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Study designed to compare the conventional stimulation programming versus the high frequency stimulation programming of the spinal cord stimulator for subjects who already have a spinal cord stimulator.
Subject with Precision models of spinal cord stimulators will be invited to take part in the study that will compare the high frequency stimulation versus low frequency stimulation to look for any changes in efficacy, and preferability between high and low frequency stimulation program for the spinal cord stimulator (SCS) system.
The study is designed as 7 week study that can take up to 9 weeks per subject. 7 weeks are divided into 3 segments. First segment will be 3 weeks of spinal cord stimulation followed by second segment of wash off period, which will take 1 week (7 days), then the last segment with 3 weeks of spinal cord stimulation. At the end of each segments, there will be a follow up visits.
Each follow up visits can occur up to 5 business days after the follow up due date for post spinal cord stimulation follow ups, and up to 3 business days after the follow up due date for the post wash off visit.
At each visits, including baseline, subject will be asked to answer Numeric Pain Rating Scale (NPRS), Oswestry Disability Index (ODI), and Patients Global Impression of Change (PGIC) to assess interval effect of the programming parameter for the spinal cord stimulator.
Visit schedule and assessment summary:
Visit 1: Screening and Baseline
Visit 2: (end of 3 week assessments, + 5 days) End of first treatment period
Visit 3: (end of wash off period, +3 days) Beginning of second treatment period
Visit 4: (end of 3 week assessment +5 days) End of Treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Active Comparator | Subjects assigned to treatment group A will begin the 7 week study with high frequency stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study. |
|
| Treatment group B | Active Comparator | Subjects assigned to treatment group B will begin the 7 week study with low frequency stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High frequency stimulation | Other | Implanted pulse generator of a spinal cord stimulator will programmed to deliver high frequency stimulation for pain relief. For our purposes, high frequency stimulation will be defined as 1000 hertz. |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Rating Scale (NPRS) | Digital pain rating system that scores patient's subjective pain rating from 0 to 10; with greater number indicating progressively worsening pain. NPRS were measured at baseline (visit1), and at each follow ups visits at visit 2, 3 and 4. Visit 2 and 4 captured post treatment (either 1000 Hz or standard stimulation depending on the randomization) results, and visit 3 captured NPRS after the wash off from the spinal cord stimulation. | Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index Questionnaire (ODI). | ODI is a outcome metrics that is design to assess the severity of disability based on 10 activity categories. ODI is based on 0 to 100% scale, where larger percentage implies worse disability. (There are 5 categories: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippled. 81-100%: Either bed bound or exaggerating symptoms). ODI were measured at baseline (visit1), and at each follow ups visits at visit 2, 3 and 4. Visit 2 and 4 captured post treatment (either 1000 Hz or standard stimulation depending on the randomization) results, and visit 3 captured NPRS after the wash off from the spinal cord stimulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Preferability | At the conclusion of the study, subjects were asked to report which spinal cord stimulation modes they preferred. Subjects were presented with two boxes (1000 Hz. stimulation and Standard stimulation) and asked to check one. | End of treatment visit on visit 4 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James M North, MD | The Carolinas Pain Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9156011 | Background | Simpson BA. Spinal cord stimulation. Br J Neurosurg. 1997 Feb;11(1):5-11. doi: 10.1080/02688699746627. No abstract available. | |
| 21528381 | Background | Lee D, Hershey B, Bradley K, Yearwood T. Predicted effects of pulse width programming in spinal cord stimulation: a mathematical modeling study. Med Biol Eng Comput. 2011 Jul;49(7):765-74. doi: 10.1007/s11517-011-0780-9. Epub 2011 Apr 29. |
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No individual participants data will be shared with anyone other than study staff for analysis purposes.
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Randomization scheme was 1 to 1 ratio. Randomization assignment was generated using random number generator, and individual results were sealed in an envelope. If subject needed to be replaced, the replacement subject will receive the same randomization assignment.
