Heel lift inserts for insertional Achilles tendinopathy

Not Applicable

Completed

• Conditions: Insertional Achilles tendinopathy; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12623000721606
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-05
• Study Completion: 2024-06-30
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 26

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified