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http://jama.jamanetwork.com/article.aspx?articleid=2293294
May 19, 2015, Vol 313, No. 19 >
< Previous ArticleNext Article >
Original Investigation | May 19, 2015
Oral Steroids for Acute Radiculopathy Due to a Herniated Lumbar DiskA Randomized Clinical Trial FREE
Harley Goldberg, DO1,2; William Firtch, MD3; Mark Tyburski, MD4; Alice Pressman, PhD, MS2,5; Lynn Ackerson, PhD2; Luisa Hamilton, MD2; Wayne Smith, MD1; Ryan Carver, MD4; Annu Maratukulam, MD3; Lawrence A. Won, MD1; Eugene Carragee, MD6; Andrew L. Avins, MD, MPH2,7,8
[+] Author Affiliations
JAMA. 2015;313(19):1915-1923. doi:10.1001/jama.2015.4468.
Text Size: A A A
Article
Figures
Tables
Supplemental Content
References
CME
ABSTRACT | INTRODUCTION | METHODS | RESULTS | DISCUSSION | CONCLUSIONS |ARTICLE INFORMATION | REFERENCES
Importance Oral steroids are commonly used to treat acute sciatica due to a herniated disk but have not been evaluated in an appropriately powered clinical trial.
Objective To determine if oral prednisone is more effective than placebo in improving function and pain among patients with acute sciatica.
Design, Setting, and Participants Randomized, double-blind, placebo-controlled clinical trial conducted from 2008 to 2013 in a large integrated health care delivery system in Northern California. Adults (n=269) with radicular pain for 3 months or less, an Oswestry Disability Index (ODI) score of 30 or higher (range, 0-100; higher scores indicate greater dysfunction), and a herniated disk confirmed by magnetic resonance imaging were eligible.
Interventions Participants were randomly assigned in a 2:1 ratio to receive a tapering 15-day course of oral prednisone (5 days each of 60 mg, 40 mg, and 20 mg; total cumulative dose = 600 mg; n = 181) or matching placebo (n = 88).
Main Outcomes and Measures The primary outcome was ODI change at 3 weeks; secondary outcomes were ODI change at 1 year, change in lower extremity pain (measured on a 0-10 scale; higher scores indicate more pain), spine surgery, and Short Form 36 Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) scores (0-100 scale; higher scores better).
Results Observed baseline and 3-week mean ODI scores were 51.2 and 32.2 for the prednisone group and 51.1 and 37.5 for the placebo group, respectively. The prednisone-treated group showed an adjusted mean 6.4-point (95% CI, 1.9-10.9; P = .006) greater improvement in ODI scores at 3 weeks than the placebo group and a mean 7.4-point (95% CI, 2.2-12.5; P = .005) greater improvement at 52 weeks. Compared with the placebo group, the prednisone group showed an adjusted mean 0.3-point (95% CI, −0.4 to 1.0; P = .34) greater reduction in pain at 3 weeks and a mean 0.6-point (95% CI, −0.2 to 1.3; P = .15) greater reduction at 52 weeks. The prednisone group showed an adjusted mean 3.3-point (95% CI, 1.3-5.2; P = .001) greater improvement in the SF-36 PCS score at 3 weeks, no difference in the SF-36 PCS score at 52 weeks (mean, 2.5; 95% CI, −0.3 to 5.4; P = .08), no change in the SF-36 MCS score at 3 weeks (mean, 2.2; 95% CI, −0.4 to 4.8; P = .10), and an adjusted 3.6-point (95% CI, 0.6-6.7; P = .02) greater improvement in the SF-36 MCS score at 52 weeks. There were no differences in surgery rates at 52-week follow-up. Having 1 or more adverse events at 3-week follow-up was more common in the prednisone group than in the placebo group (49.2% vs 23.9%; P < .001).
Conclusions and Relevance Among patients with acute radiculopathy due to a herniated lumbar disk, a short course of oral steroids, compared with placebo, resulted in modestly improved function and no improvement in pain.
