Electrical Stimulators - Cigna
Electrical Stimulators - Cigna Electrical Stimulators - Cigna
135. Stein RB, Everaert DG, Thompson AK, Chong SL, Whittaker M, Robertson J, Kuether G. Long-term therapeutic and orthotic effects of a foot drop stimulator on walking performance in progressive and nonprogressive neurological disorders. Neurorehabil Neural Repair. 2010 Feb;24(2):152-67. 136. Tan G, Rintala DH, Thornby JI, Yang J, Wade W, Vasilev C. Using cranial electrotherapy stimulation to treat pain associated with spinal cord injury. J Rehabil Res Dev. 2006 Jul-Aug;43(4):461-74. 137. Tanovic E. Effects of functional electrical stimulation in rehabilitation with hemiparesis patients. Bosn J Basic Med Sci. 2009 Feb;9(1):49-53. 138. Thompson AK. Doran B. Stein RB. Short-term effects of functional electrical stimulation on spinal excitatory and inhibitory reflexes in ankle extensor and flexor muscles. Experimental Brain Research. 2006;170(2):216-26. 139. Thrasher TA, Flett HM, Popovic MR. Gait training regimen for incomplete spinal cord injury using functional electrical stimulation. Spinal Cord. 2006;44:357-61. 140. U.S. Food and Drug Administration (FDA). Premarket approval (PMA) database: P900038 PARASTEP- I, Sigmedics, Inc. Rockville, MD: 1994 Apr 20. Accessed Jul 2, 2011. Available at URL address: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/P MAApprovals/ucm119050.htm 141. U.S. Food and Drug Administration (FDA). 510(k) Summary of Safety and Effectiveness K023212. AG Garments Conductive Electrodes. Dec 13, 2002. Accessed Jul 2, 2011. Available at URL address: http://www.accessdata.fda.gov/cdrh_docs/pdf2/k023212.pdf 142. U.S. Food and Drug Administration (FDA). 510(k) Summary of Safety and Effectiveness K090052. Cranial Electrical Nerve Stimulator. May 29, 2009. Accessed Jul 5, 2011. Available at URL address: http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090052.pdf 143. U.S. Food and Drug Administration (FDA). 510(k) Summary of Safety and Effectiveness K010565. Dynatron STS. Accessed Jul 5, 2011. Available at URL address: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=3758 144. U.S. Food and Drug Administration (FDA). 510(k) Summary of Safety and Effectiveness. EMS 7500.Mar 24, 2008. Accessed Jun 5, 2011. Available at URL address: http://www.accessdata.fda.gov/cdrh_docs/pdf8/K080661.pdf 145. U.S. Food and Drug Administration (FDA). 510(k) Summary of Safety and Effectiveness K052025 Percutaneous Urgent PC Neuromodulator System. Oct 17, 2005. Accessed Jul 5, 2011. Available at URL address: http://www.accessdata.fda.gov/cdrh_docs/pdf5/K052025.pdf 146. U.S. Food and Drug Administration (FDA). 510(k) Summary of Safety and Effectiveness. K022241. Percutaneous Neuromodulation Therapy (PNT). Sep 11, 2002. Accessed Jul 5, 2011. Available at URL address: http://www.accessdata.fda.gov/cdrh_docs/pdf2/k022241.pdf 147. U.S. Food and Drug Administration (FDA). 510(k) Summary of Safety and Effectiveness K980333. ReliefBand ® . Mar 21, 2002. Accessed Jul 5, 2011. Available at URL address: http://www.accessdata.fda.gov/cdrh_docs/pdf2/K020180.pdf 148. U.S. Food and Drug Administration (FDA). 510(k) Summary of Safety and Effectiveness K090750. RT 300. Aug 5, 2009. Accessed Jul 5, 2011. Available at URL address: http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090750.pdf 149. U.S. Food and Drug Administration (FDA). 510(k) Summary of Safety and Effectiveness K081255. Scrambler therapy MC-5A TENS device [Calmare]. Feb 20, 2009. Accessed Jul 5, 2011. Available at URL address: http://www.accessdata.fda.gov/cdrh_docs/pdf8/K081255.pdf Page 38 of 41
150. U.S. Food and Drug Administration (FDA). 510(k) Summary of Safety and Effectiveness K071869. TENS/IF 14 [Flex-It], Mar 7, 2008. Accessed Jul 5, 2011. Available at URL address: http://www.accessdata.fda.gov/cdrh_docs/pdf7/K071869.pdf 151. van Balken MR. Percutaneous tibial nerve stimulation: the Urgent PC device. Expert Rev Med Devices. 2007 Sep;4(5):693-8. 152. van der Linden ML, Hazlewood ME, Hillman SJ, Robb JE.Functional electrical stimulation to the dorsiflexors and quadriceps in children with cerebral palsy. Pediatr Phys Ther. 2008 Spring;20(1):23-9. 153. van der Salm A, Nene A, Maxwell D, Veltink P, Hermens H, IJzerman M. Gait impairments in a group of patients with incomplete spinal cord injury and their relevance regarding therapeutic approaches using functional electrical stimulation. Artif Organs. 2005 Jan;1:8-14. 154. van Middelkoop M, Rubinstein SM, Kuijpers T, Verhagen AP, Ostelo R, Koes BW, van Tulder MW. A systematic review on the effectiveness of physical and rehabilitation interventions for chronic nonspecific low back pain. Eur Spine J. 2011 Jan;20(1):19-39. Epub 2010 Jul 18. 155. van Swigchem R, Vloothuis J, den Boer J, Weerdesteyn V, Geurts AC. Is transcutaneous peroneal stimulation beneficial to patients with chronic stroke using an ankle-foot orthosis? A within-subjects study of patients' satisfaction, walking speed and physical activity level. J Rehabil Med. 2010 Feb;42(2):117-21. 156. Vandoninck V, van Balken MR, Finazzi Agro E, Petta F, Micali F, Heesakkers JP, et al. Percutaneous tibial nerve stimulation in the treatment of overactive bladder: urodynamic data. Neurourol Urodyn. 2003;22(3):227-32. 157. Walls RJ, McHugh G, O'Gorman DJ, Moyna NM, O'Byrne JM. Effects of preoperative neuromuscular electrical stimulation on quadriceps strength and functional recovery in total knee arthroplasty. A pilot study. BMC Musculoskelet Disord. 2010 Jun 14;11:119. 158. Walsh DM, Howe TE, Johnson MI, Sluka KA. Transcutaneous electrical nerve stimulation for acute pain. Cochrane Database of Systematic Reviews 2009, Issue 2. Art. No.: CD006142. DOI: 10.1002/14651858.CD006142.pub2. 159. Weber DJ, Skidmore ER, Niyonkuru C, Chang CL, Huber LM, Munin MC. Cyclic functional electrical stimulation does not enhance gains in hand grasp function when used as an adjunct to onabotulinumtoxinA and task practice therapy: a single-blind, randomized controlled pilot study. Arch Phys Med Rehabil. 2010 May;91(5):679-86. 160. Weiner DK, Perera S, Rudy TE, Glick RM, Shenoy S, Delitto A. Efficacy of percutaneous electrical nerve stimulation and therapeutic exercise for older adults with chronic low back pain: a randomized controlled trial. Pain. 2008 Nov 30;140(2):344-57. 161. White PF, Ghoname EA, Ahmed HE, Hamza MA, Craig WF, et al. The effect of montage on the analgesic response to percutaneous neuromodulation therapy. Anesth Analg. 2001 Feb;92(2):483-7. 162. Work Loss Data Institute (WLDI), California. Medical treatment utilization schedule regulations. Chronic pain medical treatment guidelines. May 2009. Accessed Jul 2, 2011. Available at URL address: http://www.dir.ca.gov/dwc/DWCPropRegs/MTUS_Regulations/MTUS_Regulations.htm 163. Wright RW, Preston E, Fleming BC, Amendola A, Andrish JT, Bergfeld JA, Dunn WR, Kaeding C, Kuhn JE, Marx RG, McCarty EC, Parker RC, Spindler KP, Wolcott M, Wolf BR, Williams GN. A systematic review of anterior cruciate ligament reconstruction rehabilitation: part II: open versus closed kinetic chain exercises, neuromuscular electrical stimulation, accelerated rehabilitation, and miscellaneous topics. J Knee Surg. 2008 Jul;21(3):225-34. Page 39 of 41
- Page 1 and 2: Cigna Medical Coverage Policy Subje
- Page 3 and 4: • microcurrent electrical nerve s
- Page 5 and 6: ongoing assessment and management a
- Page 7 and 8: Neck Pain: Following a systematic r
- Page 9 and 10: of patients with chronic pain who h
- Page 11 and 12: suppress spasticity. FES is a high-
- Page 13 and 14: nerve electrical stimulation (OG) (
- Page 15 and 16: terms of improving gait, but the ef
- Page 17 and 18: standardized protocol for IFT, and
- Page 19 and 20: velocity, which was sustained at si
- Page 21 and 22: adverse events included ankle bruis
- Page 23 and 24: Rhodes Index of Nausea, Vomiting an
- Page 25 and 26: Codes 337.20- 337.29 Reflex sympath
- Page 27 and 28: 496 Chronic airway obstruction, not
- Page 29 and 30: 2. Agency for Healthcare Research a
- Page 31 and 32: 29. Chou R, Loeser JD, Owens DK, Ro
