Effects of transforaminal balloon treatment in patients with lumbar foraminal stenosis: A randomized, controlled, double-blind trial

Pain Physician

Volumn 16, Issue 3, 2013, Pages 213-224

  Kim, Sung Hoon ^a   Choi, Woo Jong ^a   Suh, Jeong Hun ^a   Jeon, Sang Ryong ^a   Hwang, Chang Ju ^a   Koh, Won Uk ^a   Lee, Chung ^b   Leem, Jeong Gil ^a   Lee, Sang Chul ^c   Shin, Jin Woo ^a  

^a University of Ulsan College of Medicine   (South Korea)

^b Korea Cancer Center Hospital   (South Korea)

^c Seoul National University Hospital   (South Korea)

Author keywords

Fogarty catheter; Lumbar foraminal stenosis; Neurogenic claudication; Transforaminal balloon treatment

Indexed keywords

ANALGESIC AGENT; STEROID;

AGED; ANALGESIA; BALLOON CATHETER; CLAUDICATION; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; FEMALE; FOGARTY CATHETER; FOLLOW UP; FUNCTIONAL DISEASE; HUMAN; LEG PAIN; LOW BACK PAIN; LUMBAR FORAMINAL STENOSIS; LUMBAR SPINAL STENOSIS; MAJOR CLINICAL STUDY; MALE; OSWESTRY DISABILITY INDEX; RANDOMIZED CONTROLLED TRIAL; REVIEW; TRANSFORAMINAL BALLOON CATHETER; VISUAL ANALOG SCALE;

AGED; AGED, 80 AND OVER; ANGIOPLASTY, BALLOON; DISABILITY EVALUATION; DOUBLE-BLIND METHOD; FEMALE; FLUOROSCOPY; FOLLOW-UP STUDIES; HUMANS; KAPLAN-MEIER ESTIMATE; LUMBOSACRAL REGION; MALE; MIDDLE AGED; OUTCOME ASSESSMENT (HEALTH CARE); PAIN MEASUREMENT; PROSPECTIVE STUDIES; RADICULOPATHY; SPINAL STENOSIS;

EID: 84878397543     PISSN: 15333159     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (53)