Trial Registration clinicaltrials.gov Identifier: NCT00668434
May 19, 2015, Vol 313, No. 19 >
< Previous ArticleNext Article >
Original Investigation | May 19, 2015
Oral Steroids for Acute Radiculopathy Due to a Herniated Lumbar DiskA Randomized Clinical Trial FREE
Harley Goldberg, DO1,2; William Firtch, MD3; Mark Tyburski, MD4; Alice Pressman, PhD, MS2,5; Lynn Ackerson, PhD2; Luisa Hamilton, MD2; Wayne Smith, MD1; Ryan Carver, MD4; Annu Maratukulam, MD3; Lawrence A. Won, MD1; Eugene Carragee, MD6; Andrew L. Avins, MD, MPH2,7,8
[+] Author Affiliations
JAMA. 2015;313(19):1915-1923. doi:10.1001/jama.2015.4468.
Text Size: A A A
Article
Figures
Tables
Supplemental Content
References
CME
ABSTRACT | INTRODUCTION | METHODS | RESULTS | DISCUSSION | CONCLUSIONS |ARTICLE INFORMATION | REFERENCES
Importance Oral steroids are commonly used to treat acute sciatica due to a herniated disk but have not been evaluated in an appropriately powered clinical trial.
Objective To determine if oral prednisone is more effective than placebo in improving function and pain among patients with acute sciatica.
Design, Setting, and Participants Randomized, double-blind, placebo-controlled clinical trial conducted from 2008 to 2013 in a large integrated health care delivery system in Northern California. Adults (n=269) with radicular pain for 3 months or less, an Oswestry Disability Index (ODI) score of 30 or higher (range, 0-100; higher scores indicate greater dysfunction), and a herniated disk confirmed by magnetic resonance imaging were eligible.
Interventions Participants were randomly assigned in a 2:1 ratio to receive a tapering 15-day course of oral prednisone (5 days each of 60 mg, 40 mg, and 20 mg; total cumulative dose = 600 mg; n = 181) or matching placebo (n = 88).
Main Outcomes and Measures The primary outcome was ODI change at 3 weeks; secondary outcomes were ODI change at 1 year, change in lower extremity pain (measured on a 0-10 scale; higher scores indicate more pain), spine surgery, and Short Form 36 Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) scores (0-100 scale; higher scores better).
Results Observed baseline and 3-week mean ODI scores were 51.2 and 32.2 for the prednisone group and 51.1 and 37.5 for the placebo group, respectively. The prednisone-treated group showed an adjusted mean 6.4-point (95% CI, 1.9-10.9; P = .006) greater improvement in ODI scores at 3 weeks than the placebo group and a mean 7.4-point (95% CI, 2.2-12.5; P = .005) greater improvement at 52 weeks. Compared with the placebo group, the prednisone group showed an adjusted mean 0.3-point (95% CI, −0.4 to 1.0; P = .34) greater reduction in pain at 3 weeks and a mean 0.6-point (95% CI, −0.2 to 1.3; P = .15) greater reduction at 52 weeks. The prednisone group showed an adjusted mean 3.3-point (95% CI, 1.3-5.2; P = .001) greater improvement in the SF-36 PCS score at 3 weeks, no difference in the SF-36 PCS score at 52 weeks (mean, 2.5; 95% CI, −0.3 to 5.4; P = .08), no change in the SF-36 MCS score at 3 weeks (mean, 2.2; 95% CI, −0.4 to 4.8; P = .10), and an adjusted 3.6-point (95% CI, 0.6-6.7; P = .02) greater improvement in the SF-36 MCS score at 52 weeks. There were no differences in surgery rates at 52-week follow-up. Having 1 or more adverse events at 3-week follow-up was more common in the prednisone group than in the placebo group (49.2% vs 23.9%; P < .001).
Conclusions and Relevance Among patients with acute radiculopathy due to a herniated lumbar disk, a short course of oral steroids, compared with placebo, resulted in modestly improved function and no improvement in pain.
Trial Registration clinicaltrials.gov Identifier: NCT00668434
