ACTRN12619001455156已完成未知
Efficacy of Tendon Strip Injections compared to sham following failure of conservative therapy for Achilles tendinopathy
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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