The smallest worthwhile effect of nonsteroidal anti-inflammatory drugs and physiotherapy for chronic low back pain: a benefit-harm trade-off study

J Clin Epidemiol. 2013 Dec;66(12):1397-404. doi: 10.1016/j.jclinepi.2013.02.018. Epub 2013 Sep 8.


Objective: The aim of this study was to determine the smallest worthwhile effects of two treatments for nonspecific low back pain (LBP).

Study design and setting: The benefit-harm trade-off method was used to estimate the smallest worthwhile effect of nonsteroidal anti-inflammatory drugs (NSAIDs) and physiotherapy for LBP. Patients seeking care for chronic LBP were interviewed by telephone before treatment commenced and 4 weeks later.

Results: Patients need to see a median of 30% (interquartile range [IQR]: 10-40) more improvement in pain and 20% (IQR: 10-40) more improvement in disability than would occur without intervention to perceive the effect of NSAIDs are worthwhile. They would need to see 20% (IQR: 0-30) more improvement on pain and disability over natural recovery to perceive that the effect of physiotherapy was worthwhile. There was no difference in estimates of the smallest worthwhile effect elicited at baseline and 4 weeks later.

Conclusions: People with chronic back pain need to see larger effects on pain of NSAIDS than physiotherapy to consider the effects of these interventions worthwhile. These estimates of the smallest worthwhile effect can be used to interpret the findings of clinical trials and to design adequately powered clinical trials.

Keywords: Clinical trials; Drug therapy; Low back pain; Minimum clinically important difference; Research design; Sufficiently important difference.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
  • Chronic Pain / drug therapy
  • Chronic Pain / therapy*
  • Combined Modality Therapy
  • Female
  • Follow-Up Studies
  • Humans
  • Low Back Pain / drug therapy
  • Low Back Pain / therapy*
  • Male
  • Middle Aged
  • Physical Therapy Modalities* / adverse effects
  • Qualitative Research
  • Risk Assessment
  • Treatment Outcome


  • Anti-Inflammatory Agents, Non-Steroidal