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临床试验/ACTRN12623000721606
ACTRN12623000721606已完成Unknown

Efficacy of heel lifts for insertional Achilles tendinopathy: a randomised pilot and feasibility trial

Monash University0 个研究点目标入组 26 人开始时间: 2023年7月5日最近更新:
适应症

试验速览

阶段
Unknown
状态
已完成
入组人数
26

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 65 Years(—)
性别
All

入选标准

  • 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.

排除标准

  • 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)

研究者

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