CompletedPhase 4ACTRN12609000966291

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?


Sponsor

The George Institute for International Health

Enrollment

1,650 participants

Start Date

Nov 11, 2009

Study Type

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

Sex: Both males and femalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

This study investigates whether paracetamol (acetaminophen) is effective for treating new episodes of low back pain. It is for people aged 16 and over who have had low back pain for less than 6 weeks that is at least moderately severe, and have not recently had back surgery.

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

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)

Australia

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ACTRN12609000966291