PACE--the first placebo controlled trial of paracetamol for acute low back pain: design of a randomised controlled trial.

BMC Musculoskeletal Disorders
Christopher M WilliamsChung-Wei Christine Lin

Abstract

Clinical practice guidelines recommend that the initial treatment of acute low back pain (LBP) should consist of advice to stay active and regular simple analgesics such as paracetamol 4 g daily. Despite this recommendation in all international LBP guidelines there are no placebo controlled trials assessing the efficacy of paracetamol for LBP at any dose or dose regimen. This study aims to determine whether 4 g of paracetamol daily (in divided doses) results in a more rapid recovery from acute LBP than placebo. A secondary aim is to determine if ingesting paracetamol in a time-contingent manner is more effective than paracetamol taken when required (PRN) for recovery from acute LBP. The study is a randomised double dummy placebo controlled trial. 1650 care seeking people with significant acute LBP will be recruited. All participants will receive advice to stay active and will be randomised to 1 of 3 treatment groups: time-contingent paracetamol dose regimen (plus placebo PRN paracetamol), PRN paracetamol (plus placebo time-contingent paracetamol) or a double placebo study arm. The primary outcome will be time (days) to recovery from pain recorded in a daily pain diary. Other outcomes will be pain intensity, disability, function...Continue Reading

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Citations

Feb 6, 2014·Knee Surgery, Sports Traumatology, Arthroscopy : Official Journal of the ESSKA·Olufemi R AyeniMohit Bhandari
Oct 11, 2014·Manual Therapy·Mark J HancockChristopher M Williams
Nov 5, 2013·Journal of Clinical Epidemiology·Christopher M WilliamsJane Latimer
Jan 21, 2015·Journal of Manipulative and Physiological Therapeutics·Daniel SteffensJane Latimer
Feb 27, 2015·Australian Journal of Primary Health·Christina Abdel ShaheedAndrew J McLachlan
Sep 23, 2016·European Spine Journal : Official Publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society·Chung-Wei Christine LinStephen Jan
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May 16, 2018·BMC Musculoskeletal Disorders·M SchreijenbergB W Koes
Sep 24, 2015·Pain·Aron S DownieChristopher G Maher

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