1. 2010;13;223-236The Effectiveness of Fluoroscopic Cervical Interlaminar Epidural Injections in Managing Chronic Cervical Disc Herniation and Radiculitis: Preliminary Results of a Randomized, Double-Blind, Controlled Trial
   Randomized Trial
   Vidyasagar Pampati, MSc, Kimberly A. Cash, RT, Laxmaiah Manchikanti, MD, Bradley W. Wargo, DO, and Yogesh Malla, MD.

BACKGROUND: Chronic neck pain is a common problem in the adult population with a typical 12-month prevalence of 30% to 50%. Cervical disc herniation and radiculitis is one of the common conditions described responsible for chronic neck and upper extremity pain.

Cervical epidural injections for managing chronic neck pain with disc herniation are one of the commonly performed non-surgical interventions in the United States. However, the literature supporting cervical interlaminar epidural steroids in managing chronic neck pain is scant.

STUDY DESIGN: A randomized, double-blind, controlled trial.

SETTING: A private interventional pain management practice and specialty referral center in the United States.

OBJECTIVES: To evaluate the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids in providing effective and long-lasting relief in the management of chronic neck pain and upper extremity pain in patients with disc herniation and radiculitis, and to evaluate the differences between local anesthetic with or without steroids.

METHODS: Patients were randomly assigned to one of 2 groups: Group I patients received cervical interlaminar epidural injections of local anesthetic (lidocaine 0.5%, 5 mL); Group II patients received cervical interlaminar epidural injections with 0.5% lidocaine, 4 mL, mixed with 1 mL of non-particulate betamethasone.

OUTCOMES ASSESSMENT: Multiple outcome measures were utilized. They included the Numeric Rating Scale (NRS), the Neck Disability Index (NDI), employment status, and opioid intake. Assessments were done at baseline and 3, 6, and 12 months post-treatment.

Significant pain relief was defined as 50% or more; significant improvement in disability score was defined as a reduction of 50% or more.

RESULTS: Significant pain relief (≥ 50%) was demonstrated in 77% of patients in both groups.  Functional status improvement was demonstrated by a reduction (> 50%) in the NDI scores in 74% of Group I and 71% of Group II at 12 months. The overall average procedures per year were 3.7 ± 1.1 in Group I and 4.0 ± 0.91 in Group II; the average total relief per year was 39.45 ± 11.59 weeks in Group I and 41.06 ± 11.56 weeks in Group II over the 52 week study period in the patients defined as successful.

The initial therapy was considered to be successful if a patient obtained consistent relief with 2 initial injections lasting at least 4 weeks. All others were considered failures.

LIMITATIONS: The study results are limited by the lack of a placebo group and a preliminary report of 70 patients, 35 in each group.

CONCLUSION: Cervical interlaminar epidural injections with local anesthetic with or without steroids might be effective in 77% of patients with chronic function-limiting neck pain and upper extremity pain secondary to cervical disc herniation and radiculitis.

CLINICAL TRIAL: NCT01071369