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Exercise interventions for persistent non-specific low back pain: does matching outcomes to treatment targets make a difference? A systematic review and meta-analysis

The upshot

In exercise RCTs for persistent non-specific low back pain, does matching the primary outcome to the intervention's stated treatment targets produce larger measured effects than leaving them unmatched?

This exploratory systematic review asked whether matching a trial's primary outcome to the stated treatment targets of exercise changes how large the benefit looks in low back pain RCTs. Trials that matched their outcome to their targets showed a moderate effect (SMD 0.54) versus a smaller effect in unmatched trials (SMD 0.22), and matched trials were far more likely to report statistically significant benefit. However, the difference between matched and unmatched groups was not statistically significant (P = 0.10), so the authors stress this is hypothesis-generating, not confirmatory.

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Meta-analysis5,870 ParticipantsLimited evidence

Key points

  1. A treatment target is what an exercise program is actually trying to change (for example trunk stability or flexibility), and a matched outcome is one that measures exactly that.
  2. Only 7 of 27 trials (26%) matched their primary outcome to their treatment targets, and 19 of 31 identified targets appeared in just a single trial, showing little consensus on what exercise is meant to do.
  3. Matched trials had a moderate effect (SMD 0.54, 95% CI 0.23 to 0.85) versus a small to moderate effect in unmatched trials (SMD 0.22, 95% CI 0.01 to 0.44).
  4. The head-to-head difference between matched and unmatched groups was not significant (P = 0.10) and heterogeneity was very high (I2 92% to 95%), so the matching signal is suggestive only.
  5. The authors conclude exercise effectiveness may currently be underestimated if outcomes are poorly aligned to targets, but larger datasets are needed to confirm this.

How it was conducted

Design
Systematic review and meta-analysis of RCTs (PROSPERO CRD42017072023), exploratory matching analysis
Search
Eight databases to August 2019; 19,272 records screened, 27 RCTs included (5,870 participants), each powered for at least a moderate effect (>60 per arm)
Intervention
Supervised or tailored exercise for persistent NSLBP (symptoms >12 weeks) versus non-exercise comparators (usual care, placebo, brief intervention, or waitlist)
Outcomes
Standardised mean difference of exercise versus control at the primary time point, with trials classed as matched or unmatched to stated treatment targets
Analysis
Random-effects meta-analysis (RevMan 5.3) with subgroup, ratio-of-means sensitivity analyses, and Cochrane risk of bias

What they found

  • Matched trials (7 trials): pooled SMD 0.54 (95% CI 0.23 to 0.85), P = 0.0006, favoring exercise versus non-exercise controls.
  • Unmatched trials (20 trials): pooled SMD 0.22 (95% CI 0.01 to 0.44), P = 0.04.
  • Difference between matched and unmatched groups not significant (P = 0.10; prediction interval -0.12 to 0.76); overall pooled SMD across all 27 trials was 0.31 (95% CI 0.14 to 0.47).
  • Statistically significant benefit was reported in 5 of 7 matched trials (71%) versus only 4 of 20 unmatched trials (20%).
  • Pain sensitivity analysis: matched mean improvement 1.79 points (95% CI 0.11 to 3.46) versus unmatched 0.65 (95% CI 0.08 to 1.08); subgroup difference not significant (P = 0.20), heterogeneity I2 98%.

Limitations

  • The between-group difference was not statistically significant and the review was underpowered to detect one, so findings are exploratory.
  • Heterogeneity was very high (I2 92% to 95%) given the wide range of exercise types and populations pooled.
  • Almost all included trials were judged high risk of bias, mainly from lack of blinding, and only 6 of 27 met at least 5 risk of bias domains.
  • Classifying trials as matched or unmatched was a subjective, non-validated process, and trials that did match but did not state it would have been miscounted as unmatched.

Why it matters

For patients
Exercise for ongoing low back pain may help more than headline trial numbers suggest, especially when the program is measured against what it is actually trying to improve.
For clinicians
Be clear about what an exercise program is targeting and track an outcome that reflects that target, rather than defaulting to a single generic pain or function score.
For readers
How well a trial's outcome matches the intervention's goal may shape whether exercise looks effective, a methodological issue worth watching in future RCT design.

Source

doi:10.1016/j.jpain.2020.04.002

Read the original paper
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