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临床试验/ACTRN12619001455156
ACTRN12619001455156已完成未知

Efficacy of Tendon Strip Injections compared to sham following failure of conservative therapy for Achilles tendinopathy

Monash University0 个研究点目标入组 192 人开始时间: 2019年10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
192

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 o limit(—)
性别
All

入选标准

  • Previously trialled first line recommended treatment
  • Aged 18 years or above
  • more than 3 months of pain in the mid-portion Achilles area proximal to the Achilles
  • tendon insertion in the calcaneum)
  • Primary complaint of mid-portion Achilles pain on one or both lower limbs
  • VISA-A <75 points
  • Clinical diagnosis of mid-portion Achilles tendinopathy based on the following
  • o Gradual onset pain in the relevant area;
  • o Midportion Achilles pain during or after Achilles tendon loading activities (e.g. walking, running)
  • Ankle joint examination, and especially passive plantar-flexion is essentially normal,
  • Confirm diagnosis with ultrasound imaging of the Achilles tendon. One or more of the
  • following features present in the mid-portion area: (i) hypoechoic regions; and/or (ii)
  • Doppler signal indicative of vascularisation.

排除标准

  • Previous Achilles tendon surgery in the symptomatic lower limb(s)
  • Previous Achilles tendon rupture in the symptomatic lower limb(s)
  • Other ankle conditions including impingement syndrome, insertional Achilles tendinosis,
  • Achilles paratenonitis without tendinopathy
  • Tendinopathy caused by inflammatory conditions (e.g. ankylosing spondylitis)
  • Neurological disorders (i.e. Parkinson’s syndrome, stroke)
  • Inherited connective tissue disorders (i.e. Ehlers- Danlos syndrome, Marfan’s syndrome)
  • Use of fluoroquinolone antibiotics within the previous two years
  • Injection of local anaesthetic, corticosteroid, platelet rich plasma or other pharmaceutical agent into the Achilles tendon or surrounding area within the previous three months
  • Any medical and/or social reason that, in the opinion of the investigators, makes the participant unsuitable for inclusion
  • Serious mental health problem that would preclude adherence to study or treatment protocols
  • Known allergies or hypersensitivity to the study drugs
  • Needle phobia or a blood clotting disorder

研究者

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