A Randomized, Double-Blind, Active Control Trial of Fluoroscopic Cervical Interlaminar Epidural Injections in Chronic Pain of Cervical Disc Herniation: Results of a 2-Year Follow-Up

Abstract

Background: A recent evaluation of the state of U.S. health from 1990 to 2010 placed neck pain as the fourth condition leading to disability, with low back pain being the number one. Multiple treatment modalities have been described in managing neck and upper extremity pain secondary to cervical disc herniation after the failure of conservative management. The treatment modalities for chronic persistent pain of cervical disc herniation include surgery and epidural injections. The growth of interventional techniques in managing chronic spinal pain in recent years has been enormous. Evidence for the efficacy of cervical interlaminar epidural injections, however, continues to be debated, despite positive evidence derived from controlled randomized trials and systematic reviews. Study Design: A randomized, double-blind, active control trial. Setting: A private, specialty referral, interventional pain management practice in the United States. Objectives: To evaluate the effectiveness of epidural injections in managing chronic pain related to cervical disc herniation. Methods: Patients were randomly assigned to one of 2 groups of 60, with a total of 120 patients. Group I patients received cervical epidural injections with lidocaine 0.5% preservative-free, 5 mL, whereas Group II patients received 0.5% preservative-free lidocaine mixed with 1 mL or 6 mg of non-particulate betamethasone. Outcome Assessment: Multiple outcome measures included the numeric rating pain scale (NRS), the Neck Disability Index (NDI), employment status, opioid intake with assessment at 3, 6, 12, 18, and 24 months post treatment. Significant improvement was described as pain relief with a 50% improvement in functional status. Results: This evaluation showed significant improvement as 50% pain relief and improvement in functional status in 72% of the patients at 2 year follow-up in the local anesthetic group and 68% in those patients receiving local anesthetic and steroid. In the successful group of participants however, significant improvement was seen in 77% in Group I and 80% in Group II. Overall, the average number of procedures was 5 to 6 in both groups per 2 years. The average total relief for 2 years was 75.9 ± 29.9 weeks in Group I and 72.7 ± 31.1 in Group II, the successful group of participants. Taking into consideration all of the participants, the average total relief for 2 years was 69.6 ± 35 weeks in Group I and 62.1 ± 38.4 weeks in Group II. Limitations: The results of the study are limited by the lack of a placebo group. Conclusion: Cervical epidural injections with local anesthetic with or without steroids may offer significant benefit to patients suffering with chronic, persistent pain and disability related to cervical disc herniation. Key words: Chronic neck pain, cervical disc herniation, upper extremity pain, cervical epidural injections, epidural steroids, local anesthetics Trial Registration: NCT01071369

Clinical Efficacy of Epidural Injections of Local Anesthetic Alone or Combined with Steroid for Neck Pain: A Systematic Review and Meta-Analysis

“…Based on the search criteria, 10 publications were considered for inclusion; 6 of these were excluded because of duplicate publications or lack of data. Ultimately, 4 RCTs [ 31 , 32 , 34 , 36 ] were included in the present analysis.…”

“…Work status was also an outcome measure; at the 1-year follow-up, the effectiveness in terms of pain relief and functional improvement was 71.5%. The second RCT [ 32 ] included 120 patients, and the interventions and outcome measures for each group were similar to those in the first RCT. The rates of effectiveness for pain relief and functional improvements were 72% and 68% in patients who received epidural injections without and with the steroid, respectively.…”

“…Conventional meta-analysis was not feasible because there were no significant differences between patients receiving epidural injections with lidocaine alone vs lidocaine + steroid. To assess pain relief and functional improvement, we performed a single-arm meta-analysis of the data from the 4 studies [ 31 , 32 , 34 , 36 ].…”

“…Four studies [ 31 , 32 , 34 , 36 ] were included in this single-arm meta-analysis of pain relief and functional improvement (Figures 2(a) and 2(b) ). Treatment with lidocaine alone or with the steroid resulted in decreases of 4.46 and 4.29 points, respectively, in pain scores (Figures 3(a) and 3(b) ) and of 15.8 and 14.46 points, respectively, in functional scores (Figures 2(a) and 2(b) ) at 6 months.…”

“…Similar trends were observed at the 1-year follow-up: pain scores decreased by 4.27 and 4.14 points (Figures 4(a) and 4(b) ), while functional scores decreased by 15.94 and 14.44 points (Figures 5(a) and 5(b) ) in patients with neck pain who received lidocaine without or with the steroid, respectively. In the 3 studies that reported 2-year follow-up data [ 31 , 32 , 34 ], patients with neck pain treated with lidocaine or lidocaine + steroid showed 4.2- and 4.14-point decreases, in pain score (Figures 6(a) and 6(b) ) and 15.92- and 14.89-point decreases, respectively, in functional scores (Figures 7(a) and 7(b) ).…”