Transforaminal Epidural Steroid Injection With Pulsed Radiofrequency for Chronic Lumbosacral Radicular Pain Management

Summary

The purpose of this study is to examine the potential changes in levels of pain, quality of life (QoL) and activities of daily living (ADL) observed when transforaminal epidural steroid injection is administered in conjunction with pulsed radiofrequency treatment of the lumbar dorsal root ganglion during the initial 3 months follow-up period. Safety (monitoring side effects) of the treatment is determined. The study hypothesis is that the application of transforaminal epidural steroid injection (TFESI) in conjunction with pulsed radiofrequency treatment (PRF) treatment of the lumbar dorsal root ganglion would increase the treatment response of PRF and thereby provide a measurable difference in the pain scores, quality of life and activities of daily living for the patients suffering from chronic lumbosacral radicular pain.

Timeline

Start

2016-10

Primary completion

2017-10

Completion

2018-10

Publications

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• Background Vallejo R, Tilley DM, Williams J, Labak S, Aliaga L, Benyamin RM. Pulsed radiofrequency modulates pain regulatory gene expression along the nociceptive pathway. Pain Physician. 2013 Sep-Oct;16(5):E601-13.
• Background Wu B, Ni J, Zhang C, Fu P, Yue J, Yang L. Changes in spinal cord met-enkephalin levels and mechanical threshold values of pain after pulsed radio frequency in a spared nerve injury rat model. Neurol Res. 2012 May;34(4):408-14. doi: 10.1179/1743132812Y.0000000026.
• Background 11. Sluijter ME, Cosman ER, Rittman IIWB, van Kleef M. The effects of pulsed radiofrequency field applied to the dorsal root ganglion-A preliminary report. The Pain Clinic 1998;11(2):109-17.
• Background Munglani R. The longer term effect of pulsed radiofrequency for neuropathic pain. Pain. 1999 Mar;80(1-2):437-9. doi: 10.1016/s0304-3959(98)00183-3.
• Background Teixeira A, Grandinson M, Sluijter ME. Pulsed radiofrequency for radicular pain due to a herniated intervertebral disc--an initial report. Pain Pract. 2005 Jun;5(2):111-5. doi: 10.1111/j.1533-2500.2005.05207.x.
• Background Abejon D, Garcia-del-Valle S, Fuentes ML, Gomez-Arnau JI, Reig E, van Zundert J. Pulsed radiofrequency in lumbar radicular pain: clinical effects in various etiological groups. Pain Pract. 2007 Mar;7(1):21-6. doi: 10.1111/j.1533-2500.2007.00105.x.
• Background Simopoulos TT, Kraemer J, Nagda JV, Aner M, Bajwa ZH. Response to pulsed and continuous radiofrequency lesioning of the dorsal root ganglion and segmental nerves in patients with chronic lumbar radicular pain. Pain Physician. 2008 Mar-Apr;11(2):137-44.
• Background Chao SC, Lee HT, Kao TH, Yang MY, Tsuei YS, Shen CC, Tsou HK. Percutaneous pulsed radiofrequency in the treatment of cervical and lumbar radicular pain. Surg Neurol. 2008 Jul;70(1):59-65; discussion 65. doi: 10.1016/j.surneu.2007.05.046. Epub 2008 Jan 22.
• Background Shabat S, Pevsner Y, Folman Y, Gepstein R. Pulsed radiofrequency in the treatment of patients with chronic neuropathic spinal pain. Minim Invasive Neurosurg. 2006 Jun;49(3):147-9. doi: 10.1055/s-2006-944238.
• Background Pevzner E, David R, Leitner Y, Pekarsky I, Folman Y, Gepstein R. [Pulsed radiofrequency treatment of severe radicular pain]. Harefuah. 2005 Mar;144(3):178-80, 231. Hebrew.
• Background Leung SM, Chau WW, Law SW, Fung KY. Clinical value of transforaminal epidural steroid injection in lumbar radiculopathy. Hong Kong Med J. 2015 Oct;21(5):394-400. doi: 10.12809/hkmj144310. Epub 2015 Aug 14.
• Background Bateman BT, Brenner GJ. An important step forward in the safe use of epidural steroid injections. Anesthesiology. 2015 May;122(5):964-6. doi: 10.1097/ALN.0000000000000615. No abstract available.
• Background Rathmell JP, Benzon HT, Dreyfuss P, Huntoon M, Wallace M, Baker R, Riew KD, Rosenquist RW, Aprill C, Rost NS, Buvanendran A, Kreiner DS, Bogduk N, Fourney DR, Fraifeld E, Horn S, Stone J, Vorenkamp K, Lawler G, Summers J, Kloth D, O'Brien D Jr, Tutton S. Safeguards to prevent neurologic complications after epidural steroid injections: consensus opinions from a multidisciplinary working group and national organizations. Anesthesiology. 2015 May;122(5):974-84. doi: 10.1097/ALN.0000000000000614.
• Background Racoosin JA, Seymour SM, Cascio L, Gill R. Serious Neurologic Events after Epidural Glucocorticoid Injection--The FDA's Risk Assessment. N Engl J Med. 2015 Dec 10;373(24):2299-301. doi: 10.1056/NEJMp1511754. Epub 2015 Oct 7. No abstract available.
• Background Kennedy DJ, Levin J, Rosenquist R, Singh V, Smith C, Stojanovic MP, Vorobeychik Y. Epidural Steroid Injections are Safe and Effective: Multisociety Letter in Support of the Safety and Effectiveness of Epidural Steroid Injections. Pain Med. 2015 May;16(5):833-8. doi: 10.1111/pme.12667. Epub 2015 Jan 13.
• Background Bhargava A, DePalma MJ, Ludwig S, Gelb D, Slipman CW. Injection therapy for lumbar radiculopathy.Curr OpinOrthop 2005;16:152-7
• Background Abdi S, Datta S, Trescot AM, Schultz DM, Adlaka R, Atluri SL, Smith HS, Manchikanti L. Epidural steroids in the management of chronic spinal pain: a systematic review. Pain Physician. 2007 Jan;10(1):185-212.

Drugs

Indications