Interventions
orthosis, Epi-Hit®, pain
We allocated participants to receive either the OPTimisE intervention or usual physiotherapy care. We did not standardise usual care in this pragmatic trial but we recorded treatments received by participants, to allow comparison with the OPTimisE intervention. Physiotherapists providing usual care treatment had no restrictions on the treatments they could offer. Physiotherapists provided treatments for one intervention arm only, to minimise contamination. Those providing usual care did not receive training in the OPTimisE intervention.The OPTimisE intervention consisted of three elements: condition-specific and general health advice, supported by printed and online resources; a progressive exercise regime working within limits of pain deemed acceptable by individual patients; and the provision of a counter-force orthosis. Exercises were progressed when the existing exercise was no longer painful, or regressed if the exercise provoked unacceptable levels of pain. The OPTimisE Intervention Handbook is supplied as a supplementary file, providing full details of the intervention.At the first appointment, those in the OPTimisE arm were provided with a Patient Manual containing advice/education material, exercise instructions and a password to access online resources. Advice and education topics were then discussed with the physiotherapist. Participants were supplied with an orthosis (Epi-Hit® Classic), as a means of providing short-term symptomatic relief, and instructed how to fit it correctly, then taught an exercise regimen that they could progress or regress based upon their symptom response. Follow-up appointments, to review progress, discuss advice/education topics further and review/adjust exercises, were arranged at the discretion of the physiotherapist but guidance was that appointments should be spaced at least four weeks apart, as recommended by patients during the intervention design. Appointments could be face-to-face, online or by telephone.