1. Atlas SJ, Keller RB, Robson D, Deyo RA, Singer DE. Surgical and nonsurgical management of lumbar spinal stenosis: Four-year outcomes from the Maine lumbar spine study. Spine (Phila Pa 1976) 2000; 25:556-562.
2. Benoist M. The natural history of lumbar degenerative spinal stenosis. Joint Bone Spine 2002; 69:450-457.
3. Benyamin RM, Manchikanti L, Parr AT, Diwan SA, Singh V, Falco FJE, Datta S, Abdi S, Hirsch JA. The effectiveness of lumbar interlaminar epidural injections in managing chronic low back and lower extremity pain. Pain Physician 2012; 15:E363-E404.
4. Parr AT, Manchikanti L, Hameed H, Conn A, Manchikanti KN, Benyamin RM, Diwan S, Singh V, Abdi S. Caudal epidural injections in the management of chronic low back pain: A systematic appraisal of the literature. Pain Physician 2012; 15:E159-E198.
5. Manchikanti L, Buenaventura RM, Manchikanti KN, Ruan X, Gupta S, Smith HS, Christo PJ, Ward SP. Effectiveness of therapeutic lumbar transforaminal epidural steroid injections in managing lumbar spinal pain. Pain Physician 2012; 15:E199-E2456.
6. Manchikanti L, Cash KA, McManus CD, Pampati V. Fluoroscopic caudal epidural injections in managing chronic axial low back pain without disc herniation, radiculitis or facet joint pain. J Pain Res 2012; 5:381-390.
7. Manchikanti L, Singh V, Cash KA, Pampati V, Damron KS, Boswell MV. Effect of fluoroscopically guided caudal epidural steroid or local anesthetic injections in the treatment of lumbar disc herniation and radiculitis: A randomized, controlled, double blind trial with a two-year follow-up. Pain Physician 2012; 15:273-286.
8. Manchikanti L, Singh V, Cash KA, Pampati V, Datta S. Fluoroscopic caudal epidural injections in managing post lumbar surgery syndrome: Two-year results of a randomized, double-blind, active-control trial. Int J Med Sci 2012; 9:582-591.
9. Manchikanti L, Cash KA, McManus CD, Pampati V, Fellows B. Results of 2-year follow-up of a randomized, doubleblind, controlled trial of fluoroscopic caudal epidural injections in central spinal stenosis. Pain Physician 2012; 15: 371-384.
10. Manchikanti L, Singh V, Cash KA, Pampati V, Falco FJE. The role of fluoroscopic interlaminar epidural injections in managing chronic pain of lumbar disc herniation or radiculitis: A randomized, double-blind trial. Pain Pract 2012 Dec. 27. [Epub ahead of print]
11. Manchikanti L, Cash KA, McManus CD, Pampati V, Benyamin R. Fluoroscopic lumbar interlaminar epidural injections in managing chronic lumbar axial or discogenic pain. J Pain Res 2012; 5:301-311.
12. Manchikanti L, Cash KA, McManus CD, Damron KS, Pampati V, Falco FJE. Lumbar interlaminar epidural injections in central spinal stenosis: Preliminary results of a randomized, double-blind, active control trial. Pain Physician 2012; 15:51-63.
13. Manchikanti L, Falco FJE, Singh V, Benyamin RM, Racz GB, Helm II S, Caraway DL, Calodney AK, Snook LT, Smith HS, Gupta S, Ward SP, Grider JS, Hirsch JA. An update of comprehensive evidence-based guidelines for interventional techniques of chronic spinal pain. Part I: Introduction and general considerations. Pain Physician 2013; 16:S1-S48.
14. Manchikanti L, Abdi S, Atluri S, Benyamin RM, Boswell MV, Buenaventura RM, Bryce DA, Burks PA, Caraway DL, Calodney AK, Cash KA, Christo PJ, Cohen SP, Colson J, Conn A, Cordner HJ, Coubarous S, Datta S, Deer TR, Diwan SA, Falco FJE, Fellows B, Geffert SC, Grider JS, Gupta S, Hameed H, Hameed M, Hansen H, Helm II S, Janata JW, Justiz R, Kaye AD, Lee M, Manchikanti KN, McManus CD, Onyewu O, Parr AT, Patel VB, Racz GB, Sehgal N, Sharma M, Simopoulos TT, Singh V, Smith HS, Snook LT, Swicegood J, Vallejo R, Ward SP, Wargo BW, Zhu J, Hirsch JA. An update of comprehensive evidence-based guidelines for interventional techniques of chronic spinal pain: Part II: Guidance and recommendations. Pain Physician 2013; 16:S49-S253.
