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Low back pain (LBP) has a significant impact on the sufferer and society as a whole. Therefore, we read with great interest the Specific Treatment of Problems of the Spine (STOPS) trial1 suggesting that an individualised physiotherapy approach had a favourable outcome when compared with advice in a cohort of participants with LBP lasting for more than 6 weeks. These findings highlight important issues in the design and subsequent interpretation of randomised controlled trials (RCTs) in this area.
The primary purpose of RCTs is to determine if an intervention meaningfully improves clinical outcomes. This is realised by comparing the intervention with an appropriate control.2 To determine efficacy, the ideal control is a credible placebo, but this is often difficult to design for non-pharmacological treatments. Thus, an alternative intervention is frequently used as the control. This design does not estimate efficacy; rather, it compares whether one approach is superior to another. Therefore, it is possible for an intervention to be deemed effective when compared with a control for which outcomes are suboptimal. This is relevant in LBP clinical trials and in other …
Contributors All authors substantially contributed to the conception or design of the work, analysis and interpretation of the data, drafting the work, final approval of the version published and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.