miércoles, 9 de julio de 2014

A Randomized Trial of Epidural Glucocorticoid Injections for Spinal Stenosis — NEJM

A Randomized Trial of Epidural Glucocorticoid Injections for Spinal Stenosis — NEJM



AHRQ-Funded Study Finds Little Benefit From Corticosteroid Injections for Common Cause of Spine-Related Pain

The addition of a corticosteroid to epidural injections of an anesthetic does not enhance pain reduction in patients with lumbar spinal stenosis, a common cause of lower back and leg pain, according to a new AHRQ-funded study. The findings, released in an abstract and article published in the July 3 issue of New England Journal of Medicine, come from the first major clinical trial comparing epidural injections of anesthetic with and without corticosteroids for spinal stenosis. Researchers funded by AHRQ studied patients six weeks after treatment and found those whose lidocaine anesthetic was supplemented with a corticosteroid experienced minimal to no additional benefit compared with patients who received injections of anesthetic alone. Epidural injection of anesthetic with corticosteroid is a common treatment for lumbar spinal stenosis. It is estimated that more than 2.2 million lumbar epidural steroid injections are given each year to Medicare patients. Rates and associated costs of the procedure have increased nearly 300 percent over the last two decades. “This study raises questions about the benefits of combining corticosteroids with an anesthetic for patients with lumbar stenosis, and it will help patients and their physicians make better informed decisions about treatment options,” AHRQ Director Richard Kronick, Ph.D., said in an AHRQ press release about the study.

A Randomized Trial of Epidural Glucocorticoid Injections for Spinal Stenosis

Janna L. Friedly, M.D., Bryan A. Comstock, M.S., Judith A. Turner, Ph.D., Patrick J. Heagerty, Ph.D., Richard A. Deyo, M.D., M.P.H., Sean D. Sullivan, Ph.D., Zoya Bauer, M.D., Ph.D., Brian W. Bresnahan, Ph.D., Andrew L. Avins, M.D., M.P.H., Srdjan S. Nedeljkovic, M.D., David R. Nerenz, Ph.D., Christopher Standaert, M.D., Larry Kessler, Ph.D., Venu Akuthota, M.D., Thiru Annaswamy, M.D., Allen Chen, M.D., M.P.H., Felix Diehn, M.D., William Firtch, M.D., Frederic J. Gerges, M.D., Christopher Gilligan, M.D., Harley Goldberg, M.D., David J. Kennedy, M.D., Shlomo Mandel, M.D., Mark Tyburski, M.D., William Sanders, M.D., David Sibell, M.D., Matthew Smuck, M.D., Ajay Wasan, M.D., Lawrence Won, M.D., and Jeffrey G. Jarvik, M.D., M.P.H.
N Engl J Med 2014; 371:11-21July 3, 2014DOI: 10.1056/NEJMoa1313265
 Comments open through July 9, 2014
Abstract
Article
References
Citing Articles (1)
Comments (5)

BACKGROUND

Epidural glucocorticoid injections are widely used to treat symptoms of lumbar spinal stenosis, a common cause of pain and disability in older adults. However, rigorous data are lacking regarding the effectiveness and safety of these injections.

METHODS

In a double-blind, multisite trial, we randomly assigned 400 patients who had lumbar central spinal stenosis and moderate-to-severe leg pain and disability to receive epidural injections of glucocorticoids plus lidocaine or lidocaine alone. The patients received one or two injections before the primary outcome evaluation, performed 6 weeks after randomization and the first injection. The primary outcomes were the score on the Roland–Morris Disability Questionnaire (RMDQ, in which scores range from 0 to 24, with higher scores indicating greater physical disability) and the rating of the intensity of leg pain (on a scale from 0 to 10, with 0 indicating no pain and 10 indicating “pain as bad as you can imagine”).

RESULTS

At 6 weeks, there were no significant between-group differences in the RMDQ score (adjusted difference in the average treatment effect between the glucocorticoid–lidocaine group and the lidocaine-alone group, −1.0 points; 95% confidence interval [CI], −2.1 to 0.1; P=0.07) or the intensity of leg pain (adjusted difference in the average treatment effect, −0.2 points; 95% CI, −0.8 to 0.4; P=0.48). A prespecified secondary subgroup analysis with stratification according to type of injection (interlaminar vs. transforaminal) likewise showed no significant differences at 6 weeks.

CONCLUSIONS

In the treatment of lumbar spinal stenosis, epidural injection of glucocorticoids plus lidocaine offered minimal or no short-term benefit as compared with epidural injection of lidocaine alone. (Funded by the Agency for Healthcare Research and Quality; ClinicalTrials.gov number, NCT01238536.)

No hay comentarios:

Publicar un comentario