Estudio demuestra la eficacia de la terapia PEMF en la reducción del dolor crónico lumbar
Un estudio científico diseñado para 45 pacientes con dolor crónico post operatorio de cirugía lumbar, demostró que la terapia PEMF en un ancho de pulso de 42 μs disminuyó el dolor en un 40,2%. Los datos se tomaron comparando dispositivos simulados (placebo) vs un dispositivo PEMF aprobado por la FDA. También se utilizaron 2 diferentes ancho de pulsos para comprobar la efectividad de uno vs otro.
Resumen:
La incidencia de dolor posoperatorio crónico después de la cirugía de la columna lumbar ha aumentado con el aumento general de la prevalencia de la cirugía lumbar. Este estudio se realizó para evaluar la eficacia analgésica de la terapia de campo electromagnético pulsado (PEMF) en sujetos con dolor persistente después de la cirugía lumbar.
Introducción
En los EE. UU., se ha estimado que más de 80 000 personas por año experimentan dolor crónico y/o complicaciones después de una cirugía de espalda.
Por lo general se utilizan tratamientos conservadores y o minimamente invasivas para reducir el dolor.
Dentro de los enfoques alternativos para el tratamiento del dolor crónico asociado con la FBSS entra la terapia de campo magnético pulsado (PEMF).
En el caso del dispositivo PEMF utilizado en el ensayo actual, se utiliza una frecuencia portadora (27,12 MHz). Lo más probable es que los efectos biológicos que utilizan este enfoque ocurran a través de la inducción de corriente eléctrica dentro del tejido.
“El tratamiento se administró dos veces al día durante un período de 60 días. El estudio se realizó en 13 sitios en los EE. UU. y fue diseñado para inscribir a 45 pacientes.” El estudio fue aprobado por un comité de ética pertenenciente a cada estado.
Población de estudio
Los criterios de inclusión del estudio fueron una Cirugía lumbar anatómicamente exitosa y Dolor persistente en la región lumbar durante más o igual de 3 meses y menos de 36 meses.
Los dispositivos simulados eran idénticos a los dispositivos PEMF solo que los primeros estaban desactivados. También se probaron dos tipos de ancho de pulso: 42 μs y 38 μs. Las puntuaciones en el primer grupo disminuyeron el dolor en un 40.2% en comparación con el segundo grupo, que fue de un 18.6%.
Referencias que figuran en el estudio:
1. Ragab A, Deshazo RD. Management of back pain in patients with previous back surgery. Am J Med. 2008;121(4):272–278. [PubMed] [Google Scholar]
2. Baber Z, Erdek MA. Failed back surgery syndrome: current perspectives. J Pain Res. 2016;9:979–987. eCollection 2016. [PMC free article] [PubMed] [Google Scholar]
3. Chan CW, Peng P. Failed back surgery syndrome. Pain Med. 2011;12(4):577–606. [PubMed] [Google Scholar]
4. Rigoard P, Desai MJ, Taylor RS. Failed back surgery syndrome: what’s in a name? A proposal to replace “FBSS” by “POPS” Neurochirurgie. 2015;61(Suppl 1):S16–S21. [PubMed] [Google Scholar]
5. Hussain A, Erdek M. Interventional pain management for failed back surgery syndrome. Pain Pract. 2014;14(1):64–78. [PubMed] [Google Scholar]
6. Assaker R, Zairi F. Failed back surgery syndrome: to re-operate or not to re-operate? A retrospective review of patient selection and failures. Neurochirurgie. 2015;61(Suppl 1):S77–S82. [PubMed] [Google Scholar]
7. Bordoni B, Marelli F. Failed back surgery syndrome: review and new hypotheses. J Pain Res. 2016;9:17–22. [PMC free article] [PubMed] [Google Scholar]
8. Vleggeert-Lankamp CL, Arts MP, Jacobs WCh, Peul WC. Failed back (surgery) syndrome: time for a paradigm shift. Br J Pain. 2013;7(1):48–55. [PMC free article] [PubMed] [Google Scholar]
9. Kumar K, North R, Taylor R, et al. Spinal cord stimulation vs. conventional medical management: a prospective, randomized, controlled, multicenter study of patients with failed back surgery syndrome (PROCESS study) Neuromodulation. 2005;8(4):213–218. [PubMed] [Google Scholar]
10. Leveque JC, Villavicencio AT, Bulsara KR, Rubin L, Gorecki JP. Spinal cord stimulation for failed back surgery syndrome. Neuromodulation. 2001;4(1):1–9. [PubMed] [Google Scholar]
