Original contribution
Parenteral corticosteroids for Emergency Department patients with non-radicular low back pain

https://doi.org/10.1016/j.jemermed.2005.09.023Get rights and content

Abstract

Although not recommended for low back pain, the efficacy of systemic corticosteroids has never been evaluated in a general low back pain population. To test the efficacy of systemic corticosteroids for Emergency Department (ED) patients with low back pain, a randomized, double-blind, placebo-controlled trial of long-acting methylprednisolone was conducted with follow-up assessment 1 month after ED discharge. Patients with non-traumatic low back pain were included if their straight leg raise test was negative. The primary outcome was a comparison of the change in a numerical rating scale (NRS) 1 month after discharge. Of 87 subjects randomized, 86 were successfully followed to the 1-month endpoint. The change in NRS between discharge and 1 month differed between the two groups by 0.6 (95% confidence interval −1.0 to 2.2), a clinically and statistically insignificant difference. Disability, medication use, and healthcare resources utilized were comparable in both groups. Corticosteroids do not seem to benefit patients with acute non-radicular low back pain.

Introduction

Acute low back pain is common, frequently debilitating, and often causes morbidity weeks to months after an initial visit to a health care provider (1, 2). Traditional medical management is only moderately effective—despite standard treatments, up to 50% of low back pain patients have poor functional outcomes 2 to 4 weeks after a medical visit and as many as 79% of low back pain patients report persistent pain or functional limitations three months after a visit to a general practitioner (3, 4, 5, 6, 7). Research in the field is complicated by the fact that a heterogeneous group of injuries cause low back pain and that a specific etiology for an individual’s back pain is rarely found (1). Multiple well-designed studies help a physician choose acute treatment for low back pain patients, but few medical treatments have demonstrated long-term benefit (8).

Although non-steroidal agents have clear benefit in low back pain patients, the role of corticosteroids is insufficiently understood (9). A guideline statement from the Agency for Health Care Policy and Research did not endorse the use of corticosteroids for low back pain, but found inadequate evidence to comment on the topic definitively (10). The only systemic corticosteroid clinical trials performed to date do not pertain to the average patient seen in an Emergency Department (ED) or a general practitioner’s office due to referral bias, selection bias, and because standard treatment has changed over the two to three decades since those studies were performed (11, 12, 13).

Due to the evidence gap with regard to this potentially important treatment, and due to the poor prognosis of many low back pain patients, we tested the hypothesis that one dose of a long-acting parenteral corticosteroid would improve low back pain in a homogenous group of patients with acute non-radicular low back pain 1 month after discharge from an ED.

Section snippets

Study Design

This was a randomized, double-blind placebo-controlled clinical trial evaluating intramuscular methylprednisolone acetate as adjunctive therapy for low back pain. This trial randomized subjects after they had been evaluated and treated in the ED and were ready for discharge. All subjects were followed-up by telephone call 1 week and 1 month after ED discharge. In addition to the corticosteroid or placebo injection, all subjects were given a complimentary 1-week supply of naproxen 500 mg

Results

There were 241 patients screened by the research assistants, of whom 107 were eligible for the trial. The most frequent reasons for ineligibility were age greater than 50 years (n = 36), straight leg raise positive (n = 30), recent trauma as defined previously (n = 27), and non-acute pain (n = 25). Twenty patients were excluded for refusal to participate, or because the attending physician did not wish to enroll the patient (see CONSORT diagram, Figure 1). Subjects were enrolled continuously

Discussion

We did not identify any previously published randomized clinical trials of corticosteroids for low back pain in a general population using a PubMed search and an exhaustive search of references in guideline statements, topic reviews and meta-analyses. In our clinical trial, we could find no convincing clinical or statistical benefit that corticosteroids conferred upon these patients. Although guideline statements have recommended against the use of corticosteroids in a general low back pain

Limitations

Although only 1 subject was lost to follow-up, 5 subjects in each arm could not be contacted in time to record 1-week outcomes. However, the 1-week conclusions do not change even if extreme assumptions are made about the potential benefit of corticosteroids.

Secondly, the study population is primarily composed of under-represented urban minorities. Whether the results can be generalized to other populations is unclear.

Finally, we chose to use long-acting parenteral methylprednisolone rather than

Conclusions

We were unable to demonstrate a benefit of intramuscular corticosteroids in non-radicular low back pain patients who were discharged from the ED. Despite treatment with naproxen and oxycodone/acetaminophen, only 37% of these subjects were back pain free 1 week after discharge. Twenty-five percent of these subjects continued to experience functional limitations due to their back pain 1 month after discharge. Emergency physicians should ensure that their patients have appropriate expectations and

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