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Trials
Published in: Trials 1/2013

Open Access 01-12-2013 | Update

PACE – the first placebo controlled trial of paracetamol for acute low back pain: statistical analysis plan

Authors: Christopher M Williams, Chris G Maher, Jane Latimer, Andrew J McLachlan, Mark J Hancock, Richard O Day, Laurent Billot, Chung-Wei Christine Lin

Published in: Trials | Issue 1/2013

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Abstract

Background

Paracetamol (acetaminophen) is recommended in most clinical practice guidelines as the first choice of treatment for low back pain, however there is limited evidence to support this recommendation. The PACE trial is the first placebo controlled trial of paracetamol for acute low back pain. This article describes the statistical analysis plan.

Results

PACE is a randomized double dummy placebo controlled trial that investigates and compares the effect of paracetamol taken in two regimens for the treatment of low back pain. The protocol has been published. The analysis plan was completed blind to study group and finalized prior to initiation of analyses. All data collected as part of the trial were reviewed, without stratification by group, and classified by baseline characteristics, process of care and trial outcomes. Trial outcomes were classified as primary and secondary outcomes. Appropriate descriptive statistics and statistical testing of between-group differences, where relevant, have been planned and described.

Conclusions

A standard analysis plan was developed for the results of the PACE study. This plan comprehensively describes the data captured and pre-determined statistical tests of relevant outcome measures. The plan demonstrates transparent and verifiable use of the data collected. This a priori plan will be followed to ensure rigorous standards of data analysis are strictly adhered to.

Trial registration

Australia and New Zealand Clinical Trials Registry ACTRN12609000966​291
Appendix
Available only for authorised users
Literature
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Williams CM, Latimer J, Maher CG, McLachlan AJ, Cooper CW, Hancock MJ, Day RO, McAuley JH, Lin C-WC: PACE–the first placebo controlled trial of paracetamol for acute low back pain: design of a randomised controlled trial. BMC Musculoskelet Disord. 2010, 11: 1691-1696.
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Metadata
Title
PACE – the first placebo controlled trial of paracetamol for acute low back pain: statistical analysis plan
Authors
Christopher M Williams
Chris G Maher
Jane Latimer
Andrew J McLachlan
Mark J Hancock
Richard O Day
Laurent Billot
Chung-Wei Christine Lin
Publication date
01-12-2013
Publisher
BioMed Central
Published in
Trials / Issue 1/2013
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-14-248

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