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This double-blind, randomised controlled trial (RCT) was done to bridge gaps in previous literature. Previous studies of the efficacy of paracetamol in the treatement of acute low back pain had flawed methods and so could provide no information on whether paracetamol helped acute low back pain sufferers. Examples of these flaws are:
1. only one of the studies done had more than 25 participants per group. (This is considered to not be an adequate sample size)
2. none of the trials compared paracetamol with a placebo or on an as needed basis.
The PACE Study
The purpose of this study was done by Williams, Meyer and Latimer, et al to address the flaws in previous studies. 4606 participants with less than 6 weeks of low back pain (between the lower ribs and buttock) were studied between November 2009 and December 2012. the average age of the participants was 45 years and 53% of them were male.
Some patients were instructed to take paracetamol regularly, others on an 'as needed basis' and others were give a placebo.
The measurement taken: after 12 weeks of being in the study the patients were asked to report their pain level as a score out of 10, with 1 being a low level of pain and 10 being the highest level of pain.
|group||regular paracetamol||paracetamol as needed||placebo|
|number of particpants||550||546||547|
|percentage of participants reporting a score of 0 or 1 out of 10 after 12 weeks (%)||85||83||84|
The results show that paracetamol does not contribute to the recovery from acute low back pain. However, it is good for pain relief and can be used (in the absence of contra-indications) in conjuction with other treatments that do aid recovery.
The Lancet 2014; 384(9954): 1586-1596. doi:10.1016/S0140-6736(14)60805-9
double blind trial: neither the participant nor the administrator knows whether the pill given is paracetamol (in this case) or the placebo.
efficacy: the ability ot produce the result wanted
placebo: a pill that has no active ingredient (that causing and effect) in it.
RCT: the NICE definition: A study in which a number of similar people are randomly assigned to 2 (or more) groups to test a specific drug or treatment. One group (the experimental group) receives the treatment being tested, the other (the comparison or control group) receives an alternative treatment, a dummy treatment (placebo) or no treatment at all. The groups are followed up to see how effective the experimental treatment was. Outcomes are measured at specific times and any difference in response between the groups is assessed statistically. This method is also used to reduce bias.