Additional NSAIDs and/or spinal manipulative therapy: no shorter recovery from acute low back pain

2007/12/03

When patients suffering from acute low back pain receive recommended first-line care they do not recover more quickly with the addition of diclofenac or spinal manipulative therapy. This was the main outcome of a new study performed by researchers from the Back Pain Research Group, University of Sydney (Australia), with the aim to investigate whether the addition of non-steroidal anti-inflammatory drugs or spinal manipulative therapy, or both, would result in faster recovery in patients with acute low back pain.

According to treatment guidelines, general practitioners manage acute low back pain with advice, such as to remain active, to avoid bed rest, and administration of paracetamol as the first line of care. Second-line management options are NSAIDs and manipulative therapy.
Dr. Mark Hancock and colleagues included 240 patients with acute low back pain (average age 40.7 years, 44% females; with or without leg pain, duration of symptoms for less than 6 weeks) in their community-based study; these subjects, who had seen their general practitioner and had been given advice and paracetamol, were randomly assigned to one of four groups (n=60 each): group 1 received diclofenac 50 mg twice daily and placebo manipulative therapy, group 2 received spinal manipulative therapy and placebo drug, group 3 received diclofenac 50 mg twice daily and spinal manipulative therapy, and group 4 were double-placebo controls. Days to recovery from pain - as primary outcome parameter - were assessed by survival curves (log-rank test) in an intention-to-treat analysis.
The authors found that neither diclofenac nor spinal manipulative therapy had clinically useful effects on the time to recovery compared with placebo drug or placebo manipulative therapy (hazard ratio for diclofenac: 1.09, p=0•516; for spinal manipulative therapy 1.01, p=0•955). Twelve weeks after randomization, 99% (n=237) of the patients either recovered or were analyzed by survival curves. Twenty-two patients reported possible adverse effects, e.g. gastrointestinal disturbances, dizziness, and palpitations, which were evenly spread across the active and placebo groups.
These results may have relevance for the treatment of acute low back pain, the researchers conclude, as “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."

Hancock MJ, Maher CG, Latimer J, et al.: Assessment of diclofenac or spinal manipulative therapy, or both, in addition to recommended first-line treatment for acute low back pain: a randomised controlled trial. Lancet 2007;370(9599):1638-43.