ArticlesEfficacy of paracetamol for acute low-back pain: a double-blind, randomised controlled trial
Introduction
Low-back pain is the leading cause of disability worldwide.1 Guidelines for acute low-back pain universally recommend paracetamol as the first-line analgesic.2, 3 Although the effect of paracetamol for low-back pain is similar to that of other analgesics used for low-back pain,4, 5 no direct evidence supports this universal recommendation. In a systematic review6 we noted no evidence to support the use of paracetamol for low-back pain. All seven of the included trials had substantial methodological flaws, and only one trial included more than 25 participants per group. No trial has compared paracetamol with placebo or compared as-needed dosing with the regular recommended dosing. In view of these uncertainties, the Paracetamol for Low-Back Pain Study (PACE) aimed to investigate the efficacy of paracetamol taken regularly or as-needed to improve time to recovery from pain, compared with placebo for patients with acute low-back pain. PACE also aimed to establish whether regular or as-needed paracetamol improved short-term pain (1–12 weeks), disability, function, global rating of symptom change, sleep, or quality of life compared with placebo.
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Trial design and participants
PACE was a multicentre, double-dummy, randomised, placebo controlled trial. The study protocol7 and analysis plan8 have been published. In brief, 235 primary care clinicians (181 general practitioners, 50 pharmacists, and four physiotherapists) across Sydney, Australia, screened consecutive patients who sought care for low-back pain directly or in response to a community advertisement. Inclusion criteria were a new episode of acute low-back pain (defined as pain between the 12th rib and buttock
Results
From Nov 11, 2009, to Dec 13, 2012, 4606 patients were screened and 1652 patients were randomly assigned to treatment groups (figure 1). The mean age was 45 years (SD 16) and 876 (53%) patients were men. Nine patients were excluded by a masked researcher after randomisation because new information provided to researchers meant that these patients did not initially meet the eligibility criteria (figure 1). Of the 1643 participants, 550 were allocated to the regular group, 546 to the as-needed
Discussion
We have shown that neither regular nor as-needed dosing of paracetamol improved recovery compared with placebo. Consistent with the primary results, paracetamol also had no effect on pain, disability, function, global symptom change, sleep, or quality of life. Adverse events between treatment groups did not differ.
PACE was a large, high-quality, multicentre trial. The trial setting matches the recommendations in guidelines that low-back pain should mainly be managed in primary care.2, 3
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