Efficacy of customised foot orthoses in the treatment of Achilles tendinopathy

INTERVENTION: Custom foot orthoses (made from semi‐rigid polypropylene) worn for the study duration (12 months) combined with a 12 week calf muscle eccentric exercise program (3 sets of 15 repetitions performed with knee straight then flexed, twice daily, seven days per week at home) CONDITION: Achilles tendinopathy PRIMARY OUTCOME: Total score of the Victorian Institute of Sport Assessment ‐ Achilles (VISA‐A questionnaire) which is made up of pain, function and activity sub‐domains INCLUSION CRITERIA: To be included in the study, participants must meet the following INCLUSION CRITERIA: (i) Aged 18 to 55 years; (ii) Have symptoms in the Achilles tendon of one or both lower limbs for at least 3 months duration; (iii) Be literate in English and able to complete the Victorian Institute of Sport ‐ Achilles (VISA‐A) questionnaire; (iv) Score less than 80 on the VISA‐A questionnaire; (v) Regularly use footwear that can accommodate customised foot orthoses. This is defined as using footwear that can accommo date foot orthoses for at least 90% of the time during weightbearing activities; (vi) Be willing to not receive any physical therapy on the involved Achilles tendon(s) or trial of foot orthoses or bracing (other than those allocated in the current study) during the study period. Achilles tendinopathy will be diagnosed from a clinical assessment as well as from a musculoskeletal ultrasound assessment using the following criteria: SECONDARY OUTCOME: Co‐interventions: The number of participants who consume rescue medication (i.e., paracetamol) and mean consumption of rescue medication to relieve pain at the Achilles tendon(s) (mean grams of paracetamol/participant/month] will be assessed using a medications diary that participants will self‐complete. A questionnaire regarding the use of other treatments to relieve pain at the Achilles tendon(s) by participants will be completed . Other treatments will include oral non‐steroidal anti‐inflammatory medication, visits to health‐care practitioners (general practitioners, specialists and allied health professionals such as physiotherapists and podiatrists), changes to foot orthoses or wedging, massage, acupuncture, complementary medicine (such as osteopaths and naturopaths), topical medicaments (such as rubefacients or topical non‐steroidal anti‐inflammatory medication), taping or bracing. Participants will also be questioned to determine if they have changed their footwear they normally wear (worn for everyday or sporting activities) to accommodate their foot orthoses. Comfort of the interventions (customised foot orthoses and sham foot orthoses): The comfort of the customised foot orthoses and sham foot orthoses will be assessed using a 150 mm visual analogue scale with the left end of the scale (0 mm) labelled not comfortable at all and the right end of the scale (150 mm) labelled most comfortable imaginable. Participants will be asked to indicate the comfort of their shoe inserts compared to when they are not in their shoes, the further the right the more comfortable the shoe inserts. Frequency and severity of adverse events: The frequency (number of participants affected and number of cases), types (including rubbing or blistering of the feet or ankles, pain in the feet, lower limbs or other part(s) of the body) and severity (mild, moderate or severe as rated by the participant) of adverse events in each intervention group during the trial will be recorded using a questionnaire that participants will complete at 1, 3, 6 and 12 months. An open‐response type format will also be available for participant responses. Health‐related quality of life: The Short‐Form‐36 (Version two) questionnaire will be used to assess health‐related quality of life. Level of physical activity in the previous week: The level of physical activity in the previous week will be evaluated with a questionnaire, the 7‐day Recall Physical Activity Questionnaire . This questionnaire records all physical activities (work as well as leisure and household activities) during the preceding week. The questionnaire involves quantifying the time (hours) spent in moderate, hard and very hard activities during the preceding 7 days. The time (hours) spent in each activity is then multiplied by its metabolic equivalent (MET) where 1 MET is the energy expended by a person while sitting at rest (equal to 1 kilocalorie per kilogram per hour). The total calories (kilocalories) of energy expended per kilogram of body weight can then be calculated. Kilocalories per day (for the participant) can then be derived by multiplying the kilocalories per kilogram by the participant's body weight and dividing this by 7. Participant perception of treatment effect: The perception of treatment effect (5‐point Likert scale: marked worsening, moderate worsening, same, moderate improvement, and marked improvement). Responses will then be dichotomised according to success, where 'success' is defined as marked or moderate improvement on this scale