15. Armon C, Argoff CE, Samuels J, Backonja MM. Assessment: Use of epidural steroid injections to treat radicular lumbosacral pain: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2007; 68:723-729.
16. Fukusaki M, Kobayashi I, Hara T, Sumikawa K. Symptoms of spinal stenosis do not improve after epidural steroid injection. Clin J Pain 1998; 14:148-151.
17. Geisser ME, Haig AJ, Tong HC, Yamakawa KS, Quint DJ, Hoff JT, Miner JA, Phalke VV. Spinal canal size and clinical symptoms among persons diagnosed with lumbar spinal stenosis. Clin J Pain 2007; 23:780-785.
18. Smith CC, Booker T, Schaufele MK, Weiss P. Interlaminar versus transforaminal epidural steroid injections for the treatment of symptomatic lumbar spinal stenosis. Pain Med 2010; 11:1511-1515.
19. Wiltse LL, Kirkaldy-Willis WH, McIvor GW. The treatment of spinal stenosis. Clin Orthop Relat Res 1976:83-91.
20. Botwin KP, Gruber RD. Lumbar epidural steroid injections in the patient with lumbar spinal stenosis. Phys Med Rehabil Clin N Am 2003; 14:121-141.
21. McLain RF, Kapural L, Mekhail NA. Epidural steroid therapy for back and leg pain: Mechanisms of action and efficacy. Spine J 2005; 5:191-201.
22. Parke WW, Watanabe R. The intrinsic vasculature of the lumbosacral spinal nerve roots. Spine (Phila Pa 1976) 1985; 10:508-515.
23. Anderson SR, Racz GB, Heavner J. Evolution of epidural lysis of adhesions. Pain Physician 2000; 3:262-270.
24. Olmarker K, Rydevik B. Pathophysiology of sciatica. Orthop Clin North Am 1991; 22:223-234.
25. Hu SJ, Xing JL. An experimental model for chronic compression of dorsal root ganglion produced by intervertebral foramen stenosis in the rat. Pain 1998; 77:15-23.
26. Helm Ii S, Benyamin RM, Chopra P, Deer TR, Justiz R. Percutaneous adhesiolysis in the management of chronic low back pain in post lumbar surgery syndrome and spinal stenosis: A systematic review. Pain Physician 2012; 15:E435-462.
27. Racz GB, Heavner JE, Trescot A. Percutaneous lysis of epidural adhesions--evidence for safety and efficacy. Pain Pract 2008; 8:277-286.
28. Igarashi T, Hirabayashi Y, Seo N, Saitoh K, Fukuda H, Suzuki H. Lysis of adhesions and epidural injection of steroid/ local anaesthetic during epiduroscopy potentially alleviate low back and leg pain in elderly patients with lumbar spinal stenosis. Br J Anaesth 2004; 93:181-187.
29. Sakai T, Aoki H, Hojo M, Takada M, Murata H, Sumikawa K. Adhesiolysis and targeted steroid/local anesthetic injection during epiduroscopy alleviates pain and reduces sensory nerve dysfunction in patients with chronic sciatica. J Anesth 2008; 22:242-247.
30. Miller LE, Block JE. Interspinous spacer implant in patients with lumbar spinal stenosis: Preliminary results of a multicenter, randomized, controlled trial. Pain Res Treat 2012; 2012:823509.
31. Nandakumar A, Clark NA, Peehal JP, Bilolikar N, Wardlaw D, Smith FW. The increase in dural sac area is maintained at 2 years after X-stop implantation for the treatment of spinal stenosis with no significant alteration in lumbar spine range of movement. Spine J 2010; 10:762-768.
32. Manchikanti L, Cash KA, McManus CD, Pampati V. Assessment of effectiveness of percutaneous adhesiolysis in managing chronic low back pain secondary to lumbar central spinal canal stenosis. Int J Med Sci 2013; 10:50-59.
33. Manchikanti L, Singh V, Cash KA, Pampati V, Datta S. Management of pain of post lumbar surgery syndrome: Oneyear results of a randomized, double double-blind, active controlled trial of fluoroscopic caudal epidural injections. Pain Physician 2010; 13:509-521.
34. Raffaeli W, Righetti D, Andruccioli J, Sarti D. Periduroscopy: General review of clinical features and development of operative models. Acta Neurochir Suppl 2011; 108:55-65.
