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(Primary)
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)
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.
To identify the ability of subthreshold high-frequency to improve axial pain or the affective component of pain.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Frequency Stimulation, Then Placebo Stimulation | Experimental | 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. |
|
| Placebo Stimulation, Then High-Frequency Stimulation | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-frequency stimulation | Device | Patients in this group will receive sub-threshold high-frequency (aka 1200Hz) spinal cord stimulation for 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Pain Scale | Assessment of overall degree of back and leg pain during each phase of stimulation (ie conventional baseline stimulation, high-density stimulation, conventional "washout" stimulation, and sham stimulation). Scores range from 0 - 100, with a higher score indicating more pain. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 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. For purposes of this outcome measure, we focused on "now" (current pain) | 8 weeks |
| Change in SF-36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer A Sweet, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Case Medical Center | Cleveland | Ohio | 44122 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26481726 | Result | 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 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | High-Frequency Stimulation, Then Placebo Stimulation | Participants first received 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 received sham spinal cord stimulation (1200 Hz at 0 V amplitude) for 2 weeks. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (14 Days) |
| |||||||||||||
| Washout (14 Days) |
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| Second Intervention (14 Days) |
|
No subjects were randomized to the conventional spinal cord stimulation group
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 received sham spinal cord stimulation (1200 Hz at 0 V amplitude) for 2 weeks." |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analog Pain Scale | Assessment of overall degree of back and leg pain during each phase of stimulation (ie conventional baseline stimulation, high-density stimulation, conventional "washout" stimulation, and sham stimulation). Scores range from 0 - 100, with a higher score indicating more pain. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
8 weeks
No subjects were enrolled in to the Conventional Spinal Cord Stimulation group
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High-Frequency Stimulation | Participants received 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paresthesia | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Sweet, MD | Case Western Reserve University | 216-844-3192 | Jennifer.Sweet@UHhospitals.org |
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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.
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| Sham Stimulation | Device | Patients in this group will receive receive sham spinal cord stimulation (aka no stimulation) for 2 weeks. |
|
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 |
| Pain Vigilance and Awareness Questionnaire (PVAQ) | The PVAQ 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 |
| Number of Patients With Side Effects of Stimulation | Incidence of side effects of stimulation | 8 weeks |
| NOT COMPLETED |
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| NOT COMPLETED |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo Stimulation | All patients will receive 2 weeks of conventional spinal cord stimulation as a baseline (60 Hz, 200 usec, at an amplitude above sensory perception). Patients will then be randomly assigned to receive 2 weeks of sham stimulation (1200 Hz, 200 usec, 0 amplitude). Patients will then get another 2 weeks of conventional stimulation as a "washout" period. Finally, they will get 2 weeks of sub-threshold, high-density spinal cord stimulation (1200 Hz, 200 usec, at an amplitude of 90% of the sensory threshold) for 2 weeks. |
|
|
| Secondary | Change in 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. For purposes of this outcome measure, we focused on "now" (current pain) | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| Secondary | Change in 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. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| Secondary | Pain Vigilance and Awareness Questionnaire (PVAQ) | The PVAQ is a measure of vigilance and attention to pain. Total scores can range from 0 to 90, with higher scores indicating more pain vigilance. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| Secondary | Number of Patients With Side Effects of Stimulation | Incidence of side effects of stimulation | No subjects were randomized to the conventional spinal cord stimulation group | Posted | Number | participants | 8 weeks |
|
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| 0 |
| 4 |
| 0 |
| 4 |
| 2 |
| 4 |
| EG001 | Placebo Stimulation | Participants received sham spinal cord stimulation (1200 Hz at 0 V amplitude) for 2 weeks. | 0 | 4 | 0 | 4 | 2 | 4 |
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