Investigating the Effects of Ultrasound Guided Autologous Blood Injection for Chronic Plantar Fasciitis Versus Ultrasound Guided Dry-needling Alone, a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Reduction in pain - as assessed by 0-10 VAS scale
研究概览
简要总结
To investigate whether a procedure of ultrasound-guided autologous blood injections (ABI), which includes a dry-needling component within the overall procedure, has any measureable clinical benefit over ultrasound-guided dry needling alone in patients with chronic plantar fasciitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 or over who are being seen in the Department of Sports Medicine (all of whom are age 16 or over) with chronic plantar fasciitis of at least 6 months duration
- •Failure of previous conservative therapy - including physiotherapy, and podiatry input
- •Objective evidence of plantar fasciitis - either ultrasound or MRI investigations
- •No contraindications of injection therapy - anticoagulation, blood borne illness, strong needle phobia ...
排除标准
- •Patients with either partial or full-thickness tears of plantar fascia found on investigations
- •Subjects who are unable to give valid consent for study entry based on normal competency assessment
- •Subjects unable or unwilling to undergo the rehabilitation plan post-procedure
- •Subjects unable or unwilling to attend the follow-up appointments post-procedure
研究组 & 干预措施
intervention group
local anaesthetic - lidocaine 1%, dry needling, autologous blood injection,
- structured rehab programme
干预措施: Autologous Blood Injection (Other)
intervention group
local anaesthetic - lidocaine 1%, dry needling, autologous blood injection,
- structured rehab programme
干预措施: Structured rehabilitation programme (Other)
intervention group
local anaesthetic - lidocaine 1%, dry needling, autologous blood injection,
- structured rehab programme
干预措施: dry needling injection (Other)
control group
local anaesthetic - lidocaine 1%, dry needling,
- structured rehab programme
干预措施: Structured rehabilitation programme (Other)
control group
local anaesthetic - lidocaine 1%, dry needling,
- structured rehab programme
干预措施: dry needling injection (Other)
结局指标
主要结局
Reduction in pain - as assessed by 0-10 VAS scale
时间窗: 3 & 6 months - primary outcome set at 6 months for study, but using 3 month interim result as well
次要结局
- Reduction in pain / improvement in function - as assessed by several PROMS (as below)(3 & 6 months)