None listed
Conditions
Brief summary
The primary aim of this research project is to compare the effectiveness of heel lift shoe inserts versus rehabilitation therapy (calf muscle eccentric exercise) for the treatment of Achilles tendinopathy. This study is a parallel group, pragmatic randomised controlled trial with a 12 week follow-up. Participants will be randomised to receive treatment with heel lift shoe inserts (Clearly Adjustable®) or a calf muscle eccentric exercise program. Primary and secondary measures will be collected at baseline and at 2, 6 and 12 weeks. The primary outcome measure will be the total score of the Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire. Secondary measures will include Achilles tendon structure (assessed using ultrasound imaging), calf muscle function, self-reported global change in symptoms, severity of pain at the Achilles tendon during the previous week, self-reported physical activity, health-related quality of life, as well as use of paracetamol rescue medication and co-interventions.
Interventions
Heel lifts (experimental group): participants randomised to the heel lift group will be provided with three pairs of Clearly adjustable [Registered Trademark] heel lift shoe inserts at the baseline assessment. The heel lifts are 12 mm in height and made from a firm multi-layered vinyl that conforms to the shape of the foot. Three sizes are available (small, medium or large) and will be issued according to the participants' shoe size. The heel lifts are commercially available and will be covered
Heel lifts (experimental group): participants randomised to the heel lift group will be provided with three pairs of Clearly adjustable [Registered Trademark] heel lift shoe inserts at the baseline assessment. The heel lifts are 12 mm in height and made from a firm multi-layered vinyl that conforms to the shape of the foot. Three sizes are available (small, medium or large) and will be issued according to the participants' shoe size. The heel lifts are commercially available and will be covered with an 3.2 mm PPT [Registered Trademark] with an Ultralux top cover to maximise comfort and adherence. Participants will be advised to wear the heel lifts as much as possible during the study (12 weeks). A handout containing instructions about the heel lifts will also be provided to participants. Both groups will receive a modified activity program where participants will be allowed to continue with the activities that they normally have been doing provided that the amount of pain they experience in the Achilles tendon(s) does not exceed level 5 on a pain scale, where 0 is ‘no pain’ and 10 is ‘worst pain imaginable’ - during the exercise/activity. The pain after activity is allowed to reach 5 on the pain scale but should have subsided by the following morning. During activity, if the pain in the Achilles tendon increases to 6 or more on a pain scale, the participant will need to reduce their activity (if possible) so that it is less then level 6 on a pain scale. Adherence to the intervention will be measured at 2, 6 and 12 weeks, where 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.
Sponsors
La Trobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be included in this study, participants must meet the following inclusion criteria: (i) Aged 18 years or greater. (ii) Achilles tendon pain present in one or both lower limb(s) for a minimum of 2 months. (iii) Report having average daily pain during the past week rated at least 3 out of 10 on a numerical rating scale. (iv) Mid-portion Achilles tendinopathy in one or both lower limb(s). Mid-portion Achilles tendinopathy will be diagnosed based on a clinical assessment and musculoskeletal ultrasound. Respondents will be included in this study if they meet the following criteria: (a) insidious onset of pain in the region of the Achilles tendon, aggravated by weight bearing activity; (b) pain located 2 to 6 cm proximal to the Achilles tendon insertion upon palpation by the investigator; (c) musculoskeletal ultrasound of the Achilles tendon showing local thickening, irregular fibre orientation or hypoechoic areas; (v) Literate in English and able to complete the questionnaires used in this study (such as the primary outcome measure - Victorian Institute of Sport Assessment – Achilles (VISA-A) questionnaire). (vi) Regularly use footwear that can accommodate a heel lift of 12 mm height. (vii) Able to walk household distances (more than 50 m) without the aid of a walker, crutches or cane. (viii) Willing to attempt to not receive additional treatments (such as shoe modifications, physiotherapy, foot orthoses/bracing, injections, or surgery) for the Achilles pain during the course of the study (12 weeks). (ix) Willing to attempt to discontinue taking all pain-relieving medications to relieve pain for the Achilles tendon(s) (except paracetamol) for at least 14 days prior to the initial assessment and during the study period (12 weeks). (ix) Willing to attend the Health Sciences Clinic at La Trobe University (Melbourne, Victoria) for an assessment on three occasions and complete and complete and return a postal questionnaire on one occasion.
Exclusion criteria
Exclusion criteria for participants in this study will be: (i) Currently pregnant. (ii) Previous Achilles tendon surgery in the symptomatic lower limb(s). (iii) Previous Achilles tendon rupture in the symptomatic lower limb(s). (iv) Chronic ankle instability. (v) Conditions of the Achilles tendon / ankle region that are not mid-portion Achilles tendinopathy such as ankle osteoarthritis, impingement syndrome, insertional Achilles tendinopathy, Achilles paratenonitis. (vi) Inflammatory arthritis (e.g. ankylosing spondylitis). (vii) Metabolic or endocrine disorders (e.g. type I or type II diabetes). (viii) Neurological disorders (e.g. Charcot-Marie-Tooth disease). (ix) Previous breast cancer and/or use of oestrogen inhibitors. (x) Treatment with heel lifts or calf muscle eccentric exercise within the previous three months. (xi) Use of fluoroquinolone antibiotics within the previous two years. (xii) Injection of local anaesthetic, corticosteroid or other pharmaceutical agent into the Achilles tendon or surrounding area within the previous three months. (xiii) Any medical condition that, in the opinion of the investigators, makes the participant unsuitable for inclusion (e.g. clinically important pain in the musculoskeletal system other than the Achilles tendon). (xiv) Cognitive impairment (defined as a score of <7 on the Short Portable Mental Status Questionnaire).
Outcome results
None listed