None listed
Conditions
Brief summary
Primary aim is to evaluate the feasibility of conducting a randomised trial comparing heel lifts to a sham heel lift for reducing pain associated with insertional Achilles tendinopathy. Secondary aim is to obtain statistical parameters to inform the main trial sample size calculation and provide a signal of efficacy to justify the future main trial. Hypothesis: Heel lifts will lead to superior outcomes to a sham innersoles for insertional Achilles tendinopathy and a full-powered trial will be feasible.
Interventions
Heel lifts (intervention group): Participants allocated to the intervention group will be given a pair of commercially available heel lifts (Clearly Adjustable) for bilateral use. The heel lifts are 12 mm in height and made from firm (Shore A 90) multi-layered clear vinyl. To maximise comfort, a 3.2 mm PPT Ultralux top cover will be adhered to the top surface. The heel lifts will be reduced in 1 mm increments if required (e.g., heel slippage) and the final height will be recorded at baseline. Small, medium, and large heel lifts will be available and issued according to the participant’s shoe size. Participants will be asked to wear them for at least 8 hours every day for 12 weeks. Education: Both groups will be asked to maintain their regular activities/occupations (rather than complete rest), provided the amount of pain they experience in the Achilles tendon pain does not exceed a score of 5 on a 0–10 pain scale, where 0 is no pain and 10 is worst pain imaginable during exercise/activity. The pain after usual physical activities can reach a 5 on the pain scale but should subside by the following morning. During activity, if the pain in the Achilles tendon exceeds 5 on the pain scale participants will need to reduce their activity/exercise (if possible). There will be a 20-minute session at baseline where a trial investigator (JB) will demonstrate how to use the heel lifts, provide participants with their education, and answer any questions they possess. In addition, the participants will receive a handout containing instructions about the shoe inserts and education, which has been designed specifically for the study. Adherence to the intervention (heel lifts) in both groups will be assessed at monthly intervals up to 12 weeks via REDCap surveys. Participants will provide information regarding the average number of hours per day and number of days they have worn their intervention during the previous 4 weeks.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
i) Aged 18 to 65 years ii) Symptoms of insertional Achilles tendinopathy in one or both lower limb(s) for > 6 weeks iii) Report maximum Achilles tendon pain severity experienced over the past week that is > 3 out of 10 (using a numerical pain rating scale) iv) Regularly use footwear that can accommodate at least 10 mm heel lifts. This is defined as using footwear that can accommodate heel lifts for at least eight hours per day v) Be literate in English and able to complete the questionnaires used in this trial (e.g., VISA-A questionnaire) vi) Be willing to not receive any treatment on the involved Achilles tendon(s) (other than those allocated in the current study) during the study period vii) Be willing and able to attend Victoria University (Melbourne, Australia) on one occasion for assessment Clinical diagnosis of insertional Achilles tendinopathy based on the following criteria: a) Report pain in the Achilles tendon during or after weight-bearing activities including walking, running or jumping/hopping b) Pain in the distal 2 cm Achilles tendon insertion (as described by the patient and palpated by the investigator) c) Gray-scale musculoskeletal ultrasound of the Achilles tendon(s) showing diffuse or local thickening (anterior-posterior) and/or irregular fibre orientation and/or hypoechoic areas within the insertion of the Achilles tendon.
Exclusion criteria
i) Currently pregnant ii) Achilles tendon disorders that are not insertional (e.g., mid-portion Achilles tendinopathy) iii) Previous Achilles tendon rupture or surgery in the symptomatic lower limb iv) Injury or pathology of the lower limb and/or back or any condition that, in the opinion of the investigators, may interfere with participation in the study (e.g., chronic ankle instability) v) Concurrent conditions (ankle or other region) that are more severe (pain numerical rating scale) than their worst insertional Achilles tendinopathy pain vi) Treatment with foot orthoses or heel lifts within the previous three months vii) Previous breast cancer/and or use of oestrogen inhibitors viii) Inflammatory arthritis (e.g., psoriatic arthritis) ix) Neurological disorders (e.g., Charcot-Marie-Tooth disease) x) Taken fluoroquinolones within the previous two years xi) Any injection (e.g., corticosteroid) into the Achilles tendon or surrounding area in the previous three months xii) Any medical condition that deems a participant unsuitable, based on the opinion of the investigators (e.g., type I or II diabetes)
Outcome results
None listed