11. North RB, Ewend MG, Lawton MT, Kidd DH, Piantadosi S. Failed back surgery syndrome: 5-year follow-up after spinal cord stimulator implantation. Neurosurgery. 1991;28(5):692–699. [PubMed] [Google Scholar]
12. Blond S, Mertens P, David R, Roulaud M, Rigoard P. From “mechanical” to “neuropathic” back pain concept in FBSS patients. A systematic review based on factors leading to the chronification of pain (part C) Neurochirurgie. 2015;61(Suppl 1):S45–S56. [PubMed] [Google Scholar]
13. Rigoard P, Assaker R. Failed back surgery syndrome: from pathophysiology to recent therapeutic advances in neurostimulation – introduction. Neurochirurgie. 2015;61(Suppl 1):S5. [PubMed] [Google Scholar]
14. Rajaee SS, Bae HW, Kanim LE, Delamarter RB. Spinal fusion in the United States: analysis of trends from 1998 to 2008. Spine (Phila Pa 1976) 2012;37(1):67–76. [PubMed] [Google Scholar]
15. Haanpää ML, Gourlay GK, Kent JL, et al. Treatment considerations for patients with neuropathic pain and other medical comorbidities. Mayo Clin Proc. 2010;85(3 Suppl):S15–S25. [PMC free article] [PubMed] [Google Scholar]
16. Lee M, Silverman SM, Hansen H, Patel VB, Manchikanti L. A comprehensive review of opioid-induced hyperalgesia. Pain Physician. 2011;14(2):145–161. [PubMed] [Google Scholar]
17. Manchikanti L, Benyamin R, Datta S, Vallejo R, Smith H. Opioids in chronic noncancer pain. Expert Rev Neurother. 2010;10(5):775–789. [PubMed] [Google Scholar]
18. Chou R, Huffman LH. Guideline for the Evaluation and Management of Low Back Pain: Evidence Review. Glenview, IL: American Pain Society; 2007. [Google Scholar]
19. Sirohi S, Tiwari AK. Pain in the management of opioid use disorder. J Pain Res. 2016;9:963–966. eCollection 2016. [PMC free article] [PubMed] [Google Scholar]
20. Grider JS, Manchikanti L, Carayannopoulos A, et al. Effectiveness of spinal cord stimulation in chronic spinal pain: a systematic review. Pain Physician. 2016;19(1):E33–E54. [PubMed] [Google Scholar]
21. Verrills P, Sinclair C, Barnard A. A review of spinal cord stimulation systems for chronic pain. J Pain Res. 2016;9:481–492. [PMC free article] [PubMed] [Google Scholar]
22. Harper WL, Schmidt WK, Kubat NJ, Isenberg RA. An open-label pilot study of pulsed electromagnetic field therapy in the treatment of failed back surgery syndrome pain. Int Med Case Rep J. 2014;8:13–22. [PMC free article] [PubMed] [Google Scholar]
23. Guo L, Kubat NJ, Isenberg RA. Pulsed radio frequency energy (PRFE) use in human medical applications. Electromagn Biol Med. 2011;30(1):21–45. [PubMed] [Google Scholar]
24. Malmivuo J, Plonsey R. Electric and magnetic stimulation of neural tissue. In: Malmivuo J, Plonsey R, editors. Bioelectromagnetism: Principles and Applications of Bioelectric and Biomagnetic Fields. New York: Oxford University Press; 1995. pp. 363–380. [Google Scholar]
25. Guo L, Kubat NJ, Nelson TR, Isenberg RA. Meta-analysis of clinical efficacy of pulsed radio frequency energy treatment. Ann Surg. 2012;255(3):457–467. [PubMed] [Google Scholar]
26. Farrar JT, Polomano RC, Berlin JA, Strom BL. A comparison of change in the 0–10 numeric rating scale to a pain relief scale and global medication performance scale in a short-term clinical trial of breakthrough pain intensity. Anesthesiology. 2010;112(6):1464–1472. [PMC free article] [PubMed] [Google Scholar]
27. Farrar JT, Young JP, Jr, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94(2):149–158. [PubMed] [Google Scholar]
28. Pruessner JC, Kirschbaum C, Meinlschmid G, Hellhammer DH. Two formulas for computation of the area under the curve represent measures of total hormone concentration versus time-dependent change. Psychoneuroendocrinology. 2003;28(7):916–931. [PubMed] [Google Scholar]
29. Dworkin RH, Turk DC, Wyrwich KW, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008;9(2):105–121. [PubMed] [Google Scholar]
30. Scott W, McCracken LM. Patients’ impression of change following treatment for chronic pain: global, specific, a single dimension, or many? J Pain. 2015;16(6):518–526. [PubMed] [Google Scholar]
31. Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976) 2000;25(22):2940–2952. discussion 2952. [PubMed] [Google Scholar]
