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To assess lead migration rates using different methods of securing leads during Spinal Cord Stimulation trial period.
Spinal cord stimulation has two phases. Trial, which is a precursor for a permanent implantation. Trial lasts less than a week, which gives the patient an opportunity to assess the effectiveness of the treatment.
Lead migration has been a known issue/complication with spinal cord stimulation. Lead migration during the trial period can alter the success of a trial. There is no one way of securing the leads to the skin.
Our endeavor was to look at different modes of securing the leads to the skin during the trial period and present their respective lead migration rates. The three methods are
In all three groups copious amounts of benzoin and steri-strips will be used.
Fluoroscopy pictures were taken after the leads were inserted and the level of the leads will be marked. After the trial period, before the leads were removed, an AP/lateral plain X-ray was taken and compared to the fluoroscopy pictures taken at the time of lead placement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Suture | Experimental | No suture will be used to secure the leads. Benzoin and Steri-Strips will be used like in the other two arms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suture | Device | Suture (2.0 Mono-filament nylon suture) will be used to secure the leads to the skin. Benzoin and Steri-strips will also be used. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Migration of leads with different methods of securing leads during spinal cord stimulation trial period. | 3-5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward Shadid, M.D | Spine Care of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spine Care of Oklahoma | Oklahoma City | Oklahoma | 73112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15029914 | Background | Cameron T. Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20-year literature review. J Neurosurg. 2004 Mar;100(3 Suppl Spine):254-67. doi: 10.3171/spi.2004.100.3.0254. | |
| 16738284 | Background | Kemler MA, de Vet HC, Barendse GA, van den Wildenberg FA, van Kleef M. Spinal cord stimulation for chronic reflex sympathetic dystrophy--five-year follow-up. N Engl J Med. 2006 Jun 1;354(22):2394-6. doi: 10.1056/NEJMc055504. No abstract available. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D013537 | Sutures |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Lead Anchor | Device | Suture (2.0 Mono-filament Nylon suture) will be applied over the lead anchor(Lead Anchor St.Jude Medical Co, model-long, No# 1106) to the skin. Benzion and Steri-strips will also be used. |
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| 19769908 | Background | Brook AL, Georgy BA, Olan WJ. Spinal cord stimulation: a basic approach. Tech Vasc Interv Radiol. 2009 Mar;12(1):64-70. doi: 10.1053/j.tvir.2009.06.007. |
| 8748598 | Background | Holsheimer J, Barolat G, Struijk JJ, He J. Significance of the spinal cord position in spinal cord stimulation. Acta Neurochir Suppl. 1995;64:119-24. doi: 10.1007/978-3-7091-9419-5_26. |
| 14588316 | Background | Ohnmeiss DD, Rashbaum RF. Patient satisfaction with spinal cord stimulation for predominant complaints of chronic, intractable low back pain. Spine J. 2001 Sep-Oct;1(5):358-63. doi: 10.1016/s1529-9430(01)00083-3. |
| 19096610 | Background | Jang HD, Kim MS, Chang CH, Kim SW, Kim OL, Kim SH. Analysis of failed spinal cord stimulation trials in the treatment of intractable chronic pain. J Korean Neurosurg Soc. 2008 Feb;43(2):85-9. doi: 10.3340/jkns.2008.43.2.85. Epub 2008 Feb 20. |
| 16961078 | Background | Rosenow JM, Stanton-Hicks M, Rezai AR, Henderson JM. Failure modes of spinal cord stimulation hardware. J Neurosurg Spine. 2006 Sep;5(3):183-90. doi: 10.3171/spi.2006.5.3.183. |
| 16961079 | Background | Kumar K, Wilson JR, Taylor RS, Gupta S. Complications of spinal cord stimulation, suggestions to improve outcome, and financial impact. J Neurosurg Spine. 2006 Sep;5(3):191-203. doi: 10.3171/spi.2006.5.3.191. |
| 18476899 | Background | Park CH, Huh B. Lodged spinal cord stimulator trial lead: a case report. Pain Pract. 2008 May-Jun;8(3):210-3. doi: 10.1111/j.1533-2500.2008.00199.x. |