SIMPLE (Shoe stIffening inserts for first MetatarsoPhaLangEal joint osteoarthritis) trial

The primary aim of this project is to evaluate the effectiveness of shoe stiffening inserts in the treatment of pain associated with osteoarthritis of the first metatarsophalangeal joint (MTPJ) of the foot. This study is a parallel group, participant- and assessor- blinded, randomised controlled trial with a 52 week follow-up. Ninety participants will be randomised to a control group (‘sham’ shoe inserts) or an experimental group (shoe stiffening insert(s). Both groups will be prescribed the same ‘rehabilitation therapy’ program. Primary and secondary outcome measures will be collected at baseline and at 4, 12, 26 and 52 weeks. The primary outcome measure will be the foot pain domain of the Foot Health Status Questionnaire (FHSQ). Secondary outcome measures will include foot-related disability, severity of foot pain when walking, self-reported magnitude of symptom change, level of physical activity, health-related quality of life, and use of paracetamol rescue medication and co-interventions.

Staff: Dr Shannon E Munteanu, A/Prof Karl B Landorf, Prof Hylton B Menz, Maria Auhl, Jamie Allan


Study protocol: