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
Inclusion Criteria4
- Primary complaint of pain in the area between the 12th rib and buttock crease, with/without leg pain;
- New episode of low back pain, preceded by a period of at least one month without low back pain;
- Pain of less than 6 weeks duration;
- Low back pain severe enough to cause at least ‘moderate pain’ (as measured by an adaptation of item 7 of the Short Form-36).
Exclusion Criteria7
- Known or suspected serious spinal pathology;
- Currently taking recommended regular doses of paracetamol;
- Currenlty taking recommended regular doses of another analgesic for a pre-existing condition;
- Spinal surgery within the preceding 6 months;
- Currently taking psychotropic medication and whose health condition is considered to prevent reliable recording of study information;
- Serious co-morbidities preventing prescription of paracetamol;
- Pregnancy or planning a pregnancy during the one-month treatment period.
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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)
View Full Details on ANZCTR
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ACTRN12609000966291