35. Kim SH, Koh WU, Park SJ, Choi WJ, Suh JH, Leem JG, Park PH, Shin JW. Clinical experiences of transforaminal balloon decompression for patients with spinal stenosis. Korean J Pain 2012; 25:55-59.
36. Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976) 2000; 25:2940-2952; discussion 2952.
37. Tomkins CC, Battie MC, Rogers T, Jiang H, Petersen S. A criterion measure of walking capacity in lumbar spinal stenosis and its comparison with a treadmill protocol. Spine (Phila Pa 1976) 2009; 34:2444-2449.
38. Morishita Y, Hida S, Naito M, Arimizu J, Takamori Y. Neurogenic intermittent claudication in lumbar spinal canal stenosis: The clinical relationship between the local pressure of the intervertebral foramen and the clinical findings in lumbar spinal canal stenosis. J Spinal Disord Tech 2009; 22:130-134.
39. Moon HS, Kim YD, Song BH, Cha YD, Song JH, Lee MH. Position of dorsal root ganglia in the lumbosacral region in patients with radiculopathy. Korean J Anesthesiol 2010; 59:398-402.
40. Rydevik B, Brown MD, Lundborg G. Pathoanatomy and pathophysiology of nerve root compression. Spine (Phila Pa 1976) 1984; 9:7-15.
41. Merrild U, Sogaard I. Sciatica caused by perifibrosis of the sciatic nerve. J Bone Joint Surg Br 1986; 68:706.
42. Kobayashi S, Takeno K, Miyazaki T, Kubota M, Shimada S, Yayama T, Uchida K, Normura E, Mwaka E, Baba H. Effects of arterial ischemia and venous congestion on the lumbar nerve root in dogs. J Orthop Res 2008; 26:1533-1540.
43. Cooper RG, Freemont AJ, Hoyland JA, Jenkins JP, West CG, Illingworth KJ, Jayson MI. Herniated intervertebral discassociated periradicular fibrosis and vascular abnormalities occur without inflammatory cell infiltration. Spine (Phila Pa 1976) 1995; 20:591-598.
44. Dunn AL, Heavner JE, Racz G, Day M. Hyaluronidase: A review of approved formulations, indications and off-label use in chronic pain management. Expert Opin Biol Ther 2010; 10:127-131.
45. Kim SB, Lee KW, Lee JH, Kim MA, Kim BH. The additional effect of hyaluronidase in lumbar interlaminar epidural injection. Ann Rehabil Med 2011; 35:405-411.
46. Yousef AA, AS EL-D, Al-Deeb AE. The role of adding hyaluronidase to fluoroscopically guided caudal steroid and hypertonic saline injection in patients with failed back surgery syndrome: A prospective, double-blinded, randomized study. Pain Pract 2010; 10:548-553.
47. Manchikanti L, Pampati V, Cash KA. Protocol for evaluation of the comparative effectiveness of percutaneous adhesiolysis and caudal epidural steroid injections in low back and/or lower extremity pain without post surgery syndrome or spinal stenosis. Pain Physician 2010; 13:E91-E110.
48. Hammer M, Doleys DM, Chung OY. Transforaminal ventral epidural adhesiolysis. Pain Physician 2001; 4:273-279.
49. Olmarker K, Rydevik B, Holm S, Bagge U. Effects of experimental graded compression on blood flow in spinal nerve roots. A vital microscopic study on the porcine cauda equina. J Orthop Res 1989; 7:817-823.
50. Anthes DL, Theriault E, Tator CH. Characterization of axonal ultrastructural pathology following experimental spinal cord compression injury. Brain Res 1995; 702:1-16.
51. Videman T, Battie MC, Gibbons LE, Maravilla K, Manninen H, Kaprio J. Associations between back pain history and lumbar MRI findings. Spine (Phila Pa 1976) 2003; 28:582-588.
52. Mayhew PD, Kapatkin AS, Wortman JA, Vite CH. Association of cauda equina compression on magnetic resonance images and clinical signs in dogs with degenerative lumbosacral stenosis. J Am Anim Hosp Assoc 2002; 38:555-562.
53. Speciale AC, Pietrobon R, Urban CW, Richardson WJ, Helms CA, Major N, Enterline D, Hey L, Haglund M, Turner DA. Observer variability in assessing lumbar spinal stenosis severity on magnetic resonance imaging and its relation to cross-sectional spinal canal area. Spine (Phila Pa 1976) 2002; 27:1082-1086.