

Study information

• Verified date: March 2022
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Description:

This is a prospective, randomized, double-blind study of different stimulation patterns in patients undergoing implantation of neurostimulator systems for chronic medically intractable neuropathic pain. Research participants will be individuals who have undergone implantation of neurostimulator electrodes into the spinal column or peripheral nervous system for clinical treatment of neuropathic pain. All patients will already have undergone empiric programming of the stimulator using conventional settings (typically 40-60 Hz, 350-450 usec pulse width). However, other stimulation parameters, including high-frequency stimulation, are also feasible and FDA-approved using the implanted device, and it is possible to do this without producing a sensory percept, which makes it possible to test efficacy in a double blind manner. For this study, two different stimulation parameters will be tested during four two-week periods: 1000 Hz and placebo. Clinical response and side effect profile for each setting will be measured.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Stimulation

Intervention

Device:
• High-frequency stimulation
Patients in this group will receive sub-threshold high-frequency (aka 1200Hz) spinal cord stimulation for 2 weeks.
• Sham Stimulation
Patients in this group will receive receive sham spinal cord stimulation (aka no stimulation) for 2 weeks.
• Conventional spinal cord stimulation
Patients will receive conventional spinal cord stimulation (aka 60Hz, aka tonic stimulation, aka paresthesia-based stimulation) for 2 weeks

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Western Reserve University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sweet J, Badjatiya A, Tan D, Miller J. Paresthesia-Free High-Density Spinal Cord Stimulation for Postlaminectomy Syndrome in a Prescreened Population: A Prospective Case Series. Neuromodulation. 2016 Apr;19(3):260-7. doi: 10.1111/ner.12357. Epub 2015 Oct — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Pain Scale	Assessment of overall degree of back and leg pain during each arm of spinal cord stimulation. Scores range from 0 - 100, with a higher score indicating more pain	8 weeks
Secondary	Brief Pain Inventory (BPI)	The BPI assesses pain at its "worst," "least," "average," and "now" (current pain). Each item is rated on a scale of 0 - 10 with 10 indicating higher levels of pain	8 weeks
Secondary	SF-36	The SF-36 is a measure of quality of life, with scores ranging from 0 - 100, with higher scores indicating a higher quality of life.	8 weeks
Secondary	Pain Vigilance and Awareness Questionnaire (PVAQ)	The PVAG is a measure of vigilance and attention to pain. Total scores can range from 0 to 90, with higher scores indicating more pain vigilance.	8 weeks
Secondary	Number of Patients with Side Effects of Stimulation	Incidence of side effects of stimulation	8 weeks