Comparison of super selective transcatheter arterial embolization versus non-selective ultrasound guided embolization technique in plantar fascitis refractory to conservative management: an open-label pilot randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Self
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Technical success, Post procedural pain relief
研究概览
简要总结
Super-selective transcatheter arterial embolisation (TAE) is being established as a standard procedure in the pain management of musculoskeletal inflammatory conditions, particularly in patients who are refractory to conservative management. These conditions include knee osteoarthritis, frozen shoulder, and Achilles tendinopathy. The mechanism involves abnormal neo-vessel occlusion resulting from inflammation, leading to decreased inflammation.
However, evidence for TAE in plantar fascitis is limited to small observational studies and case reports. These studies describe two approaches: standard super-selective embolization and non-selective ultrasound-guided (USG) embolization, the latter involving the injection of a temporary embolic agent (imipenem/cilastatin) into the posterior tibial artery. Each method has distinct advantages and drawbacks. Super-selective embolization offers greater safety but is time-intensive and involves radiation exposure for both the patient and the operator. Conversely, non-selective USG-guided embolization requires fewer resources, such as microcatheters and digital subtraction angiography (DSA) equipment, but carries a minor theoretical risk of inadvertent embolization. The comparative efficacy of these techniques for pain relief in plantar fascitis remains inadequately explored due to a lack of robust comparative data.
This study is therefore designed to study the feasibility and compare the clinical outcomes of patients treated with super selective TAE versus Non-selective USG-guided embolization technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •A patient with
- •Tenderness at the calcaneal attachment
- •Thickened plantar fascia (more than 4 mm) on preprocedural MRI.
- •No meaningful improvement with more than 3 months of conservative treatment (rest, anti-inflammatory drugs, and physical therapy).
排除标准
- •Uncorrectable coagulopathy as defined by INR more than 2.5 or platelet count less than 30,000
- •Iodine allergy resulting in anaphylaxis
- •Renal dysfunction as defined by eGFR of less than 30
- •Currently pregnant
- •Previous foot surgery
- •Not giving consent for the study.
结局指标
主要结局
Technical success, Post procedural pain relief
时间窗: 24 hours, 7 days, 1 month, 3 month, 6 month, 12 month
次要结局
- Requirement of multiple reinterventions, Complications(24 hours, 7 days, 1 month, 3 month, 6 month, 12 month)
研究者
Akshit Kumar
All India Institue of Medical Sciences (AIIMS) New Delhi
