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

Abstract

Background: Lumbar disc herniation and radiculitis are common elements of low back and lower extremity pain. Among minimally invasive treatments, epidural injections are one of the most commonly performed interventions. However, the literature is mixed about their effectiveness in managing low back and lower extremity pain. In general, individual studies and systematic reviews of epidural steroid injections have been hampered by their study design, baseline differences between treatment groups, inadequate sample sizes, highly controlled settings, lack of validated outcome measures, and the inability to confirm the injectate location because fluoroscopy was not used. Study Design: A randomized, controlled, double blind, active control trial. Setting: A private, interventional pain management practice, specialty referral center in the United States. Objectives: To assess the effectiveness of fluoroscopically directed caudal epidural injections with local anesthetic with or without steroids in managing chronic low back and lower extremity pain in patients with disc herniation and radiculitis. Methods: One hundred twenty patients were randomized to two groups: Group I received 10 mL caudal epidural injections of local anesthetic, lidocaine 0.5%; Group II patients received caudal epidural injections of 0.5% lidocaine, 9 mL, mixed with 1 mL of steroid. Outcome Assessment: Multiple outcome measures were utilized. The primary outcome measures were Numeric Rating Scale (NRS) and the Oswestry Disability Index 2.0 (ODI). Secondary outcome measures were employment status and opioid intake. Significant pain relief improvement was defined as 50% or more improvement in NRS and ODI scores. Results: In the successful category, 77% of Group I had significant pain relief of ≥ 50% and functional status improvement of ≥ 50% reduction in ODI scores; in Group II it was 76%, whereas overall it was 60% and 65% in Groups I and II. Over the two years, Group I had an average number of procedures of 5.5 ± 2.8; Group II was 5.3 ± 2.4. Even though there was no significant difference in overall relief between the two groups, the average relief for each procedure was superior for steroids. Limitations: Presumed limitations of this evaluation include lack of a placebo group. Conclusion: Caudal epidural injections of local anesthetic with or without steroids might be an effective therapy for patients with disc herniation or radiculitis. The present evidence illustrates the potential superiority of steroids compared with local anesthetic at two year follow up based on average relief per procedure. Key words: Chronic low back pain, caudal epidural injections, disc herniation, radiculitis, lower extremity pain, local anesthetic, steroids

Lage rugpijn (aspecifieke)

“…Epidural corticosteroid injections were associated with greater improvement in pain scores at immediate-term followup (Figure 3, six trials, WMD -7.55 on 0 to 100 scale, 95% CI -11.4 to -3.74, I 2 =30%). 56,68,71,81,85,113 There were no differences between epidural corticosteroid injections versus placebo interventions in improvement in pain intensity at short-term (Figure 4, 14 trials, WMD -3.94, 95% CI -9.11 to 1.24, I 2 =85%), 50,56,58,62,65,68,76,78,81,85,90,93,109,113 intermediate-term (Figure 5, four trials, WMD 0.07, 95% CI -8.41 to 8.26, I 2 =82%), 56,81,90,93 or long-term followup (Figure 6, six trials, WMD -0.86, 95% CI -3.78 to 2.06, I 2 =0%). 50,58,78,81,90,93 There were also no differences between epidural corticosteroid injections and placebo interventions in the likelihood of a successful outcome for pain at short-term (Figure 7, eight trials, RR 1.21, 95% CI 0.98 to 1.49, I 2 =67%) 50,65,69,71,90,93,96,110 intermediate-term (Figure 8, three trials, RR 1.12, 95% CI 0.93 to 1.36, I 2 =41%), 65,…”

“…Of these, 29 (reported in 28 publications) compared an epidural corticosteroid injection to a placebo intervention. 50, 54-56, 58, 62, 64, 66, 68, 69, 71, 76, 78, 81, 85, 88, 90, 93, 96, 103, 104, 106-109, 113-115 Five evaluated transforaminal injections, 64,71,81,105,109 11 interlaminar injections, 50,62,66,69,76,90,103,106,108,113,114 nine caudal injections, 54,55,58,68,78,93,96,107,115 and two (reported in one publication) oblique interlaminar injections. 88 In two trials, the specific epidural technique was not described, but the corticosteroid dose and total volume, lack of fluoroscopic guidance, and time period appear consistent with the interlaminar approach.…”

“…Fifteen trials were conducted in the United States, 25 in Europe, one in the United States and Europe, and 14 in other countries. The most commonly used corticosteroids were methylprednisolone (17 trials), 54-56, 62, 64, 66, 68, 69, 76, 81, 85, 89, 96, 103, 106, 108, 109, 114 and triamcinolone (seven trials); 50,58,68,71,78,88 other corticosteroids were betamethasone (four trials) 93,105,107,134 and one trial each of dexamethasone, 68 hydrocortisone, 115 and prednisolone. 113 Corticosteroid doses in prednisolone equivalents were 12.5 to 125 mg for the transforaminal approach, 50 to 125 mg for the interlaminar approach, and 50 to 100 mg for the caudal approach.…”

“…The total volume of injectate was 1 to 3 ml with transforaminal corticosteroid injections, 2 to 20 ml for interlaminar corticosteroid injections, and 10 to 42 ml for caudal corticosteroid injections. All trials of the transforaminal approach used fluoroscopic guidance; one trial 134 of the interlaminar approach and one trial 93 of the caudal approach used fluoroscopic guidance; and one trial 78 of the caudal approach used ultrasound guidance. Twelve trials required imaging findings consistent with symptoms for inclusion.…”

“…50,58,78,81,90,93 There were also no differences between epidural corticosteroid injections and placebo interventions in the likelihood of a successful outcome for pain at short-term (Figure 7, eight trials, RR 1.21, 95% CI 0.98 to 1.49, I 2 =67%) 50,65,69,71,90,93,96,110 intermediate-term (Figure 8, three trials, RR 1.12, 95% CI 0.93 to 1.36, I 2 =41%), 65,90,93 or long-term followup (Figure 9, four trials, RR 1.10, 95% CI 0.94 to 1.28, I 2 =0%). 50,66,90,93 A successful pain outcome was defined as pain relief ≥50 percent, 50,71,90,93 pain relief ≥50 percent plus positive Global Perceived Effect, 65 leg pain improved ≥20 points, 110 pain improved ≥75 percent, 66 "definite" improvement in pain, 96 or pain assessment "none." 69 There were no differences between epidural corticosteroid injections and placebo interventions in improvement in function at immediate-term (Figure 10, four trials, SMD -0.75, 95% CI -1.62 to 0.11, I 2 =94%), 56,81,107,113 short-term (Figure 11, 11 trials, SMD -0.03, 95% CI -0.20 to 0.15, I 2 =53%), 50,56,58,62,65,…”