- Page 33 and 34: 59. Guido EH. Effects of sympatheti
- Page 35 and 36: 90. Laufer Y, Ring H, Sprecher E, H
- Page 37: 121. Proctor M, Farquhar C, Stones
- Page 41: Policy History Pre-Merger Last Revi
135. Stein RB, Everaert DG, Thompson AK, Chong SL, Whittaker M, Robertson J, Kuether G. Long-term<br />
therapeutic and orthotic effects of a foot drop stimulator on walking performance in progressive and<br />
nonprogressive neurological disorders. Neurorehabil Neural Repair. 2010 Feb;24(2):152-67.<br />
136. Tan G, Rintala DH, Thornby JI, Yang J, Wade W, Vasilev C. Using cranial electrotherapy stimulation to<br />
treat pain associated with spinal cord injury. J Rehabil Res Dev. 2006 Jul-Aug;43(4):461-74.<br />
137. Tanovic E. Effects of functional electrical stimulation in rehabilitation with hemiparesis patients. Bosn J<br />
Basic Med Sci. 2009 Feb;9(1):49-53.<br />
138. Thompson AK. Doran B. Stein RB. Short-term effects of functional electrical stimulation on spinal<br />
excitatory and inhibitory reflexes in ankle extensor and flexor muscles. Experimental Brain Research.<br />
2006;170(2):216-26.<br />
139. Thrasher TA, Flett HM, Popovic MR. Gait training regimen for incomplete spinal cord injury using<br />
functional electrical stimulation. Spinal Cord. 2006;44:357-61.<br />
140. U.S. Food and Drug Administration (FDA). Premarket approval (PMA) database: P900038 PARASTEP-<br />
I, Sigmedics, Inc. Rockville, MD: 1994 Apr 20. Accessed Jul 2, 2011. Available at URL address:<br />
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/P<br />
MAApprovals/ucm119050.htm<br />
141. U.S. Food and Drug Administration (FDA). 510(k) Summary of Safety and Effectiveness K023212. AG<br />
Garments Conductive Electrodes. Dec 13, 2002. Accessed Jul 2, 2011. Available at URL address:<br />
http://www.accessdata.fda.gov/cdrh_docs/pdf2/k023212.pdf<br />
142. U.S. Food and Drug Administration (FDA). 510(k) Summary of Safety and Effectiveness K090052.<br />
Cranial <strong>Electrical</strong> Nerve Stimulator. May 29, 2009. Accessed Jul 5, 2011. Available at URL address:<br />
http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090052.pdf<br />
143. U.S. Food and Drug Administration (FDA). 510(k) Summary of Safety and Effectiveness K010565.<br />
Dynatron STS. Accessed Jul 5, 2011. Available at URL address:<br />
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=3758<br />
144. U.S. Food and Drug Administration (FDA). 510(k) Summary of Safety and Effectiveness. EMS 7500.Mar<br />
24, 2008. Accessed Jun 5, 2011. Available at URL address:<br />
http://www.accessdata.fda.gov/cdrh_docs/pdf8/K080661.pdf<br />
145. U.S. Food and Drug Administration (FDA). 510(k) Summary of Safety and Effectiveness K052025<br />
Percutaneous Urgent PC Neuromodulator System. Oct 17, 2005. Accessed Jul 5, 2011. Available at<br />
URL address: http://www.accessdata.fda.gov/cdrh_docs/pdf5/K052025.pdf<br />
146. U.S. Food and Drug Administration (FDA). 510(k) Summary of Safety and Effectiveness. K022241.<br />
Percutaneous Neuromodulation Therapy (PNT). Sep 11, 2002. Accessed Jul 5, 2011. Available at URL<br />
address: http://www.accessdata.fda.gov/cdrh_docs/pdf2/k022241.pdf<br />
147. U.S. Food and Drug Administration (FDA). 510(k) Summary of Safety and Effectiveness K980333.<br />
ReliefBand ® . Mar 21, 2002. Accessed Jul 5, 2011. Available at URL address:<br />
http://www.accessdata.fda.gov/cdrh_docs/pdf2/K020180.pdf<br />
148. U.S. Food and Drug Administration (FDA). 510(k) Summary of Safety and Effectiveness K090750. RT<br />
300. Aug 5, 2009. Accessed Jul 5, 2011. Available at URL address:<br />
http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090750.pdf<br />
149. U.S. Food and Drug Administration (FDA). 510(k) Summary of Safety and Effectiveness K081255.<br />
Scrambler therapy MC-5A TENS device [Calmare]. Feb 20, 2009. Accessed Jul 5, 2011. Available at<br />
URL address: http://www.accessdata.fda.gov/cdrh_docs/pdf8/K081255.pdf<br />
Page 38 of 41
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