A Randomized Double-Blind Clinical Trial to Investigate the Use of Autologous Conditioned Plasma (ACP) for Patients With Plantar Fasciitis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- American Orthopaedic Foot and Ankle Midfoot Scale (AOFAS)
研究概览
简要总结
Plantar fasciitis presents clinically as pain in the inner heal, which is the result of degeneration of the plantar fascia, an arch supporting ligament of the foot. It manifests predominantly in those subjected to sustained weight bearing or repetitive pounding activities. Plantar fasciitis is the most common cause of inferior foot pain. Although most cases resolving within 6 months, traditional treatment regiments such as orthotics and physiotherapy are occasionally unsuccessful in treating this limitation leading to chronic symptoms (Neufeld & Cerrato, 2008; Rompe, 2009; Roxas, 2005).
Platelets are central players in clotting, inflammation and the wound healing response. Research has shown the potential of platelet rich plasma to accelerate wound healing in a variety of conditions including maxillo-fascial and plastic surgery, chronic wound healing and orthopaedics. Autologous Conditioned Plasma (ACP) is a novel treatment that may accelerate the healing of injured tissue. Treatment with ACP involves taking a blood sample from the patient, isolating the platelets and injecting them back into that patient at the injury site
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, Care Provider, 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
- •Painful inner heel pain for longer than three months
- •at least six weeks since last corticosteroid injection
- •four weeks since the last anaesthetic injection, iontophoresis, ultrasound and electromyostimulation
- •one week since the last NSAIDs taken
- •two days since the last analgesic, heat, ice, message, stretching, or modification of night splints and orthosis.
- •scores greater or equal to 5 on the VAS PFPD scale
- •scores greater or equal 30 on the AOFAS scale
- •scores of greater or equal to 5 on the VAS PFPD scale and 30 on the AOFAS scale
排除标准
- •tendon rupture
- •neurological or vascular insufficiencies in the painful heel
- •bilateral heel pain
- •Paget's disease or calcaneal fat pad atrophy
- •osteomyelitis, fracture of the calcaneus, ankle inflammation
- •recent infection in the treatment area, history of rheumatic diseases
- •collagenosis or metabolic disorders
- •immunosuppressive therapy or coagulation disturbance and/or therapy, long-term treatment with corticosteroids
- •previous heel surgery
- •malignant disease, diabetes mellitus, severe cardiac or respiratory disease, significant abnormalities in hepatic function
- •participation in another clinical study at the same time.
研究组 & 干预措施
ACP treatment
干预措施: ACP (Procedure)
Corticosteroid treatment
干预措施: Corticosteroid (celestone) injection (Drug)
结局指标
主要结局
American Orthopaedic Foot and Ankle Midfoot Scale (AOFAS)
时间窗: 6 weeks, 3, 6 and 12 months
Inlcudes subjective and objective assessments and has demonstrated test retest reliability, validity, sensitivity to change and responsiveness for conditions of the foot and ankle. A minimally important change is considered to be at least a 5 point change with an effect size of 0.59.
次要结局
- Plantar Fasciitis Pain/Disability Scale (PFPD(6 weeks, 3, 6 and 12 months)
- SF-12(6 weeks, 3,6,12 months)
研究者
Dianne Bryant
Associate Professor
University of Western Ontario, Canada