Shoe stiffening inserts for pain of the big toe joint of the foot

INTERVENTION: Full‐length shoe stiffening inserts (intervention group): Participants will be provided with a single (or pair if symptoms are bilateral) of full‐length shoe stiffening inserts at the baseline assessment. The shoe stiffening inserts are commercially available and are fabricated from 1.5 mm thick semi‐rigid pre‐pregnated carbon (Carbon Fibre Spring Plate, Paris Orthotics Ltd, Vancouver, Canada) with the following design characteristics: (i) full length that extends from the heel to the tip of the toes, (ii) no arch build‐up or contour at the heel, and (iii) contoured design from the posterior to anterior aspect to allow for the toe spring and heel elevation of footwear. To maximise comfort and adherence, the inserts will be covered with 3.2 mm PPT [Registered Trademark] with an Ultralux top layer (PPT2 809 Blue). Cambrelle [Registered Trademark] (Camtex Fabrics Ltd, United Kingdom) will also be applied to the underside of the insert to increase the durability of the insert and to make the insert appear identical to the sham insert.. Participants will be advised to wear the inserts as much as possible during the duration of the study (52 weeks). Rehabilitation therapy: Both groups will receive a standardised program of physical / rehabilitation therapy. This will be a home‐based program self‐administered by the participant daily for approximately 30 minutes for 12 weeks, then 3 times per week for the remaining 40 weeks of the trial. Each therapy session will involve: (i) application of a heat pack for 10 minutes, followed by (ii) self‐mobilisation of the first metatarsophalangeal joint for 2 minutes (distraction and gliding), (iii) toe flexor strengthening exercises (1 set of 10 isometric contractions each held for 10 seconds), and concluding with (iv) application of a cold pack (10 minutes). If the condition is bilateral, both feet will be treated. During the baseline assessment, participants will be instructed to perform the exercises correctly and this will be reviewed at 1 and 12 weeks by research personnel blinded to group allocation.. Participants will be provided with all necessary equipment, along with an instruction booklet, so that the exercise program can be performed unsupervised at home. After the 12 week review, participants will be telephoned at monthly intervals by research personnel blinded to group allocation to remind them to perform the therapy (to maximise adherence). Adherence to the interventions (shoe inserts and rehabilitation therapy) in both groups will be assessed at monthly intervals up to 52 weeks via postal survey. For the shoe insert interventions, participants will provide information regarding the number of hours per day and number of days they have worn their inserts during the previous 4 weeks. For the rehabilitation therapy intervention, participants will provide information regarding the average number of days per week they have performed their exercises during the previous 4 weeks CONDITION: Osteoarthritis of the first metatarsophalangeal joint PRIMARY OUTCOME: Foot pain domain of the Foot Health Status Questionnaire SECONDARY OUTCOME: Adherence to the interventions (shoe inserts and rehabilitation therapy) via postal survey. For the shoe insert interventions, participants will provide information regarding the number of hours per day and number of days they have worn their inserts during the previous 4 weeks. For the rehabilitation therapy intervention, participants will provide information regarding the average number of days per week they have performed their exercises during the previous 4 weeks. Adverse events (such as new pains in the body, rolled ankles, blisters, swelling) will be assessed via postal survey. The survey has been specifically designed for this study. Foot‐related disability (foot function domain of the Foot Health Status Questionnaire). General health‐related quality of life (using the EuroQol [EQ‐5D] questionnaire. General health‐related quality of life (using the Short‐Form‐12 Version 2 questionnaire). Level of physical activity (using the using the Incidental and Planned Exercise Questionnaire). Self‐reported magnitude of symptom change (using a 15‐point Likert scale where the responses range from “A very great deal better” to “A very great deal worse”). This variable will then be dichotomised into the categories of ‘effective’ (‘a very great deal better’, ‘a great deal better’, ‘a good deal better’, ‘moderately better’) and ‘ineffective’ ('somewhat better', ‘a little better’, ‘about the same, hardly any better at all’, ‘no change’, 'about the same, hardly any worse at all’, ‘a little worse’, ‘somewhat worse’, ‘moderately worse’, ‘a good deal worse’, ‘a great deal worse’, ‘a very great deal worse’). Severity of pain at the first metatarsophalangeal joint during rest over the past week (via a 100 mm VAS). Severity of pain at the first metatarsophalangeal joint while walking over a flat surface over the past week (via a 100 mm VAS). Use of paracetamol rescue medication and co‐interventions to relieve pain at the first metatarsophalangeal joint will be assessed via a medications consumption diary and postal survey. These surveys have been specifically designed for this study. INCLUSION CRITERIA: (i) Aged at least 18 years, (ii) report having pain in the first metatarsophalangeal joint (MTPJ) on most days for at least 12 weeks, (iii) report having pain rated at least 30 mm on a 100 mm visual analogue scale (VAS), (iv) have pain upon palpation of the dorsal aspect of the first MTPJ and restricted first MTPJ dorsiflexion (less than 64 degrees of dorsiflexion range of motion), (v) be able to walk household distances (>50 meters) without the aid of a walker, crutches or cane, (vi) be willing to have their foot x‐rayed, (vii) be willing to attempt to not receive additional interventions (such as shoe modifications, physiotherapy, foot orthoses, intra‐articular injections, or surgery) for the first MTPJ pain during the course of the study, (viii) be able to reach feet to perform ‘rehabilitation therapy’ of the first MTPJ, and (ix) be willing to attempt to discontinue consuming any pain relieving medications for first MTPJ OA (except paracetamol [up to 4 grams per