Moderators and mediators of effects of unloading shoes on knee pain in people with knee osteoarthritis: An exploratory analysis of the SHARK randomised controlled trial

K. L. Paterson, J. Kasza, K. L. Bennell, T. V. Wrigley, B. R. Metcalf, P. K. Campbell, D. J. Hunter, R. S. Hinman

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10 Citations (Scopus)


Objective: To investigate moderators and biomechanical mediators of effects of unloading shoes on knee pain in people with knee osteoarthritis (OA). Methods: Exploratory analysis from 164 participants in a clinical trial comparing unloading (ASICS GEL-Melbourne OA) to conventional walking shoes. The primary outcome was 6-month change in knee pain (11-point numerical rating scale (NRS)). Moderators included baseline peak knee adduction moment (KAM), radiographic severity (Kellgren & Lawrence (KL) scale), body mass, foot posture, neuropathic pain and diffuse knee pain. Mediators included change in peak KAM and KAM impulse. Results: Radiographic severity was the only moderator to interact with footwear group (P = 0.02). Participants with KL = 2 experienced greater pain reductions with conventional compared to unloading shoes (mean difference in change in pain -1.64 units, 95% CI -3.07, -0.21), while unloading shoes tended to result in greater pain reductions than conventional shoes in KL = 3 (0.98, 95% CI -0.44, 2.39) and KL = 4 (0.64, 95% CI -0.64, 1.93). No variable showed any significant mediating effect in the entire cohort. However, there was some evidence that unloading shoes may reduce pain through reductions in peak KAM (indirect effect -0.31, 95% CIs -0.65, 0.03; P = 0.07) in people with KL ≥ 3, compared to conventional shoes. Conclusion: Unloading shoes conferred additional symptomatic benefits over conventional shoes in people with moderate to severe knee OA. There was some evidence effects may be mediated by a reduction in peak KAM. However, we were underpowered for subgroup analyses. These patients may represent a subgroup to which biomechanical interventions designed to reduce the KAM may be more effectively targeted.

Original languageEnglish
Pages (from-to)227-235
Number of pages9
JournalOsteoarthritis and Cartilage
Issue number2
Publication statusPublished - Feb 2018


  • Knee adduction moment
  • Mediators
  • Moderators
  • Osteoarthritis
  • Pain
  • Phenotype

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