Is There Any Advantage of PRP Over Autologous Blood Injection in the Treatment of Chronic Plantar Fasciitis? A Prospective Randomized Double Blinded Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in American Orthopaedic Foot & Ankle Society (AOFAS ) Score
研究概览
简要总结
To explore effects of Autologous Blood Injection versus Platelet Rich plasma injection for treatment of chronic plantar fasciitis
详细描述
After clinical diagnosis of patients with plantar fasciitis. Patients were divided into two groups. Group A (PRP injection group) and Group B (ABI group) were randomized according to web based block group randomization. Patients were evaluated prior to injection in terms of Health related quality of life scores related to foot and ankle diseases (AOFAS and FADI) and VAS. After injection at 1st, 3rd and 6th months HRQoL were compared between groups. Intra group evaluation for HRQoL were performed at f/up visits. Independent t test and repeated measure ANOVA test used for statistical analysis
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who were diagnosed with chronic plantar fasciitis
- •Nonresponded to o conservative treatment (stretching exercises, nonsteroidal anti-inflammatory drugs, and heel pads) for at least 6 weeks
- •Patient should be able to understand the informed consent about type of treatment and blindness and randomization
- •Visual analog scale pain higher than 5 (on a 10-point visual analog scale)
排除标准
- •previous history of any type of local injection treatment for heel pain
- •history of surgery for heel pain, foot and ankle disorders, fractures
- •Associated pathology involving the lower limb such as
- •tarsal tunnel syndrome
- •effusion of the ankle indicating an intra-articular disease
- •Peroneal/Achilles/tibialis tendons pathology
- •any obvious deformity of foot and ankle,
- •Patients with systemic disorder like diabetes mellitus, ankylosing spondylitis rheumatoid arthritis, hematological disease, or gout
- •Use of antiocoagulation -
研究组 & 干预措施
Group A
Platelet Rich Plasm (PRP) injection group
干预措施: PRP injection (Biological)
Group B
Autologous Blood injection (ABI) group
干预措施: ABI injection (Biological)
结局指标
主要结局
Changes in American Orthopaedic Foot & Ankle Society (AOFAS ) Score
时间窗: 0,1 st 3rd and 6th month; changes between time points will be assessed
American Orthopaedic Foot \& Ankle Society (AOFAS) Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes Evaluation:0 worst 100 best
Changes in Visual Analogue Scale (VAS)
时间窗: 0,1 st 3rd and 6th month; changes between time points will be assessed
Visual Analogue Scale 10 worst 0-1 best in terms of pain outcome
Changes in Foot and Ankle Disability Index (FADI)
时间窗: 0,1 st 3rd and 6th month; changes between time points will be assessed
Foot and Ankle Disability Index Evaluation:0 worst 100 best
次要结局
未报告次要终点
研究者
Ozcan Kaya
Orthopaedics and Traumatology Specialist
Istanbul Training and Research Hospital