None listed
Conditions
Brief summary
Achilles tendinopathy is a common condition that can cause marked pain and disability. Numerous non-surgical treatments have been proposed for the treatment of this condition, but many of these treatments have a poor or non-existent evidence base. This study is a randomised trial to evaluate the efficacy of customised foot orthoses to reduce pain and improve function in people with Achilles tendinopathy.
Interventions
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)
Sponsors
Shannon Munteanu
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No
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: (i) Insidious onset of pain in the Achilles tendon region that is aggravated by weightbearing activities and worse in the morning, and/or during the initial stages of weightbearing activities; (ii) Pain and swelling located 2-6 cm proximal to the Achilles tendon insertion (as described by patient and palpated by the investigator); (iii) Musculoskeletal ultrasound imaging of the Achilles tendon showing local thickening (anterior-posterior) and/or irregular fibre orientation and/or irregular tendon structure with hypoechoic areas an d/or vascularisation within the mid-portion of the Achilles tendon.
Exclusion criteria
Exclusion criteria for participants in this study will be: (i) Previous Achilles tendon surgery in the symptomatic lower limb; (ii) Previous Achilles tendon rupture in the symptomatic lower limb; (iii) Previous lower limb trauma that has caused structural imbalance (e.g. ankle fracture); (iv) Osseous abnormality of the ankle (e.g. anterior or posterior tibio-talar osteophytes); (v) Inflammatory arthritis (e.g. ankylosing spondylitis); (vi) Metabolic or endocrine disorders (e.g. type I or II diabetes); (vii) Neurological disorders (e.g. Charcot-Marie-Tooth disease); (viii) Previous breast cancer and/or use of oestrogen inhibitors; (ix) Treatment with foot orthoses, heel lifts or eccentric calf muscle exercises within the previous 3 months; (x) Disorders of the Achilles tendon that are not mid-portion tendinopathy (such as paratendinitis and insertional Achilles tendon disorders); (xi) Taken fluoroquinolones within previous 2 years; (xii) Injection of local anaesthetic or cortisone or other pharmaceutical agents into the Achilles tendon or surrounding area within the previous 3 months; (xiii) Injury or pathology of the foot, knee, hip and/or back or any condition that, in the opinion of the investigators, may interfere with participation in the study.
Outcome results
None listed