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Evid Based Med 13:75 doi:10.1136/ebm.13.3.75
  • Therapeutics

Adjunctive diclofenac and spinal manipulation did not speed recovery of acute low back pain

Mr M J Hancock

Correspondence to: Mr M J Hancock, University of Sydney, Sydney, New South Wales, Australia; m.hancock{at}usyd.edu.au

STUDY DESIGN

Design:

randomised placebo controlled trial.

Allocation:

concealed.*

Blinding:

blinded (patients, physicians, physiotherapists [to diclofenac only], outcome assessors, {data collectors, data analysts, data safety and monitoring committee}†).*

STUDY QUESTION

Setting:

general practitioner (GP) offices in Sydney, New South Wales, Australia.

Patients:

240 patients (mean age 41 y, 56% men) who had low back pain (moderate pain between 12th rib and buttock crease), with or without leg pain, causing moderate disability for <6 weeks. Exclusion criteria included episode of pain not preceded by a pain-free period of ⩾1 month, serious spinal pathology, and nerve root compromise.

Intervention:

(i) spinal manipulation (SM; 2 or 3 sessions/wk) and diclofenac, 50 mg twice/daily (n = 60); (ii) placebo SM (detuned pulsed ultrasound) and diclofenac (n = 60); (iii) SM and placebo (n = 60); or (iv) double placebo (n = 60). See supplementary data.

Outcomes:

number of days to recovery (defined as first pain-free day [pain score 0 or 1 out of 10]. Secondary outcomes included pain (score 0–10) and disability (24-point Roland Morris Disability Questionnaire). The study had 80% power to detect a 20% difference in recovery rates (α = 0.05).

Follow-up period:

12 weeks.

Patient follow-up:

98% (intention-to-treat).

MAIN RESULTS

The table shows the results.

CONCLUSION

For adults with acute low back pain, diclofenac and spinal manipulation did not add any benefit beyond paracetamol and advice.

*See glossary.

†Information provided by author.

ABSTRACTED FROM

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;370:1638–43.

Additional data are published online only at http://ebm.bmj.com/content/vol13/issue3.

Diclofenac 50 mg twice daily (NSAID) v spinal manipulation (SM) for acute low back pain*

Clinical impact ratings: GP/FP/Primary care 6/7; Physical medicine & rehabilitation 6/7; Surgery—orthopaedics 6/7

Footnotes

  • Source of funding: National Health and Medical Research Council.

Commentary

Despite this article's title, the study by Hancock et al shows that spinal mobilisation and diclofenac do not add benefit to standard therapy for acute low back pain. The beauty of this study is its “add-on” design1 and its use of time to recovery as an outcome measure. The design does not address whether these interventions are better than placebo but, more importantly, addresses whether they improve standard care. The authors’ choice of outcome excludes the possibility of meaningful short-term benefit.

We should not generalise these results and state that spinal manipulation has no benefit. I disagree with assertions by Hancock et al and by Koes2 that a previous Cochrane review equates the effectiveness of mobilisation and manipulation.3 The only trial in the Cochrane review that directly compared these interventions had 54 patients with acute low back pain, of whom 26 received mobilisation as their sham treatment.4 In this trial, manipulation led to quicker recovery than mobilisation, although it was not clear whether mobilisation was studied under optimal use.

We still need a trial of manipulation as an add-on therapy. Unanswered questions from previous trials are (i) does manipulation lead to beneficial short-term outcomes such as reduction in medication use?3 (ii) Are there subgroups of patients most likely to benefit?5 (iii) Does the degree of enthusiasm and confidence of the operator who performs manipulation (as measured by how often the operator chooses manipulation among alternative options) alter the effectiveness and quality of the intervention?6

I am not saying that manipulation is definitely effective but rather that it remains inadequately studied.

References

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