Self-management advice, exercise and foot orthoses for plantar heel pain: the TREADON pilot and feasibility randomised trial

Abstract Background Plantar heel pain (PHP) is common and impacts negatively on physical function quality of life. Initial treatment usually comprises analgesia self-management advice (SMA), with referral to a physiotherapist or podiatrist recommended only when symptoms persist. Systematic reviews highlight limitations existing evidence for the effectiveness exercises orthoses. The objective TREADON pilot feasibility trial was inform design future main compare clinical cost-effectiveness individualised foot orthoses PHP. Methods This four-arm randomised 12-week follow-up. Adults aged ≥ 18 years PHP were identified from primary care by general practice consultation, retrospective medical record review population survey. Participants either (i) SMA, (ii) SMA plus (SMA-exercises), (iii) prefabricated (SMA-orthoses) (iv) combined (SMA-combined). Feasibility outcomes recruitment; retention; intervention adherence, credibility satisfaction; performance three potential outcome measures (pain numeric rating scale (NRS), Foot Function Index-pain subscale (FFI-pain), Manchester Pain Disability (MFPDI-pain)); parameters informing sample size calculation. Results Eighty-two participants recruited. All identification methods met target number participants. Retention at 12 weeks 67%. interventions successfully delivered as per protocol. Adherence (range over 64–100%) (93%) highest in SMA-combined arm. Satisfaction higher clinician-supported (SMA 29%, SMA-exercises 72%, SMA-orthoses 71%, 73%). Responsiveness (baseline weeks) FFI-pain (standardised response mean 0.96) NRS (1.04) than MFPDI-pain (0.57). Conservative parameter estimates standard deviation 2.5, 25 4, baseline-outcome correlations 0.5–0.6, 0.4 < 0.3, respectively. Conclusions We demonstrated conducting comparing and/or Trial registration ISRCTN 12160508 . Prospectively registered 5 th July 2016.