A Randomized, Double-Blind Controlled Trial of Lumbar Interlaminar Epidural Injections in Central Spinal Stenosis: 2-Year Follow-Up
5Medical Director of Mid Atlantic Spine & Pain Physicians, Newyark, Director, Pain Medicine Fellowship Program, Temple University Hospital, Philadelphia, PA and Adjunct Associate Professor, Department of PM&R, Temple University Medical School, Philadelphia, PA, USA
- *Corresponding Author:
- Laxmaiah Manchikanti
2831 Lone Oak Road, Paducah
Kentucky 42003, USA
E-mail: [email protected]
Received Date: January 21, 2014; Accepted Date: February 12, 2014; Published Date: February 16, 2014
Citation: Manchikanti L, Cash KA, McManus CD, Damron KS, Pampati V, et al. (2014) A Randomized, Double-Blind Controlled Trial of Lumbar Interlaminar Epidural Injections in Central Spinal Stenosis: 2-Year Follow-Up. Int J Phys Med Rehabil 2:179. doi: 10.4172/2329-9096.1000179
Copyright: © 2014 Manchikanti L, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Objective: We sought to assess the effectiveness of lumbar interlaminar epidural injections with or without steroids in providing effective and long-lasting pain relief with improvement in functional status for the management of chronic low back and lower extremity pain related to lumbar central spinal stenosis. Methods: A randomized, double-blind, active-control trial was designed with the inclusion of 120 patients assigned to 2 groups. Group I patients received lumbar interlaminar epidural injections of local anesthetic (lidocaine 0.5%) 6 mL, whereas Group II received lumbar interlaminar epidural injections with local anesthetic (lidocaine 0.5%) 5 mL mixed with 1 mL of steroids and 6 mg of betamethasone. Outcomes were assessed utilizing the numeric pain rating scale (NRS) and Oswestry Disability Index (ODI) at 3, 6, 12, 18, and 24 months post treatment. The primary outcome measure was significant improvement, defined as 50% improvement in pain and disability scores. Results: Significant relief and functional status improvement was seen in 72% and 73% of patients in Groups I and II at the end of 2 years considering all participants; however, this was 84% and 85% in the successful group. Overall significant improvement was achieved for 65.7 ± 37.3 weeks in Group 1 and 68.9 ± 37.7 weeks in Group II at the end of 2 years when all participants were considered; whereas, this was 77 ± 27.8 weeks and 77.9 ± 30.2 weeks when they were separated into successful categories. The average number of procedures per patient was 5 to 6 in both groups. Conclusion: Lumbar interlaminar epidural injections of local anesthetic with or without steroids provide relief in a significant proportion of patients with lumbar central spinal stenosis.