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临床试验/ACTRN12609000829213
ACTRN12609000829213已完成未知

Efficacy of customised foot orthoses in improving pain, function and activity in people with Achilles tendinopathy undergoing an eccentric calf muscle exercise program

Shannon Munteanu0 个研究点目标入组 140 人开始时间: 2009年9月22日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
140

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
Prevention
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 55 Years(—)
性别
All

入选标准

  • To be included in the study, participants must meet the following inclusion criteria:
  • (i) Aged 18 to 55 years;
  • (ii) Have symptoms in the Achilles tendon of one or both lower limbs for at least 3 months duration;
  • (iii) Be literate in English and able to complete the Victorian Institute of Sport - Achilles (VISA-A) questionnaire;
  • (iv) Score less than 80 on the VISA-A questionnaire;
  • (v) Regularly use footwear that can accommodate customised foot orthoses. This is defined as using footwear that can accommo date foot orthoses for at least 90% of the time during weightbearing activities;
  • (vi) Be willing to not receive any physical therapy on the involved Achilles tendon(s) or trial of foot orthoses or bracing (other than those allocated in the current study) during the study period.
  • Achilles tendinopathy will be diagnosed from a clinical assessment as well as from a musculoskeletal ultrasound assessment using the following criteria:
  • (i) Insidious onset of pain in the Achilles tendon region that is aggravated by weightbearing activities and worse in the morning, and/or during the initial stages of weightbearing activities; (ii) Pain and swelling located 2-6 cm proximal to the Achilles tendon insertion (as described by patient and palpated by the investigator); (iii) Musculoskeletal ultrasound imaging of the Achilles tendon showing local thickening (anterior-posterior) and/or irregular fibre orientation and/or irregular tendon structure with hypoechoic areas an d/or vascularisation within the mid-portion of the Achilles tendon.

排除标准

  • Exclusion criteria for participants in this study will be:
  • (i)Previous Achilles tendon surgery in the symptomatic lower limb;
  • (ii)Previous Achilles tendon rupture in the symptomatic lower limb;
  • (iii)Previous lower limb trauma that has caused structural imbalance (e.g. ankle fracture);
  • (iv)Osseous abnormality of the ankle (e.g. anterior or posterior tibio-talar osteophytes);
  • (v)Inflammatory arthritis (e.g. ankylosing spondylitis);
  • (vi)Metabolic or endocrine disorders (e.g. type I or II diabetes);
  • (vii)Neurological disorders (e.g. Charcot-Marie-Tooth disease);
  • (viii)Previous breast cancer and/or use of oestrogen inhibitors;
  • (ix)Treatment with foot orthoses, heel lifts or eccentric calf muscle exercises within the previous 3 months;
  • (x)Disorders of the Achilles tendon that are not mid-portion tendinopathy (such as paratendinitis and insertional Achilles tendon disorders);
  • (xi)Taken fluoroquinolones within previous 2 years;
  • (xii)Injection of local anaesthetic or cortisone or other pharmaceutical agents into the Achilles tendon or surrounding area within the previous 3 months;
  • (xiii)Injury or pathology of the foot, knee, hip and/or back or any condition that, in the opinion of the investigators, may interfere with participation in the study.

研究者

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