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

Background: A recent evaluation of the state of U.S. health from 1990 to 2010 placed neck painas the fourth condition leading to disability, with low back pain being the number one. Multipletreatment modalities have been described in managing neck and upper extremity pain secondary tocervical disc herniation after the failure of conservative management. The treatment modalities forchronic persistent pain of cervical disc herniation include surgery and epidural injections. The growthof 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 relatedto 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 ofnon-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 improvementin functional status in 72% of the patients at 2 year follow-up in the local anesthetic group and68% in those patients receiving local anesthetic and steroid. In the successful group of participantshowever, 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 totalrelief for 2 years was 75.9 ± 29.9 weeks in Group I and 72.7 ± 31.1 in Group II, the successful groupof participants. Taking into consideration all of the participants, the average total relief for 2 yearswas 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 offersignificant benefit to patients suffering with chronic, persistent pain and disability related to cervicaldisc herniation.Key words: Chronic neck pain, cervical disc herniation, upper extremity pain, cervical epiduralinjections, epidural steroids, local anestheticsTrial Registration: NCT01071369