Short Communication

Transforaminal epidural steroid injection for radiculopathy and the evolution to surgical treatment: a pragmatic prospective observational multicenter study

*Author for correspondence:

E-mail Address: vincent.raymaekers@gmail.be

https://orcid.org/0000-0003-2874-8654

Department of Neurosurgery, Antwerp University Hospital, Antwerp, Belgium

Faculty of Medicine & Health Sciences, University of Antwerp, Antwerp, 2650, Belgium

Faculty of Medicine & Life Science, Hasselt University, Hasselt, 3500, Belgium

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Gert Roosen

Studie- & opleidingcentrum Neurochirurgie Virga Jesse, Hasselt, 3500, Belgium

Department of Neurosurgery Jessa Hospital, Hasselt, 3500, Belgium

Department of Neurosurgery St. Trudo Hospital, Sint-Truiden, 3800, Belgium

Department of Neurosurgery St. Franciscus Hospital, Heusden-Zolder, 3550, Belgium

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Eric Put

Studie- & opleidingcentrum Neurochirurgie Virga Jesse, Hasselt, 3500, Belgium

Department of Neurosurgery Jessa Hospital, Hasselt, 3500, Belgium

Department of Neurosurgery St. Trudo Hospital, Sint-Truiden, 3800, Belgium

Department of Neurosurgery St. Franciscus Hospital, Heusden-Zolder, 3550, Belgium

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Steven Vanvolsem

Studie- & opleidingcentrum Neurochirurgie Virga Jesse, Hasselt, 3500, Belgium

Department of Neurosurgery Jessa Hospital, Hasselt, 3500, Belgium

Department of Neurosurgery St. Trudo Hospital, Sint-Truiden, 3800, Belgium

Department of Neurosurgery St. Franciscus Hospital, Heusden-Zolder, 3550, Belgium

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Salah-Eddine Achahbar

Department of Neurosurgery Jessa Hospital, Hasselt, 3500, Belgium

Department of Neurosurgery St. Trudo Hospital, Sint-Truiden, 3800, Belgium

Department of Neurosurgery St. Franciscus Hospital, Heusden-Zolder, 3550, Belgium

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Sacha Meeuws

Department of Neurosurgery Jessa Hospital, Hasselt, 3500, Belgium

Department of Neurosurgery St. Trudo Hospital, Sint-Truiden, 3800, Belgium

Department of Neurosurgery St. Franciscus Hospital, Heusden-Zolder, 3550, Belgium

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Maarten Wissels

Studie- & opleidingcentrum Neurochirurgie Virga Jesse, Hasselt, 3500, Belgium

Department of Neurosurgery Jessa Hospital, Hasselt, 3500, Belgium

Department of Neurosurgery St. Trudo Hospital, Sint-Truiden, 3800, Belgium

Department of Neurosurgery St. Franciscus Hospital, Heusden-Zolder, 3550, Belgium

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Sven Bamps

Faculty of Medicine & Life Science, Hasselt University, Hasselt, 3500, Belgium

Studie- & opleidingcentrum Neurochirurgie Virga Jesse, Hasselt, 3500, Belgium

Department of Neurosurgery Jessa Hospital, Hasselt, 3500, Belgium

Department of Neurosurgery St. Trudo Hospital, Sint-Truiden, 3800, Belgium

Department of Neurosurgery St. Franciscus Hospital, Heusden-Zolder, 3550, Belgium

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Dirk De Ridder

Department of Surgical Sciences, Section of Neurosurgery, Dunedin School of Medicine, University of Otago, Dunedin, 9016, New Zealand

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Tomas Menovsky

Department of Neurosurgery, Antwerp University Hospital, Antwerp, Belgium

Faculty of Medicine & Health Sciences, University of Antwerp, Antwerp, 2650, Belgium