All study subjects were recruited from the Carolinas Pain Institute who were implanted with Boston Scientific's Precision Plus spinal cord stimulation (SCS) system for chronic axial pain, and at the time of recruitment, was not receiving adequate pain relief from SCS system with baseline numeric pain rating scale of 5 or greater.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group A | Subjects randomized to the treatment group A will begin the 7 week study "per sequence" (e.g., "High frequency first, then Low frequency" and "Low frequency first, then High frequency"), with each stimulation modes lasting approximately 3 weeks with 7 to 10 days of "wash off" periods in between. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Low frequency stimulation | Other | Implanted pulse generator of a spinal cord stimulator will programmed to deliver low frequency stimulation for pain relief. Low frequency stimulation will be defined as conventional stimulation pulse generator programming. |
|
| Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4) |
| Patient's Global Impression of Change (PGIC) | PGIC is a 7-point scale that requires study subjects to rate the severity of their illness or medical condition after a specific treatment. 1: No change, 2: Almost the same, 3: A little better, 4: Somewhat better, 5: Moderately better, 6: Better, 7: A great deal better. Study subjects were asked to report their impression of changes at baseline visit, visit 2 through 4. | Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4) |
| 10965008 | Background | Kemler MA, Barendse GA, van Kleef M, de Vet HC, Rijks CP, Furnee CA, van den Wildenberg FA. Spinal cord stimulation in patients with chronic reflex sympathetic dystrophy. N Engl J Med. 2000 Aug 31;343(9):618-24. doi: 10.1056/NEJM200008313430904. |
| 22151862 | Background | Gordon AT, Zou SP, Kim Y, Gharibo C. Challenges to setting spinal cord stimulator parameters during intraoperative testing: factors affecting coverage of low back and leg pain. Neuromodulation. 2007 Apr;10(2):133-41. doi: 10.1111/j.1525-1403.2007.00101.x. |
| 18083639 | Background | Wu M, Linderoth B, Foreman RD. Putative mechanisms behind effects of spinal cord stimulation on vascular diseases: a review of experimental studies. Auton Neurosci. 2008 Feb 29;138(1-2):9-23. doi: 10.1016/j.autneu.2007.11.001. |
| 23442372 | Background | Fisher LE, Tyler DJ, Triolo RJ. Optimization of selective stimulation parameters for multi-contact electrodes. J Neuroeng Rehabil. 2013 Feb 27;10:25. doi: 10.1186/1743-0003-10-25. |
| 21068658 | Background | Guan Y, Wacnik PW, Yang F, Carteret AF, Chung CY, Meyer RA, Raja SN. Spinal cord stimulation-induced analgesia: electrical stimulation of dorsal column and dorsal roots attenuates dorsal horn neuronal excitability in neuropathic rats. Anesthesiology. 2010 Dec;113(6):1392-405. doi: 10.1097/ALN.0b013e3181fcd95c. |
| 12074897 | Background | El-Khoury C, Hawwa N, Baliki M, Atweh SF, Jabbur SJ, Saade NE. Attenuation of neuropathic pain by segmental and supraspinal activation of the dorsal column system in awake rats. Neuroscience. 2002;112(3):541-53. doi: 10.1016/s0306-4522(02)00111-2. |
| 9414060 | Background | Cui JG, O'Connor WT, Ungerstedt U, Linderoth B, Meyerson BA. Spinal cord stimulation attenuates augmented dorsal horn release of excitatory amino acids in mononeuropathy via a GABAergic mechanism. Pain. 1997 Oct;73(1):87-95. doi: 10.1016/s0304-3959(97)00077-8. |
| 9655623 | Background | Cui JG, Meyerson BA, Sollevi A, Linderoth B. Effect of spinal cord stimulation on tactile hypersensitivity in mononeuropathic rats is potentiated by simultaneous GABA(B) and adenosine receptor activation. Neurosci Lett. 1998 May 15;247(2-3):183-6. doi: 10.1016/s0304-3940(98)00324-3. |
| 21788322 | Background | Song Z, Meyerson BA, Linderoth B. The interaction between antidepressant drugs and the pain-relieving effect of spinal cord stimulation in a rat model of neuropathy. Anesth Analg. 2011 Nov;113(5):1260-5. doi: 10.1213/ANE.0b013e3182288851. Epub 2011 Jul 25. |
| 21514998 | Background | Song Z, Meyerson BA, Linderoth B. Spinal 5-HT receptors that contribute to the pain-relieving effects of spinal cord stimulation in a rat model of neuropathy. Pain. 2011 Jul;152(7):1666-1673. doi: 10.1016/j.pain.2011.03.012. Epub 2011 Apr 22. |
| 18753268 | Background | Ding X, Hua F, Sutherly K, Ardell JL, Williams CA. C2 spinal cord stimulation induces dynorphin release from rat T4 spinal cord: potential modulation of myocardial ischemia-sensitive neurons. Am J Physiol Regul Integr Comp Physiol. 2008 Nov;295(5):R1519-28. doi: 10.1152/ajpregu.00899.2007. Epub 2008 Aug 27. |
| 22078661 | Background | Smits H, van Kleef M, Joosten EA. Spinal cord stimulation of dorsal columns in a rat model of neuropathic pain: evidence for a segmental spinal mechanism of pain relief. Pain. 2012 Jan;153(1):177-183. doi: 10.1016/j.pain.2011.10.015. Epub 2011 Nov 9. |
| 20704677 | Background | Prager JP. What does the mechanism of spinal cord stimulation tell us about complex regional pain syndrome? Pain Med. 2010 Aug;11(8):1278-83. doi: 10.1111/j.1526-4637.2010.00915.x. |
| 22095108 | Background | Buonocore M, Bodini A, Demartini L, Bonezzi C. Inhibition of somatosensory evoked potentials during spinal cord stimulation and its possible role in the comprehension of antalgic mechanisms of neurostimulation for neuropathic pain. Minerva Anestesiol. 2012 Mar;78(3):297-302. |
| 22188868 | Background | Parker JL, Karantonis DM, Single PS, Obradovic M, Cousins MJ. Compound action potentials recorded in the human spinal cord during neurostimulation for pain relief. Pain. 2012 Mar;153(3):593-601. doi: 10.1016/j.pain.2011.11.023. Epub 2011 Dec 19. |
| 23011119 | Background | Ito S, Sugiura T, Azami T, Sasano H, Sobue K. Spinal cord stimulation for a woman with complex regional pain syndrome who wished to get pregnant. J Anesth. 2013 Feb;27(1):124-7. doi: 10.1007/s00540-012-1462-y. Epub 2012 Aug 15. |
| 21217892 | Background | Yoo HS, Nahm FS, Yim KH, Moon JY, Kim YS, Lee PB. Pregnancy in woman with spinal cord stimulator for complex regional pain syndrome: a case report and review of the literature. Korean J Pain. 2010 Dec;23(4):266-9. doi: 10.3344/kjp.2010.23.4.266. Epub 2010 Dec 1. |