32. Beck AT, Ward CH, Mendelson M, Mock J, Erbaugh J. An inventory for measuring depression. Arch Gen Psychiatry. 1961;4:561–571. [PubMed] [Google Scholar]
33. Park CH, Lee SH. Investigation of high-sensitivity C-reactive protein and erythrocyte sedimentation rate in low back pain patients. Korean J Pain. 2010;23(2):147–150. [PMC free article] [PubMed] [Google Scholar]
34. Rathod TN, Chandanwale A, Ladkat KM, Chavan S, Chavan A, Bhosale PB. High sensitive C-reactive protein-effective tool in determining postoperative recovery in lumbar disc disease. Indian J Orthop. 2014;48(4):354–359. [PMC free article] [PubMed] [Google Scholar]
35. Hayek SM, Helm S, Benyamin RM, Singh V, Bryce DA, Smith HS. Effectiveness of spinal endoscopic adhesiolysis in post lumbar surgery syndrome: a systematic review. Pain Physician. 2009;12(2):419–435. [PubMed] [Google Scholar]
36. Markman JD, Kress BT, Frazer M, Hanson R, Kogan V, Huang JH. Screening for neuropathic characteristics in failed back surgery syndromes: challenges for guiding treatment. Pain Med. 2015;16(3):520–530. [PubMed] [Google Scholar]
37. Brody H. Placebos and the Philosophy of Medicine: Clinical, Conceptual, and Ethical Issues. Chicago, IL: University of Chicago Press; 1980. [Google Scholar]
38. Conrad R. The hardest thing to see is what is in front of your eyes – quo vadis placebo analgesia? J Pain Res. 2016;9:819–823. eCollection 2016. [PMC free article] [PubMed] [Google Scholar]
39. Vase L, Petersen GL, Riley JL, 3rd, Price DD. Factors contributing to large analgesic effects in placebo mechanism studies conducted between 2002 and 2007. Pain. 2009;145:1–2. 36–44. [PubMed] [Google Scholar]
40. Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965;150(3699):971–979. [PubMed] [Google Scholar]
41. Moayedi M, Davis KD. Theories of pain: from specificity to gate control. J Neurophysiol. 2013;109(1):5–12. [PubMed] [Google Scholar]
42. Kubat NJ, Moffett J, Fray LM. Effect of pulsed electromagnetic field treatment on programmed resolution of inflammation pathway markers in human cells in culture. J Inflamm Res. 2015;8:59–69. [PMC free article] [PubMed] [Google Scholar]
43. Moffett J, Fray LM, Kubat NJ. Activation of endogenous opioid gene expression in human keratinocytes and fibroblasts by pulsed radiofrequency energy fields. J Pain Res. 2012;5:347–357. [PMC free article] [PubMed] [Google Scholar]
44. Shanthanna H, Chan P, McChesney J, Paul J, Thabane L. Assessing the effectiveness of ‘pulse radiofrequency treatment of dorsal root ganglion’ in patients with chronic lumbar radicular pain: study protocol for a randomized control trial. Trials. 2012;(13):52. [PMC free article] [PubMed] [Google Scholar]
45. Tilley DM, Cedeño DL, Kelley CA, Benyamin R, Vallejo R. Spinal cord stimulation modulates gene expression in the spinal cord of an animal model of peripheral nerve injury. Reg Anesth Pain Med. 2016;41(6):750–756. [PubMed] [Google Scholar]
46. Vallejo R, Tilley DM, Cedeño DL, Kelley CA, DeMaegd M, Benyamin R. Genomics of the effect of spinal cord stimulation on an animal model of neuropathic pain. Neuromodulation. 2016;19(6):576–586. [PubMed] [Google Scholar]
47. Kumar K, Taylor RS, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain. 2007;132:1–2. 179–188. [PubMed] [Google Scholar]
48. North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery. 2005;56(1):98–106. discussion 106–107. [PubMed] [Google Scholar]
49. Kapural L, van Buyten JP, Verrills P. Response: high frequency (10 kHz) or burst spinal cord stimulation in failed back surgery syndrome patients with predominant back pain: preliminary data from a prospective observational study. Neuromodulation. 2016;19(7):787. [PubMed] [Google Scholar]
50. Kumar K, Hunter G, Demeria D. Spinal cord stimulation in treatment of chronic benign pain: challenges in treatment planning and present status, a 22-year experience. Neurosurgery. 2006;58(3):481–496. discussion 481–496. [PubMed] [Google Scholar]
51. Tennant F, Sajben N, Mack J, Stall RS. Interpreting indications for electromagnetic therapy. Pract Pain Manag. 2013;13(5):6–7. Consensus Statement [Google Scholar]