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Mark Plazier

Faculty of Medicine & Life Science, Hasselt University, Hasselt, 3500, Belgium

Studie- & opleidingcentrum Neurochirurgie Virga Jesse, Hasselt, 3500, Belgium

Department of Neurosurgery Jessa Hospital, Hasselt, 3500, Belgium

Department of Neurosurgery St. Trudo Hospital, Sint-Truiden, 3800, Belgium

Department of Neurosurgery St. Franciscus Hospital, Heusden-Zolder, 3550, Belgium

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Published Online:5 Mar 2024https://doi.org/10.2217/pmt-2023-0121

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Abstract

Aim: The aim of this study is to analyze the real-world outcomes of transforaminal epidural steroid injections (TFESIs) in all patients with radiculopathy and their long-term outcomes. Methods: Patients with radiculopathy and failure of conservative treatment were included in a prospective, multicenter, observational cohort study. Results: In total, 117 patients were treated with one or two TFESIs. The mean duration of follow-up was 116 (±14) weeks. In total 19,6% (95% CI: 12.9–28.0%) patients were treated with surgery after insufficient symptom improvement. The evolution to surgery was not associated with etiology, symptom duration or previous spine surgery. Conclusion: Real-world data confirms that TFESIs is an effective treatment with satisfactory results in about 80% of patients for a period of 2 years.

Plain language summary

This study focusses on evaluating the real-world effectiveness of transforaminal epidural steroid injections (TFESIs) in treating radiculopathy, a condition characterized by back and leg pain due to compressed spinal nerves. This nerve compression can originate from different problems.

A total of 117 patients with radiating leg pain were included in this study. The infiltrations were administered, and the primary outcome was the need for spinal surgery within 2 years. The findings revealed that approximately 20% of patients eventually required surgery due to unsatisfactory results after injections. However, for patients with satisfactory outcomes, there was a notable reduction in back and leg pain, disability and pain medication usage, along with an improved quality of life.

Importantly, the results suggested that TFESIs could be considered as a treatment option in daily clinical practice, also after a prolonged duration of symptoms.

Despite certain limitations, such as the absence of a control group undergoing immediate surgical treatment, the real-world data supported the effectiveness of TFESIs in treating radiculopathy. This information provides valuable insights for spine surgeons and pain physicians in understanding the prognosis of TFESIs across diverse patient scenarios.

Tweetable abstract

The current real-world evidence shows that TFESIs are effective in about 80% of patients for a period of 2 years. The evolution to surgery seems not to be associated with etiology, symptom duration or previous spine surgery.

Keywords:

Papers of special note have been highlighted as: • of interest; •• of considerable interest

