Heel lift inserts for pain of the Achilles tendo

Not Applicable

Completed

• Conditions: Achilles tendinopathy; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12623000627651
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-07
• Study Completion: 2024-08-09
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

i)Aged 18 to 65 years
ii)Symptoms of mid-portion 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 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 mid-portion 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 Achilles tendon 2-6 cm proximal to the 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 mid-portion of the Achilles tendon.

Exclusion Criteria

i)Currently pregnant
ii)Previous Achilles tendon rupture or surgery in the symptomatic lower limb
iii)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)
iv)Concurrent conditions (ankle or other region) that are more severe (pain numerical rating scale) than their worst mid-portion Achilles tendinopathy pain
v)Treatment with foot orthoses or heel lifts within the previous three months
vi)Previous breast cancer/and or use of oestrogen inhibitors
vii)Inflammatory arthritis (e.g., psoriatic arthritis)
viii)Neurological disorders (e.g., Charcot-Marie-Tooth disease)
ix)Taken fluoroquinolones within the previous two years
x)Any injection (e.g., corticosteroid) into the Achilles tendon or surrounding area in the previous three months
xi)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

Primary Outcome Measures

Name	Time	Method
Pain intensity at its worst in the previous week using a 11-point numerical rating scale (NRS) with terminal descriptors of ‘no pain’ (score = 0) and ‘worst pain possible’ (score = 10).[ Baseline and 12 weeks post-commencement of the intervention. Twelve weeks is the primary time-point.]