Musculoskeletal Ultrasound Changes in the Plantar Fascia After a Single Injection of Platelet Rich Plasma Compared to Steroid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- visual analogue scale
研究概览
简要总结
a number of patient diagnosed as degenerative plantar fasciitis will be collected and divided into two groups, group I will be injected by platelet rich plasma and group II will be injected methylprednisolone
详细描述
the study will include 100 patients diagnosed as degenerative plantar fasciitis and will be evaluated by musculoskeletal ultrasound by two observes and the will divided randomly into two groups who will be injected under ultrasound imaging by either Platelet rich plasma or methylprednisolone. selection of patient will be randomly and the study will be double blinded.
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, 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
- •* Clinical diagnosis of plantar fasciitis
- •Exclusion Criteria (history or current):
- •Rheumatic diseases
- •Foot Trauma
- •Neurological diseases
- •Thyroid disease
- •Diabetes mellitus
- •Chronic Renal Failure
排除标准
- 未提供
研究组 & 干预措施
Platelet rich plasma group
platelet rich plasma (PRP) will be produced through whole blood centrifuge using a specific methodology in a strict aseptic setting. Then, blood will be collected and mixed with anticoagulant and Citrate-phosphate-dextrose adenine in a 10 volume blood to 1 volume anticoagulant ratio. The blood will be centrifuged for 10 minutes at 1000 rpm. Afterward, the plasma will be transferred to a new glass tube and centrifuged for 15 minutes at 3000 rpm. At the bottom of the tube, platelets will form a pellet. Finally, pure platelet-rich plasma will be obtained at a concentration of up to four times higher than baseline. Prior to the injection, calcium gluconate will be combined with PRP (at a ratio of 0.3 ml ca gluconate/ml PRP).
The injection will be done once.
干预措施: platelet rich plasma (Other)
Methylprednisolone group
2 ml methylprednisolone acetate 40mg/ml (total 80mg methylprednisolone acetate) together with 1 ml lidocaine 2% (total 3 ml solution) will be directly injected under ultrasound guidance to the plantar fascia.This group serves as active comparative group.
The injection will be done once.
干预措施: MethylPREDNISolone 40 MG (Drug)
结局指标
主要结局
visual analogue scale
时间窗: 3 months
visual analogue scale from 0-10, where 0 denoting maximum pain relief and 10 denoting no pain relief
Manchester-Oxford Foot Questionnaire
时间窗: 3 months
the Manchester-Oxford Foot Questionnaire is a 16-item instrument answered on a five-point Likert scale (each item is scored from 0 to 4, with 4 denoting 'most severe'). Scores for each item are summed to form three separate sub scales representing underlying domains: walking/standing problems (seven items), foot pain (five items), and issues related to social interaction (four items)
次要结局
- echogenicity in longitudinal scan gray scale ultrasound(3 months)
- plantar fascia thickness at the insertion in longitudinal scan of the heel(3 months)
研究者
Ahmed ElSayed Hafez
Principal investigator
Minia University