NCT07827638尚未招募不适用
A Randomised Controlled Trial Comparing Radial Versus Focused Extracorporeal Shockwave Therapy for Chronic Plantar Fasciitis
Homerton University Hospital NHS Foundation Trust0 个研究点目标入组 150 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- Average Heel pain at 12 weeks using a numerical rating scale ranging from 0 - 10
研究概览
简要总结
The goal of this clinical trial is to learn whether focused extracorporeal shockwave therapy (ESWT) provides better outcomes than radial ESWT for adults with plantar fasciitis. It will also learn about the safety and tolerability of both treatments.
The main questions it aims to answer are:
- Does focused ESWT lead to greater improvement in heel pain than radial ESWT?
- Does focused ESWT improve foot function more than radial ESWT?
- Do participants experience less discomfort during focused ESWT compared with radial ESWT?
- What medical problems or side effects occur with either treatment?
Researchers will compare focused ESWT to radial ESWT to see whether one treatment offers better clinical outcomes or is better tolerated.
Participants will:
- Receive three shockwave treatment sessions (radial or focused), one week apart
- Attend clinic follow-up assessments at 6 weeks, 12 weeks, 6 months, and 12 months
- Complete questionnaires about heel pain and foot function Keep a diary of symptoms, daily pain levels, activity limitations, and any use of pain medication
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18 years or older;
- •chronic plantar heel pain for at least 3 months;
- •clinical presentation consistent with plantar fasciitis / plantar fasciopathy;
- •baseline average heel pain of at least 4/10 in at least one heel proposed for study treatment;
- •imaging findings supportive of plantar fasciitis / plantar fasciopathy on either:
- •ultrasound scan (USS); or
- •magnetic resonance imaging (MRI);
- •able to understand the study and provide written informed consent;
- •sufficient spoken and written English to understand the study information and complete the planned questionnaires and telephone follow-up assessments
排除标准
- •Participants will be excluded for any of the following:
- •previous ESWT to the affected study foot;
- •corticosteroid injection to the affected region within the preceding 3 months;
- •previous plantar fascia surgery;
- •an alternative diagnosis considered to be the principal cause of the heel pain;
- •current or suspected calcaneal or other relevant stress fracture;
- •relevant inflammatory arthropathy;
- •recognised contraindication to ESWT;
- •inability to provide informed consent;
- •insufficient spoken or written English to understand the study information or complete the planned study procedures where appropriately translated materials and interpreter-supported longitudinal follow-up are unavailable;
- •any other clinical factor considered by the investigator to make participation inappropriate or unsafe
研究组 & 干预措施
Random allocation to focused ESWT
Active Comparator
干预措施: Focused Shockwave therapy (Device)
Random allocation to radial ESWT
Active Comparator
干预措施: Radial shockwave therapy (Device)
结局指标
主要结局
Average Heel pain at 12 weeks using a numerical rating scale ranging from 0 - 10
时间窗: 12 weeks
To compare the clinical effectiveness of radial versus focused Extracorporeal shockwave therapy (ESWT) for chronic plantar heel pain by assessing the difference between treatment groups in average heel pain at 12 weeks, adjusted for baseline pain. The numerical rating scale ranges from 0 - 10 with 10 being a worse outcome
次要结局
- To compare the effect of radial and focused shockwave therapy on foot related function using the modified Foot Function Index (FFI) questionnaire(12 months)
- Comparing first step heel pain after radial vs focused shockwave therpay using a numerical rating scale from 0 - 10(12 months)
- To compare procedural treatment discomfort after radial vs focused shockwave therapy using a numerical rating scale (ranging 0-10)(3 weeks)
- Patient-reported global improvement following radial vs focused shockwave therapy using a Likert scale(12 months)
- To compare patient satisfaction after undergoing radial vs shockwave therapy using a likert scale(12 months)
- To compare willingness to undergo the same treatment after undergoing radial vs shockwave therapy using a qualitative question(12 months)
- Comparing treatment related adverse events after radial vs focused shockwave therapy using a qualitative question(12 months)
研究者
Titi Jempeji
Dr Dev Mukhey (Sports and Exercise medicine Doctor) - Principal Investigator
Homerton University Hospital NHS Foundation Trust
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