ACTRN12619001765112尚未招募3 期
Evaluating transcatheter arterial embolisation and an anti-inflammatory for improvement of foot pain in people with plantar fasciopathy – a pilot study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 40
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 85 Years(—)
- 性别
- All
入选标准
- •1.18 to 85 years of age
- •2.Moderate to severe plantar heel pain
- •3.Pain resistant to conservative treatment for at least 3 months
- •a.at least one conventional therapy such as analgesia, NSAID, corticosteroid injection, orthotics, physiotherapy (e.g. stretching and/or strengthening exercises)
- •4.Willing, able and mentally competent to provide informed consent
- •a.able to read and understand the Patient Information and Consent Form which is written in English language
排除标准
- •1.Local infection
- •2.Active malignancy
- •3.Prior ipsilateral foot or ankle surgery
- •4.Ipsilateral injection into the foot or ankle in the last 3 months
- •5.Pregnant or trying to become pregnant during the study period
- •6.History of allergy to contrast media
- •7.History of allergy to carbapenem (eg, imipenem, ertapenem or meropenem), or having an immediate or severe hypersensitivity reaction to a penicillin or cephalosporin antibiotic;
- •8.History of seizures or using valproate
- •9.History of allergy to NSAIDs
- •10.Reduced kidney function or failure (chronic or acute)
- •a.Estimated GFR < 30ml/min.1.73m2
- •b.People on dialysis
- •11.Body weight greater than 200kg
- •12.Platelets < 100 x 109/L
- •13.INR > 1.5
- •14.Moderate to severe pain in other lower limb joints
- •15.Previous amputation of ipsilateral toe/s or other part of foot
- •16.Current or previous ipsilateral foot ulcer
- •17.Peripheral neuropathy lower limb/s
- •18.Charcot neuroarthropathy
- •19.Peripheral vascular disease
- •20.Rheumatoid arthritis or seronegative arthropathies
- •21.Ipsilateral foot or ankle pain (excluding plantar heel pain) due to conditions such as achilles tendinopathy or Hallux Abduco Valgus
- •22.Severe hepatic impairment or heart failure
- •23.Active or a history of gastrointestinal inflammatory disorder or ulceration, haemorrhage, chronic dyspepsia.
- •24.History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
- •25.Asthma with known sensitivity to NSAIDs
研究者
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