Direct Comparison of Spinal Cord Stimulator Parameter Settings

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-08-31

Brief Summary

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(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.

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Detailed Description

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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.

Conditions

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Spinal Cord Stimulation High-frequency Stimulation High-density Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

All subjects underwent two weeks of conventional stimulation, followed by randomization to receive either subthreshold high-density (HD) or sham stimulation; this was followed by a crossover during which the participants who had received subthreshold HD stimulation were treated with sham and vice versa.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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High-Frequency Stimulation, Then Placebo Stimulation

Participants first receive sub-threshold high-frequency spinal cord stimulation (1200 Hz frequency, 200 μsec pulse width, and an amplitude 90% of the threshold for detection of a sensory percept) for 2 weeks. After a 2-week washout period, they then receive sham spinal cord stimulation (1200 Hz at 0 V amplitude) for 2 weeks.

Group Type EXPERIMENTAL

High-frequency stimulation

Intervention Type DEVICE

Patients in this group will receive sub-threshold high-frequency (aka 1200Hz) spinal cord stimulation for 2 weeks.

Sham Stimulation

Intervention Type DEVICE

Patients in this group will receive receive sham spinal cord stimulation (aka no stimulation) for 2 weeks.

Placebo Stimulation, Then High-Frequency Stimulation

Participants first receive sham spinal cord stimulation (1200 Hz at 0 V amplitude) for 2 weeks. After a 2-week washout period, they then receive sub-threshold high-frequency spinal cord stimulation (1200 Hz frequency, 200 μsec pulse width, and an amplitude 90% of the threshold for detection of a sensory percept) for 2 weeks.

Group Type SHAM_COMPARATOR

High-frequency stimulation

Intervention Type DEVICE

Patients in this group will receive sub-threshold high-frequency (aka 1200Hz) spinal cord stimulation for 2 weeks.

Sham Stimulation

Intervention Type DEVICE

Patients in this group will receive receive sham spinal cord stimulation (aka no stimulation) for 2 weeks.

Interventions

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High-frequency stimulation

Patients in this group will receive sub-threshold high-frequency (aka 1200Hz) spinal cord stimulation for 2 weeks.

Intervention Type DEVICE

Sham Stimulation

Patients in this group will receive receive sham spinal cord stimulation (aka no stimulation) for 2 weeks.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No