| FG001 | Treatment Group B | Subjects randomized to the treatment group B will begin the 7 week study "per sequence" (e.g., "Low frequency first, then High frequency" and "High frequency first, then Low frequency"), with each stimulation modes lasting approximately 3 weeks with 7 to 10 days of "wash off" periods in between. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group A | Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study. |
| BG001 | Treatment Group B | Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Numeric Pain Rating Scale (NPRS) | Digital pain rating system that scores patient's subjective pain rating from 0 to 10; with greater number indicating progressively worsening pain. NPRS were measured at baseline (visit1), and at each follow ups visits at visit 2, 3 and 4. Visit 2 and 4 captured post treatment (either 1000 Hz or standard stimulation depending on the randomization) results, and visit 3 captured NPRS after the wash off from the spinal cord stimulation. | All study subjects were implanted with Boston Scientific's Precision Plus spinal cord stimulation system for treatment of chronic axial pain. | Posted | Mean | Full Range | units on a scale | Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4) |
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| Secondary | Oswestry Disability Index Questionnaire (ODI). | ODI is a outcome metrics that is design to assess the severity of disability based on 10 activity categories. ODI is based on 0 to 100% scale, where larger percentage implies worse disability. (There are 5 categories: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippled. 81-100%: Either bed bound or exaggerating symptoms). ODI were measured at baseline (visit1), and at each follow ups visits at visit 2, 3 and 4. Visit 2 and 4 captured post treatment (either 1000 Hz or standard stimulation depending on the randomization) results, and visit 3 captured NPRS after the wash off from the spinal cord stimulation. | All study subjects were implanted with Boston Scientific's Precision Plus spinal cord stimulation system for treatment of chronic axial pain. | Posted | Mean | Full Range | units on a scale | Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4) |
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| Secondary | Patient's Global Impression of Change (PGIC) | PGIC is a 7-point scale that requires study subjects to rate the severity of their illness or medical condition after a specific treatment. 1: No change, 2: Almost the same, 3: A little better, 4: Somewhat better, 5: Moderately better, 6: Better, 7: A great deal better. Study subjects were asked to report their impression of changes at baseline visit, visit 2 through 4. | All study subjects were implanted with Boston Scientific's Precision Plus spinal cord stimulation system for treatment of chronic axial pain. | Posted | Mean | Full Range | units on a scale | Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4) |
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| Other Pre-specified | Preferability | At the conclusion of the study, subjects were asked to report which spinal cord stimulation modes they preferred. Subjects were presented with two boxes (1000 Hz. stimulation and Standard stimulation) and asked to check one. | All study subjects were implanted with Boston Scientific's Precision Plus spinal cord stimulation system for treatment of chronic axial pain. | Posted | Number | participants | End of treatment visit on visit 4 |
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All adverse events, including serious adverse events were collected during the study duration. First study subject was enrolled on October 1st of 2014, and last subjects completed the scheduled visit on December 24 of 2014.
If adverse events or serious adverse events were reported during the study duration, study staff and principal investigator were to follow the adverse event until the resolution. However, there were no adverse events reported during the study duration, thus no subjects were followed beyond study duration.
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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 | Treatment Group A | Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study. | 0 | 11 | 0 | 11 | ||
| EG001 | Treatment Group B | Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study. | 0 | 11 | 0 | 11 |
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This study was limited by the sampling size, and by device type. Study was open to subjects who were implanted with Boston Scientific's Precision Plus device only
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James North MD | Center for Clinical Research / Carolinas Pain Institute | 3367656181 | jhong@ccrpain.com |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D017116 | Low Back Pain |
| D011843 | Radiculopathy |
| D020918 | Complex Regional Pain Syndromes |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D001342 | Autonomic Nervous System Diseases |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Average NPRS after standard stimulation |
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| Average NPRS after Wash off |
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| Best Baseline NPRS score |
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| Best NPRS score after 1000 Hz. stimulation |
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| Best NPRS score after standard stimulation |
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| Best NPRS after Wash off |
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| Worst Baseline NPRS score |
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| Worst NPRS score after 1000 Hz. stimulation |
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| Worst NPRS score after standard stimulation |
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| Worst NPRS after Wash off |
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| Treatment Group B |
Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study. |
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