1. 2010;13;E357-E369A Preliminary Report of a Randomized Double-Blind, Active Controlled Trial of Fluoroscopic Thoracic Interlaminar Epidural Injections in Managing Chronic Thoracic Pain
   Randomized Trial
   Kimberly A. Cash, RT, Carla D. McManus, RN, BSN, Laxmaiah Manchikanti, MD, Vidyasagar Pampati, MSc, and Ramsin M. Benyamin, MD.

BACKGROUND: The proportion of patients suffering from thoracic pain secondary to thoracic disorders is relatively small compared to low back and neck pain. Furthermore, thoracic interventions are not performed as often as in cervical and lumbar regions. In addition, there is a paucity of literature regarding thoracic intervertebral discs and thoracic disc herniation as causative structures of thoracic pain. STUDY DESIGN: A randomized, double-blind, active controlled trial. SETTING: A private practice, interventional pain management and specialty referral center in the United States. OBJECTIVES: To evaluate the effectiveness of thoracic interlaminar epidural injections in providing effective pain relief in managing chronic mid and upper back pain secondary to disc herniation or radiculitis and discogenic pain with local anesthetic alone or with steroids. METHODS: Inclusion criteria consisted of patients who either had disc herniation or radiculitis, or patients with discogenic pain proven by controlled comparative local anesthetic blocks not to be caused by facet joint pain. Patients were assigned to one of 2 groups. One group received injections containing local anesthetic only; the other group, local anesthetic mixed with non-particulate betamethasone. Randomization was performed by computer-generated random allocations sequence by simple randomization. OUTCOMES ASSESSMENT: Participant outcomes were measured at baseline, 3, 6, and 12 months post-treatment with the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake. Decrease of >/= 50% of NRS scores and Oswestry scores were considered significant. RESULTS: A total of 40 participants are included in this preliminary report with 20 participants in each group. Significant pain relief (>/= 50%) and reduction (by at least 50%) in ODI from baseline was seen at 12 months in 80% of patients in Group I and 85% in Group II. LIMITATIONS: This is a preliminary report and there was no placebo group.  CLINICAL TRIAL: NCT01071369