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

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

SUBMITTER: Williams CM 

PROVIDER: S-EPMC3750911 | biostudies-literature | 2013 Aug

REPOSITORIES: biostudies-literature