References

1. Tarulli AW, Raynor EM. Lumbosacral radiculopathy. Neurol. Clin. 25(2), 387–405 (2007).
MedlineGoogle Scholar
2. Guinto FC Jr, Hashim H, Stumer M. CT demonstration of disk regression after conservative therapy. AJNR Am. J. Neuroradiol. 5(5),632–633 (1984).
Google Scholar
3. Kesikburun B, Eksioglu E, Turan A et al. Spontaneous regression of extruded lumbar disc herniation: correlation with clinical outcome. Pakistan J. Med. Sci. 35, 974–980 (2019).
Google Scholar
4. Benson RT, Tavares SP, Robertson SC et al. Conservatively treated massive prolapsed discs: a 7-year follow-up. Ann. R. Coll. Surg. Engl. 92(2), 147–153 (2010).
CASGoogle Scholar
5. Oliveira CB, Maher CG, Ferreira ML et al. Epidural corticosteroid injections for sciatica: an abridged cochrane systematic review and meta-analysis. Spine (Phila Pa 1976). 45(21), E1405–E1415 (2020).
Google Scholar
6. Helm Ii S, Harmon PC, Noe C et al. Transforaminal epidural steroid injections: a systematic review and meta-analysis of efficacy and safety. Pain Phys. 24(S1), S209–S232 (2021).
Google Scholar
7. Buenaventura RM, Datta S, Abdi S et al. Systematic review of therapeutic lumbar transforaminal epidural steroid injections. Pain Phys. 12(1), 233–251 (2021).
Google Scholar
8. Shaikh H, Kumar A, Kishen TJ. Temporal pattern of pain and disability following the administration of a selective nerve root block in lumbar disc herniation with radiculopathy. Int. J. Spine Surg. 15(6),1090 (2021).
Google Scholar
9. Jonckheer Pascale, Desomer Anja, Depreitere Bart et al. Lage rugpijn en radiculaire pijn: kernelementen van een zorgpad. Brussel: Federaal Kenniscentrum voor de Gezondheidszorg (KCE); (2017). • The Belgian care pathway for radiculopathy
Google Scholar
10. Manchikanti L, Knezevic E, Knezevic NN et al. Epidural injections for lumbar radiculopathy or sciatica: a comparative systematic review and meta-analysis of Cochrane review. Pain Phys. 24(5), E539–E554 (2021). •• The Cochrane review evaluating the effectiveness of transforaminal epidural steroid injections.
Google Scholar
11. Riew KD, Yin Y, Gilula L et al. The effect of nerve-root injections on the need for operative treatment of lumbar radicular pain: a prospective, randomized, controlled, double-blind study*. JBJS 82(11), 1589–1593 (2000).
CASGoogle Scholar
12. Ghahreman A, Ferch R, Bogduk N. The efficacy of transforaminal injection of steroids for the treatment of lumbar radicular pain. Pain Med. 11(8), 1149–1168 (2010).
Google Scholar
13. Wilby MJ, Best A, Wood E et al. Surgical microdiscectomy versus transforaminal epidural steroid injection in patients with sciatica secondary to herniated lumbar disc (NERVES): a Phase III, multicentre, open-label, randomised controlled trial and economic evaluation. Lancet Rheumatol. 3(5), e347–e356 (2021).
CASGoogle Scholar
14. Sullivan MJL, Bishop SR, Pivik J. The pain catastrophizing scale: development and validation. Psych. Assessment 7(4), 524–532 (1995).
Google Scholar
15. McCracken LM. “Attention” to pain in persons with chronic pain: a behavioral approach. Behav. Ther. 28(2), 271–284 (1997).
Google Scholar
16. Roelofs J, Peters ML, Muris P et al. Dutch version of the pain vigilance and awareness questionnaire: validity and reliability in a pain-free population. Behav. Res. Ther. 40(9), 1081–1090 (2002).
CASGoogle Scholar
17. Fairbank JCT, Pynsent PB. The Oswestry disability index. Spine 25(22):2940–2953 (2000).
Medline CASGoogle Scholar
18. Cleemput I. A social preference valuations set for EQ-5D health states in Flanders, Belgium. European J. Health Econ. 11(2), 205–213 (2010).
MedlineGoogle Scholar
19. Kelly AM. The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg. Med. J. 18(3), 205 (2001).
Medline CASGoogle Scholar
20. Ostelo RWJG, de Vet HCW. Clinically important outcomes in low back pain. Best Pract. Res. Clin. Rheumatol. 19(4), 593–607 (2005).
MedlineGoogle Scholar
21. Copay AG, Glassman SD, Subach BR et al. Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire Short Form 36, and Pain Scales. Spine J. 8(6), 968–974 (2008).
MedlineGoogle Scholar
22. Vad VB, Bhat AL, Lutz GE et al. Transforaminal epidural steroid injections in lumbosacral radiculopathy: a prospective randomized study. Spine (Phila Pa 1976). 27(1), 11–16 (2002).
MedlineGoogle Scholar
23. Franklin JM, Pawar A, Martin D et al. Nonrandomized real-world evidence to support regulatory decision making: process for a randomized trial replication project [https://doi.org/10.1002/cpt.1633]. Clin. Pharmacol. Therap. 107(4), 817–826 (2020).
