Paracetamol for low back pain
In patients with acute low back pain is time contingent paracetamol, or pro re nata (PRN) paracetamol, more effective than placebo in speeding recovery from a new episode of low back pain?
The George Institute for International Health
1,650 participants
Nov 11, 2009
Interventional
Conditions
Summary
A randomised controlled trial will be conducted of 1650 patients seeking care for recent onset low back pain. The trial will assess the effect that paracetamol has on the recovery from low back pain. Specifically, it will determine whether paracetamol shortens days to recovery from low back pain compared to placebo, and whether taking a ‘regular dosing’ of paracetamol is more effective than taking an ‘as required’ dosing. The trial will also measure the effect of paracetamol on disability, function, sleep quality and determine the cost-effectiveness of paracetamol for managing patients with low back pain.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Time-contingent paracetamol: 2 tablets extended release paracetamol (665mg) 3 times daily, every 6-8 hours, spaced equally throughout the day (maximum 6 per day) until recovery or maximum 4 weeks; and PRN placebo (identical to the PRN paracetamol except for the active ingredient). PRN Paracetamol: 1-2 500mg paracetamol tablets every 4-6 hours as required for pain relief (maximum 8 per day) until recovery or maximum 4 weeks; and time-contingent placebo (identical to the time-contingent paracetamol except for the active ingredient).
Locations(1)
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ACTRN12609000966291