None listed
Conditions
Brief 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.
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 paraceta
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).
Sponsors
The George Institute for International Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 criteria
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.
Outcome results
None listed