The addition of diazepam to naproxen for patients with acute, nontraumatic, nonradicular lower back pain did not improve pain or functional outcomes at 1 week or 3 months after ED discharge compared to placebo.

Additional Information

Study design: single-center, prospective, randomized, double-blind, placebo-controlled trial

Patients:

• Adults age 21 to 69 years who preseted to the ED for management of nontraumatic, nonradicular low back pain <2 weeks in duration with score >5 on Roland-Morris Disability Questionnaire (RMDQ) who were discharged home from the ED
• Exclusion criteria: radicular back pain, nonmusculoskeletal etiology of pain, direct back trauma within past 1 month, pregnant/breast feeding, chronic pain syndrome

Treatment groups:

• Control: naproxen 500 mg PO twice daily + placebo 1-2 tablets PO every 12 hours PRN pain
• Intervention: naproxen 500 mg PO twice daily + diazepam 5 to 10 mg PO every 12 hours PRN pain

Outcomes:

• Primary: RMDQ score 1 week after ED discharge
• Secondary: pain intensity 1 week and 3 months after ED discharge

Results:

• Of 545 patients assessed for enrollment, data from 57 in the diazepam group and 55 in the placebo group were included in the primary outcome analysis
• No difference in mean improvement in RMDQ score between the naproxen + placebo (11; 95% CI 8 to 13) and naproxen + diazepam (11; 95% CI 9 to 13) groups at 1 week
• No difference in incidence of moderate or severe low back pain between the naproxen + placebo (22%; 95% CI 13% to 35%) or naproxen + diazepam (32%; 95% CI 21% to 45%) groups at 1 week or 3 months (naproxen + placebo, 9%; 95% CI 4% to 21%) (naproxen + diazepam, 12%; 95% CI 5% to 24%)
• No difference in the incidence of adverse effects between groups

Conclusions:

• The addition of diazepam to naproxen for patients with acute, nontraumatic, nonradicular lower back pain did not improve pain or functional outcomes at 1 week or 3 months after ED discharge compared to placebo.
• This study does not support adding diazepam to an NSAID to outpatient therapy for acute, nontraumatic, nonradicular low back pain.

References

Citation: Friedman BW, Irizarry E, Solorzano C, et al. Diazepam is no better than placebo when added to naproxen for acute low back pain. Ann Emerg Med 2017. PMID 28187918

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