Patients with acute low back pain receiving recommended first line-care do not recover more quickly with the addition of diclofenac or spinal manipulative therapy. These are the conclusions of authors of an Article published in this week's edition of The Lancet.
Present treatment guidelines for acute low back pain recommend that general practitioners (GPs) should give advice (remain active, avoid bed rest, and reassurance of favourable prognosis) and paracetamol as the first line of care. Non-steroidal anti-inflammatory drugs (NSAIDs, eg. Diclofenac), and spinal manipulative therapy are recommended as second-line management options to speed recovery.
Mark Hancock, Back Pain Research Group, University of Sydney, Australia, and colleagues studied 240 patients with acute low back pain who had been seen by their GPs and had been given both advice and paracetamol. They were randomly allocated to four treatment groups each comprising 60 patients: diclofenac 50mg twice daily and placebo manipulative therapy; spinal manipulative therapy and placebo drug; diclofenac 50mg twice daily and spinal manipulative therapy; or double placebo.
They found that neither diclofenac nor spinal manipulative therapy appreciably reduced the number of days until recovery compared with placebo drug or placebo manipulative therapy. 237 of the 240 patients recovered or were censored* 12 weeks after randomisation. And while 22 patients had possible adverse reactions including gastrointestinal disturbances, dizziness and heart palpitations, half of these events took place in the diclofenac arm and half in the placebo arm.
The authors say: "Neither diclofenac nor spinal manipulative therapy gave clinically useful effects on the primary outcome of time to recovery. Findings from the secondary analyses support the primary analyses, showing no significant effects on pain, disability, or global perceived effect at one, two, four, or 12 weeks, when diclofenac or spinal manipulative therapy, or both, were added to baseline care."
They conclude: "These results are important because both diclofenac and spinal manipulative therapy have potential risks and additional costs for patients. If patients have high rates of recovery with baseline care and no clinically worthwhile benefit from the addition of diclofenac or spinal manipulative therapy, then GPs can manage patients confidently without exposing them to increased risks and costs associated with NSAIDs or spinal manipulative therapy."
In an accompanying Comment, Dr Bart Koes, Department of General Practice, Erasmus University Medical Centre, Rotterdam, Netherlands, says: "The limited or absent beneficial effect of diclofenac for acute low back pain after adequate first-line treatment may have wide implications. NSAIDs are widely prescribed for a range of acute musculoskeletal disorders."
He concludes: "The important message is that the management of acute low back pain in primary care (advice and prescription of paracetemol) is sufficient for most patients."
Notes to editors: Censored is a term specific to the type of analysis used (survival analysis or Cox regression). Patients are censored if the study ends before they have experienced the event -- in this case recovery .In this type of analysis such patients still add to the data (denominator) during the period until they are censored. Therefore patients censored at 12 weeks have provided full data and are not drop outs.
Mark Hancock, Back Pain Research Group, University of Sydney, Australia T) +61430103905 E) M.Hancock@usyd.edu.au
Dr Bart Koes, Department of General Practice, Erasmus University Medical Centre, Rotterdam, Netherlands T) +31-10-4087620 E) b.koes@erasmusmc.nl
The paper associated with the press release is listed below:
http://multimedia.thelancet.com/pdf/press/Backpain.pdf
Journal
The Lancet