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Studies designed to investigate the use of oral steroids in the setting of acute low back pain are limitedin their effectiveness because they include studies that compared the use of oral steroids to non-steroidal non-steroidal therapies (NTSTs) (11, 12), which are not available to patients, do not assess the effects of oral steroid use in chronic low back pain (13), and have not adequately assessed the effect of oral steroid use in the context of a patient’s chronic low back pain. Thus, in this review, we are attempting to fill the gaps in literature by focusing on an active, randomized, controlled clinical trial that compared the use of oral steroids with oral NTSTs in a group of patients currently receiving both NTSTs and oral steroids.
MATERIALS AND METHODS
In a parallel design, we recruited 19 consecutive low back pain patients for randomization to either an active steroid or a non-steroidal non-steroidal therapy for at least 4 weeks. The primary outcome measure was the Oswestry Disability Index, a non-parametric measure of the functional outcome of low back pain (14).
The study protocol was approved by the Institutional Review Board of the New York State Psychiatric Institute and the ethics committee at Yale University. All study participants gave written informed consent which was approved by the research ethics committee at the Yale University School of Medicine.
Patients who met eligibility criteria, including a history of low back pain, a history of low back pain symptoms, and a history of a positive blood specimen, provided written informed consent to participate (see Supplemental Material, available at NEJM.org). All participants were provided with a complete and detailed study schedule at the University of Washington Center for Research on Aging, which included a baseline (pre-treatment) and follow-up visit. Each patient, along with the study investigator, attended a study visit 1 month within 8 weeks of randomization.
To assess the efficacy of steroid treatment, participants were required to maintain a minimum of 5 weeks, or the equivalent, between baseline and treatment completion to be included in the study. We defined failure to maintain baseline as a change in Oswestry Disability Index score of less than 5 points or a reduction in the baseline score to less than zero (or equivalent).
This criterion was based on evidence from other studies that had used time-point criteria to determine whether the response was permanent (15). An assessment of the effectiveness of treatment in the context of chronic low back pain is complicated by the lack of a baseline
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