Platelet Rich Plasma Injection Compared to Corticosteroid Injection for Treatment of Plantar Fasciitis. A Prospective, Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Pain and Disability of the Foot and Ankle Through Validated Questionnaires
研究概览
简要总结
The purpose of this investigator-initiated study is to clinically evaluate the efficacy of a new treatment for plantar fasciitis. This treatment consists of a platelet rich plasma injection into the origin of the plantar fascia. It is thought that plasma rich plasma injection will dramatically improve outcomes for patients suffering from plantar fasciitis.
Subjects will be randomized by choosing a slip of paper from an envelope. This process will randomize 25 patients to the experimental group, and 25 patients to the control. The experimental group will undergo a blood draw, allowing for an injection of platelet rich plasma into the origin of the plantar fascia. The control group will undergo a corticosteroid injection into the plantar fascia as the sole treatment. Patients will be followed for three months for pain, and will fill out questionnaires at the initial visit prior to receiving the injection, as well as six and twelve weeks post injection.
These questionnaires will give insight into functionality and pain changes that the plantar fascia is experiencing due to treatment.
Subjects will be outpatients. Subjects may include employees, students, minorities, and elderly, although no subsets of these will be formed.
Subjects will be between 18 and 89 years of age.
In total, subject participation will last approximately 3 months.
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
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with complaints of plantar heel pain, worse with rising in morning and/or after periods of sitting or lying presenting for at least 4 weeks
- •Examination reveals maximal tenderness at the attachment of the plantar fascia on the medial tubercle of the calcaneus
- •Willingness to participate in an investigational technique
- •Willingness to forgo any other concomitant conservative treatment modality; NSAIDS and orthotic devices during the study period
排除标准
- •Previous surgery for heel pain
- •Nerve related symptoms (radiculopathy, tarsal tunnel syndrome, tarsi sinus syndrome)
- •Patient with complex regional pain syndrome
- •Achilles tendon pathology
- •RA, DM, local or systemic infection, PVD, metabolic disease such as gout, clotting disorder, anticoagulation therapy
- •Patients that are pregnant or breastfeeding
- •Patients with metastatic cancer
- •Dysfunction of the knee, ankle, or foot
- •Work related or compensable injury
- •Previous treatment: corticosteroid injection in the last 6 months or NSAIDs treatment within the last 7 days
研究组 & 干预措施
control
corticosteroid injection into the origin of the plantar fascia
干预措施: corticosteroid injection (Drug)
experimental
platelet rich plasma injection into the origin of the plantar fascia
干预措施: platelet rich plasma (Biological)
结局指标
主要结局
Pain and Disability of the Foot and Ankle Through Validated Questionnaires
时间窗: 15 minutes prior to initial injection of corticosteroid versus platelet rich plasma
Patients will be asked to fill out 3 questionnaires to provide insight into how their condition is progressing. These questionnaires consist of a visual analog pain score, American Orthopaedic Foot and Ankle Society clinical rating system, and the Foot and Ankle Disability Index. All these questionnaires are externally validated clinical outcome measures that rate foot and ankle pain and dysfunction on various numerical scales. With the exception of the visual analogue scale pain score, there is a direct relationship to the score and positive patient outcome.
Pain and Disability of the Foot and Ankle through Validated Questionnaires
时间窗: 12 weeks from initial injection of corticosteroid versus platelet rich plasma
Patients will be asked to fill out 3 questionnaires to provide insight into how their condition is progressing. These questionnaires consist of a visual analog pain score, American Orthopaedic Foot and Ankle Society clinical rating system, and the Foot and Ankle Disability Index. All these questionnaires are externally validated clinical outcome measures that rate foot and ankle pain and dysfunction on various numerical scales. With the exception of the visual analogue scale pain score, there is a direct relationship to the score and positive patient outcome.
次要结局
未报告次要终点
研究者
William Bunnell
Medical Doctor
Loma Linda University