Abstract
BackgroundMid-portion Achilles tendinopathy is a common musculoskeletal condition characterised by degeneration of the Achilles tendon, which causes pain and disability. Multiple non-surgical treatments have been advocated for this condition including calf muscle eccentric exercise and in-shoe heel lifts. Although adherence is challenging, there is evidence to suggest that calf muscle eccentric exercise is effective in decreasing pain and improving function in people with Achilles tendinopathy. Heel lifts reduce ankle joint dorsiflexion and Achilles tendon strain, however their efficacy in the management of Achilles tendinopathy is unclear. This article describes the design of a parallel-group randomised trial comparing the efficacy of heel lifts to calf muscle eccentric exercise for Achilles tendinopathy.MethodsNinety-two participants with Achilles tendinopathy will be randomised to one of two groups: (i) a heel lift group that will receive pre-fabricated 12 mm in-shoe heel lifts (Clearly Adjustable®), or (ii) an exercise group that will be advised to carry out a calf muscle eccentric exercise program (twice a day, 7 days a week, for 12 weeks). Outcome measures will be obtained at baseline, 2, 6 and 12 weeks; the primary endpoint for assessing efficacy being 12 weeks. The primary outcome measure will be the total score of the Victorian Institute of Sport Assessment – Achilles (VISA–A) questionnaire. Secondary outcome measures will include thickness and integrity of the Achilles tendon (using ultrasound tissue characterisation [UTC]), participant perception of treatment effect on pain and function (using the 7-point Patient Global Impression of Change scale), severity of pain at the Achilles tendon (using a 100 mm visual analogue scale) in the previous week, health status (using the EuroQol-5D-5L™ questionnaire), physical activity levels (using the 7-day Recall Physical Activity Questionnaire) and calf muscle function (using the standing heel rise test). Data will be analysed using the intention to treat principle.DiscussionThe HEALTHY trial (Heel lifts versus calf muscle eccentric Exercise for AchiLles TendinopatHY) is the first randomised trial to compare the efficacy of heel lifts to calf muscle eccentric exercise in reducing pain and improving function in people with Achilles tendinopathy. A pragmatically designed trial was developed to ensure that if the interventions are found to be effective, the findings can be readily implemented in clinical practice.Trial registrationAustralian New Zealand Clinical Trials Registry: ACTRN12617001225303. Registered on August 22nd, 2017.
Highlights
Mid-portion Achilles tendinopathy is a common musculoskeletal condition characterised by degeneration of the Achilles tendon, which causes pain and disability
Achilles tendinopathy is common in running populations with prevalence rates up to 9.5% [3] and a lifetime risk of 52% for top level runners [2]
For the heel lift group, participants will provide information regarding the average number of hours per day and number of days they have worn the heel lifts in the last 2, 4 and 6 weeks respectively
Summary
Mid-portion Achilles tendinopathy is a common musculoskeletal condition characterised by degeneration of the Achilles tendon, which causes pain and disability. Mid-portion Achilles tendinopathy is a common overuse soft tissue injury causing pain and stiffness with incidence rates reported to be 1.85 per 1000 people in the general population [1]. People with Achilles tendinopathy typically report symptoms of pain and stiffness upon weight bearing after prolonged rest [5] and at the start of physical activity, which reduces as the activity continues [5]. These symptoms lead to impaired performance [6]. Pain and disability can be persistent with functional activities such as walking [7]
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