Steroid Injections vs. Platelet Rich Plasma Injections in Patients With Plantar Fasciitis: A Comparison of Clinical and Ultrasound Findings
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Pain Score
研究概览
简要总结
In cases of Plantar Fasciitis not responding to conservative management, minimally invasive techniques may be used. These include platelet rich plasma injections and corticosteroid injections. Corticosteroids have long been used for symptomatic relief. However there are growth factors present in PRP injections that contribute to the healing of the pathology, and not just symptom control.
A single blind, prospective, randomized, comparative, control study will be performed. The study population consists of a total of 80 participants. They will be randomly assigned to receive either a corticosteroid injection, or a platelet rich plasma injection. Data will be collected through questionnaires and ultrasound findings. Patients will have a follow up at 3, 6, 12, and 24 weeks after they receive their injection.
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
- Single (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
- 是
入选标准
- •Patients aged 18+
- •Patients with Plantar Fasciitis for at least 6 months which has not responded to 6 weeks of conservative therapy
- •Patients with a visual analogue score (VAS) of more than 5 in the morning
- •Patients must be able to understand the informed consent and have the ability to follow up.
排除标准
- •Patients who have had repeated corticosteroid injections within the past 3 months, or have taken a non-steroid anti inflammatory drug during the 1 week prior to receiving an intervention
- •BMI > 40
- •Patients with a previous foot deformity
- •Patients who have had previous foot surgery
- •History of anemia (Hb < 7)
- •Confirmed diagnosis of neuropathy
- •Patients who have the inability to follow up
研究组 & 干预措施
Corticosteroid injection
Corticosteroid injection
干预措施: Corticosteroid injection (Bupivacaine and Depo Medrol) (Drug)
Platelet rich plasma injection
Platelet rich plasma injection
干预措施: Platelet rich plasma injection (Biological)
结局指标
主要结局
Pain Score
时间窗: 6 months
Pain will be measured using the visual analogue score (VAS). The score is a 10cm line, where each centimeter is marked between 0-10. Patients will mark the number that corresponds to their pain, where zero is no pain and 10 being the most severe pain. Every patient must at least have a pre and post intervention score recorded. Subsequent follow-ups will also require patients to fill out a VAS score. A 30% reduction between baseline and endpoint score over a period of 6 months, without the use of analgesia beyond what is allowed according to protocol, use of adjunctive conservative therapy (excluding physiotherapy), or the patient seeking alternative therapy, will deem the treatment successful. The reduction is calculated by subtracting the baseline value from the endpoint value. The percent change is determined by multiplying the reduction by 100 and dividing by 10.
次要结局
- Ultrasound findings(3 months)