MedlineGoogle Scholar
24. Dal-Ré R, Janiaud P, Ioannidis JPA. Real-world evidence: how pragmatic are randomized controlled trials labeled as pragmatic? BMC Med. 16(1), 49 (2018). •• Emphasizes the importance of real-world evidence in daily practice.
MedlineGoogle Scholar
25. Beaulieu-Jones BK, Finlayson SG, Yuan W et al. Examining the use of real-world evidence in the regulatory process [https://doi.org/10.1002/cpt.1658]. Clin. Pharmacol. Therap. 107(4), 843–852 (2020). •• Emphasizes the importance of real-world evidence in daily practice.
MedlineGoogle Scholar
26. Raymaekers V, Bamps S, Duyvendak W et al. Real world data collection and cluster analysis in patients with sciatica due to lumbar disc herniation. Clin. Neurol. Neurosurg. 217, 107246 (2002).
Google Scholar
27. Sariyildiz MA, Batmaz İ, Yazmalar L et al. The effectiveness of transforaminal epidural steroid injections on radicular pain, functionality, psychological status and sleep quality in patients with lumbar disc herniation. J. Back Musculoskelet. Rehabil. 30(2), 265–270 (2017).
Google Scholar
28. Sabourin S, Tram J, Sheldon BL et al. Defining minimal clinically important differences in pain and disability outcomes of patients with chronic pain treated with spinal cord stimulation. J. Neurosurg. Spine 1–8 (2021). doi: 10.3171/2020.11.SPINE201431
Google Scholar
29. Lutz GE, Vad VB, Wisneski RJ. Fluoroscopic transforaminal lumbar epidural steroids: an outcome study. Arch. Phys. Med. Rehabil. 79(11):1362–1366 (1998).
CASGoogle Scholar
30. Taskaynatan MA, Tezel K, Yavuz F et al. The effectiveness of transforaminal epidural steroid injection in patients with radicular low back pain due to lumbar disc herniation two years after treatment. J. Back Musculoskelet. Rehabil. 28(3), 447–451. doi: 10.3233/bmr-140539 (2015).
MedlineGoogle Scholar
31. Wang JC, Lin E, Brodke DS et al. Epidural injections for the treatment of symptomatic lumbar herniated discs. J. Spinal Disord. Tech. 15(4), 269–272 (2002).
CASGoogle Scholar
32. Manson NA, McKeon MD, Abraham EP. Transforaminal epidural steroid injections prevent the need for surgery in patients with sciatica secondary to lumbar disc herniation: a retrospective case series. Can. J. Surg. 56(2), 89–96 (2013).
Google Scholar
33. Rosenberg SK, Grabinsky A, Kooser C et al. Effectiveness of transforaminal epidural steroid injections in low back pain: a one year experience. Pain Phys. 5(3), 266–270 (2002).
Google Scholar
34. Kovarsky D, Shani A, Rod A et al. Effectiveness of intra-venous steroids for preventing surgery for lumbo-sacral radiculopathy secondary to intervertebral disc herniation: a retrospective study of 213 patients. Sci. Reports 12(1), 6681 (2022).
CASGoogle Scholar
35. Arden NK, Price C, Reading I et al. A multicentre randomized controlled trial of epidural corticosteroid injections for sciatica: the WEST study. Rheumatology (Oxford). 44(11), 1399–1406 (2005).
CASGoogle Scholar
36. Murthy NS, Geske JR, Shelerud RA et al. The effectiveness of repeat lumbar transforaminal epidural steroid injections. Pain Med. 15(10), 1686–1694 (2014).
Google Scholar

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History

Received 19 April 2023

Accepted 7 September 2023

Published online 5 March 2024

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Keywords

Author contributions

All authors contributed to the study conception and design and data collection. Data analysis and interpretation were performed by V Raymaekers, M Plazier and DD Ridder. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Financial disclosure

This investigator-initiated study is part of a prospective big data collection in spinal pathology, supported by Medtronic Inc (grant number: NM-3422). Europe. Medtronic was not involved in the collection and analysis of the data, nor in writing the article. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Competing interests disclosure

The authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Writing disclosure

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they obtained verbal informed consent from the patient/patients for the inclusion of their medical and treatment history within this case report, which was written afterwards on the Back-App for data collection.

Data sharing statement

The authors certify that this manuscript reports original clinical trial data. The data will not be made available.

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