If you suffer from acute low back pain, are receiving recommended first line-care, you do not recover any faster if you are receiving spinal manipulative therapy and/or diclofenac, according to an article in The Lancet, this week’s issue.

(Diclofenac is marketed as Voltaren, Voltarol, Diclon, Dicloflex Difen, Difene, Cataflam, Pennsaid, Rhumalgan, Modifenac, Abitren, Arthrotec and Zolterol.)

General Practitioners (GPs) in the UK are told to give acute low back pain patients advice and paracetamol (acetaminophen) as the first line of care. The advice tells the patient to remain active, avoid bed rest, and reassures the patient that his/her prognosis is favorable. NSAIDs (non-steroidal anti-inflammatory drugs), such as Diclofenac, and spinal manipulative therapy are recommended for second-line management options for fast recovery, explain the authors.

Mark Hancock, Back Pain Research Group, University of Sydney, Australia, and team looked at 240 patients, all of whom suffered from acute low back pain. They had all been to their GPs and had received paracetamol and advice. They were randomly placed into four treatment groups׃

– Group 1
Received diclofenac 50 mg twice daily plus placebo manipulative therapy

– Group 2
Received spinal manipulative therapy and placebo drug

– Group 3
Received diclofenac 50 mg twice daily plus spinal manipulative therapy

– Group 4
Received double placebo

The researchers did not find any significant difference in the recovery times of those receiving diclofenac or spinal manipulative therapy compared to those receiving the placebo drug or placebo manipulative therapy.

237 of the 240 patients either recovered or were censored* 12 weeks after randomization. Even though 22 patients experienced possible undesirable side-effects, such as gastrointestinal disturbance, dizziness and heart palpitations, they were evenly spread across the placebo and non-placebo groups.

“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,” the researchers wrote.

“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,” they concluded.

Accompanying Comment

“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,” Dr Bart Koes, Department of General Practice, Erasmus University Medical Centre, Rotterdam, Netherlands, wrote.

Dr. Koes concluded “The important message is that the management of acute low back pain in primary care (advice and prescription of paracetamol) is sufficient for most patients.”

*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.

“Assessment of diclofenac or spinal manipulative therapy, or both, in addition to recommended firstline treatment for acute low back pain”
M J Hancock
The Lancet

Written by׃ Christian Nordqvist