SPINE Volume 34, Number 14, pp 1441–1447 ©2009, Lippincott Williams & Wilkins Efficacy of Steroid and Nonsteroid Caudal Epidural Injections for Low Back Pain and Sciatica A Prospective, Randomized, Double-Blind Clinical Trial Fares E. Sayegh, MD, Eustathios I. Kenanidis, MD, Kyriakos A. Papavasiliou, MD, Michael E. Potoupnis, MD, John M. Kirkos, MD, and George A. Kapetanos, MD Study Design. Prospective, double-blind, randomized, case-control study. Objective. To evaluate the efficacy of caudal epidural injections (CEI) containing steroid versus nonsteroid preparations when treating patients suffering from low back pain (LBP) and sciatica. Summary of Background Data. Literature seems to be deprived of well-designed randomized, controlled studies that evaluate the effectiveness of CEI in the treatment of chronic LBP; hence the value of CEI remains still the sub- ject of controversy. Methods. Patients suffering from severe chronic LBP and sciatica were randomly allocated into 2 groups. Ste- roid-group’s patients (n = 93) underwent CEI containing 12 mL of xylocaine 2% and 1 mL of betamethasone dipro- pionate and betamethasone phosphate (2 + 5) mg/dL. Water for Injection (WFI)-group’s patients (n = 90) under- went CEI containing 12 mL of xylocaine 2% and 8 mL of WFI. Both groups were statistically comparable as far as their demographic data and the cause and duration of symptoms were concerned. Patients answered the Oswe- stry Disability Index questionnaire and underwent physical examination, before and at 1 week, 1 month, 6 months, and 1 year following the CEI. Results. Symptoms improved in 132 patients (72.1%) following CEI. The mean Oswestry Disability Index ques- tionnaire score of steroid-group’s patients was statisti- cally significant lower than that of the WFI-group at all postinjection re-evaluations. Patients receiving steroid CEI experienced faster relief during the first postinjection week. The Straight Leg Rising test improved in both groups following CEI; this improvement was faster among steroid- group’s patients. Fifty-one patients (27.8%), noticed no im- provement 1 week post-CEI and underwent a second CEI (with the same preparation) 7 to 14 days later. Nineteen of them reported improvement; 32 (steroid-group:13, WFI- group:19) did not respond well and underwent operative decompression (n = 15) or spinal fusion (n = 17). Conclusion. CEI containing local anesthetic and ste- roids or WFI seems to be effective when treating patients with LBP and sciatica. CEI containing steroid preparations demonstrated better and faster efficacy. Key words: low back pain, sciatica, caudal epidural injection, caudal extradural injection, steroids, random- ized double blind study. Spine 2009;34:1441–1447 Even though chronic low back pain (LBP) is currently estimated to affect around 15% of the US population, 1 identifying its actual cause(s) can be an extremely diffi- cult task. Lumbar disc herniation seems to be one of the most frequent causes of LBP, nevertheless it is well known that many patients, complaining of LBP as well as of radiating leg pain suggesting sciatica, did not show lumbar disc herniation in magnetic resonance imaging (MRI) and Computed Tomography. 2 There is emerging evidence suggesting that this “paradox” must be proba- bly attributed to the fact that nerve root compression is not sufficient by itself to cause nerve root pain, 3 since painful radiculopathy may be the end-result of a local chemical contribution from injured tissue. 4 Treating pa- tients suffering from LBP can also be challenging and this is probably why so many treatment methods (ranging from conservative measures to operations) have been in- troduced and are supported by the literature. 2 Ever since its introduction, the value of caudal epi- dural injection (CEI) when managing spinal pain and sciatica, has been the subject of controversy. 1,5,6 Litera- ture moderately supports the use of CEI containing ste- roid preparations for the long-term relief of patients suf- fering from chronic LBP, 7 even though there seems to be a lack of relevant well-designed randomized, controlled studies. The actual effect(s)—if any—and the mode(s) of action of CEI (containing steroids or not) on patients with chronic LBP, remain more or less unknown. 7,8 Aim of this study was the evaluation of the efficacy of CEIs containing local anesthetic and either steroid or water for injection (WFI) as a means of treatment for patients suffering from severe chronic LBP and sciatica. Materials and Methods This prospective, randomized, double-blind, case-control study was approved by our institution’s Scientific Research Board and was conducted in accordance with the World Med- ical Association Declaration of Helsinki of 1964 as revised in From the 3rd Orthopaedic Department, Aristotle University of Thes- saloniki-Medical School, “Papageorgiou” General Hospital, Thessal- oniki, Greece. Acknowledgment date: August 5, 2008. Revision date: December 30, 2008. Acceptance date: January 15, 2009. The manuscript submitted does not contain information about medical device(s)/drug(s). No funds were received in support of this work. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript. This study has been approved by the Institution’s Review Board and was conducted in accordance with the World Medical Association Declaration of Helsinki of 1975, as revised in 1983. After the patients (where applicable) were fully informed, they consented that data con- cerning their cases could be submitted for publication. Address correspondence and reprint requests to Eustathios I. Kenanidis, MD, Resident Orthopaedic Surgeon, 7 Anoikseos Str., 57010 Thessal- oniki, Greece; E-mail: kena76@otenet.gr 1441